Question 1:

In NIH Policy NOT-OD-19-055, what does the term “certification” entail (what, how, who, format, when; is this similar to a “congruence review”); and, how is “recipient” defined (the person responsible for providing the certification; is this the Principal Investigator; is this the institution’s Sponsored Projects Officer processing the award)?
– Director of HRPP at a state university

Response 1:

Based on the NIH Guidance released 11 January 2019,  the certification process seems no different from how it’s been done by the institution all along:

  • The regulations at 45 CFR 46.103(d) states that the “institution” should is required to certify IRB approval.
  • For HHS funded studies, the vehicle for certification is the form certification (formerly the Optional Form 310), found on the OHRP website.  Certification is typically done by someone a representative of the IRB or by the “institutional official” who signed the federalwide assurance, not the Principal Investigator.

However, the best answer to the question of “who?” and “how?” should be addressed directly to NIH or other funding agency.

Question 2:

In the NIH Policy NOT-OD-18-211, if an institution chose to adopt this policy, were all three elements required to be implemented as a package?

Response 2:

The revised Common Rule introduced three burden reducing provisions:

  1. IRBs are no required to read entire grant proposals – only the protocol involving human research. This makes the old requirement for full-proposal review obsolete. As part of the Just-In-Time requirement, research may not be initiated until after IRB approval of the protocol. This is not new – it’s just that now only the protocol needs IRB review, not the entire proposal.
  2. The definition of “research” is revised.  This definition may be used to guide decisions about what kinds of activities are not covered by the Common Rule.
  3. The elimination of the requirement for annual continuing review for certain categories of research.

Research approved by the IRB on or after January 21, 2019, must comply with these three provisions.  The Office for Human Research Protections (OHRP) offers an unofficial guidance and a Q&A page on the revised Common Rule that includes information about implementing the revised Common Rule.