This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (59)  • Contact me when this article is cited  Related Content  • Related letter  • Similar articles in JAMA  Topic Collections  • Statistics and Research Methods  • Alert me on articles by topic  Social Bookmarking   What's this?

Jonathan Moreno, PhD; Arthur L. Caplan, PhD; Paul Root Wolpe, PhD; and the Members of the Project on Informed Consent, Human Research Ethics Group

JAMA. 1998;280:1951-1958.

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.

From the Center for Bioethics, University of Pennsylvania Health System, Philadelphia.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED LETTER

Primary Care Research and Protection for Human Subjects
John W. Beasley
JAMA. 1999;281(18):1697-1698.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Health-Related Philanthropy: Toward Understanding the Relationship Between the Donation of the Body (and Its Parts) and Traditional Forms of Philanthropic Giving
Meslin et al.
Nonprofit and Voluntary Sector Quarterly 2008;37:44S-62S.
ABSTRACT  

Informed Consent and the Capacity for Voluntarism
Roberts
Focus 2003;1:407-414.
ABSTRACT | FULL TEXT  

Opinions Regarding Who Should Consent to Research on Behalf of an Older Adult Suffering from Dementia
Bravo et al.
Dementia 2003;2:49-65.
ABSTRACT  

Knowledge and Beliefs of Nurse Researchers About Informed Consent Principles and Regulations
Higgins and Daly
Nurs Ethics 2002;9:663-671.
ABSTRACT  

Protecting Research Participants
Bauchner
Pediatrics 2002;110:402-404.
FULL TEXT  

Commercial Filming of Patient Care Activities in Hospitals
Geiderman and Larkin
JAMA 2002;288:373-379.
ABSTRACT | FULL TEXT  

Informed Consent and the Capacity for Voluntarism
Roberts
Am. J. Psychiatry 2002;159:705-712.
ABSTRACT | FULL TEXT  

National Depressive and Manic-Depressive Association Consensus Statement on the Use of Placebo in Clinical Trials of Mood Disorders
Charney et al.
Arch Gen Psychiatry 2002;59:262-270.
ABSTRACT | FULL TEXT  

Moving From Compliance to Conscience: Why We Can and Should Improve on the Ethics of Clinical Research
Kahn and Mastroianni
Arch Intern Med 2001;161:925-928.
FULL TEXT  

Quality of Informed Consent: a New Measure of Understanding Among Research Subjects
Joffe et al.
JNCI J Natl Cancer Inst 2001;93:139-147.
ABSTRACT | FULL TEXT  

Is Human Subjects Research (Ethics) in Crisis?
Merz
Journal of Health Politics, Policy and Law 2000;25:979-987.
 

A new look at international research ethics
Benatar and Singer
BMJ 2000;321:824-826.
FULL TEXT  

What Makes Clinical Research Ethical?
Emanuel et al.
JAMA 2000;283:2701-2711.
ABSTRACT | FULL TEXT  

Keeping Research Subjects Out of Harm's Way
Ellis
JAMA 1999;282:1963-1965.
FULL TEXT  

Primary Care Research and Protection for Human Subjects
Beasley
JAMA 1999;281:1697-1698.
FULL TEXT