�� Policy 6.20 - Institutional Review Board for Research on Humans

POLICY #6.20
SUBJECT: Institutional Review Board for Research on Human Participants

I. PURPOSE

The purpose of this Policy is to establish the Institutional Review Board, its membership, and its governing principles. The Policy also sets forth ethical standards for conducting Research activities that involve Human Participants. Southern Utah University (“University”) is committed to the protection of Human Participants in Research and follows federal policy. Research involving Human Participants must be conducted in a manner that prioritizes the rights and welfare of Humans participating in Research.

All students, staff, faculty, units, and affiliates of the University share in the responsibility for promoting the welfare of Human Participants in Research, primarily by adhering to the relevant laws, regulations, and professional and ethical standards governing the conduct of such Research.

II. REFERENCES

Code of Federal Regulations (C.F.R.) Title 45, Protection of Human Subjects (“Common Rule”).
Code of Federal Regulations (C.F.R.) Title 2, Research Institutions Conducting USDA-Funded Extramural Research
Department of Defense (DoD) Instruction Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted Research and -Supported Research
Health and Human Services Office of Human Research Protections (ORHP) Guidance: (1998)
Health and Human Services Office of Human Research Protections (ORHP)
Southern Utah University Policy 5.7 Conflicts of Interest
Southern Utah University Policy 5.22 Data Governance and Protection Policy
Southern Utah University Policy 5.34 Survey Policy and Procedures
Southern Utah University Policy 6.14 Responding to Allegations of Research Misconduct
Southern Utah University Policy 6.28 Faculty Professional Responsibility and Due Process
Southern Utah University Policy 6.70 Requirements to Complete Training in Responsible Conduct of Research
Southern Utah University Policy 6.71 Disclosure of Financial Interests Related to Sponsored Research
Southern Utah University Policy 11.3 Family Educational Rights and Privacy Act

III. DEFINITIONS

Common Rule: Refers to the Title 45, Part 46 of the United States Code and is a federal statute governing Research conducted with Human Participants.
Conflict of Interest: When a University employee owes a professional obligation to the University, which is or can be compromised by the pursuit of an outside activity or financial or other interest.
Generalizable Knowledge: Information obtained from systematic investigation that is intended to have an impact on others, including researchers engaged in self-study, within a discipline or field of study or is disseminated to others with the intent to influence behavior, practice, theory, or future research. (Adapted from Colorado State University).
Human Participant: A Human Participant is defined as a living individual about whom an Investigator, conducting Research, obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Institutional Review Board (IRB): A University committee of faculty, staff, and community members, some of whom have Research expertise and experience, that reviews and approves proposed Research to ensure that Human Participants’ rights are protected and that the risk of harm to participants and Researchers is minimized.
Investigator: An individual that undertakes Research activities involving Human Participants for the purpose of (i) obtaining information about or biospecimens from living individuals by intervening or interacting with them for research purposes; (ii) obtaining identifiable biospecimens or private, identifiable information about a living individual for Research purposes; (iii) obtaining the voluntary informed consent of individuals participating in Research; (iv) studying, interpreting, or analyzing identifiable biospecimens or identifiable, private information for Research purposes; or (v) communicating with the IRB or other institutional review entity regarding the performance of a Research project.
Institutional Leaders: Those university officials or officers with authority over the allocation of institutional resources, including, but not limited to: President, Provost, Associate/Assistant Provost, Vice Presidents, Associate/Assistant Vice Presidents, Deans, Associate Deans, Department Chairs, Program Directors; including those holding positions in an interim capacity who are able to directly influence salaries, appointments, resource allocation or oversight of human participant research.
Policy: References this Policy.
Principal Investigator: In addition to the above, an Investigator whose training, expertise, qualifications, and role with the institution demonstrates that they are able to take full responsibility for research involving Human Participants. The Principal Investigator (“PI”) must be a benefited employee of the institution whose job functions allow them to ensure the presence of appropriate resources for the safe and effective conduct of Research with Human Participants, have an oversight role over others carrying out responsibilities for the Research, and be knowledgeable about the professional and ethical codes of conduct which should govern the Research. Students may only serve as a Principal Investigator on Human Participants Research projects if supervised by a faculty member that is a benefited employee. Adjunct professors, instructors, and others whose job functions do not meet the aforementioned requirements may not serve as Principal Investigators unless a full-time faculty member serves as a co-Principal Investigator for the Research.
Research: Research is defined as a systematic investigation (including Research development, testing, and evaluation), whether carried out by faculty, staff, or students, designed to develop or contribute to generalizable knowledge.
Sponsored Programs, Agreements, Research, and Contracts (SPARC): SPARC is charged with assisting faculty and other university personnel to obtain funding for Research and other scholarly activity and to provide oversight on issues of Federal, state and university compliance, laws and regulations.

IV. POLICY

Incorporation of Federal Regulatory Definitions. This Policy incorporates by reference to federal regulation the terms that are defined in those regulations. In the event of a conflict between regulations, the definitions identified in the Common Rule (45 C.F.R. § 46.102) will control.
Scope and Application. All Research involving Human Participants, as defined in Section III, conducted under the auspices of the University, is subject to this Policy and must follow its requirements. Research is considered to be under University auspices if it involves one (1) or more of the following:
1. The Research is conducted by the University.
2. The Research is conducted by, or under the direction of, any employee or agent of the University in connection with their employment with the University, including the use of institutional letterhead, logo, or brandmark.
3. The Research is conducted by, or under the direction of, any employee or agent of the University using any property, equipment, or facility of the institution.
4. The Research involves the use of the institution’s non-public information to identify or contact Research participants or prospective participants.
IRB Authority
1. The IRB is authorized, by the University President, to conduct all necessary and appropriate review of proposed Research with Human Participants.
2. Its initial and ongoing review of Research will be conducted according to the standards established by the Common Rule, federal regulatory guidance, and procedures adopted by the IRB to operationalize the Common Rule at the University.
IRB Membership, Structure, and Leadership
1. The IRB shall have at least five (5) members selected with the following criteria:
  1. Each school or college dean will recommend to the Provost, or their designee, a faculty member from their school or college to serve as a member. The Provost, or their designee, approves recommended faculty for service to confirm that both scientific and non-scientific areas of inquiry are represented among members from the University faculty. Faculty members of the IRB serve three (3) year terms.
  2. One (1) member from the community or state who is not otherwise affiliated with the University and who is not part of the immediate family of a person who is affiliated with the University.
  3. One (1) member from SPARC.
2. General Member Characteristics
  1. Members of the IRB should represent varying identities, backgrounds, and disciplines to provide complete and adequate review of Research activities.
  2. The IRB will have some members with experience, expertise, and competency in the conduct of Research activities. At least one (1) member must have primary interests and concerns in scientific areas. At least one (1) member must have primary interests and concerns in nonscientific areas. Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist.
  3. Members of the IRB must complete education and training consistent with their role and responsibilities as specified by the IRB Chair and Provost’s Office.
  4. Members of the IRB must be sufficiently familiar with the characteristics of the communities and populations from which Human Participants will be recruited to demonstrate sensitivity to unique needs, interests, and vulnerabilities to promote respect for its advice and counsel in safeguarding the rights and welfare of Human Participants. When necessary, the IRB Chair may appoint an ad hoc member to the IRB for the review of a Research proposal that focuses on a population or community that is less familiar to the standing membership, so long as the ad hoc member is free of Conflicts of Interest.
  5. In addition to possessing the professional competence necessary to review specific Research activities, the IRB shall be able to ascertain the acceptability of proposed Research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
  6. Members of the IRB must be free of Conflicts of Interest with regard to proposed Research activities that they are assigned to review. In the event of a member’s conflict, they must disclose the conflict to the IRB Chair and may be required to recuse themselves if the conflict cannot be reconciled or managed.
3. IRB Leadership
  1. IRB Chair is appointed by the Provost or their designee and may require an application process prior to being appointed.
  2. IRB Chair serves a three (3) year term and may receive an extension for an additional three (3) year term at the Provost’s or their designee’s discretion.
  3. IRB Chair will receive a course reassignment/release to account for the time required to fulfill the responsibilities of the Chair.
  4. IRB Chair responsibilities include, but are not limited to, the following:
    1. Conduct initial or preliminary reviews for IRB proposal submissions or assign initial reviews to IRB members;
    2. Draft and revise standard operating procedures (SOPs) that guide the review process;
    3. Schedule and conduct meetings of the IRB;
    4. Draft determination and approval documents for Investigators;
    5. Provide training for IRB members as the need arises;
    6. Supervise student workers, interns, or graduate assistants assigned to the IRB;
    7. Monitor and respond to correspondence directed to the IRB;
    8. Maintain IRB routing platforms with the assistance of IT professionals; and
    9. Maintain the IRB websites;
  5. IRB Vice Chair is appointed by the Provost or their designee upon the recommendation of the IRB Chair.
  6. IRB Vice Chair serves a two (2) year term and may receive an extension for an additional two (2) year term at the Provost’s or their designee’s discretion.
  7. IRB Vice Chair will receive a course reassignment/release to account for the time required to fulfill the responsibilities of the Vice Chair.
  8. IRB Vice Chair responsibilities include, but are not limited to, the following:
    1. Assume the responsibilities of the IRB Chair when circumstances require;
    2. Conduct initial or preliminary reviews for IRB proposal submissions that are assigned by the IRB Chair;
4. From time to time, as necessary, the IRB through the Chair or Vice Chair, may seek expert consultation for the purpose of obtaining perspective and insight into proposed Research activities.
IRB Approval or Exemption of Research
1. No Research involving Human Participants may begin until IRB approval, exemption, or reliance is finalized. Reliance refers to those Research proposals that need oversight by an IRB outside of the University. The IRB may approve, approve with modifications, disapprove, suspend, cede review to another IRB, or terminate any research involving Human Participants, and it has the sole ability to approve Human Participants Research or designate the appropriate site for review. Other �� units or officials may disapprove Human Participants Research, but such Research may not be approved to move forward or continue until IRB approval, exemption, or reliance is in place.
2. The IRB Chair, in consultation with the IRB members, shall develop standard operating procedures for the regular and consistent review of IRB proposal submissions (sometimes referred to as “protocols”).
3. Information about how to submit IRB proposals consistent with the SOPs will be communicated to Investigators on the IRB website.
4. In its consideration of IRB proposal submissions, the IRB shall ensure that minimum ethical standards regarding Human Participants Research are met before the proposal submission is approved:
  1. Respect for Persons. The circumstances of recruitment shall be disclosed, and will not be coercive, or present undue influence or inducement, in exchange for participation. When appropriate, participants will receive all relevant information about the study in advance and in a manner that is clear to them. Questions from prospective participants and actual participants shall be answered truthfully and consistent with an approved IRB proposal, and information cannot be withheld simply to enhance recruitment. Participants will be fully aware of their rights. Vulnerable and underrepresented populations will receive advanced consideration and protection.
  2. Beneficence. Research will not expose participants to unreasonable risk of harm, including social, legal, economic, psychological, or physical harm. Risks will be minimized and benefits will be maximized. Any risks that can be avoided without undermining the legitimate scientific objectives of the research will be eliminated. Sound research design will be used to ensure the minimization of risk and maximization of benefits. Both the probability and magnitude of harm will be reasonable in relation to the anticipated direct or indirect benefits of participation in all research projects involving human subjects.
  3. Justice. Selection of participants will be equitable, with the overall goal of ensuring that the benefits and burdens of research participation are fairly distributed. Participants should be selected based on the research questions, rather than ease of access or vulnerability. Participants must not be unduly induced to participate in Research, and no procedures should be used that undermine the completely voluntary nature of Research participation. Enrollment into a study must never be the product of coercion or undue influence.
  4. Qualified Investigators. Research must be performed or closely supervised by individuals who have the expertise, experience, and training to minimize risks and ensure, as much as possible, that no harm comes to Human Participants in their Research. The Principal Investigator maintains the primary responsibility for the conduct of the Research and must ensure that all study team members are appropriately trained in Human Participants research protections, the relevant study procedures, and all applicable laws and regulations impacting the Research.
  5. Informed Consent. All participants will first be given the opportunity to receive complete information about the Research and its risks, procedures, and benefits before freely giving their consent to participate. Participants or their legally authorized representatives should provide informed consent prior to participation; in cases where a participant cannot render legally effective informed consent, they should still be given a separate opportunity to assent to the research procedures. Coercion or undue influence must never be present in a participant’s decision-making process. All information should be made available in a manner easily understood to the participants. Informed consent is an ongoing process, and investigators are responsible for ensuring comprehension and continued consent throughout the life of a research project. The IRB may waive some or all of these requirements when appropriate, and in accordance with its operating procedures and federal law.
5. Post-Review Notifications and Correspondence. After the IRB proposal submission has been reviewed, the IRB Chair will provide Investigators with written notification of the review’s outcome. If the IRB proposal submission is approved, a memorandum specifying the conditions of approval shall be provided to Investigators with information regarding the need for subsequent reviews, how to change, amend, or modify approved proposals, and the importance of disclosing deviations or departures from the approved proposal.
Responsibilities for Research Activities
1. IRB Responsibilities
  1. Engage in timely, consistent, and thorough review of IRB proposal submissions for the purpose of protecting Human Participants;
  2. Avoid Conflicts of Interest that may bias or prejudice the review of IRB proposal submissions through timely disclosure of conflicts, recusal, or conflict management when necessary;
  3. Communicate the outcome of reviews to Investigators in a timely and clear manner;
  4. Monitor IRB proposals that require regular and/periodic review after receiving initial approval; and
  5. Respond to and address reports of noncompliance with IRB policy, procedures, or approved submissions.
2. Investigators
  1. Adhere to the requirements and sequence of steps outlined on the IRB website for the submission of IRB proposals and modifications/changes;
  2. Respond to inquiries and requests for additional information when the IRB, its leaders, or members communicate the need for information or outstanding documentation;
  3. Complete all trainings required by the IRB to demonstrate the Investigator is familiar with the standards and principles of responsibly conducted Research;
  4. Disclose any potential, apparent, or actual Conflicts of Interest as part of the IRB proposal submission to ensure that potential, apparent, or actual conflicts are properly evaluated and successfully managed if necessary;
  5. Conduct Research activities in compliance with the conditions of approval, this Policy and other University policies, and the law;
  6. Refrain from initiating a change or modification to the Research activities until those changes or modifications have been reported to and approved by the IRB; and
  7. Disclose (or self-report) departures or deviations from approved IRB proposals, this Policy and other related University policies, and the law. Investigators, particularly Principal Investigators, assume full responsibility for the Research activities and compliance with this policy by all individuals working on a particular Research project.
Addressing Noncompliance and Unanticipated Risks
1. All individuals associated with Research activities are responsible for complying with the Common Rule, this Policy, and the conditions of approved IRB proposals.
2. Individuals who may have knowledge of noncompliance are required to report information to the IRB Chair or Vice Chair as soon as possible after learning of noncompliance.
3. The IRB Chair, IRB Vice Chair, or the IRB collectively have the authority to suspend, temporarily or indefinitely, any Research involving Human Participants if they:
  1. Receive a report of noncompliance that can be substantiated through gathering relevant facts;
  2. Suspect that the risks of implemented or facilitated Research activities are greater than those reviewed and approved by the IRB; or
  3. An external agency (federal or state) requests that Research activities be suspended based on information that has been shared with the agency.
4. The authority to suspend Research activities is different based on the nature of the suspension. Temporary suspensions may be authorized and implemented by the IRB Chair or Vice Chair. Temporary suspensions should not exceed sixty (60) calendar days. Indefinite or permanent suspensions must be authorized by the IRB collectively, and any Investigator facing such a suspension must be provided written notice and an opportunity to be heard by the IRB before such action is taken.
5. The IRB Chair or Vice Chair may take reasonable steps to gather facts regarding any report of noncompliance to substantiate claims within the report.
6. The IRB has authority and jurisdiction to address noncompliance that does not implicate the University’s policy regarding allegations of Research misconduct. If the IRB Chair has reason to believe that noncompliance also indicates an Investigator has engaged in Research misconduct, as that term is defined by �� Policy 6.14, the IRB Chair will refer the report to the University’s Research Integrity Officer.
7. The IRB Chair may also refer undisclosed conditions or circumstances that are subsequently learned of after IRB approval and that implicate the University’s Conflict of Interest policy to the Provost or the Provost’s designee for additional action.
8. The IRB Chair, Vice Chair, or the IRB acting collectively may institute corrective or remedial measures commensurate with incidents of noncompliance as the circumstances may require.
9. Individuals or Investigators with knowledge of unanticipated risks to Human Participants must notify the IRB Chair or Vice Chair as soon as that knowledge is obtained and provide all relevant information to enable the IRB to address the unanticipated risk, which may require the termination of Research activities.
Records related to IRB Review and Research Activities
1. The IRB shall retain records of submissions and proposal reviews for a minimum of three (3) years after the expiration of IRB approval in an electronic format.
2. Investigators are expected to retain records of their Research conducted pursuant to this Policy for a minimum of three (3) years after the completion of the Research activities.

V. RELEVANT FORMS/LINKS

VI. QUESTIONS/RESPONSIBLE OFFICE

The responsible office for this Policy is the Provost/Vice President for Academic Affairs. For questions about this Policy, contact the current Institutional Review Board Chair.

VII. POLICY ADOPTION AND AMENDMENT DATES

Date Approved: December 5, 1994

Amended: January 28, 2005; November 29, 2007; May 3, 2013; December 1, 2016 (text and charts); July 1, 2024 (temporary authorization); April 24, 2025

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POLICY #6.20 SUBJECT: Institutional Review Board for Research on Human Participants