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FDA is announcing the availability of a draft guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.” This guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated
FDA is issuing this as a draft guidance. Although many of these recommendations have appeared in other FDA guidance documents, FDA has compiled the information here in order to assure that all IRBs are aware of and have access to it. The guidance also explains how IRBs may efficiently fulfill these important responsibilities.
To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies' regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts and in consultation with OHRP. In addition, FDA acknowledges HHS's publication of the advanced notice of proposed rulemaking (ANPRM), “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” in the
The draft guidance is being issued consistent with FDA's Good Guidance Practices (GGPs) regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
This draft guidance includes information collections provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). The collections of information referenced in this guidance that are related to IRB recordkeeping requirements under 21 CFR 56.115 have been approved under OMB control number 0910-0130; the collections of information under 21 CFR Part 312 have been approved under OMB control number 0910-0014; and the collections of information under 21 CFR Part 812 have been approved under OMB control number 0910-0078. In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to these previously approved collections of information found in FDA regulations.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
Persons with access to the Internet may obtain the document at