Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach

Abstract

Lesbian, gay, bisexual, and transgender (LGBT) adolescents experience disparities in mental and sexual health. There is also a lack of research on this population relative to other adolescents, which limits our ability to effectively address these health disparities. Researchers may unfortunately avoid conducting research with this population because of anticipated or actual experiences with difficulties in obtaining IRB approval. A case example is provided to illustrate the ethical and regulatory issues related to research with LGBT adolescents. Relevant U.S. federal and local regulations related to research on sexual and mental health with adolescents is then reviewed. Data are presented demonstrating that requiring parental consent for LGBT youth under age 18 would likely alter study result. Data are also presented on participants’ appraisals of the risks and discomforts associated with research participation. The provision of such empirical data on the risks of research participation is consistent with the goal of moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based. Finally, recommendations are provided on how to approach these issues in IRB applications and investigators are called to help to build a corpus of scholarship that can advance empirical knowledge in this area.

Appendix 1: Relevant Sections from an IRB Application Related to Waivers of Parental Consent

XVII. Request for Waiver of Consent, Alteration of Consent, or Waiver of Documentation

An IRB may (1) approve a consent process that does not include, or alters, some or all of the elements of informed consent, or (2) the IRB may waive the requirement to obtain written consent (called a waiver of documentation), or (3) the IRB may waive the requirement to obtain informed consent entirely. In order to make these determinations, the IRB must ensure that the Federal requirements for each waiver/alteration criterion are met and justified for the specific research protocol.

• A. Are you requesting a waiver of informed consent or an alteration of consent under 45 CFR 46.116 (d) for all or part of the research? No Yes

  If YES are you requesting a:

  Waiver for all of the research Waiver for recruitment purposes An alteration of consent

  If a waiver or alteration is not being requested, then please proceed to question D below in the application.

  If you are requesting a waiver or alteration of consent, proceed to question B below. If you are requesting an alteration, also complete question C.

In order to apply for a waiver or alteration of consent, you must provide protocol specific justification for the four following criteria. A waiver may be requested for the entire study or for only one portion of the research (for example: a waiver of informed consent is requested to identify potential research subjects from medical records, but informed consent is still be required for the later enrollment of the subjects for research participation—called a waiver for recruitment purposes). NOTE: If you are requesting a waiver of consent and accessing PHI, a waiver of authorization is probably also required.

• B.  

  • 1. Please provide a written explanation as to why you believe the proposed research (or portion of the research) will present no more than minimal risk to the subjects who participate:

We are requesting a waiver of parental permission for participants who are ages 16–17. Minor participants will be completing interviews on topics such as their sexual behavior, drug use, mental health, exposure to violence, relationships, and personal attributes. There is minimal risk that participants will feel a little awkward about completing these questionnaires. Participants can stop the interview at anytime without negative consequences or skip any question.

There is also the possibility of loss of confidentiality. We have taken steps to minimize this possibility (1) All identifying information will be kept in password protected file on a password protected server. Only project staff will have access to it. The password will be regularly changed and will be immediately changed if there is any staff turnover. (2) Questionnaire data will be stored using ID only (with the temporary exception of retaining contact information during the scheduling process). Data entered into computer files will be maintained on a subdirectory of a password protected server. (3) All data will be collected by well trained staff members who have been trained in the protection of human subjects and who have signed a confidentiality agreement.

We will also retained youth advisors, to act as youth advocates to assist youth in making decisions about participation and to make sure youth are not coerced into participating. The youth advisor will be a staff person who is not a staff member of the current project (to make them unbiased), but who is informed about the aims and methods of the study, and who has experience working with youth.

• 2. Please explain whether or not a waiver or alteration of informed consent would adversely affect the rights and welfare of subjects:

The formal evaluation of decisional capacity by the PI and/or trained staff and the inclusion of independent youth advocates will help assure that participants’ rights are not violated. There is concern that the requiring of parental permission will put some youth at risk regarding disclosure of their sexual orientation to their parents. This may place these youth at risk for parental harassment, abuse or expulsion from the parental home.

• 3. Please explain whether or not it would be possible to conduct this research without a waiver or alteration of informed consent:

We believe that it would not be possible to complete this research without a waiver of parental permission for youth 16–17 years old. The costs and time associated with contacting the parents/guardians would be prohibitive. More importantly, in accord with national policy recommendations from the Society for Adolescent Medicine we believe requiring parental permission for the proposed study would have a number of possible negative effects, including: (1) reducing the validity of the findings by effectively eliminating potential participants unwilling to share permission forms with their parents/guardians; (2) increasing risk to some youth whose parents have a negative response to the material in the permission forms that would (correctly) suggest their child has a minority or alternative sexual orientation; and (3) adding little in the way of actual subject protection, given the minimal risk of participation in this study.

• 4. Please explain your plans, when appropriate, for providing any pertinent information to the subjects at a later date (e.g., after their participation in the study):

The fourth criterion for an alteration is appropriate under conditions in which information is deliberatively withheld from the research subjects in order to accomplish the intent of the study (e.g., psychological experiment with deception). However, this criterion would not apply to the current study since no information would be withheld.

• C. If you are requesting an alteration of consent, please describe in detail how you wish to alter the consent process and justify the need for this alteration.

We are altering the consent process for 16 and 17 year olds by waiving parental permission. Parental or guardian permission is not a reasonable requirement for our research with LGBQQ youth. Parental permission could put some youth at risk regarding disclosure of their LGBQQ identification to their parents. This may then place these youth at risk for parental harassment, abuse or expulsion from the parental home. Some of the adolescent participants may be homeless or accessing services at CBOs that provide HIV prevention services to adolescents (e.g., HIV testing, condoms) without parental knowledge. In these cases, it would be unreasonable to obtain parental consent primarily because adolescents would be unlikely to provide the name of their parent/guardian for fear of being returned home or punished. Additionally, attempting to contact a parent/guardian could place some youth at risk. Parental permission could not only place these youth at increased risk, but it would also substantially limit the generalizability of our research.

We have put in place several appropriate mechanisms for protecting the minors who participate in our research. (1) As part of the consent process, the RA will make a formal assessment of the each youth’s decisional capacity to consent prior to obtaining written formed consent. The formal assessment of a youth’s decisional capacity for participation in research will use a 2-step process. Consistent with research by Dunn and Jeste (2001), the first step will involve a determination of the participant’s understanding of the study goals as previously explained by the RA during a review of the procedures. Youth will be asked, “Can you tell me what this study is about?” In step 2, potential subjects will be asked questions designed to assess their capacity to understand, appreciate, reason with, and express a choice about participation in our specific protocol. We will use a modified version of the Evaluation to Consent Form widely used by a number of university researchers for the determination of decisional capacity to consent for participation in research (Dunn & Jeste, 2001; Moser et al., 2002; UCSD Task Force on Decisional Capacity, 2003). Participants will be asked to: (1) name things they will be expected to do during the study, (2) explain what they would do if they no longer wished to participate in the study, (3) explain what they would do if they experienced distress during the study and (4) identify potential risks for participating in the study. Respondents able to, in the judgment of the RA, communicate and give acceptable answers to these questions will be considered eligible to consent. Whenever the RA feels there is a question about the need for a more formal assessment of the decisional capacity of a potential participant he/she will be instructed to contact the PI before proceeding with the consent procedures. (2) There will always be a youth advocate on hand who is not involved in the research who will serve as an independent youth advisor. The advisors will be trained on the importance of their role and be given a brief overview of the study. After the study is explained to a potential participant, they will be given an opportunity to speak to the independent youth advisor before they make their decision to assent to participation.

The waiver is not inconsistent with Federal, State, or local law. 45 CFR 46.402(a) defines children as, “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” Illinois does not have a low about the legal age for consenting to research participation. We note that our youngest participants are age 16. In the state of Illinois persons as young as 12 are allowed to consent to STI and HIV testing and treatment, substance use/abuse treatment, and mental health care without requirement to notify parents (Field et al., 2004; Guttmacher Institute, 2010).