Question: How to resolve irregularities in the documentation of informed consent?


Our site recently concluded a clinical trial enrolling 2,500 subjects across several clinical sites. Upon review of our information we are seeing improper informed consent documentation including missing consent forms, missing signatures, missing dates, incorrect dates. We are anticipating an FDA audit. What can we do to resolve this issue?
- Director of research, large multi-site medical practice


The irregularities in documentation of informed consent that you describe may not only jeopardize the quality of the data that will be submitted to the FDA but may also raise questions about the adequacy of the informed consent process. Investigators, sponsors and IRBs are required by FDA regulations to provide ongoing oversight of clinical trials and each plays a different role in the oversight process. This response is limited to the IRB reporting requirements.  You will also need to work closely with the study sponsor.

WCG IRBs require reporting issues that represent noncompliance with the IRB-approved protocol or noncompliance with FDA’s regulations on human subjects protections within 5 days. If your protocol is approved by a WCG IRB, you are encouraged to use the WCG IRBs’ Promptly Reportable Information Form. The form provides a list of events that require prompt reporting to the IRB. Completing this form also provides you with an opportunity to analyze the reasons for the lapses in the documentation of the informed consent process and may assist you in thinking about corrective and preventive action plans. The timing and format of these reports may vary across IRBs; if this study was overseen by local IRBs, you should check their requirements for reporting.

Any corrective and preventive action plan you consider should go beyond the “we fired the offending study coordinator” solution. Appropriate corrective and preventive actions may include a plan retraining of staff on the process and documentation of informed consent; putting into place an SOP that describes the strategy for ongoing auditing/monitoring of the data; and an SOP on how the site communicates findings of noncompliance to the sponsor, the IRB, and the FDA, when required. You should also consider creating a Memo to File listing the types and frequency of the missing data so that you have a document readily available for inspection by the IRB, the sponsor or the FDA.

Once you have submitted the report of noncompliance to the IRB, the IRB may respond with additional requirements to ensure the integrity of the informed consent process. In the case of missing forms and missing signatures, the IRB may require you to contact the subject, explain the problem with documentation of informed consent, and ask the subject to re-sign a consent form.


About the Author

Yvonne Higgins | Quality Assurance Advisor, Compliance

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).

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