Informed Consent Document – Template

The revised Common Rule for human subjects protections will take effect on Jan. 21, 2019. For the most part, the changes will impact new studies, but ongoing non-exempt studies may need to revise certain aspects of their informed consent document(s) (ICD) to comply with the revised stipulations of 45 CFR 46.116(a)(5)(i). This section requires that a “concise and focused presentation of key information” precede the more detailed and extensive description of study procedures, risks, and the other essential elements required in 46.116.

The new regulation does not require that the “key elements” or their order must be as described/suggested in that section; only that the IRB determine that they are the ones that “would assist a reasonable person in understanding why one might or might not want to participate in the research.” Also, the lengthy preamble discussing the revisions (Federal Register, 82(12), Jan. 2017, p. 7214) recognizes that for many “relatively simple research studies with limited risks or benefits, the entire informed consent document may be relatively brief and still satisfy the 46.116. In such cases, the ICD could include the concise and focused presentation of 46.116(a)(5)(i) at the beginning of the ICD, followed by limited additional information required to satisfy 46.116.”

IRB-02 has revised its ICD template to reflect the new regulations and guidelines on ICD structure, which can be found below. Overall, it is very similar to the previous template, and many ongoing studies already are in compliance with the new stipulations, as they are quite brief (rarely more than two pages, often less than one full page). All active, non-exempt studies with federal funding, must comply with the new regulation by January 20, 2019 so any new enrollment will not be interrupted. The modified ICD should be submitted as a revision to the study as soon as feasible in order to comply with the January 20, 2019 deadline.

IRB-02 Standard Consent Template

Additional Consent options

Back Translations

Back-translation: “A document is translated into a target language by the researcher or colleagues; then that translation is given to a third party who is fluent in both languages, and they translate it back (hence, back-translation) into the original language, not having seen the original (or ideally, knowing much about the research).”

In our case, for example, English to Spanish, then back to English. The rationale for this is that, while for many documents, it’s enough to (a) see that the translation into the target language has been done, and (b) the translator is qualified to do so, in some cases, you want to be sure that key ideas or phrases are getting communicated clearly – language differences can be subtle, and translations can differ in small but potentially important ways. The back translation can insure that the initial translation was as intended.