Tag: consent

Blog Posts (8)

May 13, 2014

Ultrasound before Abortion: Consideration of Recent Research–Closing Comments

In my previous two posts (April 22 and April 29) I discussed an article in the January edition of Obstetrics & Gynecology entitled, “Relationship Between Ultrasound Viewing and Proceeding to Abortion.” The authors found that in Planned Parenthood clinics in LA, the voluntary viewing of ultrasounds by patients seeking abortions appeared to dissuade a very small percentage from continuing on to abortion. From their data... // Read More »
April 29, 2014

Ultrasound before Abortion: Consideration of Recent Research, part 2

Last week I began a discussion about an article in the January edition of Obstetrics & Gynecology entitled, “Relationship Between Ultrasound Viewing and Proceeding to Abortion.” The authors found that in Planned Parenthood clinics in LA, the voluntary viewing of ultrasounds by patients seeking abortions appeared to dissuade a very small percentage from continuing on to abortion. Overall there appeared to be 0.6% absolute risk... // Read More »
April 22, 2014

Ultrasound before Abortion: Consideration of Recent Research

In the January edition of Obstetrics & Gynecology was an article entitled, “Relationship Between Ultrasound Viewing and Proceeding to Abortion” by Gatter et al that has already received publicity. There is no doubt that this article will be oft-cited for many years, so it merits discussion. The authors performed a retrospective review of one year’s worth of records at Planned Parenthood clinics in Los Angeles,... // Read More »
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>
July 23, 2013

Research ethics scandals in Canada, you ask? Sadly, yes.

There are certainly plenty of people who think that research ethics scandals happen everywhere else, but not in Canada. Well, it seems that a recent report by food historian Ian Mosby at the University of Guelph has uncovered that, yes, in fact research ethics scandals can, do and have happened in Canada. Mosby’s report, published […]
November 12, 2012

Clinical Trials in Russia

Generally, when westerners think of people in foreign lands participating as human subjects in clinical trials, we think of the developing world. That image is somewhat incomplete. This was from September, but well worth a look at this NYT piece if you missed it: Russians Eagerly Participate in Medical Experiments, Despite Risks As a test […]
August 14, 2011

What Scorpion Bites Can Teach Us About Placebo Trials

A recent story in Nature highlights a few important concepts in the conduct of placebo-controlled trials. This story is about a very small placebo-controlled trial involving only 15 children who were stung by bark scorpions in Arizona. The trial’s goal was to demonstrate effectiveness of a new antivenom, Anascorp. The bark scorpion is the only […]
February 15, 2011

Prenatal Surgery, Hope for Spina Bifida and Ethical Reflection

Spina bifida is a serious developmental birth defect in which the spinal cord and backbone fail to develop completely and infants may be born with some of the spinal cord protruding out of their middle or lower back. Treatment typically involves surgery as soon as possible to repair the birth defect. There are different forms […]

Published Articles (10)

American Journal of Bioethics: Volume 10 Issue 10 - Oct 2010

HIGHEST POLICY IMPACT ARTICLE: An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme? Trial

American Journal of Bioethics: Volume 10 Issue 7 - Jul 2010

Review of The Ethics of Consent, eds. Franklin G. Miller and Alan Wertheimer

American Journal of Bioethics: Volume 9 Issue 8 - Aug 2009

Response to Open Peer Commentaries on ?Why Consent May Not Be Needed For Organ Procurement?

American Journal of Bioethics: Volume 9 Issue 8 - Aug 2009

Why Consent May Not Be Needed For Organ Procurement

American Journal of Bioethics: Volume 7 Issue 12 - Dec 2007

Defining the Scope of Implied Consent in the Emergency Department

American Journal of Bioethics: Volume 6 Issue 3 - May 2006

An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme Trial

American Journal of Bioethics: Volume 6 Issue 3 - May 2006

Against Bioethics: A Decision Analysis of Consent

American Journal of Bioethics: Volume 5 Issue 5 - Sep 2005

Response to Commentary on ?Adolescent Decisional Autonomy Regarding Participation in an Emergency Department Youth Violence Interview?

American Journal of Bioethics: Volume 5 Issue 5 - Sep 2005

Adolescent Decisional Autonomy Regarding Participation in an Emergency Department Youth Violence Interview

American Journal of Bioethics: Volume 4 Issue 3 - Sep 2004

Revisiting ?Freely Given Informed Consent? in Relation to the Developing World: Role of an Ombudsman

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News (2)

April 27, 2012 9:54 am

California Considers Criminalizing Unauthorized Collection, Use of Genetic Information (GenomeWeb)

California lawmakers are considering a new proposal that would address concerns about keeping genetic information private by making it illegal to analyze, share, or store an individual’s genetic information without that person’s written consent. The Senate Judiciary Committee in the state, which already has adopted enhanced public protections against discrimination based on genetic information, has now passed the California Genetic Information Privacy Act (SB 1267).

April 12, 2012 9:57 pm

iPod video used to encourage organ donation (Reuters)

An organ donation video people can watch on an iPod while they wait at the Department of Motor Vehicles may encourage more to become donors, a new study suggests. Researchers found that for folks getting a driver’s license in their county, the iPod video seemed to sway the decision on becoming an organ donor.