The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46. WOU's Institutional Review Board has provided Samples for your use in developing consent forms for your Study.
If the majority of the anticipated subjects do not speak English or will be unable to understand the Consent Form written in English, the consent form must be translated into a language understandable to the subjects.
Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing.dashed line
Technical answers to questions about Informed Consent can be answered at the Office for Human Research Protections (OHRP).
Institutional Research Board (503)838-9200 | or e-mail: firstname.lastname@example.org
Open the original version of this page.