Βι¶ΉΣ³»­

800. Quality Improvement Program

Updated June 11, 2024

The mission of Research Integrity & Security and the IRB is to verify and promote the continual ethical conduct of research. The Human Research Protection Program (HRPP) has a quality improvement plan that periodically assesses compliance with organizational policies, applicable laws, regulations and ethical principles. The Quality Improvement Program (QIP) is committed to providing ongoing support and services aimed to update and educate the research community of applicable regulations and University policies and procedures governing the conduct of human research. QIP shall focus on key areas of the HRPP including IRB operations, investigator activities, study participant comprehension, IRB member review activities and recordkeeping. These reviews measure the effectiveness and/or efficiency of the Research Integrity & Security/IRB procedures for protection of human participants in research.

Purpose

The purpose of the Quality Improvement Program for human participant’s protection is twofold:

  1. To provide a systematic, internal process that will increase compliance with federal, state and institutional requirements, and promote human participants protections through the ethical conduct of research.
  2. To create opportunities to educate and support the research community.

Objective

The objective of the University’s Quality Improvement Program for human participant’s protection is to measure and improve human research protection effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws. The scope of the Quality Improvement Program includes educating researchers on the mechanisms by which human participants are protected. In keeping with this intent, results of routine Post Approval Investigator Reviews are not shared with the Institutional Review Board (IRB) unless significant or serious deficiencies in human participant protections are found. QIP consists of four overall objectives, 1) compliance, 2) quality, 3) effectiveness and 4) efficiency.

Selection of Studies

Most studies will be selected at random for review. However, consideration for selection of projects or for increased frequency of reviews may be given to:

  • Higher risk studies
  • Investigator-initiated protocols
  • Studies that include vulnerable populations such as University employees and students, terminally ill and decision-impaired, or identified in 45CFR46 subparts C and D (pregnant women, fetuses, neonates, prisoners, and children)
  • Potential for conflict of interest
  • “Directed” interests of the IRB or Research Integrity & Security
  • Investigator history of noncompliance that suggests a lack of understanding about the protection of human participants
  • Research involving investigational drugs or devices for which a new safety warning or changes in labeling suggest increase risks
  • Data confidentiality or security concerns

Types of Quality Reviews to Assess Investigator Compliance

Random Scheduled Review

This type of investigator review is conducted post-approval and is considered a full review. The focus of the review includes roles and responsibilities of research team members, regulatory and IRB compliance, consent form elements, recruitment, eligibility and consenting process, case review for protocol adherence, source documentation and data collection, adverse events, file security, and other suitable aspects of the study. The review may be conducted remotely as described in Policy 801, if necessitated by remote work arrangements or other considerations. It is unlikely this type of review would occur more than once in a twelve-month period.

Directed On-Site Review

This type of investigator review is performed when concerns regarding compliance, protocol adherence, or participant safety are brought to the attention of the IRB or Research Integrity & Security. The Research Integrity & Security Director and/or IRB Chair may request a directed on-site review. This is considered a full review. This type of review may occur more than once in a twelve-month period if concerns about the protocol were brought to the attention of the IRB on multiple occasions. Additional reviews or continued monitoring may result from a review in which corrective actions were prescribed by the IRB.

Informed Consent Review

This type of investigator review is intended to support researchers in assuring that adequate informed consent is obtained from participants in their studies. The Research Integrity & Security Director and/or IRB Chair may request a consent conference review. Researchers may also request a consent conference review as an educational experience. This type of review includes observation of the consenting process; verification that the person consenting the participant is qualified and designated by the Principal Investigator (PI); review of the consent form for valid version date, signatures and date signed; confirmation that a copy of the consent documents were given to the participant, if applicable; review of the consent form for basic elements of consent according to the 2018 Common Rule, and observation and review of HIPAA consenting process. It is unlikely this type of review would occur more than once in a twelve-month period unless continued monitoring was a corrective action prescribed by the IRB as the result of a Directed review.

VA Research

The VA Research Compliance Officer (VARCO) conducts periodic research consent document audits and regulatory audits. Regulatory audits are considered a full review. The focus of the review includes roles and responsibilities of research team members, regulatory and IRB compliance, consent form elements, recruitment, eligibility and consenting process, case review for protocol adherence, source documentation and data collection, adverse events, file security, and other suitable aspects of the study. If the VARCO identifies apparent serious or continuing noncompliance, VARCO must report it directly to the facility director and copy for ACOS Research, the R&D Committee and the IRB no later than 5 business days after the discovery of the potential non-compliance.

Types of Quality Reviews to Assess Internal Compliance

Internal Assessment Review

Administrative assessment reviews are conducted by the Research Compliance Officer (RCO) and are initiated at the discretion of the Research Integrity & Security Director and/or Chair IRB. Any IRB member or Research Integrity & Security 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 & Security staff and the IRB for protection of human participants in research. The review may be specific to the IRB member completing the regulatory review. The results of an administrative assessment are shared with the Research Integrity & Security Director. The results may affect current practices and may require additional educational activities for Research Integrity & Security staff and/or IRB members. The purpose of the review is to monitor internal practices by Research Integrity & Security staff and/or IRB members, but possible noncompliance may be discerned regarding the investigators/study personnel. Examples of areas in which the QIP may periodically conduct a thorough examination of the IRB records, the Research Integrity & Security files/submissions, and/or other materials to evaluate performance include, but are not limited to:

  • IRB member performance;
  • Proper use of expedited and exemption categories;
  • Timelines of Research Integrity & Security staff responses to investigators/study personnel and/or of IRB review;
  • Volume of Research Integrity & Security’s outreach activities 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 continuing 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.

Periodic Assessment of Outreach Activities

The IRB Chairs, Research Integrity & Security Director and staff will meet at least once a year to evaluate the IRB outreach to participants, researchers and IRB members. Assessments may include interviews, surveys, focus groups, written evaluations and website feedback.

Procedures

The above audits and reviews are designed to assess compliance with local, state, and federal laws; research participant safety; and HRPP policies and procedures. Audits and reviews are designed to identify standards of excellence and potential areas for improvement to promote a solid foundation for the conduct of human research, while maintaining compliance with the federal regulations.

Annually, a meeting is held by the Research Compliance Officer, Research Integrity & Security Director and staff members in which a quality improvement plan with specific focus on 1) quality, 2) effectiveness and 3) efficiency of the HRPP is delineated. The annual plan is developed and put into place, to be carried out by an assigned Research Integrity & Security staff member to assess compliance and measure targeted levels of quality, efficiency, and effectiveness of the HRPP during the fiscal year. Each quality improvement focus for the fiscal year will be recorded in IRBNet with access for all Research Integrity & Security staff members. The conduct of the audit/review for the focused quality improvement focus will be monitored at monthly Research Integrity & Security staff meeting.

The plan will, at a minimum, contain:

  • The goals of the quality assessment/improvement plan with respect to measuring effectiveness, identifying opportunities for improvement and achieving and maintaining targeted levels of quality, efficiency, effectiveness and compliance
  • At least one objective to achieve or maintain compliance is defined
  • At least one measure of compliance is defined
  • The methods to assess compliance and make improvements are described
  • At least one objective of quality, efficiency, or effectiveness is defined
  • At least one measure of quality, efficiency, or effectiveness is defined
  • The methods to assess quality, efficiency, or effectiveness and make improvements are described

Results of the plan are reviewed by the Research Compliance Officer and Research Integrity & Security Director to identify trends and to determine if systemic changes are required. If so, the Research Compliance Officer, Research Integrity & Security Director and other relevant parties (such as the Institutional Official or the IRB Chair) will collaborate in the development of a corrective action plan, its implementation, and evaluation of its effectiveness. Documentation of the assessment and improvement (if any) will be documented in IRBNet.