Article

A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research

Ariella Binik

Assistant professor in the Department of Philosophy and an associate faculty member in the Institute on Ethics & Policy for Innovation at McMaster University

Search for more papers by this author
Spencer Phillips Hey

Faculty member and codirector of research ethics at the Harvard Center for Bioethics and a research scientist in the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital in Boston

Search for more papers by this author
First published: 20 March 2019

(Click DOI to download directly)

Citations: 4
Get access to the full version of this article. View access options below.

Log in with Open Athens, Shibboleth, or your institutional credentials.

If you have previously obtained access with your personal account, .

    • View the article PDF and any associated supplements and figures for a period of 48 hours.
    • Article can not be printed.
    • Article can not be downloaded.
    • Article can not be redistributed.
    • Unlimited viewing of the article PDF and any associated supplements and figures.
    • Article can not be printed.
    • Article can not be downloaded.
    • Article can not be redistributed.
    • Unlimited viewing of the article/chapter PDF and any associated supplements and figures.
    • Article/chapter can be printed.
    • Article/chapter can be downloaded.
    • Article/chapter can not be redistributed.

ABSTRACT

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision‐making tools are needed to help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task.

The full text of this article hosted at iucr.org is unavailable due to technical difficulties.