Do all Research Studies require Informed Consent?

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In some instances, under certain requirements, federal regulations permit the IRB to grant a waiver of informed consent or allow an adaptation to the required elements of an informed consent. The following criteria must be met to qualify for this waiver or alteration of consent [45 CFR 46.116 (d)]:

(1) The research presents no more than minimal risk to subjects

(2) The waiver will not adversely affect the rights and welfare of the subjects

(3) The research could not practicably be carried out without the waiver; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study

It is important to note that numbers (1), (2), (3) and (4) must all apply and must be cited as justification for waiver of informed consent. Number (4) is particularly important in Social Behavioral research for example in the following types of situations:

There may be new information as a result of a survey or focus group that would be relevant to the subjects.

  • The purpose of the research requires elements of deception, in order to obtain a natural response that the subject would not display if the elements of deception were disclosed prior to the exercise. However, after the completion of the study, pertinent information must be disclosed to the subject.
  • Subjects may be undergoing manipulation to elicit emotional responses.

An investigator who qualifies for an alteration of federal required elements of consent must still disclose to subject pertinent study information. This consent can be in form of a recruitment/cover letter, which includes a brief study explanation and procedures. The letter should also include a brief statement about:

  • Risks associated with the study
  • Option to withdraw
  • Voluntary participation
  • Confidentiality and
  • Appropriate contact information (principal investigator and IRB Chairman)

If a research study qualifies for a waiver informed consent, UNTHSC-IRB requires an investigator to have an oral or written script containing core information about the research study. Follow this link for a sample template of a cover/recruitment letter (used in lieu of informed consent).

Investigators must formally request a waiver of informed consent in the Exempt application or protocol synopsis. This request must also include a justification apart from citing the federal requirements.


This page was last modified on June 10, 2015