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

research subjects in seeking their informed consent to
participate in research:
* A statement that the study involves research, an
explanation of the purposes of the research, the expected
duration of the subject's participation, a description of
the procedures to be followed, and identification of any
procedures which are experimental;
* A description of any reasonably foreseeable risks or
discomforts to the subject;
* A description of any benefits to the subject or to others
which may reasonably be expected from the research;
* A disclosure of appropriate alternative procedures or
courses of treatment, if any, that might be advantageous
to the subject;
* A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained and that notes the possibility that FDA may
inspect the records;
* For research involving more than minimal risk, an
explanation as to whether any compensation and any medical
treatments are available if injury occurs and, if so, what
they consist of, or where further information may be
obtained;
1"Minimal risk" in both FDA and HHS regulations means that,
"the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of
4