Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

applications to conduct clinical research (21 CFR Parts 312,
314, 601, 812, 814).
B. Responsibilities of the Researcher
The primary regulatory obligations of the clinical investigator
are to: 1) follow the approved protocol or research plan; 2)
obtain informed consent and ensure that the study is reviewed
and approved by an IRB that is constituted and functioning
according to FDA requirements; 3) maintain adequate and
accurate records of study observations (including adverse
reactions); and, 4) administer test articles only to subjects
under the control of the investigator.
The essential core of FDA's informed consent regulations,
21 CFR Part 50, is that the clinical investigator must obtain
the informed consent of a human subject or his/her legally
authorized representative before any FDA-regulated research can
be conducted. The researcher has to make sure that, whenever
possible, the study participants fully understand the potential
risks and benefits of the experiment before the experiment
begins. The information provided must be in a language
understandable to the subject, and should not require the
subject to waive any legal rights or release those conducting
the study from liability for negligence. Specifically, the
clinical investigator must give the following information to

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