Other Considerations


For information on assent, please refer to Chapter 14.

Proxy Consent

For research involving subjects who are or may be decisionally impaired such that the subject is not capable of giving informed consent, the IRB approves the research only if it finds that proxy consent is appropriate.  For more information on how this is handled in this subject population, see Chapter 14.

Non-English Speaking Participants

Federal regulations require that informed consent information must be presented in a language understandable to the subject and, in most situations, that informed consent be documented in writing (45 CFR 46.116 (a)(3) and 21 CFR 50.20).  All required elements necessary for legally effective informed consent must be present in the consent document in the language spoken by the research subjects.  Investigators should submit the proposed consent document in English and once in final format, the non-English versions should be provided with a certified translation in the language which will be used with subjects.  This process should be utilized any time a research study is actively recruiting non-English speaking participants.

There is an alternative approach available to investigators in the event that the study is not designed to recruit non-English speaking participants. If a potential subject otherwise meets inclusion criteria, a short form written consent document can be utilized. Guidance on this approach as well as translations of the short form in several different languages are available on the HRP website A-Z Guidance.