EXCLUDING PARTICULAR INFORMATION FROM CONSENT FORMS

Abstract

Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor’s name on the consent form may allow the form to serve as a surrogate for subjects’ HIV status.

There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.

We would like to thank the investigators who brought this case to our attention, who wish to remain anonymous. We also would like to thank the members of the Program in Research Ethics (PRE) of the Johns Hopkins University Phoebe R. Berman Bioethics Institute, as well as David Wendler for thoughtful contributions to this manuscript.

Neal Dickert was primarily responsible for drafting the paper. Nancy Kass, Micahel Paasche-Orlow, and Holly Taylor worked with the primary author in developing and editing the paper.

KeyWords:

• informed consent
• consent form
• international research
• ethics
• human subjects research
• confidentiality

Notes

We would like to thank the investigators who brought this case to our attention, who wish to remain anonymous. We also would like to thank the members of the Program in Research Ethics (PRE) of the Johns Hopkins University Phoebe R. Berman Bioethics Institute, as well as David Wendler for thoughtful contributions to this manuscript.

Neal Dickert was primarily responsible for drafting the paper. Nancy Kass, Micahel Paasche-Orlow, and Holly Taylor worked with the primary author in developing and editing the paper.