Human Subjects Certifications: IRB or IEC SOP

This SOP is for grants only. Some links will work for NIAID staff only.

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Purpose

To ensure that investigators protect human subjects by having their applications reviewed by an institutional review board (IRB) for domestic applications or independent ethics committee (IEC) for foreign applications.

Procedure

NIH sets policies for human subjects research according to federal law 45 CFR 46, Protection of Human Subjects. All domestic and international grantees funded by NIH and conducting human subjects research must comply.

To determine whether your project qualifies as human subjects research, go to Decision Trees for Human Subjects Requirements and read the following:

If your application proposes human subjects research, you must comply with human subjects requirements. Once awarded, NIH considers your institution engaged in human subjects research even if another institution performs the human subjects activities for you.

Applicants

  • If you are proposing multi-site studies, you must comply with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
    • Submit with your application a plan describing the use of a single IRB (sIRB) that will serve as the IRB of record for all domestic study sites. Include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.
    • NIH will
      • Make exceptions to the sIRB policy where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.
      • Consider requests for exceptions that are not based on a legal, regulatory, or policy requirement if there is compelling justification.
      • Determine whether to grant an exception.
  • If your human subjects application falls within the fundable range, and you have not yet received IRB or IEC approval, submit a request for IRB or IEC approval immediately.
  • NIAID will require certification of IRB or IEC approval when it requests your just-in-time information. Include the title and number of your application to avoid a delay in making your award. See the Just-in-Time SOP.
  • The other certification you will need is for training in the protection of human subjects. See the Human Subjects Research Training SOP.
  • To learn more about certification and assurance requirements, read the Human Subjects SOPs.
  • Be prepared to provide IRB clearance for study protocols should your program officer request it.

IRBs and IECs

Often residing in local institutions, IRBs and IECs independently determine whether projects are human subjects research or are exempt according to 45 CFR Part 46.101(b).

For domestic sites of multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research funded by NIH, the sIRB carries out the IRB review requirements at 45 CFR Part 46 for participating sites of the multi-site study.

Their responsibilities include the following:

  • Review research protocols, grant applications, informed consent documents, and related materials to determine if the research complies with human subjects policies. See HHS regulation 45 CFR 46.118, 119, 120, 122, and 123 for details on materials reviewed.
  • Perform annual reviews of protocols.

The IRB or IEC chairperson or designated member reviews the research, retaining all authority except disapproval, which requires the full IRB or IEC.

In May 2004, the U.S. Department of Health and Human Services issued guidance for IRBs, IECs, investigators, and research institutions to avoid financial conflicts of interest that could harm human subjects. See Financial Conflict of Interest: HHS Guidance.

Grantees

  • Register IRBs or IECs with the Office for Human Research Protections (OHRP) and update the registration information as changes occur and at least once every three years.
  • Get IRB or IEC approvals for the grantee and performance sites.
  • Submit annual recertification of IRB or IEC approval before submitting each noncompeting progress report as well as any time you change your research protocol.
  • Send NIAID documentation of IRB or IEC review.
    • Submit with just-in-time information for competing applications. The Research Performance Progress Report (RPPR) does not ask for this information.
    • Note: Annual IRB or IEC reviews may be out of sync due to the timing of the initial approval, the award date, or a changed anniversary date. Make sure the approval date will be in effect after the start date of the next budget period.
  • Keep approvals for performance sites ready for NIAID review in case they are requested.
  • If you are not planning to do human subjects research immediately, you will get a restricted award for a delayed onset:
    • Do not conduct human subjects research until the IRB or IEC approves it and NIAID issues a revised, unrestricted award. If you do, NIAID will reduce the award, and you cannot use any human subjects data you obtained during that time for any activity related to the NIAID grant.
  • Make sure you comply with NIAID Clinical Terms of Award, if included in the Notice of Award.
  • For help on planning to request IRB or IEC approval, see Research Using Human Subjects.
  • Register in OHRP's Electronic Submission System for Federalwide Assurances and IRB/IEC Registrations.

Program Staff

  • For cooperative agreement clinical trials, review annual IRB and IEC approvals.
  • Review progress reports to see if the protocol has changed.
    • If it has, review the IRB or IEC approval, and indicate whether it is acceptable or unacceptable on the program officer worksheet in IMPAC.
    • If it is unacceptable, work with the principal investigator (PI) to resolve.
  • Work with the grants management specialist when the grantee has conducted human subjects research without IRB or IEC approval. Determine what human subjects research was involved, and confer with the PI and specialist about reducing the budget.

Grants Staff

  • Do not issue awards without the grantee's certification of IRB or IEC approval.
  • Documentation of IRB or IEC approval of entities other than the grantee is not required unless program or grants staff feel it is necessary.
  • Issue a restricted award at the end of the fiscal year if there is not enough time to get the certifications.
    • Follow up on restricted awards and issue a revised award once the required certifications have been approved.
    • If human subjects activity was conducted during the restricted period, contact the program officer to determine what unallowable research the grantee conducted, and decide what aspects of the budget to adjust.
  • Ensure that annual IRB or IEC approval is in place when processing progress reports.

Contacts

Grantees: Contact the appropriate program officer or grants management specialist listed on your Notice of Award.

For questions about using OHRP's electronic submission system, contact OHRP.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov.

Links

IRB Review, Office of Science Policy website

IRB Registration Process FAQs, OHRP web page

Research Using Human Subjects

NIAID Single Institutional Review Board (sIRB) Exceptions SOP

Human Subjects Research Requirements SOP and other Human Subjects SOPs

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, FDA document

OHRP: Assurances and IRB Registration and Guidance Topics, OER NIH Extramural Intranet

OHRP Step-by-Step Instructions for Registering an IRB or IEC

Trans-NIAID Clinical Research Toolkit

Content last reviewed on April 7, 2016