Human Subject Protections
August 12, 1993
NIH PHS HHS
Subject: Informed Consent--Legally Effective and Prospectively Obtained
This letter is being forwarded to Institutional Officials and Institutional Review Board (IRB) Chairs throughout the country. Its purpose is to reiterate the mandate for obtaining legally effective informed consent prospectively from each research subject or the subject's legally authorized representative. This requirement is applicable to all research activities conducted or supported by the Department of Health and Human Services (HHS) and is stipulated in the HHS regulations for the protection of human research subjects (45 CFR 46.116). The requirement is equally applicable to research which is not supported or conducted by HHS, if the research is carried out in accord with a Multiple Project Assurance (MPA) approved by the Office for Protection for Research Risks (OPRR), and no alternative procedures were presented and approved in the applicable MPA.
There are only two circumstances under which the regulations give IRBs authority to waive the required consent. The first waiver authority is applicable only to research activities designed to study certain aspects of public benefit or service programs; the conditions under which this waiver may be authorized by an IRB are detailed at 45 CFR 46.116(c). The second waiver authority is described at 45 CFR 46.116(d) as follows:
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
- the research involves no more than minimal risk to the subjects;
- the waiver or alteration will not adversely affect the rights and welfare of the subjects;
- the research could not practicably be carried out without the waiver or alteration; and
- whenever appropriate, the subjects will be provided with additional information after participation.
Recently, we have become aware of the use of a consent procedure referred to as "deferred consent" or "ratification." Informed consent procedures which provide for other than legally effective and prospectively obtained consent, fail to constitute informed consent under the HHS regulations for the protection of human research subjects. Similarly, the waiving of informed consent, using a method other than that requiring the IRB findings and IRB documentation specified at 45 CFR 46.116(c) or (d), is not in compliance with the regulations.
I urge your careful review of these requirements as they may apply to your institution's and your IRB's actions and procedures. If you have any questions as you carry out this task, please contact Bill Dommel, OPRR's Senior Policy Advisor, at (301) 496-7005.
Gary B. Ellis, Ph.D.
Office for Protection from Research Risks