HRPP Manual Section 8-4

Request for 45 CFR 46.118 Designation

Revised Common Rule (2018 Requirements)

“Assuring compliance with this policy—research conducted or supported by any Federal department or agency.

Certification is required when the research is supported by a Federal department or agency and not otherwise waived under §46.101(i) or exempted under §46.104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.” 45 CFR 46.103(d)(2018 Requirements)

“Applications and proposals lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under §46.101(i) or exempted under §46.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.” 45 CFR 46.118(2018 Requirements)

Pre-2018 Common Rule Requirements

“Assuring compliance with this policy – research conducted or supported by any Federal Department of Agency with definite plans to include Human Subjects.

Certification is required when the research is supported by a federal department or agency and not otherwise exempted or waived under §46.101(b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by §46.103 of this Policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the department or agency to which the application or proposal is submitted. Under no condition shall research covered by §46.103 of the Policy be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB. Institutions without an approved assurance covering the research shall certify, within 30 days after receipt of a request for such a certification from the department or agency, that the application or proposal has been approved by the IRB. If the certification is not submitted within these time limits, the application or proposal may be returned to the institution.” 45 CFR 46.103(f)(Pre-2018 Requirements)

“Applications and proposals lacking definite plans for involvement of human subjects

Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §46.101(b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.” 45 CFR 46.118(Pre-2018 Requirements) (emphasis added)

Certain types of applications for grants, cooperative agreements, or contracts may be submitted to federal departments or agencies with the knowledge that human subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. In such cases, the principal investigator (PI) or PI proxy submits a new study submission with the HRP-511 – Template – Request a 45 CFR 46.118 Determination and a copy of the funding materials to the Institutional Review Board (IRB) office for 45 CFR 46.118 designation for the research study. Designation under 45 CFR 46.118 is not to be used to delay submitting a human research submission until such time funding is likely. It only applies in circumstances where insufficient information is known about the specifics of the research study. Although the designations are called “45 CFR 46.118 designations,” this designation is also applicable to other agencies’ requirements equivalent to 45 CFR 46.118. The 45 CFR 46.118 designation may also be applied to non-federal sponsors (e.g. foundation, industry) when the 45 CFR 46.118 criteria are met. 

A designation under 45 CFR 46.118 may be granted if the following criteria are met:

• Application is being submitted to a federal department or agency or involves a non-federal sponsor

• Human subjects may be involved within the period of support

• Definite plans would not normally be set forth in the application or proposal

  • Institutional type grants when selection of specific research study is the institution’s responsibility

  • Research training grants in which activities involving human subjects remain to be selected

  • Research studies in which human subjects’ involvement will depend upon:

    • Completion of instruments

    • Prior animal studies

    • Purification of compounds

• Assurance from the PI that no human subjects will be involved in any research study supported by these awards until the study is determined exempt or reviewed and approved by an IRB

Once an activity is provided a designation under 45 CFR 46.118, the PI or PI proxy must re-submit the initial study submission to the IRB office for review and approval when definitive plans have been developed. No human subjects may be involved in research until an exempt determination or IRB review and approval has taken place.

Initial Request

To request a 45 CFR 46.118 designation, the PI or PI proxy submits a new study submission and the HRP-511 – Template – Request a 45 CFR 46.118 Determination for 45 CFR 46.118 designation via the Michigan State University (MSU) IRB online system. Policies and procedures. See HRPP Manual 3-1 “MSU Human Research Protection Program Plan” for a description of the MSU IRB online system.

When a request is received, the MSU IRB online system will assign the request a Study number. An IRB administrator will be assigned to review the request. Should the request meet the criteria, the IRB administrator will issue a letter issuing the 45 CFR 46.118 designation. This designation does not allow research to be conducted involving human subjects; an initial study submission must be re-submitted and determined exempt or approved by the IRB to involve human subjects in research.

The 45 CFR 46.118 designation will be given an expiration date of one month past the date, with a limit of up to one year after the date of the 45 CFR 46.118 designation, by which the PI anticipates human research plans will be definitive enough to submit for review.

Renewed 45 CFR 46.118 Designation

If a PI would like to renew the 45 CFR 46.118 designation, the PI must explain whether there have been any changes to the initial request, must provide a confirmation that no research involving human subjects has been or will be conducted prior to exempt determination or IRB review and approval of an IRB initial study, and provide an updated date by which the PI plans to submit a complete initial IRB initial study for review.

The request will be reviewed by an IRB administrator and a renewed 45 CFR 46.118 designation may be granted should the request continue to meet the criteria.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 6-15-2009. Revision 1 approved by VP Research & Graduate Studies on 8-22-2011. Revision 2 approved by VP Research & Graduate Studies on 4-7-2014. Revision 3 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 4 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 5 approved by Assistant VP Regulatory Affairs on 11-27-2021.

Related HRPP Manual Sections

• 3-1, MSU Human Research Protection Program Plan