The morality of human subject research

August 3, 2012

(Medical Xpress) -- The federal government is in the process of revising the regulations that govern most human subject research in the United States.

In a “Policy Forum” piece in the Aug. 3 issue of Science, bioethics expert Rebecca Dresser, JD, the Daniel Noyes Kirby Professor of Law and professor of ethics in medicine at Washington University in St. Louis, weighs in with recommendations for changes in the oversight process.
Dresser writes that the research oversight system must be based on a fundamental moral judgment. “Human subjects have interests that should not be subordinated to the interests of the patients, researchers, industry stakeholders, and others who gain health and monetary benefits from the research enterprise,” she writes.

Dresser makes three recommendations:

  • To promote informed choice, researchers should adopt procedures to evaluate whether prospective subjects understand essential facts about a study.
  • Because research subjects accept burdens so that others may benefit, research sponsors and institutions should cover the costs of any study-related injuries.
  • To ensure that risks to subjects are justified by the importance of the knowledge a study is expected to produce (this is an existing regulatory requirement), studies should undergo independent and rigorous merit review.
Dresser holds a joint appointment at the law school and at Washington University School of Medicine in St. Louis, teaching law and medical students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction and related topics.

She has written extensively in her field and is the co-author of a casebook on bioethics and law and a book on the ethical treatment of animals. She also is the author of a book on patient advocacy and research ethics. Her most recent work is as editor and contributor to Malignant: Medical Ethicists Confront Cancer (Oxford University Press, 2012).

She is a member of the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH) and a past member of the President’s Council on Bioethics. She also sits on the Washington University Medical Center Institutional Review Board, as well as the Washington University Embryonic Stem Cell Research Oversight Committee and Alzheimer’s Disease Research Center Ethics Committee.

Explore further: ACP's Ethics Manual examines emerging issues in medical ethics

More information: To view an abstract of the article, visit www.sciencemag.org/content/337/6094/527 .

Related Stories

ACP's Ethics Manual examines emerging issues in medical ethics

January 2, 2012
The American College of Physicians (ACP) has released the sixth edition of its Ethics Manual, published as a supplement to the current issue of Annals of Internal Medicine, ACP's flagship journal, and available online at ...

5 Questions: Magnus on the role of research ethics consultations

January 26, 2012
In the past decade, a growing number of academic medical centers have begun offering research ethics consultation services, in which bioethics experts help scientists address the ethical and societal implications of their ...

Researchers weigh in on ethics of H5N1 research

February 9, 2012
(Medical Xpress) -- In a commentary on the biosecurity controversy surrounding publication of bird flu research details, a bioethicist and a vaccine expert at Johns Hopkins reaffirm that "all scientists have an affirmative ...

Bioethicists urge less regulatory burden for low-risk comparative effectiveness research

April 17, 2012
In an opinion article published in this week's theme edition of the Journal of the American Medical Association focusing on comparative effectiveness research, a team of Johns Hopkins University bioethicists argues forcefully ...

Recommended for you

Exploring the potential of human echolocation

June 25, 2017
People who are visually impaired will often use a cane to feel out their surroundings. With training and practice, people can learn to use the pitch, loudness and timbre of echoes from the cane or other sounds to navigate ...

Team eradicates hepatitis C in 10 patients following lifesaving transplants from infected donors

April 30, 2017
Ten patients at Penn Medicine have been cured of the Hepatitis C virus (HCV) following lifesaving kidney transplants from deceased donors who were infected with the disease. The findings point to new strategies for increasing ...

'bench to bedside to bench': Scientists call for closer basic-clinical collaborations

March 24, 2017
In the era of genome sequencing, it's time to update the old "bench-to-bedside" shorthand for how basic research discoveries inform clinical practice, researchers from The Jackson Laboratory (JAX), National Human Genome Research ...

The ethics of tracking athletes' biometric data

January 18, 2017
(Medical Xpress)—Whether it is a FitBit or a heart rate monitor, biometric technologies have become household devices. Professional sports leagues use some of the most technologically advanced biodata tracking systems to ...

Financial ties between researchers and drug industry linked to positive trial results

January 18, 2017
Financial ties between researchers and companies that make the drugs they are studying are independently associated with positive trial results, suggesting bias in the evidence base, concludes a study published by The BMJ ...

Best of Last Year – The top Medical Xpress articles of 2016

December 23, 2016
(Medical Xpress)—It was a big year for research involving overall health issues, starting with a team led by researchers at the UNC School of Medicine and the National Institutes of Health who unearthed more evidence that ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.