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IRB

IUSB IRB policy for approving deception in research

Use of deception in human subjects research at IUSB requires review at a convened meeting of the IRB (i.e. ‘full’ review).This is due mainly to the difficulty in determining the necessity and predicting the consequences of using deception in human subjects research.

Consideration of the Belmont Report principle of ‘respect for persons’ is especially important in evaluating proposed use of deception in human subjects research. Accordingly, a request to use deception must be treated as a request for the waiver of the informed consent process. Such a request is subject to 45 CFR 46.116(d):

(d) 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:

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Interpretation:

  1. Deception is not allowed in human subjects research that is more than minimal risk.
  2. If a subject would probably still participate in the research even if he or she were fully informed, then this criterion has probably been satisfied.1
  3. The research requires deception – there is no other way for the research to be carried out.1
  4. Particularly, after participation, a subject must be de-briefed about all instances of deception used, except where de-briefing may cause harm to the subject. After participation, a subject must always be given the opportunity to withdraw his or her data from the research.

Additionally, the IUSB IRB may sometimes require the investigator(s) to tell each subject, before his or her participation begins, that he or she may not be fully informed about some aspect(s) of the research.



1Based on a post to the ‘IRB forum’ (www.irbforum.org) by Jeffrey Cohen on 02/03/2010.