Flexibility Coalition Conf. Call

7/13/2011 11-12 PST

Hosted by Susan Rose, USC Office for the Protection of Research Subjects

Susan Rose, USC began call

  • Background of flexibility policies
  • Un-checking the box on one’s FWA is a first and significant step toward exercising flexibility within the regulations. It provides reporting relief for studies that are not federally funded
  • Judy Birk, University of Michigan began the first project on flexibility with the encouragement and support of AAHRPP. UMI policies were highlighted at the AAHRPP Conference. Moira Keene, University of Minnesota also was early proponent of flexibility within the regulations
  • USC copied concepts from the 2 pioneers. USC worried about the implications of the California Health and Safety Code so sought advice from other CA sites and formed the coalition
  • Coalition Goal: meet in-person at PRIMR and AAHRPP meetings and conduct 2 phone calls per year on specific topics to search for and implement sound, flexible policies

Main speaker Marjorie Speers, AAHRPP

  • Flexibility within Subparts B, C, and D
  • Subpart B: Pregnant women, fetuses, neonates
  • Was revised 10 yrs ago to apply when pregnant women are involved in research (previously, the subpart only applied to research that specifically targeted pregnant women) and the research purpose is “the development of important biomedical knowledge”
  • Application of subparts need not be automatic
  • 2 flexibilities to consider for non-DHS funded studies: 1) apply Subpart only when study targets pregnant women 2) if a study may not contribute to biomedical knowledge (e.g., SBR studies), the IRB can determine that study can contribute to generalizable knowledge
  • Some institutions are not applying Subpart B to social-behavioral studies when studies involve no more than greater risk and no physical interventions (acceptable to AAHRPP).
  • In regard to surveys of pregnant women, site may fall back on assessing risk (is it no greater than minimal?) and determine which sections of the subpart are applicable. (I.e. for a survey that is minimal-risk and is not targeted toward pregnant women, a requirement to have animal data may not be applicable)
  • Some industry-sponsored studies may exclude pregnant women but if a woman becomes pregnant in the study, sponsors want to collect data to monitor the women and the fetuses. In this case, can specify in consent what will happen should the subject become pregnant (e.g., discontinue intervention but continue data collection)
  • Subpart C: Prisoners
  • Only two government bodies have regulations on prisoner research: HHS[1] and the Bureau of Prisons in Department of Justice
  • Federal regulation define prisoners as “individuals who are involuntarily detained”
  • Relevant questions to determine application of Subpart:
  • Should the following people be considered prisoners: 1) a person wearing an ankle monitor, 2) a person in rehab/ halfway house 3) a person committed to community service or any other alternative to avoid time in prison
  • What to do about subjects who become incarcerated during the course of a study? Do they continue in study? How do you review protocol? Do you define them as prisoners?
  • Prisoner research needs to be approved under 1 of the 4 categories in Subpart C (or via the Secretary’s Waiver for Epidemiologic Research [2])
  • Prisoner reps – use consultant reviewers or IRB members with appropriate background
  • If unsure how to proceed/approve a minimal risk study of benefit to prisoners, consult with other institutions or OHRP; address state law on prisoners
  • Subpart D: Children
  • Regulations exist in HHS and FDA for children as study subjects
  • Research has to fall into 1 of the 4 categories (404, 405, 406, 407), evaluate vulnerability of population and potential benefit of study, make sure the risks are minimized
  • Opportunities for flexibility with adolescent subjects
  • Waiving parental permission if the child can benefit (if permission cannot be waived based on 46.116D, consider 46.408)
  • Institutions are reluctant to waive parental consent for fear of damaging their relationship with the community

Judy Birk, University of Michigan

  • Update on Flex Initiative/ Demonstration Project
  • Allows for 2 yr approval and adds 1 new exemption category for analysis of identifiable data
  • Judy Birk estimates that several hundred projects have been exempted and several thousand have received two year approval
  • University of Michigan has not encountered any publication problems for flexed studies
  • Some PIs have requested traditional IRB approval (MS comment: journals are concerned that study received “appropriate” review meaning what is required by institution and regulations).

(University of Michigan initiative has been by all measures a huge success)

Anastasia Doherty, Stanford University

  • Announcement of new Flex Policy
  • 3 year approval for medical, no more than minimal risk, non-federally sponsored research
  • Will be implemented in Sept.
  • Targeted toward student projects, not intended for biomedical research

Additional Items

  • Susan Rose/ Marjorie Speers re: OHRP Proposed Rule Making – ANPRM – expected ASAP
  • Proposed changes would affect all of 45 Part 46
  • ANPRM includes many questions, please respond ASAP when it is released or we all have to live with what is now proposed. Answer/ address questions that matter most to your organization as the volume of questions explored in the rulemaking is daunting and broad.
  • Coalition Website/ Follow up
  • Send comments, questions to Monica Aburto at ; unsubscribe / subscribe others to list
  • OPRS “Flexibility Coalition” will include policies (with permission). Send policies if you want to share. www.usc.edu/oprs/flex.html

[1] Under 45 CFR 46.101(i) the Secretary of DHHS has the authority to waive the applicability of some or all of the provisions of the DHHS regulations for the protection of human subjects to specific research activities or classes of research activities otherwise covered by the regulations.

[2] The Epidemiological Waiver specifically allows the Secretary of DHHS to waive applicability of requirements to Subpart C: 45 CFR 46305(a)(l) and 46.306(a)(2) for research involving epidemiologic studies that meet the stated criteria. OHRP has the final say as to whether or not the research qualifies for the Epi waiver.