Informed Consent Guidelines and Templates

Do all Research Studies require Documentation of Informed Consent? II

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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.

OR

 (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. 

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  1. Informed Consent
  2. What is Informed Consent?
  3. What are the elements of the Informed Consent document?
  4. How should an Informed Consent document be written?
  5. Do all Research Studies require a written Informed Consent?
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This page last updated 07th Oct 2013