Attachment E: Recommendations on OHRP/FDA draft guidance “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs"

Attachment E:  SACHRP Recommendations on OHRP/FDA draft guidance “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs"

Approved by SACHRP October 25, 2016

On August 2, 2016 the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) issued the draft guidance “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.” The Federal Register summary states:

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.” The purpose of this draft guidance is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. The draft guidance is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.

SACHRP offers the following comments for the agencies’ consideration. All comments are applicable to both agencies, unless noted otherwise.

1. SACHRP commends the agencies for continuing to issue joint guidance and to proactively harmonize guidance to the extent possible. Although the regulations only describe seven required written procedures (45 CFR 46.103(b)(4) and (5), 21 CFR 56.108(a) and (b)), the other required IRB functions are appropriately controlled through locally written policies and procedures. As noted in the guidance, the current regulations do not provide detail on the content of IRB written procedures, which gives IRBs and institutions the flexibility to establish procedures best suited to their own operations. SACHRP believes that it is important to retain the flexibility.
2. The draft guidance refers to “written procedures” without describing the format of the written procedures. SACHRP recommends that the guidance be clear that requirements for written procedures may be satisfied by electronic records and/or paper documents that can include institutional policies and standard operating procedures, but also work instructions, checklists, and operations manuals that assist with the implementation of procedures without being considered a component of official standard operating procedures (SOPs). Regardless of the format of the written procedures, they should be controlled (e.g., version numbers, sign-offs, etc.), reviewed on a systematic basis and updated as needed to reflect changes in the IRB’s current processes, changes in regulations and relevant guidance from OHRP and FDA.
3. SACHRP recommends that the guidance clearly identify the procedures that may be the administrative responsibility of the human research protection program (HRPP) /Institution, and those that are required of the IRB. Section IV of the guidance suggests some areas for an IRB’s written procedures that are not necessarily an IRB responsibility, but are the administrative responsibility of the broader HRPP or the institution. For example, item 14 of the checklist indicates that IRBs should have a written procedure for “assessing and managing investigator conflict of interest.” Clarity could be achieved by creating a section of the checklist for “Additional considerations for HRPPs” or, at the least, clearly identifying in the Checklist those items that are required actions of the IRB itself.
4. SACHRP recommends that the document be revised in order to provide greater clarity in distinguishing items that are regulatory requirements, including determinations and/or documentation required of IRBs, from those that might be considered a best practice for IRBs and HRPPs. Section V of the checklist is labeled “Additional Considerations and Suggestions for Policies/Procedures”, yet many of the checklist items in this section include a regulatory footnote, suggesting that they are required by regulation. The guidance must provide additional clarity, differentiating between checklist items that are a “must” versus those items that are “should.”

   Examples where the guidance is not clear whether the checklist items pertain to regulatory requirements or best practices, or are the responsibility of the IRB office or the larger HRPP / institutional research administration offices include:
   
   Checklist item 47 “Training and education of the IRB chairperson, IRB members, alternates, administrative support staff, and investigators (including any orientation, continuing education, and a list of any reference materials provided as a resource).” While this may be an IRB function, it could also be a function of the HRPP or an institution’s research administration offices.
   
   Checklist item 50 “Any additional IRB considerations or requirements when reviewing sponsor-investigator research.” It is not clear what the considerations would be for IRB SOPs, and whether any procedures would be implemented by the IRB or the research administration / HRPP.
   
   Checklist item 51 “Keeping the IRB informed of study completion and close out.” This is not a regulatory requirement. Many studies close out and it can be challenging to keep the IRB informed about all of them. The utility of study closure data is also not clear.

5. SACHRP recommends that the guidance make clear that the checklist is not designed as a tool for assessing regulatory compliance. SACHRP also recommends the guidance be clear that institutions and IRBs will be held to their written procedures. When an IRB commits to a particular level of detail in written procedures (e.g., specific timelines for communicating a lapse in approval, steps to be followed when managing subject complaints) it will be expected to implement the procedure as written, even when the procedure is not a regulatory requirement.

SACHRP also notes that the checklist may require modification should a final rule be issued.

Finally, SACHRP would like to encourage OHRP and FDA to continue to issue joint guidance and to proactively harmonize guidance to the extent possible. This is very important to the administrative efficiency of the conduct of research.