50 - Assessing Compliance With the New Informed Consent Posting Requirement

Background: One change imposed by the revised Common Rule is the requirement to post an informed consent document for federally supported clinical trials to a public website. The QA/QI Unit at a University created an audit process to assess compliance in this area to inform if additional guidance was needed.

Program

Description: The audit was designed to determine if federally supported clinical trials approved on or after the effective date of the revised Common Rule successfully posted an informed consent document to either ClinicalTrials.gov or Regulations.gov. The goal of the audit was to identify and mitigate any non-compliance and inform policy or guidance changes at the institutional level.

The audit was conducted via remote survey including questions related to study status, whether an informed consent document was publicly posted and, if so, the website utilized for posting. The QA/QI Unit reviewed survey responses and information available on ClinicalTrials.gov and Regulations.gov to determine if investigators were compliant.

Following the audit, investigators were provided a report identifying findings and corrective actions. If an investigator was required to post an informed consent document, they were also provided with instructions for how to do so. Summary audit findings were also shared with HRPP leadership.

Program

Assessment: Sixty-seven percent of applicable studies were successfully audited. Of the studies audited, 15% were found to be non-compliant either because an informed consent document had not been posted or had been posted, but outside of the required time-frame. The remaining 85% of studies did not yet need to post due to ongoing enrollment/interaction with participants or had posted within the required timeframe to an applicable website.

Findings from the audit revealed root causes of non-compliance were related to general unawareness of this requirement and/or the required time frame for posting. Findings will also inform next steps related to the creation of additional guidance or policy changes at the institutional level.

The QA/QI unit intends to continue to conduct these audits, making modifications to ensure that only federally supported clinical trials without a waiver of informed consent are selected for audit. Additionally, changes to the audit notification will be made to ensure investigators understand that notification of audit does not mean non-compliance was found and the informed consent document should not be posted upon notification.

Limitations: Identification of studies subject to this requirement depends on information available in the IRB application, which is not always current. This includes funding information and current study status. This sometimes results in investigators who are not subject to the revised Common Rule Informed Consent Posting requirement, receiving a notification of review.

Discussion: Audits of compliance with the Common Rule requirement for posting of an informed consent document allowed for an assessment of compliance with a new federal requirement that impacts human subject’s research. In addition, this audit process provided insights to leadership, clarified expectations to investigators, and identified gaps to inform future quality assurance efforts.

Following the success of the pilot and favorable feedback from HRPP leadership, the QA/QI unit will continue to monitor compliance with the revised Common Rule Informed Consent Posting requirement.