Hot Topics: Research Ethics

Blog Posts (17)

April 1, 2014

Cute with a Good Story: Social Media Selects Experimental Subjects

by Craig Klugman, Ph.D.

For patients with a serious illness, accessing cutting edge drugs has just taken a new turn. In the past, a patient with cancer would undergo conventional treatments.…

February 27, 2014

Multisite Ethics Review of Research Involving Humans

<p class="MsoNoSpacing">Before research involving humans can commence, the ethical aspects of the research study are reviewed by local ethics boards in the United States known as Institutional Review Boards (IRBs). IRBs review many factors surrounding the ethics of research involving humans, including whether the science is valid, there is a favorable benefit-to-risk ratio, participants are recruited fairly and have retained the right to withdraw from research, privacy is protected, and the informed consent process will be performed such that participants are fully informed and understand the nature of the study. IRBs are located within institutions that perform human research such as universities and colleges, research centers, government agencies, and others. IRBs consist of individuals with a diversity of scientific, clinical, ethics, and legal expertise. The advantage of performing ethics review at the local level is that IRB members know their community, including the prevalence of health issues and the average educational level allowing them to be able to effectively communicate with community members and ensure they can access beneficial research. As trust is an essential element to voluntary community participation, an absence of it might lead to decreased enrolment in clinical trials. Knowing that a body of experts has reviewed the ethical aspects of research is likely to promote trust between participants and the research institution.</p> <p class="MsoNoSpacing">While local review certainly has its advantages, more research is being performed at multiple institutions, such as large phase 3 and 4 clinical trials that can be performed at dozens of research sites across the country. Currently, this means that researchers will have to submit their protocol to every individual IRB for approval. Several studies surrounding multisite ethics review have been performed and many question whether a more efficient system cannot be developed. Below we discuss some of the issues with multisite ethics review and outline a few reform strategies.</p> <p class="MsoNoSpacing"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
December 4, 2013

Where Have All the Negative Results Gone?

by Craig M. Klugman, PhD

This week I gave a lecture at a university in Texas on ways to teach research ethics.…

August 30, 2013

Faster Than the Speed of Thought

by Craig Klugman, Ph.D.

In the 1983 comedic film, The Man with Two Brains,”  Steve Martin’s character falls in love with a female brain preserved in a jar.…

April 19, 2013

John Lantos, MD weighs in on the SUPPORT study

David Magnus, Ph.D.

John Lantos, MD weighs in on the SUPPORT study. He points out that the work of self-appointed “watch-dogs” such as Public Citizen and the Alliance for Human Research Protection are a danger to bioethics.…

April 18, 2013

NEJM Responses to the support controversy

David Magnus, Ph.D.

The New England Journal of Medicine ‘s web site has the early publication of an editorial about the controversy over the SUPPORT study of oxygen saturation levels in premature infants.…

April 12, 2013

OHRP throws a wet blanket on comparative effectiveness research

David Magnus, PhD

When we go to the doctor and they recommend a treatment, we like to believe that there is good evidence that it is the best treatment available.…

April 4, 2013

Check out the April 2013 issue of AJOB!

DOES CONSENT BIAS RESEARCH? 

SICKLE CELL AND THE “DIFFICULT PATIENT” CONUNDRUM

February 19, 2013

"Innovative Treatment" vs Research: Which Is It?

Maurice Bernstein, M.D.

When does a doctor’s treatment of a patient become medical or surgical research? If what the doctor does is a standard and accepted method of therapy using proven medications or surgical techniques and represents nothing novel then at first glance what is occurring cannot be designated as research or can it?

January 7, 2013

2013 ASBH Call for Proposals

The 2013 ASBH Call for Proposals is now open.  The 2013 ASBH conference will be held in Atlanta, Georgia.  Details regarding the call can be found on the ASBH homepage. There you will find a link to the abstract submission site as well as a ...

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Published Articles (149)

American Journal of Bioethics: Volume 14 Issue 4 - Apr 2014

Is There an Ethical Obligation to Disclose Controversial Risk? A Question From the ACCORD Trial Joseph P. DeMarco, Paul J. Ford, Dana J. Patton & Douglas O. Stewart

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

Ethics and Empiricism in the Formation of Professional Guidelines Mildred K. Cho

AJOB Primary Research: Volume 5 Issue 1 - Feb 2014

AJOB Empirical Bioethics: A Home for Empirical Bioethics Scholarship Chris Feudtner, Jeremy Sugarman, Barbara A. Koenig, Peter A. Ubel, Richard F. Ittenbach, Laura Weiss Roberts & Laurence B. McCullough

American Journal of Bioethics: Volume 14 Issue 2 - Feb 2014

Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration Adnan A. Hyder, Abbas Rattani, Carleigh Krubiner, Abdulgafoor M. Bachani & Nhan T. Tran

American Journal of Bioethics: Volume 14 Issue 2 - Feb 2014

Connecting Health Systems Research Ethics to a Broader Health Equity Agenda Bridget Pratt

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Quality Improvement Ethics: Lessons From the SUPPORT Study Benjamin S. Wilfond

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Informed Consent and Standard of Care: What Must Be Disclosed Ruth Macklin & Lois Shepherd

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

What Should Be Disclosed to Research Participants? David Wendler

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care David Magnus

American Journal of Bioethics: Volume 13 Issue 11 - Nov 2013

The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials Jim McCambridge, Kypros Kypri, Preben Bendtsen & John Porter

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News (322)

April 2, 2014 2:17 pm

Guidance published on informing study participants about findings with potential health implications

In the course of a study involving human participants, it is possible that researchers may make a finding that has potential health or reproductive implications for an individual participant.

April 2, 2014 2:14 pm

PatientsLikeMe Launches “Data for Good” Campaign to Encourage Health Data Sharing to Advance Medicine

Today, PatientsLikeMe kicks off a new campaign promoting the value of sharing health information to advance research.

April 2, 2014 2:13 pm

Why I, a founder of PLOS, am forsaking open access

I co-founded the Public Library of Science (PLOS) in 2002 because I believed deeply that the open access publishing model…But in the last few weeks I have had a major change of heart.

March 24, 2014 2:34 pm

Crowdsourcing medical decisions: Ethicists worry Josh Hardy case may set bad precedent

Just hours after social-media supporters of a dying 7-year-old boy pressured a reluctant biotech company into giving him an experimental medication, the backlash began.

March 13, 2014 3:41 pm

Company Makes Drug Available To Ailing Boy Following Public Outcry

Chimerix, a small and unprofitable biotechnology company, will make an experimental drug available to a young Virginia boy who is suffering from an infection he contracted while being treated for cancer.

March 11, 2014 2:11 pm

One Author of a Startling Stem Cell Study Calls for Its Retraction

One of the authors of a study that was claimed to have discovered a simple way to make stem cells said on Monday that he was no longer sure of his team’s conclusions, and he called for the study to be retracted.

March 11, 2014 2:10 pm

Elizabeth Warren vows fight for gender equality in medical studies

Sen. Elizabeth Warren vowed yesterday to push for a new federal law to cut the gender bias from medical research if federal agencies such as the National Institutues of Health don’t take steps to address the issue.

March 4, 2014 6:13 pm

China Cracks Down on DNA Testing

Genetic testing has grown to be a business big enough in China to warrant the government’s intervention.

February 27, 2014 1:47 pm

Scientists Question Safety Of Genetically Altering Human Eggs

A panel of government advisers has expressed serious concerns about a controversial proposal to allow scientists to try to make babies using eggs that have been genetically altered to include DNA from another woman.

February 10, 2014 6:39 pm

Scientist's Experiment in Fundraising

Scientist Plans to Raise $1.5 Million Through Online Solicitations

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