Flex Coalition Talking Points: April 7, 2011

· The meeting started with introductions.

· Sharon Friend asked if Cedars Sinai would also be a part of the group.

o Susan said she would extend an invitation to EiFaang Li at Cedars to join the group.

· Sharon friend mentioned that the CTSI collaboration with Cedar’s is working well overall. She mentioned that there are some problems with each sites Radiation Safety Committee (as an example).

· Susan notified the group that USC responded to the President’s bioethics request that was in the Federal Register and will share USC’s response and asked the group to share their responses.

· Susan mentioned the goals of the group

o Share Resources

o Correspond as a group

o Potential lobbying group for Human Subject Protection Issues

o Keep Moira and Marjorie as advisory committee members.

· Susan asked if everyone has unchecked the box on their Institutional FWA.

o UCI has not yet unchecked the box, but plan too.

o Stanford has unchecked the box for their main campus but not the medical school campus. Marjorie Speers confirmed that although Stanford has not yet unchecked the box they did write in their FWA assurance with OHRP that they will not report issues with any unfunded research to OHRP.

· Sharon and John mentioned that they spoke with Legal counsel and that un-checking the box and creating flexibility is a risk, but worth pursuing. They recommended that each institution should run it by their legal counsel.

· John mentioned that to receive CERM funding, you have to check the box.

o In response to John’s concern, Marjorie said she would ask OHRP for their opinion on what a Federal Wide Assurance means.

· Marjorie noted that Michael Carome went to Public Citizen.

· Susan asked each site to give an overview of the flexibility they are building into their program.

· Kristin gave an overview of the two new exempt categories created at USC. Everyone received a copy of USC’s flexibility policy and matrix per campus. USC Social Behavioral IRB is allowing survey/focus group research with minors to qualify for the new exempt category. An overview of 2-year approvals for unfunded minimal risk research was also discussed in addition to the exclusions to the policy.

· Karen mentioned that UCI is awaiting reaccreditation before they consider adding in additional flexibility.

· John said UCSF is awaiting reaccreditation before implementing any flexibility

· John asked about what flexibility we can give in regards to amendments.

o Marjorie said OHRP already stipulated that amendments that are deemed a “non-material change” do not need to be reviewed by the IRB. Each institution’s policy can separate out what amendments need to go to the IRB vs. what can be reviewed by IRB staff.

· Marjorie suggested that institutions also give investigators flexibility in the way they write their protocols to be more general, which would reduce the number of modifications.

· The issue of stamping consent documents was brought up.

o Moira said that nowhere in the regulations does it require stamping.

o Susan asked Marjorie to have AAHRPP issue a statement that informed consent stamping is not required.

· Moira went through some of the flexibility that are utilizing:

o Allowing trained IRB staff to review expedited reviews

o IRB staff to review exempt research

o Planning to move to a 2-year approval cycle – Hesitant due to the potential appearance of a two-tiered system.

· Moira mentioned that she is concerned with calling new categories under a flex policy “exempt” or “expedited” as OHRP may add new categories in the future that may conflict.

· Marjorie and Moira mentioned that if you uncheck the box, all studies previously approved when the box was checked, are still subject to OHRP reporting requirements- for the life of the study.

· Sharon mentioned that UCLA is utilizing flexibility with pregnant women.

· Moira mentioned that institutions should consider flexibility with Subpart B, C and D.

o An example is not requiring two parent signatures for research with children and having studies that would normally fall under 45 CFR 46.407 to be reviewed by the IRB (as long as they are not FDA regulated).

· Anastasia said Stanford has not implemented any flexibility yet, but are looking into 3-year approvals and creating new exempt categories.

· Sharon liked the idea of three- year approval, which is similar to the approval period for IACUC.

· Sharon mentioned that we should start with flexibility with Subpart D before Subpart C.

· Marjorie mentioned that she would love to get rid of subpart D.

· Moira mentioned that sites should consider flexibility with adolescences as well.

· Marjorie reminded the group that flexibility can occur for biomedical campuses, as they often have schools of public health or public services that are doing no greater than minimal risk research that is not FDA regulated.

· Susan thanked everyone for coming and noted talking points will be distributed to the group.