Respect for Persons Is Not Always About Consent: The Importance of Context

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This article refers to:

To Swab or Not to Swab: Waiver of Consent to Collect Perianal Specimens from Incapacitated Patients With Severe Burn Injury

DISCLAIMER

Material has been reviewed by the Walter Reed Army Institute of Research. There is no objection to its presentation and/or publication. The opinions or assertions contained herein are the private views of the author, and are not to be construed as official, or as reflecting true views of the Department of the Army or the Department of Defense.

DISCLOSURE STATEMENT

No potential conflict of interest was reported by the author(s).

Notes

1 45 CFR 46.116 (f)(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

(i) The research involves no more than minimal risk to the subjects;(ii) The research could not practicably be carried out without the requested waiver or alteration;(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and(v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.