Faculty Bibliography

One of the Houston octuplets was born 12 weeks premature. The rest are at least 10 weeks early. Each of the babies is very tiny. Their organs are barely developed. Size matters where babies are concerned. There is a very real possibility that some or all of the babies will die. There is an even greater possibility that some or all of them will go through life with severe or moderate disabilities directly traceable to their prematurity. And their prematurity is a direct result of the decision to create a pregnancy of many babies

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.

Americans have a very difficult time dealing with sex. Granted, when the subject is the love life of a president, a British princess or an underage prostitute on one of the TV tabloid shows, we cannot shut up. But that is talk about strangers whose habits, peccadilloes and moral failings have no immediate bearing on what we do in our own bedrooms. When the conversation turns to our own sex lives, to the sexuality of our spouses, children and siblings, we have much less to say