IRB Charter, Appointments, and Administrative Structure

Standard Operating Policy Institutional Review Board
Policy Number: 02
Effective Date: 10/8/2022
Owner: CSS IRB & Vice President of Academic Affairs
Author: CSS IRB

Policy                                        

The purpose of this policy is to describe the IRB charter, appointments, and administrative structure. It is the policy of the CSS IRB that the structure and composition of the IRB be in full accordance with Health and Human Services policies at 45 CFR §46. Within HHS, the Food and Drug Administration (FDA) has oversight over FDA-regulated research as described in the FDA oversight policies Title 21, Parts 50 and 56 (21 CFR Part 56 for IRB’s and 21 CFR Part 50 for Informed Consent).

Purpose

The purpose of The College of St. Scholastica Institutional Review Board (IRB) is to ensure the protection and welfare of human subjects involved in research supported by, conducted at, or associated with The College of St. Scholastica. The specific procedures, reporting and responsibilities involved in this activity are outlined in The College of St. Scholastica Manual Governing Research Involving Human Subjects along with the CSS IRB Standard Operating Procedures (SOP’s). The CSS Manual and CSS IRB SOP’s are reviewed periodically, at the discretion of the Vice President of Academic Affairs, in conjunction with the Chairperson of the CSS IRB.

The College of St. Scholastica assures that all of its activities related to human subjects research, regardless of the source of support, will be guided by the statement of ethical principles governing the College in the discharge of its responsibilities for protecting the rights and welfare of human subjects research conducted at or sponsored by the College. The statement of principles are found in:

• The Nuremberg Code (1949)

• The Declaration of Helsinki (1964)

• The Belmont Report (1976)

IRB Charter

The CSS IRB is a duly constituted IRB, which has established membership in full accordance with the requirements of Health and Human Services regulations at 45 CFR §46.107.

Institutional Responsibilities

The College of St. Scholastica bears full responsibility for all research involving human subjects covered under its Federal Wide Assurance (FW# FWA00027482). For all HHS-conducted or supported research, all of the requirements of the HHS Regulations at 45 CFR Part 46, Subpart A, as well as Subparts B through E, must be met.

• Developing policies and procedures for effective and efficient administration of the CSS IRB..

• Ensuring that Assurances are in place and certifications of IRB review are submitted to the appropriate authorities for all HHS-sponsored research, not only for themselves, but also for collaborating performance sites for which the institution has agreed to accept oversight responsibility.

• Implementing appropriate oversight mechanisms to ensure compliance with HHS regulations and effective administration of the CSS IRB.

The College of St. Scholastica is responsible for ensuring that all institutions and investigators engaged in its HHS-supported human subject research operate under an appropriate OHRP-approved Assurance (Federal Wide Assurance (FW# FWA00027482)) for the protection of human subjects. In some cases, one institution may operate under an Assurance issued to another institution through the Independent Investigators or Institutional Investigators Cooperative Research Authorization Agreement (See, CSS IRB SOP # 19 Cooperative Research Authorization Agreements and CSS IRB SOP # 29 Extending the CSS FWA To Cover Collaborating Individual Investigators and Sample Agreement).

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 / Institutional Official (IO)

The Vice President of Academic Affairs is the Human Subjects Contact Person in accordance with the provisions of the Federal Wide Assurance. The VPAA, together with the President of The College of St. Scholastica, serving as Institutional Officials, are ultimately responsible for the following:

1. Foster, support and maintain an institutional culture supporting the ethical conduct of all research involving human subjects.

2. Ensure the CSS IRB has the resources and support necessary to comply with all institutional policies and with federal regulations and guidelines that govern human subjects research, including:

   1. Ensure CSS IRB staffing is commensurate with the size and complexity of the research enterprise. (45 CFR § 46.108(a)(1)).

   2. Ensure adequate CSS IRB space, equipment, materials, and technology.

   3. Ensure sufficient resources for the production, maintenance, and secure storage of CSS IRB records.

   4. Ensure sufficient resources for compliance activities and investigation of noncompliance.

   5. Ensure access to legal counsel.

   6. Support educational opportunities related to human research protections for CSS IRB members, CSS IRB staff, and all members of the research community.

3. Oversight of the CSS IRB within The College of St. Scholastica and ensuring the CSS IRB functions independently.

4. Appointment and oversight of the CSS IRB Chair.

5. Oversight over the conduct of research conducted by all researchers within the Organization.

6. Ensure investigators fulfill their responsibilities.

7. The VPAA and the CSS President have the authority to further review and disapprove research but cannot approve research that has been disapproved by the IRB (45 CFR § 46.112). The VPAA is kept informed of research activities and decisions of the CSS IRB through on-going and proactive discussions with the CSS IRB Chair, CSS IRB Administrator and the CSS IRB Annual Report.

8. Advise Organizational officials on key matters regarding research conducted within the Organization.

CSS IRB Chair

The CSS IRB Chair reports to the VPAA, including on matters concerning compliance with 45 CFR §46 and CSS IRB Standards of Operating Procedures. The VPAA has delegated responsibility for the daily operation of the CSS IRB to the CSS IRB Chair. The VPAA serves in an oversight role rather than a voting member of the CSS IRB. (CFR 45 §46.112; §46.113 and §46.108(4).) See also, (§46.103(a)) and CSS IRB SOP # 04 CSS IRB Meeting Management, Function and Operations).

The duties of the CSS IRB Chair include conducting CSS IRB meetings, management of protocol review process, review of protocols, development of Standard Operating Procedures, creation and revision of CSS IRB forms, recruitment and training of new members, continuing education of members and investigators, and review of member performance. The Chair responds to issues of compliance, adverse events and serious problems. The Chair serves as a resource for investigators and CSS IRB members regarding issues related to CSS and federal policies. The CSS IRB Chair is responsible for ensuring the appropriateness of all CSS IRB decisions and actions. During the budget review period the CSS IRB Chair meets with the VPAA to discuss allocation of resources in comparison to the volume of research and other administrative functions, for example maintenance of CSS IRB Standard Operating Procedures.

The CSS IRB Chair’s term of service is 3 years with the possibility of serving additional terms.

CSS IRB Vice Chair

If the CSS IRB Chair designates a CSS IRB member to serve as CSS IRB Vice Chair, the IRB Vice Chair will work closely with the IRB Chair. The CSS IRB Vice Chair may be primarily involved in reviewing protocols as needed, adverse events and IRB serious problems, and chair the CSS IRB meeting when necessary. The Vice Chair may also review expedited reviews and changes in protocol and some full board continuing reviews and changes. This individual is selected by the IRB Chair.

CSS IRB Administrator

The CSS IRB Administrator (along with the CSS IRB Chair) may manage the membership of the CSS IRB and provide oversight of member appointments, CSS IRB related activities, communications, IRBNet, and other administrative details as defined by the CSS IRB Chair and VPAA.

Administrative Structure

The IRB has direct access to the Vice President of Academic Affairs.