MSU HRPP Manual Section 1-6

Institutional Review Board Registration

Initial Registration

Each Michigan State University (MSU) Institutional Review Board (IRB) must be registered electronically through the U.S. Office for Human Research Protections (OHRP) online system. Each MSU IRB must indicate the IRB type as OHRP and must be registered before it can be designated on MSU’s Federalwide Assurance (FWA).

U.S. Food and Drug Administration (FDA) Requirements

An MSU IRB must also be registered with OHRP as an FDA IRB type when that IRB reviews or intends to review clinical investigations that are:

  • regulated by FDA under sections 505(i) or 520(g) of the act, or
  • that are intended to support applications for research or marketing permits for FDA-regulated products. A research permit under section 505(i) of the act is usually known as an investigational new drug application (IND), while a research permit under section 520(g) of the act is usually known as an investigational device exemption (IDE).

The initial registration must occur before the IRB begins to review a clinical investigation as described above.

Registration Process

The IRB registration information is submitted by the MSU Human Research Protection Program (HRPP) director and/or HRPP manager.

The following information must be provided when registering an IRB:

  • The name, mailing address, and street address (if different from the mailing address) of the institution or organization operating the IRB(s).
  • The name, mailing address, phone number, facsimile number, and electronic mail address of the senior officer or head official of that institution or organization who is responsible for overseeing activities performed by the IRB. At MSU, this is the Institutional Official. See HRPP Manual 4-4 “Institutional Official.”
  • The name, mailing address, phone number, facsimile number, and electronic mail address of the contact person providing the registration information.
  • The name, if any, assigned to the IRB by the institution or organization, and the IRB's mailing address, street address (if different from the mailing address), phone number, facsimile number, and electronic mail address.
  • The name, phone number, and electronic mail address of the IRB chairperson.
  • The approximate numbers of:
    • All active protocols; and
    • Active protocols conducted or supported by U.S. Health and Human Services (HHS).
  • The approximate number of full-time equivalent positions devoted to the IRB's administrative activities.
  • In addition, for IRBs that review or intend to review FDA regulated activities:
    • The approximate number of active protocols involving FDA-regulated products reviewed; and
    • A description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in the protocols that the IRB reviews.

An "active protocol'' is any protocol for which the IRB conducted an initial review or a continuing review at a convened meeting or under an expedited review procedure during the preceding twelve months.

The IRB registration becomes effective when reviewed and accepted by OHRP. The registration is effective for three years.

Updates

Updates to the IRB registration information are submitted by the HRPP director and/or HRPP manager.

The registration information for an IRB must be updated within 90 days after changes occur regarding the:

  • Contact person who provided the IRB registration information or
  • IRB chairperson.

For IRBs that are registered to review FDA regulated activities, the following changes must be reported within 30 days of the change:

  • An IRB's decision to review new types of FDA-regulated products (such as a decision to review studies pertaining to food additives whereas the IRB previously reviewed studies pertaining to drug products), or
  • To discontinue reviewing clinical investigations regulated by FDA.

All other information changes may be reported when the IRB renews its registration. This information may also be reported earlier as an update.

An update that is submitted to, and accepted by, OHRP begins a new 3-year effective period.

Renewal

Renewal of the IRB registration information is submitted by the HRPP director and/or HRPP manager. Each MSU IRB must renew its registration every 3 years.

Any renewal that is submitted to, and accepted by, OHRP begins a new 3-year effective period.

Disbanding

If MSU decides to disband a registered IRB which is in operation, this must be reported to OHRP in writing within 30 days after permanent cessation of the IRB’s review of HHS-conducted or supported research or FDA regulated activities. This information will be reported by the HRPP director and/or HRPP manager.

Approved By

Vice President for Research and Innovation on 12-8-2021.

This policy and procedure supersedes those previously drafted.

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