Guidelines for Single IRB

NIH Sponsored Research

NIH sponsored research must comply with the Single IRB Policy for Multi-site Research. The policy requires research involving multiple sites establish a single IRB (sIRB) for review of non-exempt human subject research. The goal of the policy is to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subject protections.

Which Studies Must Follow the NIH Single IRB Policy?

The NIH policy applies to all studies that:

  • Are funded through grants, cooperative agreements, or contracts with submission due dates to NIH on or after January 25, 2018, and
  • Involve non-exempt human subjects research, and
  • Involve multiple sites, all of which are conducting the same protocol.

The policy does not apply to studies that are:

  • Funded to foreign awardees, or
  • Conducted at foreign sites, or
  • Funded through career development, research training or individual fellowship awards, or
  • Conducted under circumstances where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy, or
  • Collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

NIH will consider other requests for exceptions. These other requests are reviewed by the NIH sIRB Exceptions Review Committee (ERC).

Federally Funded/Sponsored Research

Single-IRB review applies to all research sponsored by signatory Federal agencies. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

Non-federally funded projects

In the spirit of the revised common rule, MIT has decided to apply the sIRB requirement to all research, regardless of funding.

MIT is a member of SMART IRB, a platform designed to ease common challenges associated with initiating multi-site research. Investigators are encouraged to utilize the SMART IRB platform whenever possible. See Participating Institutions for a list of signatory institutions.

COUHES does not automatically apply the SMART IRB agreement to requests to rely on external IRBs. The decision to use the SMART IRB agreement is typically made by the lead research team in consultation with the reviewing IRB, also referred to as the Single IRB (sIRB), or IRB of Record.