ELEMENT I.5.A.

ELEMENT I.5.A.: The organization conducts audits or surveys or uses other methods to assess compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization makes improvements to increase compliance, when necessary.

An organization’s quality improvement program should include measures of compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance.

The organization’s quality improvement program should include an evaluation of the HRPP to determine whether it is effective in achieving compliance.

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

The number of audits or surveys, or the breadth of the audits or surveys, conducted should be determined by the organization and sufficiently robust to provide data that inform the quality improvement program.

Regulatory and guidance references

DOE: 210 CFR 745, DOE Order 443.1B, Chg. 1 (April 21, 2016), DOE Notice 443.1 (January 21, 2016), and their accompanying Contractor Requirements Documents (CRDs)
VA: VHA Handbook 1058.01, VHA Handbook 1200.05, 14, 29

Required written materials

Essential requirements:
1. The organization has a quality improvement plan that periodically assesses compliance of the HRPP.
  1. The plan states the goal of the quality improvement plan with respect to achieving and maintaining compliance.
  2. The plan defines at least one objective to achieve or maintain compliance.
  3. The plan defines at least one measure of compliance.(iv) The plan describes the methods to assess compliance and make improvements.
When following DOE requirements:
1. The organization must periodically conduct self-assessments to ensure compliance with the HRPP procedures and other requirements.
When following VA requirements:
1. Policies and procedures indicate the facility director is responsible for ensuring appropriate auditing of local human participants research studies to assess compliance with all applicable local, VA, and other federal requirements including, but not limited to, Office of Research Oversight requirements.
2. A research compliance officer is an individual whose primary responsibility is auditing and reviewing research projects relative to requirements for the protection of human participants, and who:
  1. Conducts annual consent document audits.
  2. Conducts triennial regulatory audits on all research protocols.
3. The VA facilit's lead research compliance officer must report directly to the facility director. The activities of the research compliance officer may not be determined or managed by the Research Service, research investigators, or any other research personnel.
4. The IRB may observe, or have a third party observe research activities, including the informed consent process. Procedures must include, but are not limited to:
  1. Criteria that might prompt increasing the frequency of audits beyond the minimal required frequency.
  2. The timeframe for reporting audit findings to the IRB.
  3. Types of corrective actions the IRB can require based on the audit findings. (iv) Who should implement and review the corrective actions.
  4. How to evaluate the results of any corrective actions.
5. The IRB can accept audits conducted by the research compliance officer to fulfill auditing requirements.
6. The IRB may require more frequent audits by the research compliance officer or by other means. The IRB also may require the research compliance officer to conduct more focused audits of one or more aspects of the study. The requirement to increase the frequency of audits or to audit specific aspects of the study might be based on considerations including, but not limited to:
  1. Involvement of vulnerable populations.
  2. Level of risk.
  3. Phase I or Phase II studies.
  4. Involvement of FDA approved drugs for which there has been a new safety warning issued, or change in the labeling that indicates increased risks.
  5. Issues of noncompliance.
  6. Data confidentiality or security concerns.

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

Compliance plans
Audits, surveys, or data collection tools
Surveys
Evaluation reports

Outcomes

The organization monitors compliance based on objective data and makes improvements, when necessary.

Proceed To: ELEMENT I.5.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.5.A.