Do all Research Studies Require Documentation of Informed Consent?

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The Institutional Review Board under federal regulations can waive the requirement to obtain documented informed consent (i.e. initials, signature). Research studies that fall under the following criteria may qualify for a waiver of documentation of consent:

(1) The only record linking the subject and the research would be the consent document; and the principal risk would be potential harm resulting from a breach of confidentiality.

45 CFR 46.117 (c) (1)

For example, a study recruiting individuals involved in criminal activities may qualify for this waiver as their signature alone (personal identifier), if exposed, could lead to criminal liability.


(2) The research presents no more than minimal risk of harm to subjects; and involves no procedures for which written consent is normally required outside the research context.

45 CFR 46. 117 (c) (2)

For example, a study evaluating the effectiveness of a smoking cessation program among its participants. The anonymous questionnaire containing no personal identifiers will be administered after the completion of the program. The research is deemed by IRB chair to be no more than minimal risk and study procedures (evaluation survey) would normally be carried out regardless of research intention. This study may qualify for a waiver of documentation of consent. 

It is important to note that either regulation needs to apply in order to qualify for this waiver. Both do not need to apply to justify for this waiver. An explanation for waiver of documentation of consent must be included in the application or protocol synopsis.

An investigator who qualifies for a waiver of documentation of consent must still disclose to subject pertinent study information. This consent can be in form of a recruitment/coverl etter, 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).