Jessica Huening

by Jessica Huening

IRB Written Procedures: New FDA-OHRP Draft Guidance and Checklist

New draft guidance was issued for comment by the Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) titled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. Both FDA and OHRP require IRBs subject to their oversight to have written procedures in place for various IRB activities.1

About the Guidance

The draft guidance provides recommended practices and regulatory requirements for both agencies to assist IRBs and other institutional officials responsible for developing and maintaining written IRB procedures.  The agencies acknowledge written procedures for IRBs can vary widely due to the nature of research conducted at an institution, as well as uncertainty about necessary scope and content. Therefore, they seek to provide a point of consistency for IRBs with the draft guidance.

The guidance recommends critically assessing IRB responsibilities, functions, operations, and organizational structure as the starting point when formulating IRB written procedures.  From there, the relevant individuals responsible for carrying out the various functions can be identified and referenced in the procedures by title rather than by name, so that updates are not required every time there are changes in staffing.

It is stressed that there should be sufficient information in IRB written procedures to ensure the IRB operates in conformity with the regulations, and to that end, the guidance provides an IRB Written Procedures Checklist to help prompt the evaluation of essential functions relevant to developing IRB written procedures.  The IRB Checklist is broken down into those sections requiring written procedures. Each section cites the relevant agency authority specific to the written procedure and also includes helpful operational details and recommendations that should be included in the procedure specific to the particular IRB activity.

Resources and Tips

The guidance provides a list of resources that may be useful in developing written IRB procedures and recommends IRBs make their written procedures available to investigators to communicate responsibilities and expectations, ultimately furthering compliance. Resources include guidance on running clinical trials, Good Clinical Practice (GCP), continuing review, and IRB continuing review after clinical investigation approval.

The draft guidance notes that IRBs may want to include additional information in their own checklists based on the specific nature of research they review. The goal is ultimately to increase human subject protections through clear written procedures with a convenient tool designed to clarify requirements and expectations. Indeed, IRBs will likely find the IRB Checklist very useful in creating new written IRB procedures and in reviewing the thoroughness of existing procedures.

Comments on the draft guidance are being accepted through October 3, 2016.

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1 See 45 CFR 46.103(b)(4) and (5), 21 CFR 56.108(a) and (b); IRB functions required by FDA and OHRP to have written procedures include processes for continuing review, determining when projects need a more than an annual review period, reporting procedures for findings, changes to research activity, as well as unanticipated problems, serious or continuing noncompliance, and suspension or termination of IRB approval.


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