Disclosing Adverse Clinical Trials Results: Research Ethics in the Academic Literature

In a recent “target article” for an AJOB Open Peer Commentary, S. Matthew Liao, Mark Sheehan and Steve Clarke make a case for a moral duty to disclose all adverse clinical trial results to potential participants. They argue, in short, that consent is not “informed” when participants lack risk information. Pharmaceutical companies, however, have an interest in protecting information about the development of new products. Although the authors believe the safety of human subjects should be protected even when intellectual property may be disclosed, their analysis concludes that current regulatory practices “fail to promote the duty to disclose adverse clinical trial results and … fail to ensure that sensitive information are not passed on to commercial competitors”. They point to both the US FDA Modernization Act (FDAMA) of 1997 and the US FDA Amendments Act of  (FDAAA) 2007 as inadequate. The Modernization Act makes “no requirement to disclose any adverse trials results to trial participants.” Likewise, the Amendments Act of 2007 does not require the disclosure of safety tests conducted in phase I and phase II trials. At the same time, the authors assert, these regulations make no effort to protect commercial interests. To remedy these inadequacies, the authors propose a database of adverse clinical trial results administered by an oversight body. Additionally, the authors argue for legally binding agreements to protect human subjects and pharmaceutical companies:

Pharmaceutical companies would face appropriate penalties for failure to make disclosure of adverse clinical trial results. Prospective participants would be required to sign a confidentiality agreement regarding the information that has been disclosed to them by the oversight body and would face appropriate penalties for any breaches of this agreement.

Reference:

Liao, S. Matthew; Sheehan, Mark; Clarke, Steve. “The Duty to Disclose Adverse Clinical Trial Results” The American Journal of Bioethics 9.8 (2009). 19 Aug. 2009. DOI: 10.1080/15265160902984988

Peer Commentaries:

Hassoun N. The Duty to Disclose (Even More) Adverse Clinical Trial Results. AJOB 2009; 9(8):33.

McGoey L. Compounding Risks to Patients: Selective Disclosure is Not an Option. AJOB 2009; 9(8):35.

Shah KR, Batzer FR. Improving Subject Recruitment by Maintaining Truly Informed Consent: A Practical Benefit of Disclosing Adverse Clinical Trial Results. AJOB 2009; 9(8):36.

Oakley J. Respecting Participant Autonomy and the Disclosure of Clinical Trial Results. AJOB 2009; 9(8):38.

Banja JD, Dunlop B. Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results. AJOB 2009; 9(8):39.

Saunders PT. The Duty to Register Phase I Trials. AJOB 2009; 9(8):41.

Wu KC. Precautionary Harm Disclosure in Clinical Trials. AJOB 2009; 9(8):43.

Vernillo A. Disclosure of Adverse Clinical Trial Results—Should Legal Immunity Be Granted to Drug Companies? AJOB 2009; 9(8):45.

Related Links:

ClinicalStudyResults.org

ClinicalTrials.gov

[ClinicalTrials.gov Protocol Registration System] PRS and U.S. Public Law 110-85

ClinicalStudyResults.org

Food and Drug Administration Amendments Act (FDAAA) of 2007

Food and Drug Administration Modernization Act (FDAMA) of 1997

WHO International Clinical Trials Registry Platform

Other Recent Research Ethics Articles (August 2009)

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