We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Comment & Response |

Regulation and Comparative Effectiveness Research

Lynn E. T. Shaffer, PhD1
[+] Author Affiliations
1OhioHealth Research and Innovation Institute, Columbus
JAMA. 2014;312(9):963-964. doi:10.1001/jama.2014.7655.
Text Size: A A A
Published online


To the Editor Dr Platt and colleagues1 proposed waiver of informed consent and regulatory changes to facilitate the conduct of low-risk comparative effectiveness trials. Their point regarding changes implemented by health care systems in the absence of systematic evaluation is well taken, yet their thesis raises questions.

Risks and unintended consequences of research extend beyond the view by Platt et al1 of adverse events due to the intervention; their example concerning “a comparison study of marketed agents for routine bathing” (actually a study testing 3 screening and decolonization strategies for methicillin-resistant Staphylococcus aureus using 1 agent) is illustrative.2 If 1 strategy is superior, some patients may develop an infection (or an adverse reaction to an antibiotic) because of the research. In general, other potential risks exist, such as cost implications for patients based on treatment assignment.


Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview




September 3, 2014
Richard Platt, MD, MS; Nancy E. Kass, ScD; Deven McGraw, JD, LLM, MPH
1Harvard Pilgrim Health Care Institute, Boston, Massachusetts
2Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland
3Manatt, Phelps & Phillips LLP, Washington, DC
JAMA. 2014;312(9):964. doi:10.1001/jama.2014.7667.
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


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

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

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

See Also...