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At least 37 records · Page 2Linked to original sources
PubMed1998

Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure--FDA. Notice.

On November 10, 1997, the Food and Drug Administration (FDA), in consultation with the Office for Protection from Research Risks (OPRR) at the National Institutes of Health, requested written comments relating to the proposed republication of the list that identifies certain research activities involving human subjects that may be reviewed by the Institutional Review Board (IRB) through the expedited review procedure authorized in 21 CFR 56.110. The comment period closed on March 10, 1998. FDA and OPRR received a combined total of 108 comments. After a review of the comments, FDA and OPRR are now simultaneously publishing identical revised lists of categories of research activities that may be reviewed by the IRB through the expedited review procedure.

Human Experimentation↗
PubMed1993

Ethical considerations in planning and conducting research on human subjects.

The ethical conduct of research on humans requires more than a caring researcher and a legalistic adherence to federal regulations. It requires good planning and managing of issues accruing from the research relationship--communication, risk and perception of risk, and benefits--to all who have a stake in the relationship and outcome. In 1978 the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research identified ethical principles that should govern research on humans. Institutional review boards (IRBs) now exist in every organization that receives federal funding for human-subjects research. Researchers have an obligation to study the requirements of their IRB when they plan their research. Further, they must establish appropriate procedures for obtaining informed consent and assessing risk, risk perception, and ways to increase the benefits of research.

Advisory Committees↗
PubMed1998

Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group.

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.

Advisory Committees↗
PubMed1998

Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances.

This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that arose surrounding the application of these regulations to emergency research circumstances, and the methods by which the regulations were changed. The new regulations introduced by the U.S. Food and Drug Administration (FDA) also are reviewed.

Disclosure↗