CSS IRB Federalwide Assurance (FWA)
CSS IRB Registration and Administration

Standard Operating Procedure Institutional Review Board
Policy Number: 01
Effective Date: 10/8/2021
Owner: CSS IRB & Vice President of Academic Affairs
Author: CSS IRB

Policy

It is the policy of The College of St. Scholastica (CSS) that the CSS IRB will file and maintain an agreement with the Department of Health and Human Services (HHS) through the Office of Human Research Protection (OHRP) through a Federal Wide Assurance (FWA). The College of St. Scholastica has declared that all institutional components listed under CSS FWA Assurance Number: FWA00027482 must comply with this assurance. In addition, the CSS IRB is registered with the Department of Health and Human Services. HHS IRB Registration Number: IRB00011463 .

OHRP's approval of The College of St. Scholastica assurance of compliance does not mean that OHRP has determined that CSS is complying with the requirements of the HHS Protection of Human Subjects regulations, 45 CFR part 46. It means that CSS has submitted all of the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects research conducted or supported by HHS or other research covered by the assurance of compliance. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.

As a condition of receiving federal research support, The College of St. Scholastica has signed a Federal-Wide Assurance (FWA) that has been approved by the federal agency that oversees human subject research. It is important to note that CSS has assured that ALL CSS investigators, including those at affiliated institutions, will comply with ALL federal regulations, regardless of the funded or non-funded sources that support their research in human subjects.

Purpose

The purpose of this policy is to describe the agreement with the Department of Health and Human Services Office of Human Research Protection (OHRP) through the FWA.

Administration

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

• 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 for the protection of human subjects. In some cases, one institution may operate under an Assurance issued to another institution through the Individual Investigator Agreement.

The College of St. Scholastica leadership is committed to upholding the CSS Assurance, improving the research infrastructure to ensure a strong CSS IRB and, through evaluation and assessment, initiate required improvements in the IRB. At The College of St. Scholastica, the Signatory Official is the individual responsible for the Assurance and its implementation and is the President of the College. The intent in requiring that the Signatory Official be a high-level individual is two-fold. First, OHRP encourages institutions to promote a culture of conscience for the ethical conduct of human subjects research at the highest level within the institution. Second, the Signatory Official should be at a level of responsibility that would allow authorization of necessary administrative or legal action should that be required.

The President of The College of St. Scholastica (Signatory Official) together with the Vice President of Academic Affairs (Human Subjects Contact Person) are responsible for:

• Designating the CSS IRB as the IRB that will review research covered by the institution's FWA;

• Providing sufficient resources, space, and staff to support the IRB's review and record keeping duties;

• Providing training and educational opportunities for the IRB and investigators;

• Setting the "tone" for an institutional culture of respect for human subjects;

• Ensuring effective institution-wide communication and guidance on human subjects research;

• Ensuring that investigators fulfill their responsibilities;

• Encouraging that all staff engaged in the conduct or oversight of human subject research participate in education activities;

• Ensuring that the CSS IRB has the resources and support necessary to comply with federal regulations and guidelines that govern human subjects research;

• Represents him/herself as legally authorized to represent the institution in matters regarding human subject research;

• Is the signatory official for all Assurances and assumes the obligations of the CSS Assurance;

• Is responsible for review and evaluation of reports on the CSS IRB performance;

• Is responsible for further institutional review and approval or disapproval of research approved by the CSS IRB (neither the President nor any other CSS official can approve research that was disapproved by the IRB).

To facilitate this oversight function, the CSS IRB makes available to the President and/or VPAA copies of all IRB meeting minutes, containing reports of IRB deliberations on human subjects protocols. All correspondence and reports sent to federal regulatory agencies regarding investigator or institutional noncompliance are signed by the CSS President.

Reporting Relationship

The College of St. Scholastica Vice President of Academic Affairs is referred to in the Assurance as the Human Subjects Contact Person. The VPAA is also the Institutional Official who serves as a knowledgeable point of contact for OHRP. Some functions of the CSS President may be delegated to the VPAA. The CSS Institutional Review Board will report to the Vice President of Academic Affairs. The IRB is responsible for reporting to the Vice President for Academic Affairs any serious or continuing noncompliance by investigators with the requirements and determinations of the IRB.

IRB Authority and Responsibilities

To fulfill the requirements of DHHS regulations and this policy, the CSS IRB shall have the following authority and responsibilities:

1. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by federal regulations, state law, and CSS institutional policy.

2. The IRB shall require signed informed consent by human subjects where required by 45 CFR 46.116 & 117.

3. The IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

4. Except when an expedited review is used, the IRB shall review proposed research at convened meetings at which a quorum of the members of the IRB are present. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

5. The IRB shall not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

6. The IRB shall ensure appropriate training for Investigators whose research includes Human Subjects.

7. The IRB shall conduct continuing reviews, as deemed necessary, of research at intervals appropriate to the degree of risk but not less than once per year. The IRB shall have the authority to determine which research requires review more often than annually.

8. The IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with its approval.

9. The IRB shall have the authority to suspend or terminate approval or require modification to research that has been associated with unexpected serious harm to subjects (e. g. Adverse event). Any suspension or termination of approval shall include a statement of reasons for the IRB action and shall be reported promptly by the IRB Chair to the investigator, the investigator’s sponsor (if applicable) and the VPAA.

10. The IRB will maintain appropriate records regarding investigator training, research projects, and federal certificates.

11. The IRB shall disseminate its policies and procedures that detail requirements for research with Human Subjects.

12. The IRB will ensure that the College meets its obligations for Federal Wide Assurance and make appropriate changes in light of new regulations.

Food and Drug Administration

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 IRBs and 21 CFR Part 50 for Informed Consent). The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The basic requirements for IRBs and for informed consent are congruent between the HHS and FDA regulations. Differences center on differences in applicability:

• HHS regulations at 45 CFR Part 46 apply to research conducted or supported by HHS.

• FDA regulations apply to clinical investigations of FDA-regulated products: drugs, devices, or biologics.

The College of St. Scholastica will comply with all applicable state laws regarding human subjects research. If research takes place outside the state of Minnesota, the IRB will consult with legal counsel who provides interpretation and guidance to the CSS IRB. In situations where there are conflicts between federal and state, or other applicable laws, legal counsel will be consulted to advise on resolution of the conflicts.

In general, it is the responsibility of all faculty and research staff, IRB members, IRB staff, CSS staff negotiating with research sponsors, and anyone else involved in human subjects research to uphold the ethical standards delineated in the Belmont Report and assure that the highest level of human subjects protections are in place and implemented at all times.

Resources

OHRP Assurance Process Frequently Asked Questions https://www.hhs.gov/

OHRP Assurance Training https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals

/index.html/assurance-training#Module-1

Food and Drug Administration 21 CFR Part 50 and 21 CFR Part 56 University of Texas at Austin https://research.utexas.edu/ors/ Seattle Pacific University

https://www.google.com/url?client=internal-uds-cse&cx=010768069351356013927:snjgfukxg_g&q=http s://spu.edu/~/media/academics/college-of-arts-sciences/health-and-human-performance/documents/S PUIRBcharter.ashx&sa=U&ved=2ahUKEwjInMnswoPlAhUQoZ4KHWmUDYEQFjAAegQIABAC&usg=AOvVa w2zBL8LR0vIIJXuYPnY86Q3

University of Lincoln Nebraska https://research.unl.edu/researchcompliance/human-subjects-research