Featured Research

from universities, journals, and other organizations

Ethics experts call for refocus of scientific review to ensure integrity of research process

Date:
May 17, 2010
Source:
Carnegie Mellon University
Summary:
In a paper published this week in the journal Science, experts caution that important ethical issues in the testing of new therapies like stem cells may not be receiving the attention they deserve. The authors examine the way scientists, physicians, and regulators evaluate risk and benefit when testing new drugs in human beings for the first time.

In a paper published this week in the journal Science, experts caution that important ethical issues in the testing of new therapies like stem cells may not be receiving the attention they deserve.

Carnegie Mellon University's Alex John London joined McGill University's Jonathan Kimmelman and Marina Emborg of the Wisconsin National Primate Research Center at the University of Wisconsin-Madison to examine the way scientists, physicians, and regulators evaluate risk and benefit when testing new drugs in human beings for the first time. According to their report, scientists and regulators tend to focus on how individual patients should be protected from risks, and as a result, overlook how medical advance itself can be adversely affected by poorly designed clinical trials.

For the past few decades, numerous highly innovative therapies have been introduced into human testing, including genetic-based approaches, stem cells and therapies aimed at reprogramming the immune system. Patients with serious illnesses often flock to these studies in hope of a cure. These studies are often controversial, however, because some scientists and regulators consider them too risky while others suggest it is unethical to deny critically ill patients access to these studies.

London and his co-authors argue that debates over access neglect key ethical issues. "Right now, ethical oversight is highly focused on protecting research participants and giving individuals access to scientific developments," said London, associate professor of philosophy and director of Carnegie Mellon's Center for the Advancement of Applied Ethics and Political Philosophy. "These are important issues. But ethical oversight needs to also ensure that decisions about launching human testing are based on a range of considerations that are not easily captured in the current focus."

"What is often overlooked," said Kimmelman, "is that allowing studies of poor scientific quality to proceed potentially undermines the entire scientific enterprise, because they undermine trust, consume scarce research resources, and weaken incentives for medical scientists to perform the best research they can."

"Clinical research is like a scientific bucket-brigade," London added, "where one group of scientists hands knowledge to the next, and they do a trial and hand their results to the next, and a problem with one link in the chain can derail a whole program."

To safeguard the advancement of medical research, the authors suggest that four key questions must be answered when researchers propose human studies of new therapies. They are:

  • Did animal experiments show reliable effects on disease?
  • Are the animal models similar enough to human beings that favorable results are to also occur in human trials?
  • To what extent are researchers justified in believing that observations in animals will hold up in human beings? and
  • Will clinical trials apply the exact conditions that were used in successful animal studies?

The authors suggest that there are instances when human trials are initiated despite unsatisfactory answers to these questions.

"Without critical feedback between preclinical and clinical investigators, oversight committees and sponsors, experiments lose focus and trials risk failure," Emborg notes. "Multilevel cooperation is needed for obtaining meaningful results in translational studies."

"The knowledge and interventions that science produces are valuable social goods," London said. "Everyone who cares about medical advance has an interest in preserving the integrity of the process that makes these goods possible."


Story Source:

The above story is based on materials provided by Carnegie Mellon University. Note: Materials may be edited for content and length.


Journal Reference:

  1. Alex John London, Jonathan Kimmelman, and Marina Elena Emborg. Beyond Access vs. Protection in Trials of Innovative Therapies. Science, 2010; 328 (5980): 829-830 DOI: 10.1126/science.1189369

Cite This Page:

Carnegie Mellon University. "Ethics experts call for refocus of scientific review to ensure integrity of research process." ScienceDaily. ScienceDaily, 17 May 2010. <www.sciencedaily.com/releases/2010/05/100513143449.htm>.
Carnegie Mellon University. (2010, May 17). Ethics experts call for refocus of scientific review to ensure integrity of research process. ScienceDaily. Retrieved April 21, 2014 from www.sciencedaily.com/releases/2010/05/100513143449.htm
Carnegie Mellon University. "Ethics experts call for refocus of scientific review to ensure integrity of research process." ScienceDaily. www.sciencedaily.com/releases/2010/05/100513143449.htm (accessed April 21, 2014).

Share This



More Science & Society News

Monday, April 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Drought Concerns May Hurt Lake Tourism

Drought Concerns May Hurt Lake Tourism

AP (Apr. 18, 2014) Operators of recreational businesses on western reservoirs worry that ongoing drought concerns will keep boaters and other visitors from flocking to the popular summer attractions. (April 18) Video provided by AP
Powered by NewsLook.com
Small Reactors Could Be Future of Nuclear Energy

Small Reactors Could Be Future of Nuclear Energy

AP (Apr. 17, 2014) After the Fukushima nuclear disaster, the industry fell under intense scrutiny. Now, small underground nuclear power plants are being considered as the possible future of the nuclear energy. (April 17) Video provided by AP
Powered by NewsLook.com
Heartbleed Hack Leads To Arrest

Heartbleed Hack Leads To Arrest

Newsy (Apr. 17, 2014) A 19-year-old computer science student has been arrested in relation to a data breach of 900 social insurance numbers from Canada's revenue agency. Video provided by Newsy
Powered by NewsLook.com
Scientists Create Stem Cells From Adult Skin Cells

Scientists Create Stem Cells From Adult Skin Cells

Newsy (Apr. 17, 2014) The breakthrough could mean a cure for some serious diseases and even the possibility of human cloning, but it's all still a way off. Video provided by Newsy
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