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 meet the human subjects protection requirements for NIH-funded research by having their proposed research 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 the applicable human subjects policy requirements. NIH holds the primary grant awardee responsible for ensuring that human subjects policy requirements have been met. Therefore,  even if another institution performs the human subjects activities for you, as the primary awardee you are the responsible party for ensuring that policy requirements are met and maintained.

Applicants

  • If you are proposing research at multiple sites under the same protocol, you must comply with the NIH Single IRB Policy for Multisite Research.
    • Foreign sites and research training (T) awards are not subject to the sIRB policy, nor are other domestic sites at which sIRB review is prohibited by a federal, tribal, or state law, regulation, or policy.
    • Follow the SF 424 Section 3.2 Instructions. The sIRB plan is not required for NIH applicants.
  • If your human subjects application falls within the fundable range (see NIAID Paylines), 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 in the form of the corresponding approval date when it requests your just-in-time information. Including your IRB or IEC approval date in your application can avoid a delay in reviewing your award. See the Just-in-Time SOP.
  • NIAID will require certification for training in the protection of human subjects. See the Human Subjects Research Training SOP.
  • To learn more about certification and assurance requirements, see the Human Subjects Rules & Policies—Special Considerations.
  • 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 the participating sites.

 IRB and IEC responsibilities include the following:

  • Review research protocols, informed consent documents, and related materials to determine if the research complies with human subjects policies. See HHS regulation 45 CFR 46.11846.11946.12046.122, and 46.123, for details on materials reviewed.
  • Perform annual reviews of protocols if required by 45 CFR 46.109 subpart e or other federal, state, or local regulation or policy, or otherwise specified in the funding opportunity announcement or contract solicitation.

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 and NIAID’s Financial Conflicts of Interest for Awardees SOP.

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.
  • If applicable per 45 CFR 46.109 subpart f, 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. See 45 CFR 46.109 subpart f to determine whether you are required to maintain continuing review.
  • Post informed consent documents on a public federal website after recruitment closes and no later than 60 days after the last study visit. Learn more at Posting Clinical Trial Informed Consent Forms. For additional guidance, see Informed Consent Questions and Answers.
  • Keep approvals for performance sites ready for NIAID review in case they are requested.
  • If you have delayed onset human subjects research, NIAID may issue a restricted award, meaning human subjects research cannot begin until you provide the corresponding IRB or IEC approval date and NIAID issues a revised, unrestricted award. Note: do not confuse delayed onset with delayed start. For clarification, see What is “Delayed Onset”?
    • If human subjects work is conducted without approval, 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; 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.
  • It may be necessary to 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.

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

NIH Single IRB Policy for Multisite Research

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: Register IRBs and Obtain FWAs

OHRP: Filing a New Registration for an Institutional Review Board (IRB) by an Institution or Organization (IORG)

Rules and Policies for Clinical Research

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