For decades, all federally funded research involving human subjects
has been subject to regulations that require the informed consent of
the subject and oversight by the local institution. These regulations
last underwent major revision in 1981 and have remained unchanged
despite significant changes in the nature of clinical science, the
financial sources of research support, and the institutional
environment in which clinical research is conducted. In the intervening
years, doubt has evolved as to whether the regulations currently in
place adequately protect the welfare and rights of research subjects in
today's clinical research environment and whether the costs, in terms
of time, bureaucracy, and delay, are justified by the level of
protection afforded. The Human Research Ethics Group, administered by
the Center for Bioethics at the University of Pennsylvania Health
System, extensively reviewed the status of existing human subjects
protections with the aim of making recommendations to improve and
reform the regulations. Here, we present recommendations constituting a
consensus of the group members for reform in 3 key areas: protecting
subject populations with special needs and vulnerabilities, oversight
by institutional review boards, and regulatory policy.
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