Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 29
Effective Date: 10/8/2021

Policy

This document describes a permissible mechanism under which an institution holding an Office for Human Research Protections (OHRP)-approved Federalwide Assurance (FWA) (hereafter referred to as The College of St. Scholastica [CSS] IRB as the assured institution) may extend – for one or more research protocols – the applicability of its FWA to cover two types of collaborating individual investigators: collaborating independent investigators and collaborating institutional investigators.  See also, CSS IRB SOP #19 Cooperative Research Authorization Agreements and Sample Agreements.

Purpose

Investigators from off-site locations that do not normally conduct research (non-assured institutions) may request the CSS IRB extend its Federalwide Assurance to cover their research activities by signing an Individual Investigator’s Agreement with the IRB. The purpose of this policy is to clarify the procedure for the CSS IRB to follow in order to assume the responsibility of an oversight IRB for Human Subjects Research for a non-assured Institution and/or Independent Investigators that do not routinely conduct human subjects research.

Definitions

The OHRP notes that some human subjects research conducted by an assured institution may involve the following two types of collaborating individual investigators:

1. A collaborating independent investigator is:
   1. Not otherwise an employee or agent of the assured institution;
   2. Conducting collaborative research activities outside the facilities of the assured institution; and
   3. Not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the assured institution.
2. A collaborating institutional investigator is:
   1. Not otherwise an employee or agent of the assured institution;
   2. Conducting collaborative research activities outside the facilities of the assured institution;
   3. Acting as an employee or agent of a non-assured institution with respect to his or her involvement in the research being conducted by the assured institution; and
   4. Employed by, or acting as an agent of, a non-assured institution that does not routinely conduct human subjects research.

Conditions for Extending an FWA To Cover Collaborating Independent Investigators or Institutional Investigators

The OHRP will permit an assured institution (the CSS IRB) to extend its FWA to cover a collaborating independent or institutional investigator provided all of the following conditions are satisfied:

1. The principal investigator at the assured institution directs and appropriately supervises all of the collaborative research activities to be performed by the collaborating individual investigator outside the assured institution.
2. The extension of the coverage of the FWA is put in place by use of an appropriate written agreement, such as the sample Individual Investigator Agreement (below), for each collaborating individual investigator who will be engaged in the research being conducted by the assured institution. The assured institution must maintain the Individual Investigator Agreement, or other written agreement used by the assured institution, on file and provide copies to OHRP upon request.
3. For collaborating institutional investigators, the appropriate authorities at the non-assured institution state in writing that the conduct of the research is permitted at their institution.
4. The assured institution and the responsible IRB designated under the FWA approve the extension of the assurance through either the Individual Investigator Agreement or other written agreement used by the assured institution.
5. The following documents are made available to the collaborating individual investigator:
   1. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (see http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html) or other internationally recognized equivalent (see section B.1. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-humansubjecct/index.html);
   2. The HHS regulations for the protection of human subjects at 45 CFR part 46 (see http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html) or other procedural standards designated by a non-U.S. institution under its FWA (see section B.3. of the Terms of the Federalwide Assurance (FWA) for International

(Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-humansubjecct/index.html);

3. The FWA and applicable Terms of the FWA for the assured institution; and
4. The relevant institutional policies and procedures for the protection of human subjects of the assured institution.

6. The collaborating individual investigator understands and accepts the responsibility to comply with the standards and requirements stipulated in the documents referenced in the preceding paragraph and to protect the rights and welfare of human subjects involved in research conducted under the Individual Investigator Agreement or other written agreement used by the assured institution.
7. The collaborating individual investigator agrees to comply with all other applicable federal, international, state, and local laws, regulations, and policies that may provide additional protections for human subjects participating in research conducted under the Individual Investigator Agreement or other written agreement used by the assured institution.
8. The collaborating individual investigator agrees to abide by all determinations of the CSS Institutional Review Board (IRB) designated under the FWA of the assured institution and agrees to accept the final authority and decisions of the IRB, including but not limited to directives to terminate participation in designated research activities conducted under the Individual Investigator Agreement or other written agreement used by the assured institution.
9. The collaborating individual investigator agrees to complete any educational training required by the CSS IRB prior to initiating research covered under the Individual Investigator Agreement or other written agreement used by the assured institution.
10. The collaborating individual investigator agrees not to enroll subjects in research under the Individual Investigator Agreement or other agreement used by the assured institution, prior to an application for research being reviewed and approved by the CSS IRB.
11. The collaborating individual investigator agrees to report promptly to the IRB any proposed changes in the research conducted under the Individual Investigator Agreement or other agreement used by the assured institution. The collaborating institutional investigator agrees not to initiate changes in the research without prior CSS IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.
12. The collaborating individual investigator agrees to report immediately to the IRB any unanticipated problems involving risks to subjects or others in research covered under the Individual Investigator Agreement or other agreement used by the assured institution.
13. The collaborating individual investigator, when responsible for enrolling subjects, agrees to obtain, document, and maintain records of informed consent for each such subject or each subject’s legally authorized representative as required under HHS regulations at 45 CFR part 46 (or any other international or national procedural standards selected in the FWA for the College of St. Scholastica IRB referenced above) and stipulated by the CSS IRB.
14. The collaborating individual investigator acknowledges and agrees to cooperate with the IRB in its initial and continuing review, record keeping, reporting, and certification for the research covered by the Individual Investigator Agreement, or other agreement used by the assured institution. The collaborating institutional investigator agrees to provide all information requested by the CSS IRB in a timely fashion.

(The above content created by Office for Human Research Protections - Content last reviewed on March 19, 2016)

Resources

Office for Human Research Protections - Extending an FWA to Cover Collaborating Investigators (2005)

(Content last reviewed on March 19, 2016)

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual

-investigator-agreement/index.html

Sample Commitment Statement of an Individual Investigator to Institutional Human Subject Protection

Policies and IRB Oversight – (https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/unaflsup.rtf)

This is a new policy per the 2018 Common Rule Requirements.