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IV. Gary B. Ellis, Ph.D.

Gary B. Ellis, Ph.D., Director, Office for Protection from Research Risks, NIH, discussed the issues of informed consent in all research conducted under the Department of Health and Human Services (HHS). The Federal Regulations of June 18, 1991 were approved by 17 departments and agencies and are also used by other research institutions. Dr. Ellis reviewed the 8 required elements of informed consent in Section 46.116 of the regulations, which include a description of the research, risks and benefits, alternative treatments, confidentiality, compensation and treatment available for injuries, contact persons, voluntary participation and rights of refusal. Six more elements are included, when appropriate: risks to fetus, project termination, costs to subject, withdrawal of subject, new findings, and number of persons in the study. General requirements for informed consent are that coercion should be minimized and language used should be understandable to the subjects or their legally authorized representatives. Ellis reviewed the 8 part "chain of judgements" on the research process that are designed to protect human subjects from harm.


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