SOP #19 Cooperative Research Authorization/Reliance Agreements and Sample Agreements

Cooperative Research Authorization/Reliance Agreements and Sample Agreements

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 19
Effective Date: 5/23/24
Supersedes: 10/8/21

Policy

When participating in a cooperative project with another institution, the CSS IRB may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort (45 CFR § 46.114 (c)).

The CSS IRB may agree to delegate the responsibility for initial and continuing review to another institution's IRB. In turn, that institution’s IRB agrees to assume responsibility for initial and continuing review. The institution delegating the responsibility for review should understand that it is agreeing to abide by the reviewing IRB's decisions. The delegating institution remains responsible for ensuring that the research conducted within its own institution is in full accordance with the determinations of the IRB providing the review and oversight.

The IRB, which agrees to review studies conducted at another institution, has responsibility for initial and continuing review of the research. Such an IRB, in initially reviewing the study, should consider the required criteria for approval, the facilities and capabilities of the other institution, and the measures taken by the other institution to ensure compliance with the IRB's determinations. The reviewing IRB needs to be sensitive to factors such as community attitudes. The IRB should be sensitive to community laws and mores because state and local laws and community attitudes pertaining to research may be more restrictive than Federal regulations or the prevailing standards of the community where the IRB is located.

Purpose

The purpose of this policy is to facilitate clarity and consistency in how human subject research protocols are reviewed when research conduct involves multiple collaborating institutions. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

Definitions

Cooperative Research

Cooperative research projects are those projects covered by this policy which involve more than one institution.

Authorization/Reliance Agreement

A written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities. This agreement may also be referred to as a reliance agreement, cooperative agreement or cede review agreement.

Individual Investigator Agreement (IIA)

There are instances when an individual, who is not acting as an employee or agent of CSS is “engaged” in human subjects research in collaboration with a CSS researcher. In most cases, that individual will not have access to an IRB to provide approval and/or oversight for the research activities being performed. For these situations, an Individual Investigator Agreement (IIA) may be appropriate. An IIA is a formal agreement describing the expectations and responsibilities for the individual and is signed by the individual investigator as well as the CSS Institutional Official or designee. All inquiries related to an IIA should be directed to the CSS IRB Chair.

Cede Review

The act of transferring IRB review and oversight.

IRB of Record - (External IRB – Reviewing IRB)

The IRB of record performing review on the behalf of one or more institutions, also referred to as the single IRB and/or central IRB. An external reviewing IRB must hold an FWA issued by OHRP in order to be qualified (approved) to serve as the IRB of record or to serve as a relying institution.

Relying Institution

The entity that agrees to rely upon the Reviewing IRB.

Sponsors and Funders

Generally, this refers to any entity that is supporting research and includes non-profit and for-profit entities.

Roles & Responsibilities

The College of St. Scholastica

CSS provides for an Institutional Review Board (IRB) to carry out review and approval processes for all research involving human subjects. The institution accepts the responsibility to provide adequate resources necessary to implement an Authorization/Reliance Agreement. The CSS IRB holds a Federalwide Assurance. FWA Assurance Number: FWA00027482

Institutional Official (IO)

The President of The College of St. Scholastica is the Signatory Official in accordance with the provisions of the Federal Wide Assurance (FW# FWA00027482). The Institutional Official is the individual authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The VPAA of The College of St. Scholastica is the Human Subjects Contact Person and also serves as an Institutional Official.

Human Subjects Contact Person

The Human Subjects Contact Person is The College of St. Scholastica Vice President of Academic Affairs. The CSS IRB reports directly to the VPAA.

Institutional Review Board (IRB)

The main function of the CSS IRB is to conduct reviews of all cooperative research /

Authorization/Reliance Agreements involving human subjects to ensure it is conducted in accordance with ethical principles and federal guidelines.

IRB Chair

The IRB Chair refers to the CSS IRB chair who leads the IRB ensuring it carries out its responsibilities as required by ethical principles, CSS policy, state law and federal regulations.

Investigator

The investigator is any individual responsible for the design, conduct or reporting of research or proposals for research. This may include principal investigator (PI), co-investigator, postdoctoral associates, senior scientists, students, collaborators or consultants, as appropriate.

PIs are responsible for identifying all organizations and investigators participating in collaborative research, the responsible IRB(s), and the procedures for dissemination of study information (e.g., IRB initial and continuing approvals, reports of unanticipated problems, study modifications (if any), interim reports) between participating organizations and investigators.

Research Advisors

Faculty members or instructors who advise students involved in cooperative research who actively participate in securing an IRB Cooperative Authorization/Reliance Agreement.

IRB Administrator

The IRB administrator implements procedures to execute multi-study, collaborative authorization review agreements and serves as a procedural resource for administrative execution of single study IRB Authorization/Reliance Agreements.

IRB of Record – Reviewing IRB The IRB of Record holds the responsibility to ensure compliance with their IRB’s determinations and terms of its OHRP-approved Federalwide Assurance. The IRB of Record is responsible to provide relevant minutes, and records of any IRB related activities (amendments, renewals, adverse events and terminations) upon request from an external (relying) cooperating IRB.

IRB of RECORD DECISION-MAKING CRITERIA

The College of St. Scholastica IRB, will use the following criteria when determining which institution is most appropriate to serve as the IRB of Record when conducting cooperative research:

  1. Do both sites have a current Federalwide Assurance approved through the Office of Human Research Protections? The IRB of Record should have a current FWA signifying compliance with federal regulations governing human subject research.
  2. What other policies and procedures are in place to ensure compliance with laws and regulations governing review of human subject research? For example, does the research collaborator require human subject research education for investigators and other research team members?
  3. At which location will most contact with the research participants occur?
  4. Does one of the IRBs specialize in regulatory processes and protections related to specific population(s) being researched? For example, research involving patients, who are covered by special regulatory protections that a health system IRB manages more regularly, may best be reviewed by a health system’s IRB.

Procedures – IRB of Record

A. CSS IRB as the IRB of Record (Reviewing for an External Institution)

  1. When appropriate, the CSS IRB may serve as the IRB of record for a relying institution. Examples of appropriate circumstances include, but are not limited to the following:
    1. multi-center research studies where a CSS principal investigator (PI) is the overall study PI or steering committee chair;
    2. multi-center research studies where a CSS PI serves as the PI for multiple regional sites;
    3. research studies where greater than minimal risk study interventions or procedures occur at CSS and where follow-up procedures that are performed at external sites are not greater than minimal risk.
    4. other compelling circumstances where, due to the nature and location of the research activities, CSS is best situated to safeguard the rights and welfare of research subjects.
  2. Reliance on CSS’s IRB as the IRB of record will be governed by a signed Authorization/Reliance Agreement.
    1. The Authorization/Reliance Agreement will define the terms, scope and limits, and roles and responsibilities of the joint review arrangement.
    2. Authorization/Reliance Agreements may apply to multiple studies between institutions or may be developed on a case-by-case basis for a single study. If the latter, the CSS IRB Administrator and/ or CSS IRB Chair will work with the IRB Administrator at the external IRB to establish an IRB Authorization/Reliance Agreement.
    3. The CSS IRB may extend its FWA to cover collaborating independent or institutional investigators. See, CSS IRB SOP # 29 Extending the CSS FWA to Cover Independent or Institutional

Investigators.

  1. The Institutional Official or designee, will serve as the signatory authority for IRB

Authorization/Reliance Agreements negotiated with other IRBs, collaborating Independent Investigators or Collaborating Institutional Investigators.

Responsibilities – IRB of Record

A. CSS IRB as the IRB of Record (Reviewing for an External institution)

  1. Maintain an FWA with OHRP and the registration with both OHRP and the FDA;
  2. Maintain a Board membership that satisfies the requirements of 45 CFR 46, 21 CFR 56 and provide special expertise as needed from Board members or consultants to adequately assess all aspects of the study;
  3. Make available to the relying institution, upon request, the CSS IRB Standard Operating Procedures;
  4. Perform initial reviews, continuing reviews, reviews of submitted Serious Adverse Events, reviews of protocol amendments, and reviews of any other documents submitted by the Principal Investigator of the research study subject to this agreement;
  5. Maintain and make accessible to the relying institution, upon request, the CSS IRB application, protocol reviews, letters to Principal Investigators, approvals and disapprovals, adverse events and selected portions of the minutes of the CSS IRB meetings relevant to the protocol;
  6. Notify the relying institution immediately in the event of a suspension or restriction of the CSS IRB’s authorization to review studies; and
  7. Notify the relying institution of any CSS IRB policy decisions or regulatory matters that might affect the relying institution’s reliance on CSS IRB reviews or performance.

Reporting an Adverse Event when the CSS IRB is the IRB of Record

Procedure

The PI must report to the CSS IRB, any serious adverse events/unanticipated problems that occur, within a timely manner. The PI must also report the event or problem to the external relying IRB. The CSS IRB of Record will review the adverse event according to the standard operating procedures. The IRB Chair will update the external relying IRB of any required changes to the study as well as any decisions made related to the study due to CSS IRB review.

Required Documentation When CSS is the IRB of Record

In addition to the application submission requirements, the following must be submitted to the IRB when CSS is the IRB of record:

  1. The accreditation status of the outside relying IRB;
  2. Conflict of Interest management plans of all investigators at the outside relying institution (when applicable); and
  3. The role of the investigators at the outside relying institution in the research.

Amending an Approved Authorization/Reliance Agreement Research Study when CSS is the IRB of Record

Procedure

The CSS IRB processes the amendment as outlined in their standard procedures. The IRB Administrator contacts the external relying IRB in an email stating their decision to amend the research study with any supporting documentation.

RELYING INSTITUTION – When CSS Agrees to Rely Upon an External Reviewing IRB of Record

Procedures – Relying IRB

A. CSS as the Relying IRB (Relying on an External IRB )

  1. When appropriate, the CSS IRB may rely on an external IRB to serve as the IRB of record. Examples of appropriate circumstances include, but are not limited to the following:
    1. multi-center research where a specialized central IRB has been established for the sole purpose of reviewing a category of investigative studies (e.g., the NCI CIRB [The Central

Institutional Review Board for the National Cancer Institute]);

  1. multi-center research where a cooperative study group has designated an IRB to serve as the

IRB of record for a study or group of studies;

  1. research where the sole involvement of CSS is the participation of a CSS investigator, but where all subject-related activities will take place at an external institution;
  2. research where greater than minimal risk study interventions or procedures occur at an external institution and where the follow-up procedures performed at CSS are not more than minimal risk;
  3. other compelling circumstances where, due to the nature and location of the research activities, an external IRB is equally situated to safeguard the rights and welfare of research subjects at CSS.
  1. This reliance on an external IRB will be governed by a signed IRB Authorization/Reliance Agreement that will define the terms, scope and limits, and roles and responsibilities of the joint review arrangement. The agreement may apply to multiple studies between the institutions or may be developed on a case-by-case basis for a single study.
  2. The CSS IRB Administrator and/or CSS IRB Chair will work with the IRB Administrator at the other site to establish an IRB Authorization/Reliance Agreement.
  3. The Institutional Official or designee, is the signatory authority for IRB Authorization/Reliance Agreements negotiated with other IRBs.

Responsibilities - CSS As The Relying Institution

  1. Maintain a Federal Wide Assurance (FWA);
  2. Maintain a human subjects protection program, as required by the DHHS OHRP;
  3. Provide the IRB of Record with the current names and addresses of the contact person who has the authority to communicate with the IRB of Record (e.g., the CSS IRB administrator);
  4. Maintain the IRB membership that satisfies the requirements of 45 CFR 46 and 21 CFR 56;
  5. Notify the IRB of Record immediately if there is ever a suspension or restriction of the CSS IRB’s authorization to review studies;
  6. Adhere to its institutional conflict of interest policies and procedures, which includes providing the IRB of Record with any applicable COI management plan related to the study;
  7. Ensure that the investigators and other staff conducting the research are appropriately qualified and meet the institution’s standards for eligibility to conduct research;
  8. Notify the IRB of Record immediately if there is a suspension or restriction of the investigator at the CSS institution;
  9. Ensure the safe and appropriate performance of the research at the relying institution. This includes, but is not limited to:

                        ▪     monitoring study compliance;

▪     reviewing major protocol violations, and any unanticipated problems involving risk to subjects and others that occur at the institution;

▪     ensuring a mechanism exists by which complaints about the research can be made by local study participants or others.

Any actions taken as a result of problems that are identified in these areas should be shared with the IRB of Record and the Principal Investigator.

  1. Require the PI at CSS to maintain appropriate copies of all approvals, and other correspondence documenting the review and approval of the research as required by the regulations.
  2. Maintain compliance with any additional state, local, or institutional requirements related to the protection of human subjects.

Reporting an Adverse Event when the CSS IRB is the Relying IRB

Procedure

The PI must report to the external IRB of Record any serious adverse events/unanticipated problems that occur within a timely manner. The PI must also report the event or problem to the CSS IRB. The external IRB of Record will review the adverse event according to their standard operating procedures. The external IRB of record will update the CSS IRB of any required changes to the study as well as any decisions made related to the study due to their review.

Required Documentation When CSS is the Relying Institution

The following must be submitted, upon request, to the CSS IRB when CSS is the relying institution:

  1. A copy of the initial approval letter from the IRB of record
  2. A copy of the protocol
  3. A copy of the informed consent document(s) and any recruitment materials that will be used at CSS.

Continuing Review and Modifications A copy of the following:

  1. Approval letters for each continuing approval and approved modifications issued by the IRB of record
  2. Current version of the approved protocol
  3. Current version of the approved consent form.

Terminating / Discontinuing an IRB Authorization/Reliance Agreement

IRB Authorization/Reliance Agreement for a single study terminates when the study is completed.

The IRB of Record Chairperson contacts the relying IRB in a written letter stating their intention to discontinue an IRB Authorization/Reliance Agreement. Reasons for discontinuing/termination include but are not limited to:

  1. Risks associated with the study have changed;
  2. The IRB of Record determines they would like to take over administration of a given study;
  3. No additional cooperative studies are expected.

If needed, The College of St. Scholastica will remove the partner IRB reliance from its FWA.

References

45 CFR § 46.114

21 CFR § 56.114

Office for Human Research Protections. IRB Authorization/Reliance Agreement.

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/irb-authorization-agreement/index.html FDA Information Sheets – Non Local IRB -

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-local-irb-review; Cooperative Research -

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-research The University of St. Catherine IRB of Record Decision-Making Criteria https://stkate.app.box.com/s/emlmg9qiqruc5m9z6kbtw6b3x8dy2cu3

Children’s Hospital of Philadelphia (CHOP) - https://irb.research.chop.edu/policies

OHRP Extending an FWA to Cover Collaborating Investigators (2005) Sample Form.

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

University of Pittsburgh https://www.irb.pitt.edu/fwas-and-agreements and

http://www.hrpo.pitt.edu/sites/default/files/Individual%20Investigator%20Agreement_v5_01.16.2020.pdf OHRP Individual Investigator Agreement

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/individual-investigator-agreement/index .html

 

 

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