Examining Provisions Related to Consent in the Revised Common Rule

Abstract

The long-standing overarching policy governing research with human subjects conducted and supported by most federal agencies and departments in the United States, known as the Common Rule, has recently been revised, with most requirements slated to become effective in 2018. Although there are multiple alterations to the current regulations, some of the most significant changes aim to enhance consent for research. While some of the particular provisions in this regard will be easy to apply and promise to help meet this goal, others may be more challenging to implement despite their intuitive appeal. In this article, I examine some of the provisions in the revised Common Rule that relate to consent: (1) new required consent elements; (2) the goal of comprehension in the consent process; (3) consent forms; and (4) broad consent. By raising issues about these provisions now and suggesting possible ways to overcome their potential shortfalls, the hope is that future efforts can be taken to help clarify and appropriately implement them.

Keywords: consent; regulation; research ethics.