Show Summary Details
Page of

(p. 88) Invasive Placebos, Patient Burdens, and Community Advocacy: A Federal Ethics Panel Protocol Review 

(p. 88) Invasive Placebos, Patient Burdens, and Community Advocacy: A Federal Ethics Panel Protocol Review
Chapter:
(p. 88) Invasive Placebos, Patient Burdens, and Community Advocacy: A Federal Ethics Panel Protocol Review
Author(s):

Donna L. Snyder

, Catherine S. Lee

, and Robert M. Nelson

DOI:
10.1093/med-psych/9780190647254.003.0006
Page of

date: 20 January 2019

The “Additional Safeguards for Children in FDA-Regulated Clinical Investigations,” 21 CFR 50 subpart D, places limits on the risk to which a child can be exposed in a study. Absent a prospect of direct clinical benefit, institutional review boards (IRBs) cannot approve an intervention or procedure that exceeds “a minor increase over minimal risk.” If there is an ethical justification for the study to proceed, the IRB may refer the protocol for review by a federal panel under 21 CFR 50.54. A study allowing use of a totally implantable central venous access device (TICVAD) to provide placebo was referred for federal panel review; the committee voted unanimously in favor of a TICVAD. A determination by the Food and Drug Administration commissioner was issued within 10 weeks of the initial referral, an unprecedented time line. The Duchenne Muscular Dystrophy community was instrumental in initiating the referral and informing the panel’s decision.

Access to the complete content on Oxford Clinical Psychology requires a subscription or purchase. Public users are able to search the site and view the abstracts and keywords for each book and chapter without a subscription.

Please subscribe or login to access full text content.

If you have purchased a print title that contains an access token, please see the token for information about how to register your code.

For questions on access or troubleshooting, please check our FAQs, and if you can't find the answer there, please contact us.