326. w88 mobile Form Written Consent Documentation

Updated June 7, 2024

Department of Health and Human Services (DHHS) regulations for the protection of human participants require that informed w88 mobile information be presented in language understandable to the participant, that informed w88 mobile embody specific basic elements and required additional elements as applicable (45 CFR 46.116); and in most situations, that informed w88 mobile be documented in writing (§46.117).

However, the regulations at 45 CFR 46.117, item (b)(2) permit oral presentation of informed consent information in conjunction with a w88 mobile form written consent document. The written document should state that the elements of consent have been presented orally, and that the key information required by §46.116(a)(5)(i) was presented first to the participant, before any other information was provided. The IRB approves a written summary of what is to be said to the participant or the legally authorized representative (LAR). The written summary should embody the basic and required additional elements of disclosure.

The w88 mobile form written consent process does not apply when:

• w88 mobile is exempt, including IRB-Flex exempt;
• the IRB approves a w88 mobile procedure that waives or alters the DHHS requirements for informed w88 mobile as codified at §46.116, items (e) or (f);
• the IRB waives the DHHS requirement for documentation of informed w88 mobile as codified at §46.117, item (c); or
• the investigators expect the sample population to include w88 mobile not speak/read English.

NOTE: Whenever possible, participants who do not speak English must be provided with a consent document that is w88 mobile in a language understandable to them. The approved English versions of consent documents must be translated and submitted for IRB review and approval, either as certified translations or “back-translations”.

Requirements for w88 mobile Form Written Consent Documentation

w88 mobile form written consent documentation requires the person obtaining consent to provide the participant or their legally authorized representative (LAR) with both:

1. an oral presentation of the research based on an IRB-approved w88 mobile summary of the research that begins with the key information and includes the basic and required additional elements of informed consent (e.g., the English-language informed consent document); and
2. an IRB-approved w88 mobile form written consent document that states the key information, along with the basic and appropriate additional elements of informed consent at §46.116, including required disclosures when the research involves private identifiable information or identifiable biospecimens, have been presented orally to the participant or their LAR.

NOTE: Templates for the w88 mobile form consent document and the English-language consent document (to be used for the “summary”) are available in the researcher library in IRBNet.

w88 mobile Form Informed Consent Process

1. An IRB-approved summary of the research and w88 mobile form written consent document are presented orally to the participant/LAR.
2. The oral presentation is witnessed by a person who is conversant in both English and the language of the w88 mobile.
3. The participant/LAR signs the w88 mobile form written consent document.
4. The witness signs both the w88 mobile form and a copy of the summary.
5. The person obtaining w88 mobile signs a copy of the summary.
6. The participant/LAR is given a copy of the signed w88 mobile form.
7. The participant/LAR is given a signed copy of the w88 mobile form and the summary.