ELEMENT I.5.B.

ELEMENT I.5.B.: The organization conducts audits or surveys or uses other methods to assess the quality, efficiency, and effectiveness of the Human Research Protection Program. The organization identifies strengths and weaknesses of the Human Research Protection Program and makes improvements, when necessary, to increase the quality, efficiency, and effectiveness of the program.

An organization’s quality improvement program should include measures of quality, efficiency, and effectiveness to evaluate the performance of the HRPP. The organization should use results from the quality improvement program to design and implement improvements.

The organization should collect objective data through audits, surveys, or other methods and use the data to make improvements and monitor quality, efficiency, and effectiveness on an ongoing basis.

Regulatory and guidance references

VA: VHA Directive 1058.01, VHA Directive 1200.01(1)

Required written materials

Essential requirements:
1. The organization has a quality improvement plan that periodically assesses the quality, efficiency, and effectiveness of the HRPP.
2. The plan states the goals of the quality improvement plan with respect to achieving targeted levels of quality, efficiency, and effectiveness of the HRPP.
  1. The plan defines at least one objective of quality, efficiency, or effectiveness.
  2. The plan defines at least one measure of quality, efficiency, or effectiveness.
  3. The plan describes the methods to assess quality, efficiency, and effectiveness and make improvements.
When following VA requirements:
1. For VA facilities:
  1. The VA facility Director is responsible for:
    1. Ensuring that the VA medical facility’s research review and oversight programs function effectively, and that the VA medical facility provides the resources necessary to comply with all requirements applicable to the responsible conduct of research.
  2. The VA Research and Development (R&D) Committee is responsible for:
    1. Assisting the medical facility director in fulfilling responsibilities for the facility’s research program by making recommendations regarding personnel, training, space, equipment, and other resource needs of the research program.
    2. Reviewing all research related committees and subcommittees at least annually in part by: reviewing the minutes of each subcommittee that reviews VA research protocols; by close communication with the subcommittees; and through Quality Assurance and Quality Improvement activities.
      1. When a VA facility uses an IRB other than its own internal IRB, such as, but not limited to, the VACO IRB, the IRB of another Federal agency, or a non-VA academic institution’s IRB, the role of the R&D Committee is to review and evaluate facility-specific aspects of these relationships, rather than the subcommittee itself, to ensure the obligations as detailed in the MOU are being met. For example, review of an external committee would include evaluation of the number of projects handled by the committee, communication between entities, changes in MOUs or other agreements, change in processes, and challenges. A summary of these reviews and evaluations must be sent to the medical facility director annually.

Common types of materials that may be used to meet the element

Quality improvement plan
Audits, surveys, or other data collection tools
Evaluation reports

Outcomes

The organization:
- Identifies targets for quality, efficiency, and effectiveness of the HRPP.
- Plans improvements based on measures of quality, efficiency, and effectiveness.
- Implements planned improvements.
- Monitors and measures the effectiveness of improvements.

Proceed To: ELEMENT I.5.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.5.B.