Position Statement 26: Participant Protections in Psychiatric Research
Mental Health America (MHA) is dedicated to promoting mental health, preventing mental health and substance use disorders and achieving victory over mental illnesses and substance abuse and dependency through advocacy, education, research and service. One of MHA’s goals is the development of a broad-based national research agenda that includes basic research, diagnostic and treatment research, services research and prevention research.
MHA strongly supports continued and expanded research into the causes, progression and treatment of the full range of mental health and substance use disorders. Research is necessary to enhance existing treatment and service methods and to discover and test safer, more effective, evidence-based interventions. 1 To accomplish this, the participation of human subjects is essential. Thus, a balance is needed to protect individuals with mental health and substance use conditions participating in such research. The federal regulations concerning the “Protection of Human Subjects” 2 strike a good balance in providing that protection.
When provided with accurate and complete information, people with mental health and substance use conditions can make thoughtful and informed decisions about participation in psychiatric research, adhere faithfully to research protocols, and provide valuable, randomized evidence to improve treatment. It is extremely challenging to provide information about research studies that is both complete and understandable to individuals without specialized medical training, but every effort should be made to do so. In all cases, a number of measures must be taken to ensure protection of the health, safety, and rights of participants. Such protective measures (described under Background) include ensuring:
- A thorough Institutional Review Board (IRB) assessment
- Access to an independent advisor
- Access to reasonably clear and complete information
- Informed consent
- The opportunity to create advance directives
- The right to withdraw from the study at any time
- Protection of confidentiality
- Receipt of new and updated information as the study proceeds; and
- Arrangements for post-study care.
Where there is a significant risk of acute psychotic episodes or other cognitive impairment, potential treatment issues should be raised during the consent process, and advance directives should be offered to assure that the treatment dialogue takes place prior to any loss of capacity.
Partnerships between mental health consumers and researchers are essential to continually improving our understanding and treatment of mental health and substance use disorders. MHA believes that the following measures are essential to protecting the health and rights of research participants, while also facilitating scientific advances:
Prior to implementation, proposed research projects must be reviewed by an Institutional Review Board (IRB) in accordance with federal regulations and Office of Human Research Protections (OHRP) guidance. 3
Access to an Independent Advisor
Each IRB must include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. OHRP guidance also makes provision for an independent advisor 4 (Ombudsman) to advise potential participants on the risks and benefits of participation in the proposed research project, as required. MHA believes that, before giving initial consent, participants should have access to an Ombudsman or other healthcare advisor upon request who is independent from the interests of the research project or institution and who will advocate for the safety of research participants. The Ombudsman should be approved by the IRB and should be sufficiently trained to be able to effectively advise research participants about the risks and benefits of the research. In addition, the Ombudsman should be available to advocate for research participants whenever their continued ability to provide informed consent is uncertain, or when there is a significant risk that continued participation could produce deleterious effects on a participant. This is particularly important if the participant is incarcerated or civilly committed. 5
Persons with mental health conditions must give informed consent to participate in medical research. 6 MHA does not support enabling authorization by another person as a legal representative for the purpose of the initial consent to participate in medical research. Children who are capable of understanding their role in proposed research should be required to give their assent before parents can give consent to their participation. 7
Steps should be taken to ensure that participants comprehend the information they receive not only before they agree to study participation, but throughout each phase of the study. All written and verbal information provided to a participant (or potential participant) must be linguistically appropriate, and written using language that is appropriate for the potential participants’ reading level. Any necessary accommodations must be made for people with disabilities or with low literacy levels. (e.g., by providing information in sign language or Braille). 8
MHA supports the use of advance directives concerning participation in medical research as a means of encouraging people with severe mental illness to participate in advancing the effectiveness of treatment. All research participants should have the right to provide advance directives for treatment or research prior to participation in the study, which are followed by the research staff. MHA supports the inclusion of advance directives as part of the informed consent process for all research studies. 9
Right to Withdraw at Any Time
All participants have the right to withdraw from a research study at any time without consequence. In those cases where abrupt discontinuation of treatment could harm the participant (e.g., sudden discontinuation of a medication), the research team must work with the participant to ensure that the withdrawal process is monitored and conducted as safely as possible, and that substitute treatment is provided.
All research participants have the right to confidentiality of their medical records, unless otherwise specified in the consent form.
Provision of New Information
All research participants must be informed of any new information that becomes available during the course of the study that might affect continued study participation (e.g., changes in the risk associated with the research). 10
All medical research designs should ensure continuity of care for participants following the conclusion of the research project. Participants should be followed for a minimum of six months post-research to ensure that they are medically stabilized and reconnected with essential services.
This policy was approved by the Mental Health America Board of Directors on June 9, 2012. It is reviewed as required by the Mental Health America Public Policy Committee.
Expiration: December 31, 2017
- See, generally, MHA Position Statement 12, Evidence-based Healthcare, http://www.nmha.org/go/position-statements/12
- 45 CFR, Part 46, http://ohsr.od.nih.gov/guidelines/45cfr46.html
- 45 CFR §§46.107-46.115.
- CITATION NEEDED
- 45 CFR §§46.301-46.306.
- 45 CFR §46.116. For more details on the process necessary to obtain informed consent, please see "What should you ask before agreeing to participate in a research study?," prepared by Mental Health America in partnership with the National Institute of Mental Health, June 2001 http://www.mentalhealthamerica.net/go/information/mental-health-info/research-studies/what-should-you-ask-before-agreeing-to-participate-in-a-research-study
- Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. 45 CFR §§46.401-46.409.
- Paul P. Christopher, M.D., Mary Ellen Foti, M.D., Kristen Roy-Bujnowski, M.A. and Paul S. Appelbaum, M.D. “Consent Form Readability and Educational Levels of Potential Participants in Mental Health Research,” Psychiatric Services 58:227-232 (2007).
- See, generally, MHA Position Statement 23, Advance Directives, http://www.nmha.org/go/position-statements/23
- 45 CFR §46.116(b)(5)