Featured Research

from universities, journals, and other organizations

Ethical need for better health care regulatory oversight

Date:
March 18, 2014
Source:
Johns Hopkins Berman Institute of Bioethics
Summary:
A call and recommendations for better regulation and guidance of crucial quality improvement health care research has been made by a group of ethicists and health policy experts. Looking specifically at the generally low- or no-risk type of research known as comparative effectiveness research, the article asks: what level of oversight is necessary? The authors offer recommendations for both the current health policy landscape and a hopeful vision of “harmonized regulation” in transparent, data-driven health care systems of the future.

Patients in health care systems are suffering for a lack of clear federal regulatory guidance in support of low-risk quality improvement research, according to a "viewpoint" article by health and policy experts in the Journal of the American Medical Association (JAMA).

"The Office for Human Research Protections, the Office for Civil Rights, and the US Food and Drug Administration should provide more complete and coordinated advice," to avoid institutions making unnecessarily restrictive decisions on what research can go forward because of uncertainty about what regulations allow, thus impeding much-needed medical research, the article says, under the heading "Time for a Change."

Looking specifically at the generally low- or no-risk type of research known as comparative effectiveness research, the viewpoint asks: what level of oversight is necessary? The authors offer recommendations for both the current health policy landscape and a hopeful vision of "harmonized regulation" in transparent, data-driven health care systems of the future.

"Our federal regulatory system is critical in protecting patients when research poses risks or threats to their wellbeing. But our regulations also need to have flexibility to allow different oversight options for research that alters patients' care very little yet has the opportunity to improve care enormously," says Nancy Kass, co-author of the viewpoint and the Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics.

"All clinical care carries risk, and to assume that research automatically imposes additional risks beyond those the same patient would otherwise have experienced in clinical care may overinflate the risks of research and underestimate the risk of not conducting these evaluations," the viewpoint states.

Joining Kass in the opinion is Richard Platt, a research physician trained in infectious diseases, of Harvard Medical School and Pilgrim Health Care Institute, and Deven McGraw, a health care lawyer and privacy expert, of the Center for Democracy and Technology.

The authors highlight the paradox of stringent research regulations for studies evaluating changes in how healthcare is organized coexisting alongside the lack of oversight when "administrative" decisions are made to health system operations. Such administrative clinical decisions are not considered research and thus are not subject to review, patient consultation or other transparency yet can have considerable impact on patients' experience and successful treatment. The authors use the example of changing the ratio of nurses to patients, which could have profound effects on patient outcomes.

The viewpoint also stresses the importance of patient engagement in oversight and in the research process. The engagement of patients and other stakeholders will be critical to collecting and using data in ways that seem respectful and acceptable to patients.

"Ethics has a central role to play in ensuring that patients in our health care system are safe and are treated with respect. We must uphold these commitments both through research oversight and care delivery, so that policy, clinicians and patients are working in harmony to find the most effective, safe and respectful solutions," Kass says.


Story Source:

The above story is based on materials provided by Johns Hopkins Berman Institute of Bioethics. Note: Materials may be edited for content and length.


Journal Reference:

  1. Richard Platt, Nancy E. Kass, Deven McGraw. Ethics, Regulation, and Comparative Effectiveness Research. JAMA, 2014; DOI: 10.1001/jama.2014.2144

Cite This Page:

Johns Hopkins Berman Institute of Bioethics. "Ethical need for better health care regulatory oversight." ScienceDaily. ScienceDaily, 18 March 2014. <www.sciencedaily.com/releases/2014/03/140318154808.htm>.
Johns Hopkins Berman Institute of Bioethics. (2014, March 18). Ethical need for better health care regulatory oversight. ScienceDaily. Retrieved September 18, 2014 from www.sciencedaily.com/releases/2014/03/140318154808.htm
Johns Hopkins Berman Institute of Bioethics. "Ethical need for better health care regulatory oversight." ScienceDaily. www.sciencedaily.com/releases/2014/03/140318154808.htm (accessed September 18, 2014).

Share This



More Health & Medicine News

Thursday, September 18, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Cost of Ebola

The Cost of Ebola

Reuters - Business Video Online (Sep. 18, 2014) — As Sierra Leone prepares for a three-day "lockdown" in its latest bid to stem the spread of Ebola, Ciara Lee looks at the financial implications of fighting the largest ever outbreak of the disease. Video provided by Reuters
Powered by NewsLook.com
What HealthKit Bug Means For Your iOS Fitness Apps

What HealthKit Bug Means For Your iOS Fitness Apps

Newsy (Sep. 18, 2014) — Apple has delayed the launch of the HealthKit app platform, citing a bug. Video provided by Newsy
Powered by NewsLook.com
Residents Vaccinated as Haiti Fights Cholera Epidemic

Residents Vaccinated as Haiti Fights Cholera Epidemic

AFP (Sep. 18, 2014) — Haitians receive the second dose of the vaccine against cholera as part of the UN's vaccination campaign. Duration: 00:34 Video provided by AFP
Powered by NewsLook.com
Raw: Elephant Undergoes Surgery in Tbilisi Zoo

Raw: Elephant Undergoes Surgery in Tbilisi Zoo

AP (Sep. 18, 2014) — Grand the elephant has successfully undergone surgery to remove a portion of infected tusk at Tbilisi Zoo in Georgia. British veterinary surgeons used an electric drill to extract the infected piece. (Sept. 18) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins