Do Certificates of Confidentiality (CoC) increase enrollment in clinical trials by ensuring participant privacy?

From the Guidelines

The correct answer is A. TRUE. Certificates of Confidentiality may indeed contribute to increased enrollment in clinical trials because they provide strong privacy protections for research participants. These certificates can help alleviate concerns regarding data usage and sharing, especially among minoritized communities that have been negatively impacted by researchers' misuse of data in the past 1. By providing assurance of privacy and confidentiality, Certificates of Confidentiality can improve trustworthiness in research and make potential participants feel more secure about joining studies that collect sensitive personal information. Some key points to consider include:

• The importance of appropriately recording participants' demographic data, including data on medical condition, sex and gender, age, ethnic group, geography, and overall representativeness of the trial 1.
• The need for research institutions to be mindful of communities' concerns regarding data usage and sharing, and to provide assurance of privacy, confidentiality, and the option to not answer delicate questions 1.
• The role of Certificates of Confidentiality in formalizing confidentiality and providing strong privacy protections for research participants, which can help overcome a significant barrier to recruitment and potentially lead to increased enrollment rates in clinical trials.

From the Research

Certificates of Confidentiality and Trial Enrollment

• There is no direct evidence in the provided studies to support the claim that Certificates of Confidentiality contribute to increased enrollment in trials due to assurance of participant privacy 2, 3, 4, 5, 6.
• The studies provided focus on various topics such as exercise-based cardiac rehabilitation, searching the MEDLINE literature database, mepolizumab to prevent exacerbations of COPD, neural manifolds for the control of movement, and the association between mRNA COVID-19 vaccine boosters and mortality in Japan.
• None of these studies address the specific topic of Certificates of Confidentiality and their impact on trial enrollment.

Relevance of Provided Studies

• The provided studies do not offer any relevant information to answer the question about Certificates of Confidentiality and their contribution to increased trial enrollment.
• Therefore, it is not possible to determine the correct answer based on the available evidence.