804. Internal Assessment Review

Updated July 19, 2021

The IRB/Research Integrity Quality Improvement Program (QIP) serves to improve human research protections. One of the primary quality improvement activities is the internal assessment review. Internal assessment reviews are conducted by the Research Compliance Officer (RCO) and are initiated at the discretion of the Research Integrity Director and/or IRB Chair. Any IRB member or Research Integrity staff member may suggest procedures or process for internal review. A thorough examination of the IRB records may be conducted for improvement of management or to evaluate the procedures applied and/or issues addressed by the Research Integrity staff and the IRB for protection of human participants in research. The results of an administrative assessment are shared with the Research Integrity Director. The results may affect current practices and may require additional educational activities for Research Integrity staff, IRB members, or investigators/study personnel.

Internal assessment reviews measure the effectiveness and/or efficiency of Research Integrity /IRB procedures for protection of human research participants. An internal assessment may require selection of specific protocols for examination of a variety of topics including, but not limited to review type, funding source, off-site research, event types, special research categories, specific IRB committee and/or assigned Research Integrity staff. Generally, the RCO chooses protocols meeting the criteria for the administrative assessment randomly; however, the RCO and Research Integrity Director have the discretion to identify specific studies for assessment. If identifying specific protocols is not necessary for the type of administrative assessment conducted (e.g., review of meeting minutes, review of a committee’s workload, evaluation of the performance of IRB members), the RCO obtains and reviews other related materials.

Based on performance results, the Research Integrity Director or designee takes measures to strengthen certain areas of the Human Research Protection Program (HRPP). Any performance evaluation topic may be incorporated into an internal assessment review at the discretion of the Research Integrity Director and/or the IRB Chair.

The RCO shares the results of an internal assessment with the Research Integrity Director. The results may affect current practices and may require additional educational activities for Research Integrity staff and IRB members. The Research Integrity Director determines whether significant deficiencies necessitate reporting to the IRB and the Vice President for Research and Innovation (VPRI). The IRB determines whether to report the findings to the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), or the study sponsor, and/or other applicable internal departmental faculty/staff. To support continuous improvement when policy or procedure changes because of QIP review findings, the RCO may perform a follow-up review to determine whether the existing processes remain effective.

Examples of areas in which the RCO may periodically conduct a thorough examination of the IRB records, the database, and/or other materials to evaluate performance include, but are not limited to:

• IRB member performance;
• Proper use of expedited and exemption categories;
• Proper determination for a HIPAA Waiver with documentation complying with federal regulations;
• Timeliness of Research Integrity staff responses to investigators/study personnel and/or of IRB review;
• Volume of the Research Integrity outreach activity for investigators and research participants (e.g., web page “visitors” report);
• Major versus minor revisions at initial review;
• Appropriate consideration and documentation for protecting vulnerable or potentially vulnerable populations;
• Timeliness of continuation review of approved research;
• Documentation for and approval of waivers of informed consent and/or alteration of elements of informed consent;
• Inclusion of all the elements of informed consent as required by the IRB;
• IRB consideration for data and safety monitoring;
• Completeness of IRB minutes;
• Quality of the HRPP and IRB system as measured by accreditation assessment tools.

Assessment of Expedited Review

If the RCO conducts an assessment for protocols reviewed using expedited procedures, he/she/they verifies conformance with policies and procedures, which may include, but are not limited to:

• Assignment to appropriate expedited reviewer;
• Notification of IRB members of expedited reviews;
• Review of protocols using expedited procedures according to the eligibility requirements for expedited review (i.e., proper use of expedited category);
• Documentation for the basis of allowing expedited review (i.e., expedited category selected);
• Performance of expedited reviewer;
• Timely processing of applications by Research Integrity staff and/or the IRB reviewer.

Assessment of Exempt Review

If the RCO conducts an assessment for protocols reviewed for exemption certification, he/she/they verifies conformance with policies and procedures, which may include, but are not limited to:

• Allowable category of exempted research;
• Assignment to appropriate exempt reviewer;
• Documentation for the basis (allowable category) of making the exempt determination;
• Timely processing of applications by Research Integrity staff and/or IRB.

Assessment of Risks and Benefits

If the RCO assesses the IRB’s determination of risk versus potential benefit for a protocol, including designation of minimal risk when appropriate, he/she/they verifies documentation in the research records that includes, but is not limited to:

• Documentation in the meeting minutes or IRB records of the IRB’s evaluation of risks of the research;
• Provisions for safety monitoring;
• Determination that risks to participants are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes;
• Determination of the level of risk;
• Determination of the risk level of investigational device, if applicable;
• Appropriate disclosure of risks and benefits in the informed consent process.

Evaluation of IRB Member Performance

Approximately once each academic year, Research Integrity staff sends the IRB members an IRB Performance Questionnaire to assess representation of appropriate knowledge, skills, and abilities respective to IRB member and IRB Chair roles. Questions intend to collect information including, but not limited to:

• ability to participate (e.g., attendance);
• individual members’ ability to apply knowledge of the federal regulations and ethical principles that serve as guidelines for responsible research and whether additional training is necessary to facilitate appropriate reviews;
• committee competence in relation to appropriate review (e.g., expertise, representation); and,
• IRB Chairperson leadership (e.g., efficiency and promotion of discussion).

The Research Integrity Director and staff analyze the responses and notify the IRB Chair if any of the responses appear to reveal issues with membership qualifications. If the results identify problems with membership qualifications, the Research Integrity Director discusses the issues with the Vice President for Research and Innovation (VPRI). The VPRI may direct the Research Integrity Director to ask an IRB member to resign and to appoint an appropriate replacement.

Research Integrity provides aggregated evaluation responses (to maintain anonymity of responders) to the IRB members.

Human Research Protection Program Evaluation

This assessment focuses on maintenance of applicable documentation representing current policy and procedures, utilization of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) Self-Evaluation Instrument, and evaluation of current human research protection practices to ensure appropriate fulfillment of accreditation and HRPP standards. The program assessment serves to determine whether the University’s HRPP is effective in achieving its intended outcomes and provides the opportunity to develop improvement plans as deemed necessary.

The HRPP is assessed annually. The RCO, with input from the Research Integrity Director and/or designees, conducts the assessment using the AAHRPP Evaluation Instrument and feedback from AAHRPP. Research Integrity staff, the IRB, investigators, and other administrative units may participate in the assessment process. Throughout the course of the assessment, the Research Integrity Director may determine the need for revisions to current HRPP policies, procedures, and/or practices to ensure appropriate fulfillment of accreditation standards. Based on the nature of the revisions to the HRPP, the Research Integrity Director develops appropriate education plans for Research Integrity staff, IRB members, investigators, and other affected units, if applicable.

Elements of Informed Consent Evaluation

When the RCO conducts a review to evaluate appropriate inclusion of the elements of informed consent, he/she/they verifies conformance with the required elements of informed consent according to IRB policy. The nature of the research dictates whether some additional elements of informed consent are necessary, but for required additional elements which have been excluded (e.g., significant new findings statement), the RCO confirms the IRB records contain appropriate documentation of the IRB’s determination. Upon completion of the informed consent evaluation, the RCO shares the results with the Research Integrity Director and, if appropriate, the IRB Chair. If the informed consent evaluation identifies deficiencies, the Research Integrity Director, designated Research Integrity staff, and/or IRB Chair provide follow-up training to IRB members, and/or education to researchers on best practices.

Assessment for Appropriate Representation and Expertise for Vulnerable Population Protocol Reviews

If the RCO conducts an assessment for appropriate representation and expertise for full review research involving vulnerable populations (e.g., children, prisoners), he/she/they verifies that the appropriate IRB representative(s) was present at the convened meeting as a reviewer or consultant. If research involving vulnerable populations is eligible for expedited review, the RCO verifies the Expedited Reviewer had appropriate expertise or a consultant review was obtained. The RCO or Research Integrity Director may decide to focus this assessment on a specific vulnerable population during a particular time.