Safe from Subpoena - The Importance of Certificates of Confidentiality to the Viability and Ethics of Research
35 Pages Posted: 4 Jun 2020
Date Written: 2015
One thousand individuals participate in a drug trial for an ulcerative colitis medication to see if it is effective for treatment-resistant colitis. Substantial debilitating side effects are discovered that were unknown before the drug was FDA-approved. Many people who were prescribed the drug and experienced these side effects-none of whom participated in the study-initiate a class-action lawsuit against the drug's manufacturer and cite the published results of the research study as evidence. The drug's manufacturer seeks to subpoena all of the research records and data, including the participants' identities and complete medical histories, to defend itself against the suit.
Keywords: Confidentiality, Ethics, Research
Suggested Citation: Suggested Citation