Navigation Links
Experts propose overhaul of ethics oversight of research

The longstanding ethical framework for protecting human volunteers in medical research needs to be replaced because it is outdated and can impede efforts to improve health care quality, assert leaders in bioethics, medicine, and health policy in two companion articles in a Hastings Center Report special report, "Ethical Oversight of Learning Health Care Systems." One of the authors calling for a new approach is the main architect of the current ethical framework.

Seven commentaries in the publication, written by leaders with national responsibility for ethical oversight of medical research and efforts to improve health care quality, find areas of agreement and offer critiques.

In an accompanying editorial, co-guest editors Mildred Z. Solomon, President of The Hastings Center and Ann C. Bonham, Chief Scientific Officer at the American Association of Medical Colleges, wrote that by inviting these commentaries, they aimed to "provoke a national conversation." According to Solomon, "The challenge is to design oversight that adequately protects patients without impeding the kinds of data collection activities we need to improve health care quality, reduce disparities, and bring down our rate of medical errors." (See video of Dr. Solomon on the importance of this debate.)

For nearly four decades, protection of human participants in medical research has been based on the premise that there is a clear line between medical research and medical treatment. But, the two feature articles argue, that distinction has become blurred now that health care systems across the country are beginning to collect data from patients when they come in for treatment or follow-up. The Institute of Medicine has recommended that health care organizations do this kind of research, calling on them to become "learning health care systems."

In particular, the articles challenge the prevailing view that participating in medical research is inherently riskier and provides less benefit than receiving medical care. They point out that more than half of medical treatments lack evidence of effectiveness, putting patients at risk of harm. On the other hand, some kinds of clinical research are no riskier than clinical care and are potentially more beneficial; an example is comparative effectiveness research to find out which of two or more widely used interventions for a particular condition works best for which patients.

"Relying on this faulty research-practice distinction as the criterion that triggers ethical oversight has resulted in two major problems," the authors write. First, it has led to "delays, confusion, and frustrations in the regulatory environment" when institutional review boards, which are responsible for the ethical oversight of research with human subjects, have difficulty distinguishing between research and clinical practice. Second, it has "resulted in a morally questionable public policy in which many patients are either underprotected from clinical practice risks (when exposed to interventions of unproven effectiveness or to risks of medical error) or overprotected from learning activities that are of low risk . . . and that stand to contribute to improving health care safety, effectiveness, and value."

The authors call for a new ethical framework that "is commensurate with the risk and burden in both realms." Their second article outlines such a framework for determining the type and level of oversight needed for a learning health care system. The basic structure consists of seven obligations: 1) to respect the rights and dignity of patients; 2) to respect the clinical judgment of clinicians; 3) to provide optimal care to each patient; 4) to avoid imposing nonclinical risks and burdens on patients; 5) to reduce health inequalities among populations; 6) to conduct responsible activities that foster learning from clinical care and clinical information; and 7) to contribute to the common purpose of improving the quality and value of clinical care and the health system. The first six obligations would be the responsibility of researchers, clinicians, health care systems administrators, payers, and purchasers. The seventh obligation would be borne by patients.

Authors of the feature articles are Nancy E. Kass, deputy director for public health in the Johns Hopkins Berman Institute of Bioethics; Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics; Steven N. Goodman, associate dean for clinical and translational research at the Stanford University School of Medicine; Peter Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins; Sean Tunis, founder, president, and chief executive officer of the Center for Medical Technology Policy in Baltimore; and Tom L. Beauchamp, a professor of philosophy at Georgetown University and a senior research scholar at the Kennedy Institute of Ethics. Beauchamp was a chief architect of the Belmont Report, which established the existing research ethics framework in the United States.

The commentaries on the articles find common cause with the need to update clinical oversight for learning health care systems, but offer important critiques of the proposed framework. In particular, some hold that the research-treatment distinction is still useful and are concerned that the obligation for patients to participate in quality improvement efforts would exempt too many studies from voluntary informed consent and IRB protections.


Contact: Susan Gilbert
845-424-4040 x244
The Hastings Center

Related medicine news :

1. Experts Offer Advice After Yankee Pitchers Trampoline Injury
2. NYU Langone experts present research, clinical advances at neurosurgeons meeting
3. Red Tide Likely in New England This Season, Experts Warn
4. No Proof That Gum Disease Causes Heart Disease, Experts Say
5. Leading experts on congenital muscular dystrophy convene at University of Nevada, Reno
6. Glaucoma Need Not Steal Sight, Experts Say
7. Healthy Behaviors Extend Life After Cancer, Experts Say
8. Routine Kidney Disease Screening Not Worthwhile, Experts Say
9. Columbia University Medical Center and NY-Presbyterian experts at APA meeting
10. Aim Skin Cancer Warnings at the Young, Too, Experts Say
11. Experts call for clinical trials to test non-skeletal benefits of vitamin D
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... TyloHelo ... parts and accessories. , Sauna accessories help improve the bather experience in the ... From basic styles for the purist looking for simplicity in design to accessories ...
(Date:11/25/2015)... ... 2015 , ... For the first time, Vitalalert is donating half of its ... The partnership between the two groups began in 2014 with Vitalalert pledging a portion ... International was founded in 1954 and is an international Christian-based health organization whose mission ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, ... for the Narconon network, announced the release of a new cutting edge recovery program ... organization has been working with drug- and alcohol-addicted individuals with the purpose to free ...
(Date:11/25/2015)... ... November 25, 2015 , ... Smiles by Stevens ... Disorder, Bruxism, and moderate facial wrinkling. While many patients are aware of the benefits ... great success Botox® delivers to those suffering with discomfort, soreness, and pain as a ...
(Date:11/25/2015)... Livonia, MI (PRWEB) , ... November 25, 2015 , ... ... at Presence Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the ... the medical and surgical intensive care units (totaling 30 beds) from May 2014 through ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the European Therapeutic Drug Monitoring ... Forecasts, Competitive Intelligence, Emerging Opportunities"  report ... ) has announced the addition ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Marker Testing Market: Supplier ... to their offering.  --> ... of the  "2016 Future Horizons and ...
(Date:11/25/2015)... WOODBURY, N.Y. , Nov. 25, 2015  Linden ... access and optimizing treatment outcomes for patients suffering from ... its request for a Temporary Restraining Order (TRO) enjoining ... between the two companies. --> ... aggressively pursuing all of its legal options. ...
Breaking Medicine Technology: