IRB: Ethics & Human Research

Data-Sharing Dilemmas: Allowing Pharmaceutical Company Access to Research Data

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles require us to look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research.

Key words/concepts: research data, data-sharing, informed consent

James R. Anderson and Toby L. Schonfeld, “Data-Sharing Dilemmas: Allowing Pharmaceutical Company Access to Research Data,” IRB: Ethics & Human Research 31, no. 3 (2009): 17-19.