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VIII. Functions of the IRB

1. Scope of Review– The IRB reviews all new and continuing protocol applications for the following:

  1. Determine that the use of human participants has research relevance and that ethical issues have been addressed -with regard to the study’s design and conduct;

  2. Review of funded and unfunded research;

    • (i)UT Arlington IRB will rely on the peer review process of a federal funded agency. This reliance applies to all protocols that have received a formal peer review from a federal funding agency. In this instance, the UT Arlington IRB will not be required to consider the research design and scientific merit of federally-funded protocols.

    • (ii) For unfunded research protocols, the UT Arlington IRB is responsible for assessing the research design and scientific merit in order to determine the risk vs. benefit analysis. In this assessment, the IRB will determine the validity of the research and the nature and degree of risk as well as the nature and level of the anticipated benefits in the research design.

  3. Identify the levels of risk and that everything has been done to minimize risk to the extent possible;

  4. Identify the probable benefits to be derived from the research;

  5. Evaluate the scientific merit for protocols above minimal risk;

    • (iii) The IRB is responsible for reviewing and evaluating the probability of risk and the state of benefits associated with the research.

    • (iv) The IRB may consider ways to minimize risk by reviewing information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, which includes the results of previous studies. For protocols above minimal risk, the IRB may request additional information to support its review of research design and scientific merit. This may include justification for inclusion of human subjects, literature review, additional explanations of direct or indirect benefit, and additional explanation of research design.

  6. Balance the risks against the benefits and importance of the knowledge to be gained;;

  7. Assure that potential participants are provided with an accurate and fair description of the risks or discomforts and the anticipated benefits;

  8. Evaluate the proposed research design in the context of a risk vs. benefit analysis;

    • (v) Consider the research design as it relates directly to the scientific merit and prospect to yield knowledge that is beneficial to society;

    • (vi) Consider the research design as it relates directly to the risk assessment and protection of human subjects;

    • (vii) Examine the proposed research design and risk vs. benefit assessment to determine if the risks that will be presented to the subjects are justified;

    • (viii) The review of research design is not required by federal regulation for exempt research; however, recommendations may be made by the IRB (or designee) to improve research design in the context of a risk vs. benefit analysis. The IRB has no obligation to disapprove the research on this basis.

  9. Determine intervals for periodic review;

  10. Where appropriate, determine that adequate provisions are in place for monitoring the collected data;

  11. Determine the adequacy of the provisions to protect subject privacy and maintain data confidentiality; and

  12. Where the participants are likely to be members of a vulnerable population, determine that appropriate additional safeguards are in place to protect the rights and welfare of these participants..

2. Special Consideration for Projects Involving Vulnerable Populations- The IRB considers certain groups of human participants to be particularly vulnerable in a research setting and considers additional protections for research activities involving pregnant women, human fetuses and neonates, prisoners, children, and cognitively impaired persons. In reviewing these research projects, the IRB ascertains that the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population.

The IRB considers for approval research projects involving vulnerable populations if one of the following conditions is met: i) the research does not involve more than minimal risk to the subject; ii) the research is likely to benefit the subject directly, even if the risks are considered to be more than minimal; or iii) the research involves greater than minimal risk with no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the subject's disorder or condition.

Requests for approval of any research that exposes vulnerable populations to risks that do not meet one of the above criteria must be submitted to the Secretary of the Department of Health and Human Services (DHHS) for review and approval.

For review of protocols involving the use of prisoners in research, the IRB must have a designated prisoner advocate present at the meeting. An IRB member may approve new studies limited to retrospective review of prisoner records and minor modifications using expedited review procedures after review and comment by the prisoner advocate.

3. Suspension or Termination of IRB Approval- The IRB has the authority to suspend or terminate approval of research involving human participants that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate IOs, and the department or agency head.

4. Noncompliance Investigations and Actions- Non-compliance is defined as a failure on the part of the PI or any member of the study team to follow: (1) federal regulations, state laws, or institutional policies relevant to human subjects research; or (2) the requirements and determinations issued by the reviewing Institutional Review Board (IRB). Information regarding non-compliance in research studies involving human subjects may come to the attention of the IRB through several pathways. These include internal monitoring of research projects, information contained in new applications, continuing reviews, adverse experience reports, and reports from collaborators, employees, subjects, or others.

Serious non-compliance is defined as non-compliance with federal regulations or institutional policies that, in the judgment of the reviewing IRB, affects the rights and welfare of subjects or that may cause a significant risk to enrolled subjects or others.

Continuing non-compliance is defined as a pattern of non-compliance that indicates a deficiency likely to result in further non-compliance (e.g., a pattern that indicates lack of attention to or knowledge or understanding about regulations or ethics) or a circumstance in which an investigator fails to cooperate with investigating or correcting non-compliance.

A.) Non-compliance Allegations or Findings - Reports can be either allegations or findings of non-compliance. Allegations of non-compliance that have yet to be proven are reviewed and investigated. An allegation determined to be true based on a preponderance of the evidence becomes a finding. Generally, self-reported instances by investigators will be accepted as a finding of non-compliance.

B.) Reviews of Allegations or Findings of Non-compliance - All reports of non-compliance are initially evaluated by the IRB Staff as the designee of the IRB. A report will either be designated as not requiring further action by the IRB, or will be escalated for review and/or action by the IRB.

      • (i) A report requires no further action by the IRB if the non-compliance is:

      • (ii) A factual assertion of non-compliance (generally self-reported by the investigators);

      • (iii) Neither serious nor continuing; and

      • (iv) Addressed by the investigator through a corrective action plan to remedy the problem.

If a report of non-compliance does not require further action, the incident and corrective action plan will be documented in writing and stored in appropriate files, and reported to the IRB at the next convened meeting. Findings of possible serious or continuing non-compliance are referred to the IRB for review.

If a report of non-compliance is an allegation, the Director of Regulatory Services or designee will review the report and choose one of the following courses of action in investigating the allegation:

      • (a) Conduct the review alone

      • (b) Conduct the initial review in coordination with the IRB Chair

      • (c) Delegate some of the review to IRB Staff

      • (d) Delegate all of the review to IRB Staff

      • (e) Empanel a reviewing subcommittee of the IRB

      • (f) Request that legal counsel provide advice and conduct the review

      • (g) Request assistance from others at UT Arlington (e.g., Office of Internal Audit, Office of General Counsel, or outside consultants)

The individual(s) or subcommittee conducting the investigation may take any of the following actions necessary to determine whether allegations are true, and to determine the seriousness or number of occurrences of the actions: (1) Review written materials, (2) Interview knowledgeable sources, and (3) Collect relevant documentation

Allegations which, in the opinion of the Director or delegate and the IRB Chair, are supported by the preponderance of evidence are determined to be findings of non-compliance. If the non-compliance is neither serious nor continuing, the Director or delegate, alone or with the IRB Chair, will examine whether the Investigator understands the non-compliance and has an adequate corrective action plan. If so, the decision and corrective action plan are documented and filed; otherwise the report is referred to the IRB (the convened IRB, the IRB Chair, or their delegate) for additional review. Findings of possible serious or continuing non-compliance are referred to the IRB for review.

C.) Noncompliance Determined to be Serious and/or Continuing - If the acts of noncompliance appear to be serious or continuing, the IRB Staff will notify the Chair, and the issue will be discussed at the next available convened IRB meeting. If necessary or appropriate, an emergency meeting may be scheduled. At the convened meeting, the IRB will review the circumstances regarding the incident and will determine if the alleged practices appear to: (1) cause injury or any other unanticipated problems involving risks to subjects or others, or (2) constitute serious or continuing noncompliance with IRB determinations or federal regulations.

As a result of this review, the following actions may be taken:

      • (i) The IRB may determine that additional information is needed and request that such information be obtained before further action is taken.

      • (ii) The IRB may determine that non-compliance did not occur or that non-compliance occurred but was neither serious nor continuing, and either take no further action or require or recommend an appropriate corrective action plan.

      • (iii) The IRB may determine that non-compliance occurred and that it was serious or continuing. In this case, the IRB will: (1) Take action appropriate for the situation (see possible actions below), (2) Follow the reporting procedure required by federal regulation 45 CFR 46 and/or funding agency requirements, and (3) Notify the Institutional Official

For concerns not within the IRB’s purview (e.g., research misconduct), the IRB will refer the matter to the appropriate official at the University. IRB determinations and actions will be recorded and communicated as appropriate to the relevant, involved individual(s), normally including the Investigator.

D.) Possible IRB Corrective Actions for Serious and/or Continuing Non-Compliance - In considering actions for serious and/or continuing non-compliance, the IRB seeks to:

      • (i)Correct the non-compliance,

      • (ii) Deter it from occurring again (e.g., hold the relevant individuals accountable for their actions and provide education on how to comply), and

      • (iii) Attempt to mitigate any adverse effects on participants.

      • (iv) The IRB must consider: (1) Suspension or termination of the protocol pursuant to 45 CFR 46.113. The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the relevant regulatory or funding agencies. (2) Notification of current subjects (required when such information may relate to subjects’ willingness to continue to take part in the research).

Other possible actions include, but are not limited to, the following:

      • (a) Monitoring of the research

      • (b) Monitoring of the consent process

      • (c) Referral to other organizational entities (e.g., legal counsel, risk management, institutional official)

      • (d) Modification of the research protocol

      • (e) Modification of the information disclosed during the consent process

      • (f) Provision of additional information to past subjects

      • (g) Requiring re-consent of current subjects to continued participation

      • (h) Modification of the continuing review schedule

      • (i) Participation by research team members in additional training or education

When appropriate, applying any corrective action to all similar protocols.

5. Reporting to Federal Oversight Agencies- The Institutional Official or designee notifies the Office for Human Research Protections (OHRP) of any changes to the Federalwide Assurance Statement and IRB Registration. When applicable, the Institutional Official or designee reports to OHRP, FDA, and/or any applicable funding agencies for instances of serious and/or continuing non-compliance, any unanticipated problems involving risks to subjects or others, or suspension or termination of IRB approval.

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