803. Informed Consent Review

Updated October 17, 2023

This type of review is intended to support researchers in assuring that adequate informed consent is obtained from individuals participating in their studies. The review is performed at the request of the IRB or Research Integrity Director and may be requested by researchers as an educational experience. 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.

The purpose of the review is to monitor the consent process to determine whether procedures for the administration of the informed consent process are proper. The Research Compliance Officer (RCO) will schedule the review with study team to ensure the review aligns with the prospective participants scheduled consent interview.

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 was given to 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.

This type of review may also include investigator self-assessment of the informed consent process and documentation via a dedicated tool provided by the Research Compliance Officer.

The informed consent process involves giving a participant adequate information concerning the study, providing adequate opportunity for the participant to consider all options, responding to the participant’s questions, ensuring that the participant has comprehended this information, obtaining the participant’s voluntary agreement to participate and, continuing to provide information as the participant or situation requires. To be effective, the process should provide ample opportunity for the investigator and the participant to exchange information and ask questions.

The RCO will observe the consent process and determine whether the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant and that the informed consent was freely given by the participant. The RCO may survey participants enrolled in the study about the informed consent process and their experience as a participant. The person who conducts the consent interview should be knowledgeable about the study and able to answer questions.

Outcome of Reviews

The RCO conducts the exit interview after completion of the review of the site/records. The RCO may request any clarification regarding the protocol and procedures. The RCO shares verbal summary of the findings pertaining to the records with the investigator/research staff. The RCO writes a report outlining the findings. The Report of Review Findings concluding the review will be sent to the PI within twenty (20) business days.

Suspected Serious or Continuing Noncompliance

If the consent is not legally effective and the prospective participant was entered into the study, consideration must be given that a suspected serious or continuing noncompliance exist and will be verbally reported immediately to the Research Integrity Director. The chair of the IRB will be informed within five business days. The IRB Chair may determine to suspend the study activities, in which case the suspension procedures outlined in the IRB policy in suspensions or terminations of IRB approval will be followed.

The PI will be directed in writing to implement the corrective action plan within no more than thirty (30) calendar days. A shorter term for implementation may be appropriate when quick action is necessary to protect research participants. The final Report of Review Findings with the Corrective Action Plan will be sent to the IRB chair and Research Integrity director to assess whether risks to participants increased as a result of any of the findings. The appropriate next level of review is determined by and at the discretion of the IRB chair and Research Integrity director.

If the Research Integrity Director and/or IRB Chair determine that 1) risks to participants did not increase, and 2) only minor, non-continuing noncompliance, if any, occurred, and 3) the corrective action plan provided by the PI is adequate and likely to satisfy the noted deficiencies, the investigator will be directed in writing to implement the corrective action plan within thirty (30) calendar days.

If the Research Integrity Director and/or IRB Chair determine that noncompliance occurred but are unable to determine that it was only minor, non-continuing noncompliance, the final Report of Review Findings and Corrective Action Plan may be reviewed by a designated sub-committee of the IRB or sent to the full IRB for review at a scheduled meeting. The Research Integrity Director will offer possible IRB members to serve on the designated sub-committee. The RCO will organize the sub-committee promptly.

Review by Designated Sub-committee of the IRB

In the event that the final Report of Review Findings and Corrective Action Plan is reviewed by a designated sub-committee of the IRB and the sub-committee determines that 1) risks to participants did not increase, and 2) only minor, non-continuing noncompliance, if any, occurred, and 3) the corrective action plan provided by the investigator is adequate, the investigator will be directed in writing to implement the corrective action plan within thirty (30) calendar days.

If the designated sub-committee of the IRB cannot determine that only minor, non-continuing noncompliance occurred, the final Report of Review Findings and Corrective Action Plan will be sent to the full IRB at a scheduled meeting. The RCO will document the determination by the sub-committee and provide documentation as attachment to the IRB meeting agenda. The RCO will attend the scheduled IRB meeting and offer assistance in interpretation of the federal regulations, University policy and findings pertinent to the on-site directed review.

Review at Convened IRB Meeting

The RCO schedules a review at the next available regularly convened IRB meeting. Documentation of the sub-committee determination and the final Report of Review Findings and Corrective Action Plan will be discussed as an action item. The IRB members vote for one of the following actions:

• Approved-No further action is required. The RCO will send a letter to investigator describing the outcome of the IRB review.
• Revisions/additional information required. The IRB withholds approval pending submission of revisions and/or additional information. The IRB may determine the Chair has the authority to approval non-substantial revisions/additional information or require review of substantial revisions/additional information at next scheduled IRB meeting. The RCO sends a letter to investigator describing the IRB’s request. Upon receipt of the revisions/additional information, the RCO will schedule on next IRB agenda. The RCO will work closely with the IRB Chair and Research Integrity staff to place as an action item on the agenda with supporting documentation.
• Suspension or termination of the research. The RCO will send a letter to investigator describing the outcome of the IRB review.

Implementation of Corrective Actions

The Investigator must notify the RCO once the action plan has been successfully implemented or completed. Through review or discussion of the PI’s notification of completion of the correction action plan, the RCO or other Research Integrity staff confirms that the Corrective Action Plan has been successfully implemented. The RCO sends a close-out letter to the pi. The IRB will be notified on an upcoming meeting agenda of the status or the corrective action plan and closure of the on-site directed review.