Psychology students need the ability to create informed consent and debriefing forms that adequately state the purpose of studies to the participants in an ethical manner. In your capstone class (your

Psychology students need the ability to create informed consent and debriefing forms that adequately state the purpose of studies to the participants in an ethical manner. In your capstone class (your
PSY-550 Research Methods Topic 3 Consent Debriefing Form Scoring Guide Grading category Points Comments Consent contains information pertaining to the study as a whole. /10 Potential risks and benefits of the experiment are clearly outlined for the participant. /10 Procedures to be followed are fully explained with an opportunity for participants to ask any questions. /10 Assurance is given that all data will remain private and confidential. /10 Consent form is written in a clear and concise manner in understandable language at the appropriate reading level for the participants. /5 Solid academic writing is evident /5 Total /50 Research Methods in Psychology, 2e © W. W. Norton & Company, Inc. By Beth Morling
Psychology students need the ability to create informed consent and debriefing forms that adequately state the purpose of studies to the participants in an ethical manner. In your capstone class (your
Adolescent health brief Protecting Adolescent Confidentiality: A Response to One State’s “Parents’Bill of Rights” D 1 XX Patrick W. Butler,D 2 XX Ph.D., L.C.S.W.*, andD 3 XX Amy B. Middleman,D 4 XX M.D., M.S.Ed., M.P.H. University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma Article History:Received September 19, 2017; Accepted March 10, 2018 ABSTRACT Purpose:In November, 2014, the State of Oklahoma enacted legislation potentially eliminating the pro- vision of conditional confidential pediatric care. A consent form for treatment specific to adolescent con- fidential care was developed in response. This study examines parent/guardian response to the consent form. Methods:The consent to treatment form describes the clinical and developmental benefits of condi- tional confidential treatment of adolescent minors and asks parent/guardians to waive the right to: (1) access confidential portions of the medical record, (2) be present for the physical exam, (3) be present for risk behavior discussions, and (4) consent for hormonal contraception, if indicated. Results:Of 269 parent/guardian respondents to the consent form, over 95% waived their rights for each of the four provisions. Conclusions:When provided with information on the rationale for provision of conditional confidential care, a diverse group of parent/guardians in a conservative state overwhelmingly agree to this standard of care. © 2018 Society for Adolescent Health and Medicine. All rights reserved. IMPLICATIONS AND CONTRIBUTION The development and use of comprehensive written con- sent for care for adolescents is an effective response to legislation potentially limit- ing conditional confidential- ity. When presented with the clinical and develop- mental benefits of confiden- tial treatment of adolescent minors, parent/guardians overwhelmingly agree to confidential care for their adolescents. The provision of conditional confidential care in Adolescent Medicine as a standard in addressing teen risk behavior is a corner- stone of the subspecialty. Conditional confidentiality assures the patient that sensitive information from the medical visit will not be shared with others, including parents, unless there is reason- able belief of imminent danger to the patient or others in not doing so or if the information requires mandated reporting. Adolescents are more willing to communicate and seek care from physicianswho assure confidentiality, as privacy concerns decrease the will- ingness of adolescents to engage providers on sensitive issues [1 4]. Laws governing confidentiality in adolescent health care vary from country to country; in the United States, they vary state to state[5]. Despite significant variability in policy across legal jurisdictions regarding multiple areas of concern (e.g., access to the medical record, mental health and substance abuse treatment, and contraceptive care), pediatric providers remain committed to the standard of conditional confidentiality in providing high qual- ity care to adolescents[6,7]. The perception of erosion of“parental rights,”including control of information on adolescent sexual and reproductive health, is a focus of recent adolescent health legislation that endangers evi- dence-based practice regarding the provision of conditionally See Related Editorial on p. 265 Conflicts of Interest:Dr. Middleman receives royalties as section editor for UpTo- Date.com. Dr. Butler has no conflicts of interest to report. * Address correspondence to: Patrick W. Butler, Ph.D., L.C.S.W., University of Oklahoma Health Sciences Center, 1200 Children’s Avenue, Suite 12200, Oklahoma City, OK 73104. E-mail address:[email protected](P.W. Butler). 1054-139X/© 2018 Society for Adolescent Health and Medicine. All rights reserved. https://doi.org/10.1016/j.jadohealth.2018.03.015 Journal of Adolescent Health 63 (2018) 357 359 www.jahonline.org confidential care to adolescent patients[8]. In November, 2014, the State of Oklahoma enacted the Parents’Bill of Rights that gives par- ent/guardians full access to their child’s medical record (unless otherwise specified by law) and requires written parental consent to perform a physical examination on a child. This law adds to 1976 legislation addressing the ability of adolescents in Oklahoma to consent to their own healthcare; minors in Oklahoma may only consent independently to the use of hormonal contraception if they are or have been pregnant. A Consent for Treatment form (CTF) specific to confidential care in Adolescent Medicine clinic at The University of Oklahoma Children’s Hospital was developed in direct response to the Parents’Bill of Rights to protect established best practice in the care of adolescents. This study examines par- ent/guardian responses to the form’s requests to waive specific parental rights associated with their minor child’s care. Methods Treatment providers and the legal counsel of OU Children’s Physicians developed a CTF in response to the law[9]. The form details the specific parent/guardian rights under the 2014 Okla- homa law, describes the clinical and developmental benefits of conditional confidential treatment of adolescent minors (under 18), and asks parents to waive their rights to: see confidential portions of the record; be present for the child’s physical examination; be present for discussions of risk behaviors; consent to hormonal therapy, if indicated. The CTF clearly states that refusal to waive rights does not impact whether or not care will be provided, only that parent/ guardians are required to read the form in order for the patient to be seen by the physician. The Adolescent Medicine clinic at OU Children’sisarefer- ral-based subspecialty service serving a statewide population, with a small base of local primary care patients. Clinic front desk staff began distributing the CTF to parent/guardians for review and signatures in May, 2016; data for this study were collected between May, 2016 and January, 2017. The CTF is presented to all parent/guardians of minor patients, both new patients and return patients who had not yet signed the form, upon arrival to the clinic. If parents have questions and/or are not comfortable signing the form, they are told that the physi- cian will discuss their concernsas part of the scheduled visit. The physician addresses the questions regarding the waiver of any specific right as the visit commences as an opportunity to advance dialog with parent/guardians on best practice in the treatment of adolescents. During the time frame of the study, no parents refused to review and sign the primary treatment portion of the form or left without their child being seen. This study was conducted as a quality assurance project and was granted exempt status after review by the Institutional Review Board of the University of Oklahoma Health Sciences Center. Results Two hundred sixty-nine patient CTFs were obtained during the study period (Table 1). Over 95% of parents waived the right to see confidential portions of the record, be present for a physical exam- ination, and be present for sensitive risk discussions (Table 2). Among parent/guardians of female patients, over 96% waived theright to consent to hormonal therapy. Two hundred forty-six par- ent/guardians waived their rights to all four elements requested; six parent/guardians declined to waive their rights to all four. Although numbers of those not waiving their rights were low, thus affecting power, chi-square analysis found no significant differen- ces in responses to any waiver item based on patient age, gender, race, ethnicity, or insurance provider. Efforts to promote best practice in the care of adolescents can be derailed by ill-informed laws that erode the provision of confi- dential care for adolescents. In this case, the assumption of the leg- islature was that the provision of best practice in the form of confidential care and maintaining an alliance with parents to sup- port their child’s care are mutually exclusive. The parents’demon- strated support of the standard of conditional confidential care in this study runs counter to laws being promulgated through the state legislature. When the rationale and evidence for conditional confidential care are presented to parent/guardians, parents make decisions consistent with best practices in the treatment of their minor children. Limitations of this study include possible selection bias of parents presenting for subspecialty care for their adoles- cents, a relatively high reading level of the CTF potentially result- ing in lack of full understanding of the form, and statistically inadequate power to determine differences based on demographic variables. This study suggests that when provided with information on the rationale and efficacy of confidential care, a diverse group of parent/guardians in a conservative state supports this standard of care for their adolescent children. Table 1 Participant demographic characteristics. Total number of consent forms returned = 269 Variable N % Gender of patient Female 208 77.3 Male 61 22.7 Ethnicity Hispanic 41 15.2 Non-Hispanic 209 77.7 Race White 188 69.9 Black 54 20.1 American-Indian 15 5.6 Asian 3 1.1 Insurance Medicaid 149 55.4 Private 107 39.8 Table 2 Proportion of parent/guardians who waived their rights Waived the right to N % See the confidential record 257 95.5 Be present for physical exam 256 95.2 Be present for risk discussions 263 97.8 Consent for hormonal contraception a 200 96.2 All four rights waived 246 91.4 None of the four rights waived 6 2.2 aDenominator represents parent/guardians of female patients. 358P.W. Butler and A.B. Middleman / Journal of Adolescent Health 63 (2018) 357 359 Acknowledgments We would like to thank Heather McClure, JD, for her expertise and support in the development of the comprehensive consent form and review of thefinal manuscript. This brief report was ini- tially presented at a Poster Symposia at the 2017 SAHM Annual Meeting in New Orleans, LA. Supplementary materials Supplementary material associated with this article can be found, in the online version, atdoi:10.1016/j.jadohealth.2018.03.015. References [1]Ford CA, Thomsen SL, Compton B. Adolescents’ interpretations of conditional confidentiality assurances. J Adolesc Health 2001;29:156. [2]Ford CA, Millstein SG, Halpern-Felsher BL, Irwin Jr. CE. Influence of physician confidentiality assurances on adolescents’ willingness to disclose information and seek future health care. A randomized controlled trial. JAMA 1997;278:1029. [3]Lehrer JA, Pantell R, Tebb K, Shafer MA. Forgone health care among U.S. adoles- cents: associations between risk characteristics and confidentiality concern. J Adolesc Health 2007;40:218. [4]Ford CA, Bearman PS, Moody J. Foregone health care among adolescents. JAMA 1999;282:2227. [5] Guttmacher Institute, Minors’access to contraceptive services,State Laws and Policies (as of August 2016), 2016. [6]American Academy of Pediatrics. Committee on Adolescence Policy Statement: achieving quality health services for adolescents. Pediatrics 2008;121:1263. [7]Ford CA, English A, Sigman G. Position paper of the society for adolescent medi- cine: confidential care for adolescents. J Adolesc Health 2005;35:160. [8] Oklahoma Parents’Bill of Rights. Oklahoma House Bill 1384 (OK, 2014).[9]https://www.uptodate.com/contents/image?imageKey=PEDS%2F109404&to- picKey=PEDS%2F106&source=outline_link&search=confidentiality,%20adoles- cent &selectedTitle=1»43(Accessed January 10, 2018). P.W. Butler and A.B. Middleman / Journal of Adolescent Health 63 (2018) 357 359359
Psychology students need the ability to create informed consent and debriefing forms that adequately state the purpose of studies to the participants in an ethical manner. In your capstone class (your
ORIGINAL ARTICLE—ETHICS Truth and Consequences: Ethics, Confidentiality, and Disclosure in Adolescent Longitudinal Prevention Research CHRISTINE LOTHEN-KLINE, M.P.H, C.H.E.S., DONNA E. HOWARD, Dr.P.H., ELLEN K. HAMBURGER, M.D., KEVIN D. WORRELL, M.D., AND BRADLEY O. BOEKELOO, Ph.D., M.S. Purpose:To examine data from a natural experiment resulting from a change made in the confidentiality agreement midway through a randomized, longitudinal, controlled trial to prevent or delay adolescent alcohol use. The investigators explored the impact of the change on adolescents’ rates of participation and affirmative responses to a question on suicidal thoughts. Methods:Adolescents 12–17 years old were adminis- tered a question on suicidal thoughts as part of a confi- dential exit interview after a general health examination with their primary care provider. After administration to 263 adolescents, the exit interview was made condition- ally confidential with the remaining 181 adolescents. The revised consent form and protocol stipulated that re- searchers would reveal to appropriate professionals and parents any adolescent indicating suicidal thoughts. Prevalence estimates for the suicidal thoughts question and study participation rates were computed for condi- tions both before and after the change. Results:Fewer adolescents responded affirmatively to the suicidal thoughts question when they were recruited using the revised (1%) than the original (8%) consentform and protocol (p .001). The revised confidentiality agreement did not affect participation rates. Conclusions:Adolescents who assent to participate in research studies may be less likely to disclose personal information regarding suicidal thoughts if they know that their disclosure may result in a break in confidenti- ality. Specific guidelines are needed for conditional and unconditional confidentiality agreements to study men- tal health in adolescent longitudinal prevention research. ©Society for Adolescent Medicine, 2003 KEY WORDS : Adolescents Confidentiality Disclosure Ethics Longitudinal research Mental health Prevention Randomized controlled trial Risk behavior Suicide Prospective research is necessary to investigate the effectiveness of interventions aimed at preventing risky behavior in adolescents. Yet, investigators en- gaged in behavioral prevention research with ado- lescents face many challenges. The challenges relate to the nature of the issues under study, the regula- tions and guidelines directing research with minors, and particularly concerns with confidentiality and disclosure. From the Department of Public and Community Health, College of Health and Human Performance, University of Maryland, College Park, Maryland (C.L.-K., D.E.H., B.O.B.); School of Medicine and Health Sciences, Departments of Medicine and Pediatrics, George Washington University, Washington, DC (E.K.H.); and Mid-Atlantic Permanente Medical Group, Rockville, Maryland (K.D.W.). Address correspondence to: Bradley O. Boekeloo, Ph.D., M.S., Department of Public and Community Health, University of Maryland, 2387 Valley Drive, HHP Building, College Park, MD 20742. E-mail: [email protected] Manuscript accepted March 10, 2003.JOURNAL OF ADOLESCENT HEALTH 2003;33:385–394 © Society for Adolescent Medicine, 20031054-139X/03/$–see front matter Published by Elsevier Inc., 360 Park Avenue South, New York, NY 10010 doi:10.1016/S1054-139X(03)00184-8 Many adolescent health problems are related to sensitive, even illicit, behaviors such as underage drinking, illegal drug use, smoking, and sexual ac- tivity. Longitudinal survey research on these behav- iors requires that adolescents disclose their private thoughts, intimate social interactions, and personal practices. Owing to the sensitive nature of this infor- mation, adolescents may be concerned that it will be disclosed to others, particularly parents, and that they could suffer consequences from such disclosure [1–4]. To enhance the likelihood that youth will honestly disclose information about personal behaviors, a promise of confidentiality may be required. Confi- dentiality may, however, be hard for the researcher to guarantee. If, during the course of data collection, adolescents reveal information that suggests they may be in harm’s way, researchers may be ethically and legally obligated to disclose this information in their efforts to assist individual adolescents. Guidelines and Laws Directing Research Current guidelines concerning issues of confidential- ity, disclosure, and informed consent, as applied to research with minors, are incomplete. Title 45 Code of Federal Regulations Part 46 (The Code) is gener- ally viewed as the accepted standard for the protec- tion of human subjects [5]. Although the Code does have a separate section focused on research involv- ing children, it does not differentiate between ado- lescents and young children [5]. The Code does not provide any guidance on the circumstances under which a researcher has an obligation to report infor- mation that suggests an adolescent may be at risk for harm or intervene to reduce risk [5–9]. Even when professional guidelines stipulate more directly the responsibility of the researcher to take action if a child appears in jeopardy, no guidance is given as to what constitutes“jeopardy”or an appropriate inter- vention [6,10]. Furthermore, when the intervention research occurs within a clinical setting, additional issues are raised regarding the responsibility for mandatory reporting by the academic researchers and/or clinical staff. Mandatory Reporting Requirements Much of the discussion about mandatory reporting of research subjects centers around the issue of child abuse. Although there are certain categories of pro- fessionals, such as teachers, psychologists, clergy,and physicians, who are legally mandated to report disclosures of abuse or suicidal intent [11], the re- sponsibility of the researcher in similar situations is more ambiguous. Steinberg et al [11] point out that although all states have mandatory child abuse re- porting laws, no state specifically designates re- searchers as being among those listed as mandatory reporters. Some states specify, however, that people who do not have appropriate training in identifying and reporting child abuse cannot be required to report [11]. Despite this, many Human Subject Protection Committees interpret the state laws as applying to researchers and require mandatory reporting [11]. It has been argued that researchers are morally, if not legally, obligated to report suspected child abuse [11–14]. Steinberg et al note that specifically naming researchers as mandated reporters is in the best interest of not only the child but also the researcher, in that inclusion as a mandated reporter also serves to protect them from civil or criminal liability for their“good faith”efforts [11]. Yet, not all researchers may have the training to be able to identify children in jeopardy [15]. Researchers themselves vary in their interpreta- tion of whether, when and how, to intervene with adolescents at potential risk for harm. For example, one survey study explored how childhood depres- sion researchers had prepared for and responded to children in community samples whose nonanony- mous scores on a self-report depression inventory indicated that they might be severely depressed or suicidal [16]. One-fourth of the 16 researchers indi- cated that they did not anticipate identifying se- verely depressed or suicidal children, nor did they make any plans as to how they would respond if they had. Nineteen percent had anticipated the risk, but also did not have a plan, whereas 25% antici- pated the risk, but chose to take no action. Of the five (31%) respondents who anticipated the risk and made plans to respond, all planned to intervene if an adolescent met the criteria for being severely de- pressed, and three planned to if an adolescent ex- pressed suicidal ideation. Three of the five did not specify in the consent form who would be contacted if the criteria for intervening with an adolescent were met. Other concerns surrounding the issue of manda- tory reporting include whether or not the research tools provide sufficient information with which to intervene. Fisher cautions investigators to be wary of the potential to either overestimate or underestimate the diagnostic validity of assessment tools used in 386LOTHEN-KLINE ET AL JOURNAL OF ADOLESCENT HEALTH Vol. 33, No. 5 research [6,17,18]. Scott-Jones points out that this is particularly critical when the assessment instrument has not been normed on the study population [15]. Others suggest that only researchers in a quasi- clinical relationship with their study participants should be required to take action to protect potential victims, arguing that the clinical setting is necessary to allow for adequate information with which to make a“reasonable judgment”of potential harm [19]. Steinberg et al point out that not all types of research provide adequate information to make clin- ical judgments. They suggest that“research involv- ing only questionnaires or telephone surveys”will not typically result in adequate information on which to base a judgment regarding abuse [11]. It has been recommended that researchers include more comprehensive evaluations in their research to allow for adequate information with which to make a judgment regarding a child’s current level of risk [11,14,20]. Another important issue is whether or not man- datory reporting laws actually decrease adolescents’ health risks. Gans and Brindis suggest that manda- tory reporting undermines research on the preva- lence, nature and etiology of many adolescent health problems [21]. There is evidence that adolescents do not seek needed health care when they fear their parents will find out the nature of their visit [1–4,22]. Several authors have explored the impact of requir- ing parental consent on adolescents’decision to be tested for HIV [23–25]. Meehan et al [24] found that after mandatory parental consent for HIV testing was abolished in Connecticut in 1992, the number of adolescents obtaining an HIV test increased by 44% in the 12 months after the change, compared with the 12 months preceding the change. Confidentiality and Disclosure Unconditional confidentiality can be defined as the circumstance under which there are no exceptions to protecting the confidentiality of information dis- closed by participants in a research study. Condi- tional confidentiality suggests, however, that certain conditions may necessitate a break in confidentiality agreements between researchers and study partici- pants. These confidentiality requirements may affect participation rates and the veracity of adolescents’ responses. In survey research conducted among ad- olescents, issues of confidentiality are often side- stepped by the use of anonymous self-report ques- tionnaires that allow trend data to be generated on adolescent risk behavior. For example, the YouthRisk Behavior Survey (YRBS) [26] uses an anony- mous, cross-sectional survey methodology. This ap- proach achieves unconditional confidentiality, po- tentially minimizing adolescent concerns regarding confidentiality, while relieving the investigator of any obligation to respond to any disclosures that may signal that a youth is in trouble or at personal risk. The anonymity of disclosure makes it impossi- ble for the investigator to intervene, regardless of the nature of the information revealed. To evaluate the effectiveness of intervention trials, however, it is often necessary to track changes in participant be- haviors over time, and anonymity cannot be guaran- teed. In the present study, the implementation of a randomized, controlled, longitudinal, prevention trial (RCT) on adolescent alcohol use provided an opportunity for a natural experiment to examine how changes in confidentiality agreements affected adolescents’reporting of suicidal thoughts. Specifi- cally, three questions were explored: (a) Did changes in the consent form from unconditional to condi- tional confidentiality result in a change in reporting of suicidal thoughts? (b) Did changes in the consent form from unconditional to conditional confidential- ity result in a change in adolescent participation rates? (c) How many adolescents continued to have suicidal thoughts that were unaddressed by parents and providers after the researchers implemented the unconditionally confidential follow-up telephone call? Methods Study Design and Sample The study used baseline data gathered from a 1-year longitudinal, randomized controlled effectiveness trial of a brief office-based intervention to prevent or delay adolescent alcohol use. All adolescents be- tween the ages of 12 and 17 years, who received a general health examination during the study period with any one of the 27 participating providers at five pediatric primary care practices in the Washington, DC metropolitan area, were eligible to participate in the study. Survey Procedures and Measures Parents of eligible participants were sent a letter, signed by their primary care providers, encouraging participation in the study. Written informed consent from parents and assent from adolescents were ob- November 2003 ETHICS AND ADOLESCENT PREVENTION RESEARCH387 tained separately by a research assistant on the day of the adolescent’s primary care visit. At the time of consent, parents and adolescents were given a list of community substance use and other support services for teenagers. All parents were given a booklet on underage drinking. All of the adolescents completed interviewer-assisted surveys at the clinic before (pre- visit) and after (exit) their visits with their primary care providers. The interviewer did not see adoles- cents’responses to the survey questions, as adoles- cents responded to questions by circling an answer on an answer form. This baseline data collection was conducted in five primary care sites during the year 2000. The study was approved by Institutional Re- view Boards (IRBs) of two medical institutions with sites participating in the study and the principal investigators’academic research institution. The exit survey included a battery of psychosocial measures, including a 10-question mood inventory. The mood inventory was included to explore the relationship between adolescent risk-taking behavior and mood. One of the questions in the mood inven- tory (M16) addressed suicidal thoughts. The ques- tion read as follows:For the last 2 weeks, have you had thoughts that you would be better off dead or of hurting yourself in some way nearly everyday?The 10-question mood inventory, which was based on the Prime MD Mood Module [27], was selected because it was short and readily adapted to an assisted survey format as well as a telephone survey format that was the method of follow-up data collection. Just before the visit with the provider, a research assistant administered one of three study protocols, depending on the random assignment of each ado- lescent. Adolescents in the usual care control group (Group I) listened to a Walkman radio for 15 min. Intervention Groups II and III listened to a 15-min Walkman audio program on alcohol risk prevention, on which they were asked to respond to nine ques- tions assessing their potential risk in relationship to alcohol. For Group III only, youth responses were shared with their providers as a method of physician prompting for the visit. More information about theintervention and study design can be found else- where [28]. During the initial period of study data collection, and as the initial data were being entered into an electronic database, it was noted that 9% of adoles- cents answered“yes”to a question (M16) in the mood inventory suggesting suicidal thoughts. The research team consulted with the project co-investi- gators, both pediatricians at the two medical institu- tions with sites participating in the study, and it was agreed that the IRB-approved general protocol for adolescents at high risk for harm should be imple- mented. Also, the large number of adolescents re- sponding“yes”to this question indicated that this issue could not be treated as an infrequent isolated incident to be handled on a case-by-case basis based on the IRB-approved general protocol, but required special attention and a detailed, standardized proto- col for follow-up. A detailed telephone protocol based on the IRB-approved general protocol was developed, which specified actions to be taken for youth who responded“yes”to M16 (Table 1). Con- current with implementation of the detailed tele- phone protocol, the telephone protocol along with the most current prevalence data for affirmative responses to question M16 were sent to the three IRBs overseeing the study. Two of the IRBs approved the telephone protocol. The third IRB determined that the telephone protocol was insufficient and accordingly suspended the study at their sites, effec- tively suspending the entire study, until an accept- able protocol was put into place. The third IRB committee suspended the study because it could not come to consensus as to what follow-up was warranted. The administrator and lawyer for this IRB committee made it clear to the principal investigator, however, that a protocol that included parental notification was necessary. After extensive consultation with national experts and review of existing guidelines and literature [5,7,29], a new follow-up protocol was developed. Ultimately, it was determined that most of the mental health experts supported breaking confidentiality for ado- Table 1.Original Actions Taken to Address Adolescents’Suicidal Thoughts Reported on Questionnaire Item M16 Actions Taken By Researchers With Each Adolescent Who Reported Suicidal Thoughts 1. The researchers telephoned each adolescent and reread question M16 to see if the adolescent still had suicidal thoughts. 2. Encouraged all adolescents to grant permission for researchers to contact his or her parent and provider. 3. Contacted the parent and provider of those who granted permission. 4. Provided information about a 24-hour suicide hotline and how to access mental health services within the adolescent’s health plan. 5. Strongly encouraged adolescents to talk to their parent and/or provider. 388LOTHEN-KLINE ET AL JOURNAL OF ADOLESCENT HEALTH Vol. 33, No. 5 lescents who had responded“yes”to question M16. Therefore, the new protocol stipulated that a consult- ing psychologist would follow up by phone with all adolescents who had responded“yes”to question M16. The psychologist would assess the adolescents’ current suicidal risk (i.e., thoughts, plan, access, and intent) and inform parents and providers of the adolescents’suicidal thoughts (Table 2). The new protocol also required that the consent form for future participants be rewritten to include a state- ment in the confidentiality clause stating that if the adolescent revealed suicidal thoughts, then his or her provider and parents would be informed. The re- vised consent form read as follows: This study is not about sexual abuse and researchers will not ask about sexual abuse. Nevertheless, if an adolescent tells them about sexual or other abuse, researchers are required by law to report it to the appropriate officials to protect the adolescent. The privacy of the information will be strictly maintained at all times.If teens tell research- ers they are being abused or are suicidal, however, researchers must tell appropriate authorities so that help can be provided. Researchers must tell health authorities and parents if they learn an adolescent is suicidal(the information added to the revised con- sent form is in bold text). The 10-question mood inventory was moved to the previsit survey. After asking the suicidal ideation question (M16) during the previsit survey, the re- searcher stated:“If you answered‘yes’to question M16, please tell me now so that you and I can talk to your doctor.”After the adolescent completed the survey, the researcher then reviewed the adoles- cent’s answers and notified the provider, before the health examination, if an adolescent responded“yes” to question M16. This enabled the provider to assess the adolescent and take appropriate action, if needed, during the scheduled visit. After a period of months, these protocol changes were approved by allthree IRBs, the study was reinstated, and the ap- proved protocols were implemented. Data Analysis Prevalence estimates for the suicidal thoughts ques- tion (M16) and study participation rates were com- puted for conditions both before and after the con- sent form was changed. Both Fisher’s Exact Test and Pearson Chi-square analysis were performed to eval- uate differences between conditional and uncondi- tional confidentiality. All statistical analyses were performed using SPSS statistical software. Results Demographic characteristics of participants in the randomized controlled trial overall and by wave are represented in Table 3. The sample was comprised of slightly more females than males. Roughly 60% of the participants were between 14 and 17 years of age, and approximately 80% were African-American. A higher percentage of participants in Wave #2 of the study were African-Americans, 85.6% in Wave #2 versus 75.3% in Wave #1 were African-American (p .008). Providers at one study site no longer wanted to participate after the IRB suspended the project. Study sites were represented differently in Wave #1 and Wave #2 (p .000), with most participants coming from just two sites in Wave #2. The percentage of adolescents who responded “yes”to question M16 under circumstances of un- conditional (Wave #1) and conditional (Wave #2) consent regarding suicidal thoughts are presented in Table 4. Compared with circumstances of uncondi- tional confidentiality, significantly fewer adolescents responded“yes”to question M16 when the consent form explicitly stated that this response would ne- Table 2.Follow-up Actions Taken, as Approved by IRBs, to Address Adolescents’Suicidal Thoughts Reported on Questionnaire Item M16 Follow-up Action Taken By a Certified Clinical Psychologist With Each Adolescent Who Reported Suicidal Thoughts 1. A certified clinical psychologist telephoned adolescents, assessed their current suicidal risk (i.e., thoughts, plan, access, and intent), and told them that their parent/guardian and provider would be informed of their answer to M16. 2. The clinical psychologist informed the parent and provider about the adolescent’s response to M16 and made suggestions for follow-up. 3. A consent clarification letter indicating the change from unconditional to conditional confidentiality was sent to each family that consented using the original consent form before more follow-up data were collected from adolescents. 4. Question M16 was moved from the exit survey to the previsit survey for future participants and reviewed before the adolescent’s general health check-ups so that immediate follow-up with the provider could be arranged. 5. The consent agreement for future participants was changed to indicate conditional confidentiality regarding suicidal thoughts. November 2003 ETHICS AND ADOLESCENT PREVENTION RESEARCH389 cessitate breaking the confidentiality agreement. As all but two affirmative responses to question M16 were among African-American adolescents and the proportion of African-Americans increased from Wave #1 to Wave #2, the decrease in affirmative responses between waves was not owing to ethnic differences between waves. An affirmative response to M16 was not associated with site during Wave #1 (p .371). The two sites contributing 99% of the study participants during Wave #2 had a total of 10 (9.5%) affirmative responses to M16 during Wave #1 and 2 (1.1%) affirmative responses during Wave #2. This drop in the number of M16 cases between Waves was significant (p .0000). Hence, the reduc- tion in affirmative responses between Waves was not owing to some sites with high rates of affirmative response during Wave #1 not being represented in Wave #2. Examination of the participation rates under cir- cumstances of unconditional and conditional confi- dentiality, that is, before and after the consent form was revised to state that confidentiality would be broken if an adolescent responded“yes”to question M16, revealed nonsignificant differences (Table 4).Under circumstances of unconditional confidential- ity the participation rate was 47.6%, compared with 53.4% for conditional confidentiality. Results of the initial follow-up contact by the research team, with the 21 youth who had responded “yes”to the question about suicidal thoughts (M16), are presented in Table 5. One of the adolescents had moved away from home and the parent would not provide the researchers with follow-up contact infor- mation. Seven of the adolescents, after being reread M16, emphatically stated that they no longer had suicidal thoughts and three of these said their“yes” answer on the questionnaire was in error. Two of the adolescents were evasive about whether they actu- ally had suicidal thoughts. All adolescents were asked directly whether they intended to take action on suicidal thoughts and none of the adolescents indicated that they did. Four said they had told their parent about their thoughts and two others said their parents knew about their thoughts. All adolescents were asked if they would grant permission for their parents and providers to be informed. Verbal con- sent for the researcher to notify parents and health care providers was granted by two and three youths, Table 3.Participant Characteristics Total Participants N (%)Wave pValue #1 Unconditional Confidentiality N (%) #2 Conditional Confidentiality N (%) Gender Male 199 (44.8) 112 (42.6) 87 (48.1) Female 245 (55.2) 151 (57.4) 94 (51.9) .254 Ethnicity African-American 353 (79.5) 198 (75.3) 155 (85.6) Non–African-American a 91 (20.5) 65 (24.7) 26 (14.4) .008 Age (yrs) 12–13 169 (38.1) 95 (36.1) 74 (40.9) 14–17 275 (61.9) 168 (63.9) 107 (59.1) .310 Site A 1 6 (1.4) 6 (2.3) 0 (0.0) B 2 235 (52.9) 87 (33.1) 148 (81.8) C 3 88 (19.8) 87 (33.1) 1 (0.6) D 4 65 (14.6) 65 (24.7) 0 (0.0) E 5 50 (11.3) 18 (6.8) 32 (17.7) .000 aNon–African-American includes Asian, Hispanic, Native American, Caucasian/White and other. Table 4.Percent of Adolescents Participating in the Study and Reporting Suicidal Thoughts by Type of Confidentiality in the Consent Form Confidentiality AgreementEligibles NParticipants N (%)pValue a Suicide Thoughts N (%)pValue b Unconditional 553 263/553 (47.6) .091 21/263 (8.0) .001 Conditional 339 181/339 (53.4) 2/181 (1.1) aPearson Chi-Square.bFisher’s Exact Test. 390LOTHEN-KLINE ET AL JOURNAL OF ADOLESCENT HEALTH Vol. 33, No. 5 respectively, during this initial follow-up. The re- searchers informed the two parents and three pro- viders of the adolescents’answers to M16. After IRB approval of a new protocol, the consult- ing clinical psychologist followed up with the re- maining 19 adolescents for whom both parents and providers were not contacted by the researcher at initial contact (Table 5). Of these, two had persisting suicidal thoughts and both stated that they did not intend to act on these thoughts. One of the 19 adolescents said she had told her provider about the suicidal thoughts, eight said they had shared their suicidal thoughts with parents. One adolescent ver- bally expressed resistance to parent and provider notification of her suicidal thoughts but the psychol- ogist was unable to obtain any information to pre- vent contacting the parents and providers about the thoughts. One teen had turned 18 since the initial contact with the researcher and did not have suicidal thoughts when the psychologist conducted the fol- low-up assessment. For this teen, only the provider was notified, according to the adolescent’s wishes. Hence, the psychologist informed all 18 providers and 18 of the remaining 19 parents who had not previously been informed during the initial contact by the researcher. In summary, 21 adolescents reported suicidal thoughts on a questionnaire. After researchers con- ducted follow-up telephone calls to adolescents, the researchers could not rule out persisting suicidal thoughts for 14 adolescents based on their ability to contact and communicate with the adolescents, and they received adolescents’permission to notify two parents and three providers. At the second follow-up telephone call by the psychologist, most of the ado- lescents denied persisting suicidal thoughts. The two adolescents that reported continued suicidal thoughts had not told a parent or provider about their thoughts. Discussion This longitudinal alcohol prevention research project allowed for a natural experiment to study the impact on adolescents’reports of suicidal thoughts when the confidentiality agreement regarding such thoughts was changed midway through the project. Results suggested that conditional confidentiality agree- ments appear to have a censuring effect on adoles- cent reporting of suicidal thoughts. After being in- formed that their parent and provider would be notified if they reported suicidal thoughts, adoles- cents may have reconsidered whether their thoughts were serious enough to warrant answering the ques- tion affirmatively. Alternatively, adolescents who would have responded affirmatively may have cho- sen not to because they did not want their response to be disclosed to their provider and/or their parent. Assurances of unconditional confidentiality from physicians have been shown to increase the number of adolescents willing to disclose sensitive health information about sexuality, substance abuse, and mental health, and increase the number willing to seek future health care when compared with assur- ances of conditional confidentiality [22,30,31]. Ado- lescents given confidentiality assurances from pro- viders also reported increased honesty of reporting and likelihood of future visits [30,31]. Overall, this study and the literature seem to support the premise that disclosure of sensitive information increases when confidentiality is emphasized [30–33]. This situation has potential implications for the individual adolescent as well as for research on sensitive health topics. Adolescents who may have suicidal thoughts, and may even want assistance from a responsible adult, may not report their sui- cidal thoughts under conditions of conditional con- fidentiality because they do not want their parent to be told. Adolescents who do disclose their suicidal Table 5.Summary of Telephone Contacts With Adolescents Who Reported Suicidal Thoughts on a Questionnaire Researcher ObservationTelephone Follow-up Time 1 (n 21) a Time 2 (n 19) b Adolescent denied persisting suicidal thoughts 7 17 Adolescent stated intent to take action on suicidal thoughts 0 0 Adolescent stated their parent/guardian knew about their suicidal thoughts 6 8 Adolescent stated they told their provider about their suicidal thoughts Not asked 1 aOne of the 21 adolescents had moved away from home and the parent would not provide contact information. The researchers had not located this adolescent before the study was suspended and, therefore, contact was only made at Time 2. bTwo adolescents contacted at Time 1 were not re-contacted at Time 2 because they gave permission for their parents and providers to be informed at Time 1. November 2003 ETHICS AND ADOLESCENT PREVENTION RESEARCH391 thoughts under condition of conditional confidenti- ality are probably different from adolescents who choose to withhold under this condition. If adoles- cents are not responding honestly to this question on suicidal thoughts (M16), because of concerns that their provider and/or parent will be informed of their response, then the information collected on this particular issue will not be valid, affecting research conclusions and recommendations, and ultimately jeopardizing future research. At the very least, these findings suggest that researchers reporting studies on adolescent risk behavior need to disclose whether they used conditional or unconditional confidential- ity, to aid others with the interpretation of their results. The impact of a change in the consent form from unconditional to conditional confidentiality, on the combined parent-adolescent study participation rates, was also examined. No significant difference was found. Provisions for breaching confidentiality agreements, when specifically defined in the consent form, did not appear to affect the combined parent- adolescent willingness to participate in the study. These findings appear to contradict a previous study that explored parent-youth concordance on severity ratings for 14 risks and on the effect of four reporting options (taking no action, providing a referral to the teen, telling a parent, or informing a school coun- selor) on their decisions to participate in adolescent risk research [34]. Although there was high concor- dance on ratings of severity, there was less agree- ment on consent decisions. Over 90% of parents indicated that they would consent to allow their teen to participate in a research study if parental notifica- tion was required for reports of suicidal thoughts and child abuse. In contrast, only two-thirds of youth stated they would consent under those conditions. Roughly 70% of youth said they would participate in a study that provided referrals to available resources for teens who reported suicidal thoughts or abuse, whereas less than half of parents agreed to such consent conditions. This unplanned research situation also allowed for an exploration of how adolescents who reported suicidal thoughts responded to researchers who con- tacted them about their disclosure. Even among adolescents who confirmed a history of persistent suicidal thoughts, most adolescents tried to convince the researchers that no follow-up with parents and providers was needed. At the second telephone follow-up with a clinical psychologist a couple of months later, it was learned that many of these adolescents had not gone on to tell a parent and mostdenied continued suicidal thoughts. These findings suggest that most adolescents resisted a break in their confidentiality that is counter to what would be expected based on the Fisher et al study [6]. In that study, when hypothetical scenarios were presented to urban adolescents who were asked to rate whether they felt confidentiality should be broken, most ad- olescents felt that suicidal risk warranted a break in confidentiality. There are several explanations for these discor- dant findings. First, the M16 question, asked as part of the mood inventory, may not reliably predict suicidality but a mood state less threatening to adolescents. Although youth may report recurring thoughts of suicide, they may not perceive these as serious symptoms of emotional instability or crisis, but part of the normal mood swings that accompany their adolescent years. Second, responses to hypo- thetical situations may not accurately represent how youth would respond when they are the ones having suicidal thoughts. Thirdly, adolescents actually expe- riencing suicidal thoughts may feel embarrassed or concerned about the burden they would place on their providers and parents. Additionally, these youth represented a subset who self-reported sui- cidal thoughts; thus they did not represent a general population of youth. The decision to break confidentiality was a diffi- cult one for the researchers. One of the most pressing concerns was that the adolescents chose to partici- pate in the study based on a“good faith”agreement with the research team. This agreement did not state that adolescents’responses would be reported if they answered“yes”to the question on suicidal thoughts (M16). The researchers were also concerned about the validity of the instrument in assessing suicidal risk. The question (M16) was part of a larger, more comprehensive instrument designed to screen for mood disorders, not specifically suicidal risk. In addition, the instrument had not been normed on adolescents and was being used on an exploratory basis to determine if mood was altered in relation- ship to changes in the frequency of alcohol use. Project researchers felt that a breach of confidential- ity was only warranted in cases of clear danger to the adolescent. The researchers were also concerned that by inter- vening and disclosing the responses to question M16 to parents, they may inadvertently increase rather than decrease the adolescent’s risk of harm. A thor- ough psychological and home assessment was thought to be beyond the researchers’purview. Dur- ing the initial follow-up, some of the youth did 392LOTHEN-KLINE ET AL JOURNAL OF ADOLESCENT HEALTH Vol. 33, No. 5 indicate that it was their home situation that had triggered their emotional stress. Researchers were concerned about the potential contexts in which confidentiality could be broken, as well as who was the person best equipped to evaluate intended and unintended consequences of disclosure and to con- vey the information to providers and parents. A final concern was related to maintaining study integrity. The breach of adolescents’confidentiality, and the subsequent follow-up with providers and parents, constituted an additional, unintended inter- vention effect. Secondary intervention effects and the extent to which they might compromise or confound the examination of planned program effects from the original RCT was a serious consideration. The ultimate decision to break confidentiality was made after consultation with numerous mental health researchers and clinicians. The prevailing sen- timent was that the risk of not breaking confidenti- ality was greater than the risk of breaking confiden- tiality. Implications The results of this study highlight several important considerations when conducting longitudinal pre- vention research on sensitive health topics with adolescents. It is critical to have a well-informed process when selecting questions on adolescents’ mental and emotional states for inclusion in a sur- vey. This is particularly so if these questions are not central to the study aims, as their inclusion may require the researchers to intervene with adolescents who select certain responses and this intervention may affect the validity of the central study. Although mood is a relevant domain for prevention research, prevention researchers must be sensitized to poten- tial expectations regarding follow-up with adoles- cents who indicate potentially life-threatening mood disorders. Researchers must carefully weigh the risks and benefits to adolescent health and the study design when including mood measurements, partic- ularly if conditional confidentiality is required. Fac- tors to consider include: how to optimize full disclo- sure by adolescents; what specifically, if anything, constitutes“imminent harm”requiring intervention by the researchers; what would a harm reduction protocol consist of for adolescents requiring inter- vention; and how would this protocol, as covered in the confidentiality agreement, affect adolescent dis- closure? Adolescent mental health experts should be involved, beginning with the study development, in this deliberation to clarify the issues and to helpformulate a clear plan for how researchers will respond if adolescents do report emotional distress. This plan must be clearly stated in the consent forms for participants and their parents. The results of this study suggest that many ado- lescents will not report suicidal thoughts when told that the researchers will share information with their providers and parents. Given that researchers may not be able to guarantee unconditional confidential- ity to adolescents in relationship to issues such as suicidal thoughts, longitudinal prevention research on suicidal thoughts may not be feasible unless the information has already been shared, such as in cases where adolescents are already in ongoing clinical care. Also, prevention research that attempts to in- clude mood indicators may only be feasible if ques- tions related to severe mood disorders such as sui- cidal thoughts are avoided. Finally, this case illustrates that risk-benefit anal- yses currently used by IRBs are subjective. Although all three of the IRBs overseeing this research project reviewed the same initial protocol for adolescents who responded“yes”to M16, the three IRBs did not agree on how to proceed. Summary Adolescents who assent to participate in research studies may be less likely to self-disclose personal information that may suggest mental distress if they know such disclosures will necessitate a breach in their confidentiality agreement. Unless researchers can guarantee adolescents full privacy for any self- disclosures, they may be unable to answer important research questions regarding adolescents’mental health. These issues underscore the broader need for guidelines that more specifically address the ambi- guities surrounding the issue of imminent harm as it relates to adolescent preventive health research. The authors thank Judith Jerry, Kathleen O’Connor, and Wilhel- mena Lee-Ougo for their assistance in this research. This research was supported by a grant (Grant #: RO1AA1225701) from the National Institute on Alcohol Abuse and Alcoholism (Bradley Boekeloo, Principal Investigator). References 1. Reddy DM, Fleming R, Swain C. 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Psychology students need the ability to create informed consent and debriefing forms that adequately state the purpose of studies to the participants in an ethical manner. In your capstone class (your
Brock Education Journal 29 (1) To view our interview with Jan DeFehr regarding this article, visit our Meet the Authors site: https://journals.library.brocku.ca/bro cked/index.php/home/meet -the -authors 7 “Voluntarily, Knowingly, and Intelligently”: Protecting Informed Consent in School – Based Mental Health Referrals A journal of educational research and practice 20 20 Vol. 29 (1) 6 – 23 https://journals.library.brocku.ca/brocked Jan N. DeFehr University of Winnipeg Author Note : Correspondence concerning this article should be addressed to Jan DeFehr, Faculty of Education at the University of Winnipeg, MB R3B 2E9 . Abstract Coherent with mental health literacy curricula, mental health assessment and referral is embedded in Canadian educational contexts. Mental health literacy excludes the substantial scholarly critique of mental health produced by psychiatry, the disciplinary base of the field of mental health. In -school student referrals to mental health professionals may similarly omit important critical information. Key critical areas of concern include scientific evidence, psychiatric drugs, psychiatric diagnosis, misinfor mation, and potential for harm. Professional ethics codes call for full disclosure of risk and open access to any relevant information needed for informed decision -making. Some mental health interventions commonly take place on an implied consent basis wit hin first -time consult appointments. Consequently, parents and students require access to critical mental health knowledge before or during referral processes. Beyond aligning mental health referral with the ethical principle of informed consent, professio nal ethics require institutional divestment from any mental health premises and practices that cause harm and lack scientific, intellectual, and ethical integrity. Keywords: mental health literacy , critical psychiatry, referral, mental health promotion , informed consent DeFehr 8 Anchored in mental health literacy discourse, informal mental health assessment and referral has become a whole -school endeavor for secondary schools in Canada (Kutcher, Wei, & Morgan, 2015). Mental health literacy programs, such as The Guide , call upon ev ery member of the school community to recognize or read problematic feelings and behaviours as symptoms of individual mental disorder, a term synonymous with mental illness, mental health condition, psychiatric illness, and neuropsychiatric disorder (Kutch er & Wei, 2017). According to mental health literacy, even young people can learn to spot mental disorders in themselves and others and schools can teach them early -detection strategies. Psychiatrist Stan Kutcher and colleagues advise, “It is fundamental t hat schools not only promote positive mental health, but also enable students to differentiate normal mental distress from mental health problems/disorders” (Kutcher, Yifeng, Costa, Gusmao, Skokauskas, & Sourander, 2016, p. 568) . Embedding informal mental health assessment and referral within the everyday life of the school ensures that mental health assessment can be offered by anyone at any time whether requested or not. Hundreds of published articles affirm mental health literacy training, early detection, and referral (Jorm, 2000; Kutcher et al, 2016). Unless school communities are aware of the critical mental health literature, they may not know there is cause for concern. In this article, I draw on cri tical mental health scholarship and professional codes of ethics to invite critical inquiry into school -based mental health referrals. I will use a definition of referral that includes both case -by -case individual student referral , as well as the school -wi de mental health referral achieved by mental health literacy curricula. In advancing a critical approach, my major claims are as follows: psychiatry, unlike other fields of medicine, lacks scientific evidence of pathology despite at least seventy years of research ; second, psychiatry’s diagnostic manuals design psychiatric diagnosis to endure through out the lifespan and although mental disorder diagnosis can open doors, it can also be used against students many years after diagnosis is initially documented; and third, psychiatric drug s, each with their characteristic potential for dependence, adverse , and harmful effects, exert no disease -specific action but rather act on t he central nervous system to superimpose a state of intoxication that may or may not be noticeable or helpful (Moncrieff, 2013) . I draw attention to critical mental health research because I am concerned that educators may be facilitating student referral to mental health professionals on the basis of misleading and incomplete information. Critical mental health scholarship exten ding back to the 1950s documents misinformation, missing information, and potential for serious harm implicit within mainstream mental health and its disciplinary base of psychiatry (Bracken et al, 2012; Burstow, 2015; Cooper, 1967/2001; Foucault, 1954/201 1; Goffman, 1961 , 1963; Johnstone & Boyle, 2018; LeFrancois, Menzies, & Reaume, 2013). The critical literature also articulates a vast range of alternative ways of understanding and addressing the phenomena commonly classified as mental health issues (Ande rson, 1997; Clark, 2016; DeFehr, 2016 , 2017; Foucault, 1954/2011; Linklater, 2014). M ental health promotion materials exclude critical scholarship thereby contributing to an illusion of disciplinary consensus. T he Critical Mental Health Nursing Network (2015) asserts it is neither accurate nor ethical to present the field of mental health as a unified cohesive field. This article begins with a review of key critical mental health concerns , outlining critique regarding scientific evide nce, psychiatric d rugs , and psychiatric diagnosis . To address the 9 Brock Education Journal 29 (1) question of how to begin integrating critical scholarship with school -based discussions of student mental health in a constructive, compassionate , and ethical manner, I present informed consent directives from professional codes of ethics for Canadian counsellors and psychologists . The artic le concludes with an open -ended series of questions for consideration . My central argument is that mental health referral practices — whether intended for individual students or whole school communities — breach the ethical principle of informed consent if the y omit relevant critique articulated within critical mental health scholarship. Students and parents are entitled to full disclosure (Canadian Counselling and Psychotherapy Association, 2015). I engage with both conventional and critical mental health scholarship as a former counsellor for twenty years, first, in government -named youth corrections, and then within publicly funded community healthcare settings and university student counselling s ervices. I now teach and research critical mental health as a professor in a university faculty of education. With an ongoing commitment to work for anticolonial social and environmental justice, I approach the topic of critical mental health from a geopol itical location, as a settler living and working in Treaty 1 territory and the homeland of the Métis Nation. Absence of Biomarker Evidence of Illness Prior to their attendance at a first mental health consultation appointment, students , parents, and guardians require basic knowledge of key critical concerns regarding mental health premises and practices. The topic of scientific evidence provides an essential foundation for critical mental health awareness. Educators may not be aware that psychiatry has not produced any scientifically valid biological evidence of illness for any of its 300 -plus mental illness diagnoses (Frances, 2013; Johnstone & Boyle, 2018; Kinderman, 2014; Rose, 2015) . This criticism contrasts with mental health promotion curricula which routinely advises that mental illness is like any other illness. Although the body, with its genes, biochemistry, and brain, is inevitably in volved in all human experience, hypotheses about the pathol ogical nature of mental disorder have never been substantiated by science. There is no scientific evidence of illness, pathology, or disease, for any mental disorder listed in psychiatry’s latest diagnostic manual. “[W]hen DSM -5 was published in 2013, there was not a single clinically validated biomarker for any psychiatric disorder” (Rose, 2015 , p. 1 ). Psychiatry’s crisis of legitimacy has been openly acknowledged by both critical and conventional psychiatrists. Thomas Insel’s (2013) infamous remarks can still be read at the National Institute of Mental Health (NIMH) website: “While DSM has been des cribed as a “Bible” for the field, it is, at best, a dictionary, creating a set of labels and defining each… the weakness is its lack of validity” (para. 2). Insel wrote these words as director of the NIMH , the largest funder of ment al health research in the world (National Institute of Mental Health, 2019). Allen Frances (2013) Chair of the DSM -IV Task Force similarly acknowledge d: “The brain has provided us with no low -hanging fruit — thousands of studies on hundreds of putative biological markers have so far come up empty ” (p. 11). Related to the issue of evidence , educators should be aware that psychiatry has not developed a single objective laboratory test for any of its diagnoses; no scan, X -ray, or test of fluids or tissues has ever been available or required for any psychiatric diagnosis (Guest, Guest, DeFehr 10 & Martins -de Souza, 2016 ; Kinderman, 2014 ). P sychiatry has no laboratory test for chemical imbalance , just as it has never produced or utilized any test for measuring chemical balance (Lynch, 2015) . Although chemical imbalance is commonly presumed to be a leading cause of supposed mental disorder s, extensive critical scholarship credits the marketing departments of pharmaceutical companies with the popularization of this unproven assumption (Healy, 2012; Whitaker & Cosgrove, p. 2015 ). David Kupfer, chair of the most current DSM edition (DSM -5) (APA , 2013), criticized psychiatry’s lack of objective, scientifically validated biological evidence when research for DSM -5 was beginning : … the goal of v alidating these [DSM] syndromes and discovering common etiologies has remained elusive . Despite many proposed candidates, not one laboratory marker has been found to be specific in identifying any of the DSM -defined syndromes . (Ku pfer, First & Regier, 2002 , p. xviii) Calling for a paradigm change within psychiatry, Kupfer and colleagues ( Kupfer, First & Regier, 2002) argued it was “falsely optimistic” to regard mental disorders as “discrete biomedical entities” (p. 8). Approximately one decade later , however, with DSM -5’s publication date fast approaching , Kupfer and Regier (2011) publically disclosed , “DSM -5 does not represent a radical departure from the past…” (para. 7) . In a n American Psychiatric Association press release, DSM -5 chair David Kupfer (2013) elaborated : In the future, we hope to be able to identify disorder s using biological and genetic markers that provide precise diagnoses that can be delivere d with complete reliability and validity. Yet this promise, anticipated since the 1970s, re mains disappointingly distant. We’ve been telling patients for several decades that we are waiting for b iomarkers. We’re still waiting . (Kupfer, 2013, para. 1) Kupfer’s (2013) announcement warrants critical discussion . Other medical specialties such as neurology are grounded in scientific evidence , while psychiatry is soon to enter its eighth decade of “waiting. ” Psychiatry’s first diagnostic manual was published in 1952. Kupfer’s language of waiting deflects attention from the billions of dollars and thousands of person -hours spent in pursuit of basic genetic, neurologic , or biochemical evidence of pathology (Rose , 2015). The term waiting presents the profession of psychiatry as appropriately dormant when instead it has been significantly expanding its diagnostic manuals , treating and profiting from the treatment of pathology it has not yet discovered. Kupfer’s claim that psychiatry has been “telling the public for several decades ” is also problematic. Psychiatric experts , such as mental health promotion proponents, have done the opposite, speaking extensively of mental disorder as biological illness (Hyman, 1999) . The popular classroom resource Canadian Mental Health and Highschool Curriculum Guide (2017) declares that “mental illness es are diseases” ( Kutcher & Wei, 2017, p. 8). Describing “the Guide” (p. 4) as an “evidence -based” (p. 4) mental literacy resource, its authors Kutcher and Wei attribute problematic emotions and behaviours to brain deficiency : “It is a medical condition” (Kutcher & Wei, 2017, p. 20) , “a health condition arising from changes in usu al brain functioning” (Kutcher & Wei, 2017 , p. 8) , “a specific part of the brain that needs to be working in a specific manner is working in the wrong way” (Kutcher & Wei, 2017 , p. 17). These claims about brain pathology have not been substantiated by scientific evidence and are made without any reference to academic scholarship. No brain scan has ever been required or available for mental disorder diagnosis (APA, 2013). The well -known Canadian Mental Health 11 Brock Education Journal 29 (1) First Aid program for practi tioners who work with youth similarly coaches its trainees to advise distressed young people that “they have a real medical condition” (Mental Health Commission of Canada, 2010, p. 4) , even though this scientific claim lacks biological evidence, as DSM -5 chair David Kupfer has acknowledged . Part of a larger longstanding pattern of medicalization (Conrad , 1992 , 2007), practitioners in the helping professions routinely discuss human distress and difference as though difficult or problematic feelings and behaviours are manifestations of mental illness (Strong, 2017). When learning communities gain familiarity with basic outcomes of critical mental health research, they are better able to interrogate widespread assumptions and constructively engage with a broader range of explanations and strategies. Psychiatric Drugs: Effective Treatments? Just as ethical referral to mental health professions requires critical awareness of psychiatry’s crisis of evidence , ethical in -school referral requires critical awareness about psychiatric drugs. The critical scholarship of practicing and academic psychiatrist Joanna Moncrieff ( 2008 , 2009 , 2013 , 2018 , 2019 ) is relevant to students, parents, and teachers considering the possibility of chemical intervention. Co -chair of the UK -based Critical Psychiatry network, Moncrieff (2009) contends that members of the public make decisions about beginning psychiatric drug use “on the basis of totally inadequate information” (p. 124 ). Western medicine categorizes psychiatric drugs within the class of psychoactive substances along with other recreational drugs, such as caffeine, nicotine, alcohol, amphetamines, heroin, LSD, cocaine, and cannabis (Moncrieff, 2009) . Moncrieff (2013) discourages moralizing about whether the prescribed substances are good or bad and instead argues for fully informed evaluation of the full range of potential harms and benefits of psychiatric drug use. It is crucial that school communities unders tand a central outcome of Moncrieff’s (2008 , 2013 , 2018 , 2019 ) research: there is no scientific evidence that p sychiatric drugs exert any disease -specific action , no scientific evidence t hat psychiatric drugs cleverly target illness, stopping, revers ing, preventing, or changing illness in any way. Correspondingly , psychiatric drugs do not corr ect physiological anomalies or provide chemicals that so -called normal bodie s produce. Rather than changing a disease process , psychiatric drugs act on the central nervous system to superimpose a state of intoxication , part of humanity’s ancient history of using substances to relieve suffering, induc e euphoria , or enhance life (Moncrieff, 2013) . The altered state of consciousness produced by psychiatric drugs may or may not be noticeable , pleasant, or preferable. Moncrieff (2009) argues it is incorrect to equate psychiatric drug -induced effects with normalcy: Drugs do not simply reproduce ordinary emotional stat es. They produce characteristic altered states, which vary according to the pharmacolo gical properties of the drug concerned. Drugs are not a sophisticated way of restoring or enhancing normal functioning. They are just drugs. They can make you fast or slow, euphoric or dysphoric. They can produce some curious and usually unpleasant expe riences and sensations. But they do not make a troubled person happy or a disturbed person normal . (p. 126) Psychiatric drug classes vary but all produce their characteristic range of effects regardless of whether people meet psychiatric diagnostic criteria or not (Moncrieff, 2013) . DeFehr 12 If psychiatric drugs do not modify a process of illness, might they at least relieve students’ “symptoms” of the phenomena presumed to be mental illness? Critical mental health scholarship indicates that although psychiat ric drugs can alter feelings, behaviours, perc eptions, and thinking, these substances also produce toxicity (Breggin, 1991) . Pharmaceutical companies use the term “side ” effects to acknowledge unwanted outcomes of psychiatric prescriptions , but critical scholars see the word “side” as a marketing strategy that arbitrarily partitions some effects , always the negative effects, from other effects (Moncrieff, 2009 , 2013) . The term “side effect” wrongly implies the drugs exert a central disease -specific action. Further, the word “side” serves to minimize the seriousness and potential centrality of common unpleasant and harmful psychiatric drug effects . Psychiatric drugs can produce a full range of harms, such as facial tics, metabolic disorders, brain damage, suppress ed growth and increased risk of death (Breggin, 2014; Moncrieff, 2009 , 2013) . Major tranquilizers, also referred to as a ntipsychotic s, atypicals, neuroleptics, and more recently renamed and remarketed as mood stabilizers (Healy, 2006) can produce d ebilitating movement disorders accompanied by intellectual impairment ( APA , 2013 ; Moncrieff, 2013 ). Psychiatric drugs produce a blunt global effect throughout the body , changing not only cognitive or emotional experience but also physical processes such as increasing blood pressure and heart rat e (Moncrieff, 2009) . Desperate for improvement , students’ teachers and caregivers may presume the prescribed drug use can simply be dis continued if it is not helpful . Mental health promotion campaigns do not publicize that discontinuation of psychiatric dr ugs , even when taken as prescribed , can be severely difficult (Read, Gee, Diggle & Butler, 2019). Psychoactive substances, including psychiatric drugs, commonly produce dependence, as evidenced by the phenomena of tolerance and withdrawal syndromes (Moncrieff, 2009 ; Moncrieff , Cohen & Porter, 2013 ). Careful withdrawal from psychiatric drug use can be swift and uncomplicated o r it can be excruciating and debilitating , requiring a period of months or years ( Cartwright, Gibson, Read, Cowan & Dehar, 2016 ; Moncrieff, 2009 ; Read, Gee, Diggle & Butler, 2019 ). Students who have not been cautioned about withdrawal syndromes commonly conclude that their “mental disorder” is returning when what they are experiencing is a drug withdrawal syndrome (Moncrieff, 2006 ). M any people first notice the effects of their ps ychiatric drug (say in the case of antidepressants) when they attempt to stop taking it (Moncrieff, Cohen & Porter, 2013). The body produces adaptations to regular psychoactive substance use and thus, drug -induced effects presumed to be therapeutic are oft en temporary and not sustainable over time (Moncrieff, 2009). Parents, guardians, and students contemplating the prospect of consulting a mental health diagnostic professional may also benefit from knowledge about the saturation of for -profit industry within mental health services. Cosgrove and Wheeler’s (2013) research indicates 69% of DSM -5 task force and 58% of DSM -5 panel members maintain financial conflicts of interest with pharmaceutical industry. Phenomena of ghost writing , publication bias , and disease mongering , are additional well -documented examples of psychiatry’s scientific compromise in exchange for corporate gain (Cos grove & Wheeler, 2013; Healy, 2012; Whitaker & Cosgrove, 2015) . While individual authors may indicate they have no conflicts of in terest, the field of psychiatry itself deeply intertwines with pharmaceutical industry (Burstow, 2015; Healy, 2012 ; Whitaker & Cosgrove, 2015) . DSM -IV Chair Allen Frances (2013) reports that psychiatric drugs are “the star revenue producers” (p. xv) for pharmaceutical corporations . Unique as a medical 13 Brock Education Journal 29 (1) specialty, p sychiatry’s absence of biological markers of pathology make s it m ore prone to industr y influence (Cosgro ve & Wheeler, 2013) , “a marketer’s dream” (Healy, 2012, p. 39) . Mental Illness Diagnosis How it H appens Students and parents require critical knowledge regarding mental disorder diagnosis. Prior to a first consult with a professional in the helping professions , people need to know that psyc hiatric diagnosis commonly take s place invisibly in the thinking and questioning of the professional in the first minutes of the first appointment (France s, 2013) . Expecting a medical procedure, p atients reporting distress or unusual problematic behavior to their service provider may not know that a mental disorder diagnostic process has already begun and may be well underway. Some diagnoses , such as personality disorder diagnoses, can be profoundly stigmatizing, but even commonplace diagnoses mark students as defective, different from others, less than their ideal sel ves (Gergen, 1994). Implied Consent The conventional in-office process of psychiatric diagnosis is based on implied consent and requires no explicit permission or agreement from the student or student’s guardian or parent . After a first appointment with a diagnosing professional has begun , there is no way for a studen t to secure a particular diagnostic outcome . Simply attending an appointment or consult as a patient or client of a diagnosing professional is the only indication of consent required for mental disorder diagnosis in Canada. Because consent to diagnos is is implied in medical settings , it is important that students and parents access critical knowledge about diagnosis prior to their first appointment . The ethical principle of informed consent must therefore be explicitly and conscientiously integrated with all mental health referral process es. Who Diagnoses Mental Disorders? Prior to the first appointment, persons planning to attend should understand whether the professional they anticipate meeting has been granted mental disorder diagnostic privileges . The Canadian colonial state grants psychiatrists, family physicians, pediatricians, psychologists, and nurse practitioners ultimate naming rights — the authority to diagnose their patients with mental disorder labels . Canadian s ocial workers, fa mily therapists, psychiatric nurses, and guidan ce counsellors are not authorized to diagnose clients, but these non -diagnosing professionals commonly assume informal yet powerful diagnostic roles as they affirm and disseminate psychiatric assu mptions , adopt ps ychiatric diagnostic vocabulary , and facilitate refer ral to diagnosing professionals ( DeFehr, 2017 ). Teachers also commonly contribute powerfully to diagnos tic processes as they draw on psychiatric truth claims to understand and address student distress and difference . At times, educators may be called upon to shape diagnostic process and out come with their own documented observations of students. Can the Diagnosis be Dropped? School -based referrals to diagnosing professionals should inform students that even though diagnosis can happen quickly, it endures throughout the lifespan in ways that contrast with diagnosis of pathology in the rest of medicine. As I discuss shortly, the longevity of psychiatric diagnosis can have detrimental legal, social, personal, and fina ncial effects for DeFehr 14 students long after diagnosis is initially documented. An uncomfortable or disappointing mental disorder diagnosis cannot be given back like shoes returned to the mall. Psychiatry provides no mechanism such as a laboratory test to objectively verify recovery (APA, 2013; DeFehr, 2017; Kirk, Cohen & Gomory, 2015). Psychiatry offers no diagnosis, label, or criteria for normal, healed, cured, or recovered (Rose & Abi -Rached, 2013). Mental health awareness campaigns advertise recovery without revealing that the only post -diag nosis options provided by DSM -5 are remission (full or partial) or relapse (APA, 2013). While some diagnoses indicate specific age ranges, there is no separate youth or pre -school nosology for mental disorder diagnosis (APA, 2013). There is always potentia l for students to pick up additional diagnoses but like a hallway without an exit, the DSM -5 provides no means for subtraction. Arguing for the abolishment of psychiatric diagnosis along with his colleagues from the British Psychological Society (Johnstone & Boyle, 2018) , psychologist Peter Kinderman (2014) discusses the way psychiatric diagnosis is uniquely designed to endure over time: “the label sticks to them [the student], not to the disembodied ‘symptoms’” (p. 54). Students objecting to their diagn oses may seek a second professional opinion, but the second opinion cannot reverse the first opinion, even if both opinions clearly differ or contradict. The second consult produces additional diagnostic opportunity (DeFehr, 2017). Some medical diagnostici ans might document their objection to a previous mental disorder diagnosis, and they may document their opinion that the person in question no longer meets diagnostic criteria, but any changes noted must be made in a way that preserves the original documen tation of diagnosis (Canadian Medical Protective Association, 2019). Diagnosing medical professionals may choose to cease documenting references to the mental disorder diagnosis and they may even remove diagnoses from patient problem lists, but they may no t delete or destroy the original documented diagnosis. Parents and students need to understand that if they are assigned a mental disorder diagnosis by a diagnosing medical professional, “you will never be able to remove such a diagnosis from your health r ecords” (Kirk, Cohen & Gomory, 2015, p. 77). I will soon discuss how the courts, insurance corporations, and professional licensing authorities help to produce the durability of mental disorder diagnosis with their “have you ever been” lines of inquiry spe cific to psychiatric diagnosis. Comorbidity ? Students and parents may benefit from knowing that diagnoses are often assigned in multiples. DSM -5 frequently deploys the concept of comorbidity to account for the considerable overlap between diagnostic classifications (Frances, 2013). For example, anxiety disorders are said to resemble unipolar depressive disorders, thus DSM -5 advises that “individuals whose presentation meets criteria for generalized anxiety disorder are likely to have met, o r currently meet, criteria for other anxiety and unipolar depressive disorders” (APA, 2013, p. 226). Some have wryly observed that DSM -5’s frequent comorbidity statements resemble YouTube “recommended for you” suggestions . What psychiatry names comorbidity can alternatively be understood as poor diagnostic reliability . Assignment of psychiatric diagnoses in clusters further entrenches a deficit -oriented psychiatric identity. Costs of Diagnosis People often describe their experience s of diagnosis as helpful however it is crucial that educators know that diagnosis can be particularly costly and detrimental at various life junctures. 15 Brock Education Journal 29 (1) Diagnosis , given the public’ s general understanding of mental disorder diagnosis , may initially bring relief, validation, and clarity; many families take hope and comfort from the realization that their struggle is known, has a name and can be explained and presumably treated or healed. Often the process of diagnosis reduces the isolati on as students and their families realize they are not alone in their struggle . Some school divisions make psychiatric diagnosis a requirement for special funding or accommodation. Psychiatric d iagnosis of children and youth can diminish parents’ feelings of guilt or embarrassment. Psychiatric diagnosis can also create impairments and barriers decades after diagnoses are initially documented . Many educators and students may not realize that their psychiatric diagnoses must be declared at different junctures in life. Some professional licensing, such as physician licensing (Morris, 2017) requires on -going disclosure of personal mental health his tory. A psychiatric diagnosis can be used against students later in life to influence adoption proceedings and child custody deliberations (Deutch & Clyman, 2016) . Court orders can require diagnosticians to release diagnostic information. Mental disorder diagnosis is a factor determining eligibility and cost of life, house, and disability insurance, and can be used to determine whether people are able to drive a vehicle ( Frances, 2013; Manitoba Public Insurance, 2018) or manage their own legal and medical decisions (Caplan & Cosgrove, 2004) . Even when access to medical history is not required, diagnosed persons may feel compelled to disclose their mental disorder diagnoses to family members or poten tial life partners . Consequently, the privacy characterizing the inaugural diagnostic moment usually diminishes to include numerous unanticipated others throughout the lifespan. Diagnosis and Identity After mental disorder diagnosis, it can be difficult for diagnosed students to distinguish their own human feelings and behaviours from their so -called psychiatric symptoms. As Gergen (1994) noted, In effect, once people understand their actions in terms of mental deficits, they are sensitized to the problematic potential of all their activities and how they are infected or diminished. The weight of the “problem” now expands manifold; it is an inescapable as their own shadow. (p. 150 -151) Many adults lament that they have never had opportunity t o know a diagnosis -free, drug -free identity; they have been psychiatric subjects for as long as they can recall (Delano, 2010) . Demystifying Diagnosis: A Case Example In my experience, direct engagement with the DSM -5 text r apidly clarifies and demystifies psychiatric diagnosis for teachers . I recommend that teachers read the DSM -5, not to diagnose themselves or others, but to see for themselves how the diagnoses psychiatrize a wide range of human feelings and behaviours, many of which are common and wholly understandable. In the courses I teach, I find that teachers and pre -service teachers quickly grasp the simplicity of the diagnostic criteria and the circularity of its logi c. The diagnosis of General Anxiety Disorder , perhaps the most common diagnosis in schools, illustrates the word -bound, subjective nature of psychiatric diagnosis. The first purported symptom of Generalized Anxiety Disorder, according to DSM -5, is anxiety: “excessive anxiety and worry (apprehensive expectation), occurring more days than not for at DeFehr 16 least 6 months , about a number of events or activities (such as work or school performance) ” (APA, 2013, p. 222). The second DSM -5 criteria for General Anxiety Disorder asserts that “the individual finds it difficult to control the worry” (p. 222). The third criteria form the bulk of the diagnostic criteria for General Anxiety Disorder : “The anxiety and worry are associated with three (or more) of the following six symptoms (with at least some symptoms having been present for more days than not for the past 6 months)” (p. 222 ). DSM -5 ( APA , 2013) uses the following words to comprise the core of the General Anxiety Disorder diagno stic criteria : 1. “Restlessness or feeling keyed up or on edge. ” 2. “Being easily fatigued. ” 3. “Difficulty concentrating or mind going blank. ” 4. “Irritability. ” 5. “Muscle tension. ” 6. “Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep ).” (APA, 2013, p. 222) The criteria states that “Only one item is required in children” (p. 222) thus almost ensuring that any child persistently overwhelmed by problems at home or school can readily acquire the General Anxiety Disorder diagnosis. Within a conventional mental health rationality, students anxious about life conditions directly resulting from past and present -day colonization and genocide can have their understandable feelings of distres s and resistance inappropriately read as individual mental pathology instead of understood as an understandable human response to environmental, social, and economic injustice (Blackstock, 2012; Clark, 2016; Linklater, 2014; Million, 2013). DSM -5 further specifies that “anxiety, worry, or physical symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning” ( APA, 2013 , p. 222). The phrase clinically significa nt distress is vague and not quantified. It is important to notice the assumption that the fully -human response of anxiousness is presumed to be the root cause of the “impairment in social, occupational, or other important areas” (p. 222) rather than the hardship, injustice , or problematic cognitive habits to which the anxiousness may be a response. DSM -5 openly acknowledges that young persons acquire the General Anxiety Disorder diagnosis through very common and legitimate worries: “Children and adolescents ten d to worry more about school and sporting performance, whereas older adults report greater concern about the well -being of family or their own physical heath” (2013, p. 223) . DSM -5 notes further that children and adolescents worry also about environmental catastrophe and atrocity caused by war (p. 224). Indeed, these worries seem widespread and important, even necessary to human survival. Like other diagnoses in DSM -5, the un specified and other specified anxiety diagnoses allow diagnostic labelling to take pla ce even in situations where even the minimal diagnostic criteria are not met. The dragnet function of unspecified and other specified diagnoses can be seen in the Unspecified Anxiety Disorder diagnosis which can be assigned in situations in which the clinician chooses not to specify the reason that the crit eria are not met for a specific anxiety disorder and includes presentations in which there 17 Brock Education Journal 29 (1) is insufficient information to make a more specific diagnosis (e.g., in emergency room settings. (APA , 2013, p. 233) Like all other psychiatric diagnoses, including schizophrenia (APA, 2013, p. 87) , ADHD (APA, 2013, p. 59) and bipolar disorders (APA, 2013, pp. 123 -154) , DSM -5 General Anxiety Disorder diagnosis requires no medical procedure and offers no criteria for recovery . Critical awareness of mental disorder diagnosis is esse ntial for ethical referral processes in school. Aligning Referral with Professional Ethics If teachers contribute to mental hea lth assessment and referral process es in schools , it would seem they should know and uphold the informed consent ethics standard s outlined by mental health professional codes of ethics . Professional codes of ethics discuss informed consent as the centerpiece of ethical practice (Robinson, Lehr & Severi, 2015). According to the Canadian Counselling an d Psychotherapy Association i nformed consent must be granted “voluntarily, knowingly, and intelligently ” (Robinson, Lehr & Severi, 2015, p. 54) . Voluntarily means the consent must be given “freely without pressure, coercion, or without powerful incentives to do so” (Canadian Counselling and Psychotherapy Association, 2015, p. 15) . To offer consent knowingly means professionals must fully disclose relevant information including information a bout “implications of diagnosis,” “limits of confidentiality,” and “potential risks and benefits” (p. 16). To give consent intelligently means that clients can understand descriptions of the expected and potential “treatments and procedures ” (p. 15) well e nough to make informed decision s. The Standards of Practice guidelines further specify that clients should be permitted to withdraw their consent, and further , “counsellors should not equate silence with consent” (Canadian Counselling and Psychotherapy Association, 2015, p. 16) . In contrast with implied consent practices, professional ethics standards for counsell ors encourage documentation of consent although “e ffecting a proper consent necessitates completion of a consent process, which is considerably more involved and detailed than simply getting a signature on a form” (Robinso n, Lehr & Severi, 2015, p. 27). Teachers and school counsellors may understandably feel reluctant to speak about potential for harm within helping systems , yet professional ethics demand straightforward, clear and full disclosure of risks (Canadian Psychological Association, 2017; Robinson, Lehr & Severi, 2015) . Psychologists must provide as much information as persons would reasonably want to know before making decisions or consenting to intervention (Canadian Psychological Association, 2017) . Ethics codes call for integrity, truthfulness, accuracy, open communic ation and honesty throughout every professional -client encounter (Canadian Psychological Association, 2017) . As a profession, p sychologists are to promote “freedom of enquiry, innovation, and debate (including scientific and academic freedom)” (Canadian Ps ychological Association, 2017, p. 30) . Psychologists are to help encourage “critical analysis” and “participate in the discipline’s process of critical self -evaluation ” (p. 32) . Psych ologist codes of ethics require psychologists to ensure that psychological knowledge is used for “just and beneficial ” purposes (p. 31). Further, if structures or policies seriously ignore or oppose the principles of respect for the dignity of persons a nd peoples, responsible caring, integrity in relationships , or responsibility to society, psychologists involved have a responsibility to speak out …. [a] nd advocate for DeFehr 18 appropriate change to occur as quickly as possible . (Canadian Psychological Association, 2017, p. 31) Psychologists “have a higher duty of care to members of society than the general d uty of care that all members of society have to each other” (Canadian Psychological Association, 2 017, p. 3). Regarding discussion of risk of harm, psychologists must do more than merely offer full disclosure of potential hazards . They must “terminate an activity when it is clear that the activity carries more than minimal risk of harm and is found to be more harmful than beneficial, or when the activity is no longer needed” (Canadian Psychological Association, 2017, p. 15) . Psychol ogists must refuse to participate in practices or assumptions that are known to cause harm. Furthermore, psychologists must “be open to the concerns of others about perceptions of harm that they as a psychologist might be causing” (Canadian Psychological A ssociation, 2017, p. 23 -24) and again, the code of ethics reminds psychologists they are required to not only “stop activities that are causing harm” , they must “not punish or seek punishment for those who raise such conc erns in good faith” (p. 23 -24). Beyond full disclosure of potential for harm, it is crucial that discussions of student well – being not only refrain from disseminating unsubstantiated claims , but it is also important that educators counter the profoundly flawed assumption that difficult, strange , or extreme emotions and behaviours are manifestations of physiological pathology. To the extent that schools publicize the erroneous claim that mental illness is like any other illness, schools must correspondingly assume responsibility for system atically correcting this misinformation and addressing its associated harms. Conclusion The following open -ended series of questions might be useful as educators consider the extent to which their school facilitates awareness of critical scholarship in the field of mental health. Are students aware that there are many ways to understand and address their difficulties , and that the psychiatric paradigm is just one option ? Are students and their caregivers aware that phenomena referred to as mental illness fundamentally differ s from physical illness ? Are they aware that there are correspondingly no objective laboratory tests or m edical procedures required for mental illness diagnoses? Regarding psychiatric drugs such as antianxiety or antidepressants , are students, parents, and guardians aware that psychiatric drugs, in the same class of substances as recreational drugs, do not cl everly target disease s but instead produce an altered drug -induced state that may or may not be useful (Moncrieff, 2013)? Are they aware of potential unpleasant and devastating drug effects , drug tolerance, dependence , and withdrawal syndromes? Concerning diagnosis, a re they aware of which helping professionals assign psy chi atric diagnoses ? Are they aware of how and when diagnosis typically takes place ? Are students, parents, and guardians aware that diagnosis of young persons can create significant barriers for them at various junctures in their lives? These are only a few examples of questions that help build student and parent awareness of critical mental health knowledge. Referral to mental health services, whether accomplished through school -wide mental health literacy curricula or through case -by -case discussion , is itself a mental health intervention. An ethical goal , as I see it, is not to persuade students to adopt conv entional or critical 19 Brock Education Journal 29 (1) perspectives nor to dispense medical advice, but rather to compassionately and respectfully open school access to the critical scholarship that is routinely omitted from me ntal health promotion progra ms . Educators can help ensure that school -based referrals to helping professionals align with the ethical principle of informed con sent. 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Psychology students need the ability to create informed consent and debriefing forms that adequately state the purpose of studies to the participants in an ethical manner. In your capstone class (your
GnRHa (‘Puberty Blockers’ ) and Cross Sex Hormones for Children and Adolescents: Informed Consent, Personhood and Freedom of Expression David Pilgrim Department of Psychology, University of Southampton, Southampton, UK Kirsty Entwistle Independent Practice, Guimarães, Portugal Ethical concerns have been raised about routine practice in paediatric gender clinics. We discuss informed consent and the risk of iatrogenesis in the pre- scribing of gonadotropin-releasing hormone analogues (GnRHas) and cross sex hormones to children and adolescents respectively. We place those clinical concerns in a wider societal context and invite consideration of two further rel- evant ethical domains: competing rights-based claims about male and female personhood; and freedom of expression about those claims. When reflecting on the assessment and medicalization of children and adolescents presenting at gender clinics, the matters of informed consent and iatrogenic risk should be the most pressing for clinicians. However, this is not just a matter of medical ethics, it also implies the need for a full ethical debate on competing notions of personhood and the defence of freedom of expression about trans- gender and its implications within contemporary democracies. keywords Sex, gender, transgender, capacity, iatrogenesis Introduction This article widens the lens on the controversial matter of paediatric gender tran- sition which entails the current standard practice of prescribing gonadotropin- releasing hormone (GnRH) analogues (more commonly known as ‘puberty This article has been republished with minor changes. These changes do not impact the academic content of the article. the new bioethics, Vol. 26 No. 3, 2020, 224 –237 © 2020 Informa UK Limited, trading as Taylor & Francis Group DOI 10.1080/20502877.2020.1796257 blockers’) to children and adolescents and cross sex hormones to adolescents. The first part of the article introduces some of the main concerns about informed consent and iatrogenic risk in paediatric gender transition. The second part argues that those concerns should be considered within the context of the competing claims about male and female personhood, most strongly disputed by transgender activists and gender critical feminists. The third part argues that current restrictions on freedom of expression on transgender and paediatric gender transition in modern democracies have implications for the question of whether children and adolescents are able to give informed consent. Those restrictions also bring into doubt whether clinicians are truly free to discuss the challenges of their practice. Paediatric gender transition became subject to increasing demand in recent years, before either empirical evidence or prolonged ethical debate had created a clear consen- sus on an optimal healthcare policy. This will be evident below in relation to arguments about what can and cannot be said about transgender, whether that is in relation to clinical case work or service rationales. Moreover, with reference to what ‘cannot be said ’, for now there is not only an absence of evidence and ethical consensus, there is also a tendency towards the selective proscription of opinion or argument. Reflecting this contemporary picture of relatively absent published research, many of the citations below are necessarily from the ‘grey literature ’, because it is in conference reports, social media discussions and mass media reporting that we find a rapidly evolving public debate about service developments. The latter have emerged prior to larger ethical deliberation or clinical and epidemiological research being published and interrogated in the academic literature. Rather than interven- tions being tested out for safety and efficacy in advance (as is the case typically in other clinical examples), paediatric gender transition services were implemented with a rationale but with only a weak evidence base. A proper reckoning about safety and efficacy could only then accrue on a post hocbasis. The first children ’s gender clinic to take an ‘affirmative approach ’(i.e. affirming transgender identification in adolescents) opened in The Netherlands in 1987 (de Vries and Cohen-Kettenis 2012), followed by the UK in 1989 (Di Ceglie 2018). What has come to be known as the ‘Dutch protocol ’was first introduced in 2000 (de Vries et al.2011). In this model GnRHa is prescribed to ‘halt puberty ’after 12 years old, added to with cross sex hormones to ‘masculinise or feminise ’the body at 16 years old and, after 18 years of age, vaginoplasty for males and mastect- omy, hysterectomy with ovariectomy and phalloplasty for females. In the UK, the Tavistock Gender Identity Development Service (GIDS) began prescribing GnRHa to children as young as 10 years old in 2011, as part of the ‘Early Intervention Study’ (Biggs2019). The latter author documents the debates and controversies sur- rounding that decision and the ongoing contention about the study. In recent years the mainstream mass media have been largely sympathetic to the concept of the transgender child. Television series such as ‘I am Jazz ’and ‘Butterfly ’ and tabloid reports emphasize the transformation of effeminate little boys into pretty girls in the context of their family. Social media, particularly YouTube, docu- ment the Female to Male (FtM) or Male to Female (MtF) ‘journey time lines ’of young people modifying their bodies with hormones and surgeries. Lewis (2019 ) has documented some of the recurring themes and messages in YouTube transition THE NEW BIOETHICS 225 videos, since they first began appearing in 2006, and notes that their increasing popularity coincides with increasing referrals to Tavistock GIDS.These dramatic testimonials and ‘infotainment ’have not been matched in volume by the more sober reporting of concerns and criticisms of recent norms about pae- diatric transition. Critics include lesbians and gay men, who recognize the contem- porary description of gender dysphoria as a familiar experience during their childhood and adolescence, as part of their emerging homosexuality. Accordingly, they are concerned that children and adolescents who might otherwise grow up to be homosexual are being pre-emptively shepherded into becoming transgender. Het- erosexual women have also raised their concerns that they would likely have been unnecessarily subject to medicalization if paediatric transition had been available decades ago (Hourican 2019). In the wake of this relatively recent expansion in the provision of paediatric gender transition in the UK, along with increased demand and the criticisms and controversies that at times have been provoked, the three ethical domains of concern have emerged for our consideration. We now offer a view about each of them. Informed consent, capacity and iatrogenic risk At the centre of this first ethical matter is whether children and adolescents should be diagnosed with gender dysphoria and whether they have capacity to give informed consent to GnRHas and cross sex hormones. Both of these are important, given the risk of clinical iatrogenesis. When the diagnosis of Gender Identity Disorder of Childhood (GIDC) was first introduced in the third edition of the Diagnostic and Statistical Manual (DSM-III) (American Psychiatric Association 1980) it was immediately controversial. In par- ticular, Bryant ( 2006) reporting that history noted that the DSM authors received ‘ voluminous ’letters of objection from feminist mental health professionals, some of whom called for the diagnosis to be discarded altogether (see later). In his pres- cient conclusion about DSM-III, Bryant (2006 ) cautioned against the trend towards a narrowing of focus on gender identity. Instead he offered an approach that did not define the child as the problem but rather helped families and children cope with the challenges of gender non-conforming behaviour. More recently, others have echoed this need for caution with regards to decontextualizing a child ’s or ado- lescent ’s transgender identification (Schwartz 2012, Marchiano 2017). Today, the production of case by case biopsychosocial formulations is an implicit and sometimes explicit push back against a point diagnosis approach to assessment. For this reason, the legitimacy of DSM diagnoses is brought into focus in debates about understanding the clinical presentation of particular cases. In the most recent iteration of DSM (DSM-5) (American Psychiatric Association 2013) ‘ Gender Identity Disorder ’was replaced by the putatively ‘less pathologising ’diag- nosis of ‘Gender Dysphoria ’. Gender clinics usually cite the guidelines of the World Professional Association of Transgender Health (WPATH), currently in their seventh edition (Coleman et al. 226 DAVID PILGRIM AND KIRSTY ENTWISTLE 2012). These are produced on the basis of consensus by experts, namely the clini- cians and academics, who work in gender clinics and university gender studies departments, several of whom are transgender themselves. The guidelines have been criticized for their poor-quality evidence base (Swinford 2020). As with many other forms of professional guidelines, they reflect the interests of those invested in current forms of service provision (Ioannidis 2018) and so might be approached sceptically. Indeed the WPATH guidelines have been criticized as part of the pending UK Judicial Review of whether children and adolescents are able to give informed consent to GnRHa at the Tavistock Gender Identity Development Service (GIDS) (Swinford 2020). Concerns about hormonal interventions are also reflected in the fact that NHS England has recently commissioned an independent review of the evidence for GnRHas and cross sex hormones being prescribed to children and adolescents (Update on gender identity development service for children and young people 2020 ). This policy stock-taking has occurred in a context of recent changes and expanding practices in paediatric gender clinics in many countries, with a sharp increase in the rate of referrals and a switch in the sex ratio of children being referred, which is now biased towards females (Kaltiala-Heino, et al.2015, Zucker, 2019). Concerns about the need for a particular consideration of autistic features of the children referred to gender clinics, have been raised (Bradley 2017, Stagg and Vincent 2019). Currently there are no reliable diagnostic or assessment tools avail- able in routine use that would enable a practitioner to discern the extent to which a child ’s autism is contributing to their wish to make a gender transition. The ‘Dutch approach ’originally posited GnRHas as ‘offering time to make a balanced decision about gender reassignment ’(de Vries and Cohen-Kettenis 2012 ). However, it has emerged that children and adolescents prescribed GnRHas invariably go on to cross sex hormones (de Vries et al.2011, Biggs 2019, Cohen and Barnes 2019). In the absence of evidence from randomized controlled trials, we are left to speculate as to why so few children and adolescents seemingly desist from their transgender identity and accept their natal sex while they are being medi- cated with GnRHas. This broad patient compliance brings with it iatrogenic risks that may include compromised bone health, fertility, genital development and sexual function (Laidlaw et al.2019). Puberty is a key period in human development, including brain maturation (Blakemore 2019) but the impact of GnRHas on the latter in ado- lescents remains largely un-investigated. However there is evidence from animal studies that GnRHas compromises cognitive functions (Hough et al.2017). Asking a child or adolescent to make a decision on whether they wish to put at risk their fertility, their genital development, their capacity for full sexual function and their brain development, in a context of an expressed need to resolved their immedi- ate distress is thus ethically problematic This leap in faith could only be unambigu- ously ethical if medical transition ensured a life better than the status quofor the patient. Indeed trans-affirmative advocates make this very claim. For example, in 2008 Giordano, the bioethicist, who had an influential role in the UK adoption of GnRHas at GIDS, claimed that ‘anything (sic) is better than life in an THE NEW BIOETHICS 227 alien (sic) body’(cited in Biggs 2019; see also Giordano 2008and Giordano and Holm 2020). However, in clinical practice, and case by case, there is no confident basis from which to test this dogmatic claim. Logically and empirically it is not poss- ible to prove whether the same child would fare differently if, instead of the biome- dical routines of the Dutch protocol, they were given psychological support in line with Bryant ’s advice noted above or they were simply offered no interventions at all from healthcare. An alternative view to Giordano is that a child may report that their body feels wrong and that they wish for something other but there is nothing objectively wrong or ‘alien ’about their body (cf. Brunskell-Evans and Moore 2018). Giorda- no ’s phrasing is an ontological statement (indicating that the body isalien) whereas a subjective account or experience is an epistemic matter, driven or even constituted by a state of existential confusion and distress. This alternative view then would be that there is nothing wrong with the child ’s body (indeed physically no abnormality is detected) but instead the child is unhappywith that healthy body. To propose a biomedical solution to this experienced distress, with no guarantee of mental health gain, risks the child ’s future health and so is a serious matter. The extent to which clinicians can transparently elaborate to patients their full knowledge or gaps in their knowledge about iatrogenic risk is always challenging, even with adults. In the case of children, because of lesser capacity the dilemma is amplified. A specific consideration about informed consent and the wish to make a gender transition is that the existential state often contains within it a strong desire for a speedy physical resolution to psychological distress. Accordingly, because of this urgent and anxious expressed need, adult patients may be inclined to discount iatrogenic risks in their pursuit of masculinizing or fem- inizing their bodies; such risk taking is also seen in patients with various types of body dysmorphia. That tendency in children and adolescents is then compounded by further constraints on capacity because of their age (Levine 2018). The latter author notes that, as a consequence, the imperative to affirm gender identity and clear a path for hormonal interventions leads to a contradiction. On the one hand the WPATH guidance recommends an informed consent process but on the other it calls for ‘hormones on demand ’. A free market in the latter would undermine a careful risk appraisal with patients. Despite this risk, some trans-affirmative authors currently object to the ‘gatekeeping ’imposition on patients about hormone availability (e.g. Ashley 2019). In light of all of this contention, the rationale and fate of the original ‘Dutch pro- tocol ’invites scrutiny. Genital surgeries are not available until the patient is at least 18 years old. Even so, in the initial Dutch cohort one of the 55 patients, who began their gender transition as an adolescent, died at approximately 20 years old. The cause of death was necrotizing fasciitis, following vaginoplasty (de Vries et al. 2014 ). Proponents of the Dutch protocol confirm its success, despite this fatality and the fact that five other patients from the first cohort failed to participate in the one year follow up (de Vries et al.2014). Furthermore, there were important missing data; at that follow up point, none of the females had yet undergone the risky procedure of phalloplasty. 228 DAVID PILGRIM AND KIRSTY ENTWISTLE Despite this weak evidence base for the universal adoption of the Dutch protocol, recently there have been calls on gender clinics and lawmakers to reduce the legal age for genital surgeries in the US and mastectomies in Sweden (Mattisson and Jemsby 2019 ). In the UK, Susie Green the CEO of Mermaids, the charity for transgender children, took her own child to Thailand for vaginoplasty at 16 years old (Gilligan 2019 ) and in 2018 Mermaids lobbied UK parliament to lower the age for children to access cross sex hormones (Mermaids 2018). However, pushing back against that lobbying, the UK Government announced in April 2020 that those under the age of 18 would be protected from making irreversible decisions (Minister for Women and Equalities Liz Truss Sets Out Priorities to Women and Equalities Committee 2020 ). Political caution about recent taken for granted forms of good clinical practice seems to be warranted on ethical grounds, in light of our earlier description of the Dutch protocol and its touchstone role. There have been a few observational, longi- tudinal studies on paediatric gender transition and high quality evidence on long term effects is lacking (Chew et al.2018, Heneghan and Jefferson 2019). Further- more, there have been no randomized controlled trials to compare the outcomes for different interventions for resolving gender dysphoria. Given the absence of clear evidence about efficacy but the known iatrogenic risks of hormone treatments, it is ethically problematic for clinicians or gender affirmative campaigners to claim that they will successfully ‘treat ’gender dysphoria and significantly reduce the risk of suicide. This point about political and ethical caution has been highlighted further by the emergence of ‘detransitioners ’and their testimonies. They report that their decisions to detransition are not being systematically documented by their gender clinics and that one of their aims in speaking out publicly is to forewarn other incipient patients. At the first UK conference for detransitioners in 2019‘Livia ’, a detransitioned woman in her early twenties reported: Lately, I ’ve just felt like it’ s incredibly important to get these stories out. I really never heard of detransitioners or detransitioning …I really thought that with gender dys- phoria you cannot regret transition …transition simply didn ’t help me …I pass as male …I’m treated as male and that felt really, really good but when I went back home and could look at myself in the mirror and I still didn ’t see a man. When I look at my body I realise I ’m never going to see a male body …so why am I doing this? Alternative accounts of the complex outcomes of cross sex hormones and gender surgeries gleaned from social and printed mass media have foreshadowed systematic research because service developments and objections to them have occurred already. The field of paediatric transgender medicine is not like drug or vaccine development, where there was a long period of testing before clinical innovations were permitted. Instead, services themselves are the trial for the widely adopted ‘Dutch protocol ’noted above, in the sense of being a naturalistic experiment, which is already accruing its supporters and critics. Currently, paediatric medical transition is conceptualized as a staged process, where the child or adolescent consents to medical interventions at each ‘stage ’. However, it has not been rigorously investigated as to whether the putative stage THE NEW BIOETHICS 229 distinctions are actually valid. As was noted above, nearly all children who are pre- scribed GnRHas go on to cross sex hormones, de factoblurring the stage distinction, even though gender clinicians do not obtain informed consent for both at the outset. There is also a blurring of the ‘stages ’between testosterone and hysterectomy for female patients. For example, an information leaflet from a UK NHS Adult Gender Clinic recommends a hysterectomy routinely, after two years of taking tes- tosterone because of typical thickening of the uterine wall (Seal 2016). If this patient advice is accurate then paediatric gender clinics should have a duty to present female adolescents with the same information given in adult services, when they are eligible to begin testosterone at around 16 years old. Overall, there appears to be a strong case that for female patients GnRHas, testosterone and hys- terectomy are inextricably linked and so informed consent should be obtained for the three interventions at the outset. These concerns about physical effects predomi- nate in ethical considerations about iatrogenesis. In addition there is the matter of defining mental health outcomes, which itself is a point of contention in this field. For example, in the 1970s feminist mental health professionals, led by Ann Chap- pelle (Bryant 2006) objected to the creation and inclusion of Gender Identity Dis- order in Childhood in DSM-III, published in 1980, because they did not believe ‘ masculine girls ’should be pathologized (a concern that has now come to pass in current services). As Lev ( 2006) commenting on this period noted, DSM did ‘not appear to recognise the impact of forty years of feminism ’and referred to the DSM-IV-TR diagnostic criteria for Gender Identity Disorder as the ‘clinical reifica- tion of sexism. ’However, that position was one of second wave feminism of the 1970s. As we will now discuss, third wave feminism imported a different ideology about sex and gender. Competing notions of personhood The above ethical considerations about informed consent and iatrogenic risk are being debated in a wider context in which rights about personhood are also being contested. In particular there is an incommensurability between claims from gender critical feminists that a woman is an ‘adult human female ’and those from transgender activists and allies that ‘a transwoman is a woman ’. The two positions are not just about different versions of ethical warranting about the nature of male and female personhood, they reflect incommensurable presuppo- sitions about ontology. For those who state that a woman is an ‘adult female ’, sex is determined at fertilization and then describedat birth. This realist assumption follows from the evidence that in over 99.9% of cases in all mammals, including humans, there is clear sexual dimorphism. Intersex phenomena are the exception that proves this rule of biological ontology and even in those cases what happens at fertilization is immutable (Delimata 2019). For philosophical realists, the notion of ‘non-binary ’is simply unwarranted in relation to sex. If a woman is an adult female and a man is an adult male, then cross sex hormones and/or surgery of phenotypical presentations do not alter that ontological distinction. Realists concede though that gender expression can vary across time and place; its range and forms of meaning are linguistically mediated 230 DAVID PILGRIM AND KIRSTY ENTWISTLE and socially negotiated. They also concede that, subjectively, people may be dis- tressed about the sense of who they are. However, these matters of gender non-con- formity and identity confusion have no logical bearing on the immutability of biological sex (Hull2006, Pilgrim 2018). The prospect that this realist conventional wisdom might be open to question began with the transsexual patient during the twentieth century and with it the notion of a ‘sex change ’was now possible making sex an option not a biological fact (Gherovici 2010). If psychologically and culturally ‘sex ’might be a matter of choice, not biology, then medical science could be called upon to confer mutability in practice. In parallel to this, the social science research community began to replace ‘ sex ’with ‘gender ’to describe subjects in order to respect and reflect this cultural shift about self-identity (Haig 2004). Today the taken for granted assumption from transgender activists and supporters is that ‘gender ’and/or ‘sex ’is assigned at birth (Human Rights Campaign n.d). This social constructivist position then is at odds with traditional realist understandings of biological facts noted above. Not only are sex and gender conflated they are ren- dered a linguistic matter, perspective or the subjective judgement of the adults present, with no ontological referent. This epistemological position of ‘perspecti- vism ’emerged, during the 1980s with post-structuralism, Queer Theory and third wave feminism, marking a break with the realist orthodoxy of both biological science and second wave feminism (Butler, 1999, Feinberg 1999). We now have a tense legacy with both of the above contrasting metaphysical positions shaping healthcare policy unevenly. Reflecting this postmodern turn, the glossary on the UK GIDS website states, Gender assigned at birth is a term used to describe the gender that someone was identified as at birth, usually by looking at their genitalia …Historically, our service used the terms “natal / born ”or “biological ”to describe the sex and gender someone was identified as at birth. However, we try where possible to avoid these terms now as some people feel that they privilege biology over their lived and felt identity. ( https://gids.nhs.uk/glossary ). This service philosophy then has a strong embedded constructivist presumption and its anti-realism runs the risk of confusing young patients. There is a clear difference between children and adolescents believing that hormones and surgery will make them the opposite sex and them believing that although their sex will not change, hormones and surgeries might enable them to ‘pass ’as the opposite sex. If a young female patient believes that testosterone and surgery will enable her to produce sperm and impregnate a woman (Chiniara et al.2019) then she is mistaken and so a naïve gender affirmation policy in clinics would risk that patient being misled. Moreover, the feeling of being an imposter may emerge or remain: ‘ passing ’has been reported to bring its own problems (Mccann 2017, Switz 2019). Finally in this section we can note the importance of sex-linked pathology. The failure to distinguish sex from gender can matter profoundly in healthcare. The naïve replacement of sex with gender will create problems in attending to sex- linked forms of pathology, which is important for medical records (Dahlen 2020). Abdominal pains for a transwoman will never be because of uterine fibroids and THE NEW BIOETHICS 231 only natal men, not transmen, might develop testicular cancer. The different immune response triggered by XX or XY chromosomes affect both mortality and morbidity (Moalem2020). For example, in the Covid pandemic of 2020, biological males were twice as likely to die as females. Freedom of expression In contrast with the ethics of paediatric medical transition, other controversial matters such as abortion or the de-pathologisation of homosexuality have been recurrently and fully debated by protagonists adopting different and competing ethical stances, arising for religious or scientific reasons. However, the increasing incidence of paediatric medical transition is occurring in a different context. There is clear evidence that those expressing ethical or political doubts about clinical rou- tines, which are predicated on a gender-affirmative approach, which prioritizes the diagnosis of gender dysphoria over psycho-social formulations case by case, are being constrained or silenced, A key event occurred in 2015 when the clinical psychologist Ken Zucker was dis- missed from his lead role at the Family Gender Identity Clinic at the Centre for Addiction and Mental Health (CAMH) in Toronto. His biopsychosocial model for childhood gender dysphoria (Zucker et al.2012) aimed to help children ‘feel comfortable in their own skin ’. His preference for psycho-social interventions, rather than biomedical ones (though he did not reject these wholesale), attracted the attention of transgender activists. They created a petition entitled ‘Eliminate Dr Kenneth Zucker and his Practice of Transgender “Reparative Therapy ”’, which obtained over 2000 signatures. After he was dismissed, and following litiga- tion, he received an apology from his previous employers and a substantial financial settlement, though he was not re-instated. Zucker and his supporters have argued that his biopsychosocial model was mis- represented as ‘conversion therapy ’and that gender dysphoric children are likely to be affected detrimentally because of the impact of ‘strident politics ’(Herbert 2016). However, there are activists and academics in North America and the UK who con- tinue, inaccurately, to describe Zucker’ s practice as‘conversion therapy ’(Wright et al. 2013). The Zucker case appears to have had a contradictory recent cultural impact. On the one hand many sceptical clinicians may fear expressing their doubts about service philosophies, notably the Dutch protocol. On the other hand, this has also stimulated critique and robust opposition from a range of parties, who in turn have then been attacked by their opponents. That tension was evident before the Zucker case, with trans-activist attacks being evident in relation to academic critiques of the metaphysical assumptions of their ideology (e.g. Bailey 2003, Dreger 2015). These hostile reactions were also evident in response to the suggestion by Blanchard (2005 ) that some transgender patients are sexually aroused by the image of themselves as a woman ( ‘autogynephilia ’). These episodic attacks on anyone who, for any reason, might query trans affirma- tive assumptions and aims have taken a variety of forms, both in professional dis- course and in wider public discussions. As well as the Zucker case, some gender 232 DAVID PILGRIM AND KIRSTY ENTWISTLE critical feminists have been‘no platformed ’on university campuses or have suffered hostile lobbying about their teaching (publicized cases in Britain include those of Julie Bindel, Linda Bellos, Kathleen Stock, Selina Todd and Germaine Greer). Fur- thermore, women attempting to meet to discuss their sex based rights have been met by angry demonstrations and actual or threatened violence (including bomb threats). These female academics are today sustaining a position from second wave feminism about the ontology of sex (Oakley 1972, Greer 1999). Another example of attacks upon academic freedom was in 2017 when James Caspian a research student at Bath Spa University was banned from investigating detransi- tioners. He challenged in the ban in court but was unsuccessful. Thus, a shift in both public and academic discourse is now discernible. The tra- ditional emphasis upon freedom of expression and the avoidance of ad hominem attacks associated with defences of liberal democracies (Mill 1859, Arendt 2005) have now been challenged by the growth of identity politics. Criticism from the latter can now extend to the denial of freedom of expression, with ad hominem attacks being warranted by the claim of ‘epistemological privilege ’. In this case the logic or evidence offered by a critic can be deemed to be irrelevant and dismis- sible if they are not transgender themselves. The legitimacy of the speaker or writer and that of their view become conflated. In another example of the subversion of open dissent about gender, in 2019 the British Psychological Society (BPS) issued guidance that uses terminology such as ‘ gender assigned at birth ’and indicates that transgender is a ‘part of human vari- ation ’(a truism). The guidelines state that clinicians should typically take an affirma- tive stance towards transgender identity and that they must provide ‘robust clinical reasoning ’, when and if they do not support a client ’s transgender identity, including in forensic or neuropsychological contexts (British Psychological Society 2019). This guidance renders any researcher or clinician expressing doubts about a policy of ubiquitous gender affirmation in their work as being ethically suspect. Such doubts, according to the guidance, may reflect ignorance or prejudice; they are not afforded any legitimacy as viewpoints. With this guidance in mind, clinicians might then be constrained in their discussion of clinical complexity or the increasing numbers of referrals of adolescent females to paediatric gender clinics. Psychologists may also wish, in good faith, to explore gender dysphoria in adoles- cents as being embedded in a wide range of psychosocial difficulties, emerging from particular familial, educational and social contexts. Psycho-social complexity is likely to be unacknowledged if the focused and routine expectation in psychology services is to affirm transgender identity, diagnose gender dysphoria and refer on to endocrinology services. Currently, the BPS guidance would seem to inhibit, not encourage, ethical debate about all of these matters. The implications of the BPS guidance, if taken as a prescription for good practice and a warning against deviations from its strictures, are several. The heterogeneity of clinician viewpoints about their practice would be denied or their discussion supressed (Hilário 2019). On the demand side the highly varied emergent context of gender non-conformity in young people would be dismissed in favour of a reduc- tionist form of practice based on routine affirmation and diagnosis of gender dys- phoria, with a typical referral on to endocrinology services. In particular the THE NEW BIOETHICS 233 variegated mental states of children referred (including autism) and particular par- ental motives would be obscured and their full exploration discouraged.Ironically, the BPS guidance legitimizes a very limited psychologicalrole within a form of practice necessarily dominated by biomedicine (hormones and surgery). This fails to exhaust other psychologically-informed forms of practice, including individual and family therapy or even the normalizing choice of deliberate non-inter- vention. These options are commonplace in mental health services more widely and yet paediatric transition, for now, is governed by a much more limited approach. The BPS guidance strongly reinforces, rather than cautiously debates, these current restrictive clinical norms. Conclusion We have widened the lens beyond the clinical practice of prescribing GnRHas and cross sex hormones to children and adolescents presenting at gender clinics. We pro- vided reasons why paediatric gender transition should be considered holistically and that the current practice of obtaining informed consent to medical interventions individually is open to serious question. There is a lack of evidence to date to show that the benefits of the ‘Dutch protocol ’ outweigh its iatrogenic risks. Children and adolescents are being asked to make sig- nificant decisions about their future lives and appearance, even though no public consensus has been established about male and female personhood. The Dutch pro- tocol, guided by a trans-affirmative approach, was enacted and adopted elsewhere internationally before the ethics of medical transitioning in children had been debated or the efficacy and safety of hormonal and surgical interventions had been established properly. At present paediatric gender clinics may claim that a child is able to provide informed consent to GnRHa as the ‘first step ’. However, GnRHa is not a circum- scribed intervention as part of a clear and neatly staged set of decisions. Instead it is the beginning of a highly complex medico-legal process that has become highly contested. In the current context of ethical controversy, gaps in evidence and unre- solved legal proceedings, informed consent cannot be ensured for patients. Accord- ingly, caution is implied and the stricture of non-maleficence should be considered seriously. We have argued that it is necessary to situate paediatric medical transition in the social context of rights-based arguments about male and female personhood and we finished by considering the wider ethical question of freedom of expression. The debates on paediatric transition and the conflict between women ’s rights and trans- gender rights are unusual because they have been characterized by processes of suppression. Freedom of expression about unresolved empirical and ethical matters in relation to paediatric gender transition has been constrained by a range of recent cultural forces. These include the intimidation of academics, the punishment and disparage- ment of dissenting clinicians and the insinuation of an uncritical gender affirmative approach into guidance from professional organizations. 234 DAVID PILGRIM AND KIRSTY ENTWISTLE We conclude that ethical discussions about paediatric medical transition should attend to all three of the domains outlined at the start. The second and third provide us with a context of reflection, beyond the immediate pressing dilemmas facing clinicians encountering children and adolescents in gender clinics. This is a wider public policy contention that is not limited to clinical dilemmas alone. Disclosure statement No potential conflict of interest was reported by the author(s). Notes on contributors Dr David Pilgrim is Visiting Professor of Clinical Psychology, University of South- ampton. His books include Critical Realism for Psychologists (Routledge, 2020) and Child Sexual Abuse: Moral Panic or State of Denial? 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