Flex Coalition
Conference Call Notes
June 14, 2012
10:00 – 11:30 p.m. PST
Topics/Speakers:
Ø Welcome & Goals of Call
(Susan Rose, USC)
Ø Broader/More Generic IRB Applications, Flexibility with Engagement
(Marjorie Speers, AAHRPP)
Ø Flexibility with Meeting Minutes
(Sharon Friend, UCLA)
Ø Flexibility with Engagement and International Social-Behavioral Research
(Moira Keane, University of Minnesota)
Welcome & Goals of Call (Susan Rose, USC)
· Future in-person flex meetings: PRIMR December 2012 in San Diego and at AAHRPP (spring 2013)
· The flex effort is receiving growing attention nationally. Thank you all for your enthusiasm
· The OHRP Advance Notice of Proposed Rule Making is still receiving media attention due to unclear status of proposed changes. In keeping with the Flex Coalition, a laudable approach would be flexibility with the existing regulations, not more regulations
Action Item: Flex group members, please send flex items to to share and discuss
o Challenges and situations that could be helped with flexibility (“How would you handle this?”)
o Innovative policies at your institution
o Announcements/events at your institution
o Community Based Participatory Research flexibility
Broader/More Generic IRB Applications, Flexibility with Engagement Determinations (Marjorie Speers, AAHRPP)
· Accepting broader/more generic IRB applications reduces the need for amendment submissions. The following research methods were offered as amenable to generic templates:
o Inclusion/exclusion criteria– IRBs can accept submissions with ranges or classes of populations instead of narrowly defined categories
o Surveys– Before a study is submitted, IRBs can predetermine categories of survey instruments that are acceptable instead of requiring submission of single instruments (e.g., behavioral, quality of life)
o Focus groups– PIs should be able to describe what general info they will seek instead of crafting/submitting specific script questions that are not likely to be used in the field
o Perception/psychological experiments– protocols should be written to allow for variation in perceptual stimuli. IRB can be informed about range of stimuli instrument, color, shape, words, etc.
o Protocol templates– Some PIs/Depts submit protocols that are repeats of previous submissions with small variations (e.g. same protocol but at a new location or different PI). The IRB could accept the new protocol in the form of an amendment to the previous one
o Disaster research– Institutions could share a preapproved protocol with partner institutions in their region that would be kept “on the shelf” in anticipation of a flood, earthquake, or other disaster
o Retrospective research– Baylor and University of Pittsburg both have models for registry of retrospective data collection. Their IRB requires departments to submit an annual report of studies that utilized a registry that had predefined study characteristics
· IRBs can solicit/encourage departments to craft generic protocols (schools of education, social work, and epidemiology). (Not an IRB task)
Action Item: Sharon Friend (UCLA) will ask John Heldens (UCSF) for their generic epidemiology protocol
· Flexibility with Determining Engagement in Research: Institutions can substitute their own word for engagement (such as “involved in research”) to increase flexibility and would not have to meet regulatory definition of engagement. When the research is low risk and does not have federal funding or a sponsor, the IRB should exercise flexibility and apply equivalent protections.
Action Item: UCLA is working on guidance for IRB staff to consider flexible approaches to engagement. UCLA will share when ready.
Flexibility with Meeting Minutes (Sharon Friend, UCLA)
· OHRP seems to require everything to be documented in the IRB minutes. Why not build more of the required information into the protocol/IRB submission? There’s an expectation that all IRB discussions have to be captured in the IRB meeting minutes. However, some items can be included in the protocol or IRB application and referenced as such in the minutes. UCLA has modeled their IRB application to address approval criteria and discussion of policy or controverted issues. For other issues the protocol or application sections are referenced.
o At Cedars-Sinai if there are controverted issues or policy issues/concerns they are added to the IRB meeting minutes but generally mintues refer to the specific sections of the IRB application
o The USC IRB does this also. The justification language required in regulations is supplied as options on the USC IRB application (eg “Minors are a necessary subject population because the condition, situation, or issue under study affects minors”…) instead of an open-text box which could be submitted with an inadequate answer. The USC IRB application is accessible through the sandbox http://istartraining.usc.edu
Flexibility with Engagement and International Social-Behavioral Research
(Moira Keane, University of Minnesota)
· Engagement
o University of Minnesota IRB routinely asks for approval from the involved research site via an IRB Authorization Agreement but does not parse who is doing what
o A problem arises when partner institutions are rigid with documentation requirements
o Some multi site clinical trials have different reporting requirements
· Risk aversion among IRBs is a problem that needs more study. Many institutions are over regulating
· International Research
o Some research cannot be flexed: IND/IDE or federally funded
o An assumption exists that other countries do not provide adequate human subject protections. Many IRBs stumble at figuring out consent, privacy, and data gathering concerns and local laws abroad.
§ University of Minnesota IRB would not expect formal documentation for low-risk, almost casual study (e.g., interviewing previous teachers).
§ University of Minnesota educates students early-on to be familiar with requirements and interact with the Global office to be educated on local mores and culture
§ The challenge is to inculcate students during the research planning phase
§ University of Minnesota IRB works with the global programs office to track where students are in the world (conflicted countries)
Bronwyn (University of Virginia): UV IRB works with the international studies office to provide an IRB component to the cultural sensitivity workshop for students going abroad. Students were encouraged to attend (not mandatory). Students have not complained. UV is currently considering expanding workshop to researchers conducting studies in culturally isolated/immigrant communities within the US.
§ The International studies/ Global Programs office is a wonderful resource for the IRB regarding research sites abroad
§ Using a local consultant from the host country is another creative protection.
Credentialing Foreign-Trained Research Staff (Susan Rose, USC)
· A recent OHRP Determination Letter www.hhs.gov/ohrp/detrm_letrs/YR12/feb12b.pdf showed that The University of Maryland Medical Center uses an institutional credential program to allow unlicensed foreign-trained MDs to conduct limited research procedures. OPRS will work on contacting someone to discuss this during our next meeting.
· New Guidance Documents issued:
o FDA: “IRB Continuing Review after Clinical Investigation Approval” www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558
o OHRP: (Draft Guidance) “Transferring a Previously-Approved Research Project to a New IRB or Institution” www.hhs.gov/ohrp/newsroom/rfc/transferdraftdoc.html
Action Items
· Flex group: send ideas for future discussion such as:
o Challenges and situations that could be helped by flexibility (“How would you handle this?”)
o Innovative policies at your institution
o Announcements/events at your institution
o Community Based Participatory Research
· Flex group: if any “on the shelf” disaster protocols have been crafted at your institutions, send them to
· Flex group: share template versions of frequently used protocols
· Sharon (UCLA) will ask John Heldens (UCSF) for their generic epidemiology protocol
· USC will find more information on institutional-level credentialing of foreign trained research staff
· UCLA is working on guidance for IRB staff to consider flexible approaches to engagement. UCLA will share when ready.