Informed Consent (IC) Audits

The cornerstone of clinical research is the informed consent process.  History has taught both investigators and research participants many valuable lessons.  Informed consent is more than just a document. It is an ongoing process of communication and mutual understanding between an individual and the investigator. The participant’s initial agreement to participate in the clinical research study is evidenced by signing an IC document. Since 2016, with the creation of the Office of Education and Compliance, routine audits of the informed consent process for all active CCR protocols has been conducted. The focus of the audits have been on non-IND intervention and observational studies. Below are the audit summaries. Any questions, please contact the Office of Education and Compliance

Informed Consent Audit Summaries

March: Summary of Informed Consent Process, Non-English Speaking
February: Summary of Informed Consent Process, CTEP and Network-Sponsored

October: Summary of Informed Consent Process, Industry-Sponsored
July: Summary of Use of iMed Informed Consent Process

2020: Overall Audit Findings for Non-English speaking participants on 01C0129 and 04C0165

2019: Overall IC Audit Findings with comparison to 2017

2017: Overall IC Audit Findings 2016 - 2017

Last updated by Grady, Deborah (NIH/NCI) [E] on May 24, 2024