0
Medical Ethics |

Informed Consent for Clinical Research Involving Patients With Chest Disease in the United States

John M. Luce, MD; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Author and Funding Information

*From the Division of Pulmonary and Critical Care Medicine, University of California, San Francisco, and San Francisco General Hospital, San Francisco, CA.

Correspondence to: John M. Luce, MD, Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, 1001 Potrero Ave, Room 5 K1, San Francisco, CA 94110; e-mail: john.luce@sfdph.org


Editor's note: This review addresses the eighth topic in the core curriculum of the ongoing Medical Ethics series.—Constantine A. Manthous, MD, FCCP, Section Editor, Medical Ethics.

Dr. Luce has no conflicts of interest to disclose.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2009;135(4):1061-1068. doi:10.1378/chest.08-2621
Text Size: A A A
Published online

The concept of informed consent was applied to clinical research in the United States after research abuses were documented in Nazi Germany and this country. The concept is imbedded in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Federal regulations governing clinical research require both the consent of subjects and peer review of research proposals by institutional review boards (IRBs). Subpart A of the Code of Federal Regulations contains basic provisions for the protection of research subjects and requirements for informed consent by subjects or their surrogates; surrogate consent may or may not be allowed under state law. Other subparts contain further protections for subjects with diminished capacity, such as children, that limit the kind of research in which they can participate. Whether these protections should be extended to decisionally impaired adults, including those who are critically ill, remains to be determined. Consent can be deferred or waived for emergency research only rarely in the United States, in contrast to other countries.


Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543