XIII. Thomas B. Friedman, Ph.D.

Thomas B. Freidman, Ph.D., Chief, Laboratory of Molecular Genetics, NIDCD, provided two examples of difficult experiences he had in obtaining informed consent in studies of hereditary deafness in ethnic groups outside the USA that had caused him to better define future strategies. In one international project the subjects had congenital deafness, used a unique sign language, and were not literate. A special consent form was developed through a long process, and was delivered in their sign language. The process utilized a native interpreter as a witness to obtain oral consent from subjects. After consent had been obtained in this way, Friedman reported that OPRR had rejected the approach, because the regulations require a signature. A second consent was then obtained using a witness and a thumbprint. Friedman described a second experience where he felt that it was a mistake not to have had advice from an anthropologist. He felt that in small, more identifiable populations it is extremely important to carefully disguise family pedigree so as to not disclose carrier status. Dr. Friedman proposed a two-form strategy that would include a clear, direct consent form with large print for deaf persons to sign, which states that the person was informed of the necessary information, paired with a longer written form for reference.

[Note: In the discussion that followed, Pat Kvochak stated that the simple form met the regulations provided it was signed by the subject. She further stated there are three ways to get informed consent: (1) a written document that subjects read and sign; (2) a written document that is orally presented and signed by subject; or (3) a short-form written consent document including the required elements of consent that is presented orally and signed by the subject, as long as a written summary of what was said was approved by an IRB and there is a witness to the oral presentation. [See 45 CFR 46.117(b)(2).]