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

None

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.
  4. The plan describes the methods to assess compliance and make improvements.
When following requirements:
1. For VA facilities:
  1. The VA facility Director is responsible for:
    1. Notifying the appropriate Office of Research Oversight (ORO) workgroup(s) of the initiation of a research program or the substantial alteration of an existing research program that is related to the implementation, suspension, or termination of an HRPP.
    2. Notifying, or designating an individual to notify, the appropriate ORO workgroup(s) within five (5) business days after receiving written notification of any situation that is reportable to ORO under VHA Directive 1058.01. NOTE: The VA medical facility director’s report is required regardless of whether the situation has been resolved at the time of the report
    3. Appointing at least one full-time Research Compliance Officer (RCO) to conduct research informed consent and regulatory audits unless the VA Office of Research and Development (ORD) and ORO jointly approve a waiver to permit appointing of a part-time RCO.
      1. The RCO, or a lead RCO if one is designated in instances where a VA medical facility employs more than one RCO, must report directly to and be supervised by either the VA medical facility Director or a senior individual who reports directly to and is supervised by the VA medical facility Director and whose primary responsibilities at the VA medical facility pertain directly to compliance.
        RCO activities must not be determined or managed by the Associate Chief of Staff for Research and Development (ACOS/R&D) or any other individual or research review committee in a VA medical facility’s Research Service.
        The VA medical facility director must ensure that the RCO(s) has the necessary expertise, through education or experience, to fulfill the duties of the RCO position.
        The VA medical facility director must ensure that the RCO(s) has ready access to research program and study documentation so that the RCO can effectively fulfill the responsibilities of the position. This includes access to documentation (e.g., research review committee meeting minutes, study approval letters, researcher study documentation) necessary to fulfill requirements related to auditing of informed consents and study protocols. NOTE: In situations where the VA medical facility relies upon a research review committee operated by a non-VA entity, the VA medical facility director must ensure that agreements to rely on such committees or other documents (e.g., the committee’s SOPs) require that the VA medical facility’s RCO has access to the committee’s records to the extent necessary for the RCO to fulfill research auditing requirements.
    4. Ensuring that all research compliance reports from any state or federal oversight entity (including ORO), as well as research accreditation reports/determinations, are provided to the ACOS/R&D, the R&DC, any other relevant research review committees, and the RCO within five (5) business days after receipt.
  2. The VA Associate Chief of Staff for Research and Development (ACOS/R&D) is responsible for:
    1. Promptly reviewing and reporting events as specified in VHA Directive 1058.01.
    2. Alerting, or designating an individual to alert, the VA medical facility Director and ORO by email or telephone within one (1) business day after receiving the initial oral notification of a local research death of a human participant and providing relevant information requested.
  3. The VA Research Compliance Officer (RCO) is responsible for:
    1. Auditing VA medical facility research projects including performing annual informed consent and triennial regulatory audits of approved study protocols and other post-approval monitoring activities as specified by ORO.
      1. RCO audits must be conducted in accordance with a written audit plan or SOP that describes the RCO’s auditing process, including procedures for planning and executing audits, procedures for soliciting study researcher’s responses to preliminary audit findings and timelines for providing all audit results (regardless of findings) to the relevant research review committees, including the Research and Development (R&D) Committee.
    2. Informing the VA medical facility Director and applicable research review committees about research compliance concerns.
    3. Performing additional research oversight duties assigned by his or her supervisor, including assisting in compliance education to researchers, research staff and research committee staff/members; accreditation activities; the completion of the VA medical facility Director’s Certification of Research Oversight; and ad hoc audits of individual studies or programs. Such duties must not conflict with or delay completion of the RCO’s research audit responsibilities.
  4. The VA Research and Development (R&D) Committee Chair is responsible for:
    1. Ensuring the committee’s prompt review and reporting of events as required by VHA Directive 1058.01 and applicable federal regulations and policies pertaining to VA research.
    2. Within one (1) business day after receiving written notification of the local research death of a human participant, assessing and documenting whether any actions are warranted to eliminate apparent immediate hazards to participants or others and, if so, initiating those actions. This may be delegated to another qualified committee voting member.

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.