Dear research community member,
The process of obtaining consent for research requires researchers to affirmatively establish that every prospective participant, or their legally authorized representative, understands the risks and benefits of the proposed study, as well as the available alternatives to participation.
The Institutional Review Board (IRB) has released new policies and forms related to capacity to consent that directly impact your role as a member of a human study research team. The new policies, which were approved August 2016, will be enforced starting October 15, 2016 and are applicable to all research conducted by University of Minnesota, Fairview and Gillette researchers.
Policy HRP-110: Research Involving Adults with Absent, Diminished, or Fluctuating Capacity to Consent to Participate in Research establishes requirements for investigators who plan to enroll adults with absent, diminished, or fluctuating capacity to consent. This includes the use of one of the following validated tools to be used to assess capacity to consent in research studies:
- For greater than minimal risk research: MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)
- For minimal risk research: UCSD Brief Assessment of Capacity to Consent (UBACC)
Investigators working with these populations may choose to use another validated instrument, but they must provide a rationale for use of the instrument and description of the training plan for study staff who will administer the assessment.
Policy HRP-111: Research Involving Adults Under Court Jurisdiction establishes that researchers may not recruit or enroll certain persons in any psychiatric drug, device, or biological trial, including individuals:
- Subject to a commitment petition
- Temporarily confined involuntarily under: a) 72-hour emergency admission hold; b) “intent to leave” period; c) peace officer/health officer authority or a court apprehend and hold order
Policy HRP-403C: MN Laws that Affect Research reflects two changes to Minnesota law effective August 1, 2016:
- Prohibits investigators from enrolling a patient on an involuntary hold (72-hour emergency admission hold, peace officer transport hold, or court apprehend and hold order) into any clinical drug trial
- Requires investigators in the Department of Psychiatry conducting clinical drug trials to notify the Minnesota Ombudsman for Mental Health and Disabilities within 24 hours of a research participant’s death or serious injury
To access and review these and other policies online, visit:
HRPP Toolkit (HRP-110, HRP-111)
IRB Policies (HRP-403C and all other IRB policies)
Revised Application and Appendix I
Questions about how investigators address vulnerable populations are now in the biomedical and social and behavioral application, where an expanded definition of vulnerability is provided. Appendix I has been revised to focus exclusively on Adults Lacking Capacity to Consent or with Diminished or Fluctuating Capacity to Consent.
Companion Documents to Policies HRP-110 and HRP-111: HRPP Toolkit
The HRPP Toolkit is a set of documents for use and reference by IRB staff, IRB committee members and researchers. While the HRPP Toolkit is still being developed (complete rollout is anticipated in approximately six months), many important documents, including SOPs, worksheets and checklists related to capacity to consent, are now available.
More information about the HRPP Toolkit will be shared with the research community in the coming months. In the meantime, please take the time to review the resources below and feel free to contact one of the HRPP staff members if you have any questions about how they can help investigators with the consent process.
The IRB will require training of all personnel who participate in the consent process whenever adults with absent, diminished, or fluctuating capacity to consent will be enrolled. An online, interactive course, Assessing Capacity to Consent to Research, is now open for enrollment. The course is accredited by the University of Minnesota Office of Continuing Professional Development and is certified for 4.0 AMA PRA Category 1 Credits™.
While the primary focus of the course is the administration of capacity assessment tools in research, including the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the UCSD Brief Assessment of Capacity to Consent (UBACC), everyone who participates in the consent process with adult participants is welcome (and encouraged) to complete this course.
Complete the registration request to start enrollment.
Town Hall Meetings
Representatives from the IRB will discuss these new policies and documents at two town hall meetings:
- September 27, 9:00am – 10:00am, Moos Tower 2-690
- October 11, 2:30pm – 3:30pm, Moos Tower 2-530
Please register to attend.
Two drop-in sessions are also available to meet with IRB staff to discuss the new requirements: These sessions will be held on the following days:
- September 30,11:00am – 1:00pm
- October 14, 11:00am – 1:00pm
Drop-in sessions are held in the HRPP conference room (D528 Mayo). Registration is not required.
Thank you for your commitment to the ethical and responsible conduct of research and your continued efforts to ensure that the rights and welfare of research participants are protected.
Debra A. Dykhuis, CIP
Executive Director, Human Research Protection Program