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Bioethikos: Bringing Life to Bioethics

Archive for January, 2009

 

Shifting Standards in International Research Ethics

Tuesday, January 20th, 2009 by Dr. Dennis Sullivan

The Declaration of Helsinki has long been regarded as the leading international standard on human research ethics. Drafted in 1964, the Declaration upholds basic patient rights and governs the business practices of clinical researchers. In spite of the Declaration’s widely accepted ethical authority, the U.S. Food and Drug Administration terminated its reliance on the Declaration for international research in October 2008, and instead adopted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP).

Although GCP protocols claim common themes with the Declaration, key ethical requirements contained in the Declaration are absent from the GCP. These requirements include: post-trial access to treatment for the patient; the condition that research, especially research done in developing countries, should benefit and be responsive to the health needs of the populations of that country; that the study design be publicly disclosed; and that investigators reveal their sponsors, funding, and potential conflicts of interest to research ethics committees and study participants.

Key tenets of ethical human research include the right of the patient to informed consent, and protection of those who are vulnerable. Both of these important qualifications may be lost in GCP-guided international research. It would be impossible for a patient to truly exercise informed consent if the researchers are less than honest about the study design, sponsors, and potential conflicts of interest in the study. In addition, historic evidence demonstrates that people with fewer educational opportunities and lower socioeconomic status are often more vulnerable to pressure to join medical research. Many populations in third world countries could be vulnerable to undue pressure to participate in research studies.

Sadly, many developing countries lack the financial and healthcare resources to offer their own citizens the benefits of new treatments, even when their citizens participate in research for the treatment. A long-held concept of research ethics contends that research should be conducted only on populations that would receive benefit from the research. Populations that will receive no benefit, even due to socioeconomic reasons, do not seem to be ethically sound sources for research participants.

Good ethics has a global outlook. What we consider impermissible in U.S. research should not be accepted in international research. The Bible teaches us to love our neighbor as we love ourselves. We must stand up for our neighbors around the globe, and call for more accountability from the FDA in international medical research.

The Lancet Article

The Neuhaus Legacy

Thursday, January 8th, 2009 by Dr. Dennis Sullivan

Father Richard John Neuhaus died recently at the age of 72. It would be hard to overestimate the influence of this godly man and gifted academic.

Fr. Neuhaus, a Lutheran pastor for 30 years, converted to Roman Catholicism in 1990, and was ordained a Catholic priest one year later by New York Cardinal John O’Connor. As a social conservative, he helped to shape the dialogue of the religious right in its opposition to abortion and to the devaluation of human life. In the 1990s, he worked closely with Chuck Colson to start the movement called “Evangelicals and Catholics Together” that formed the basis for common cause on pro-life advocacy and theological engagement between Catholics and Protestants.

Fr. Neuhaus wrote several books, including his best-known work: The Naked Public Square: Religion and Democracy in America. He also was the founding editor of the journal First Things, the only magazine I read cover-to-cover each month (I highly recommend it: go to www.firstthings.com).

Fr. Neuhaus was a powerful and clear writer, after whom I have often wished to pattern my own efforts. He somehow managed to be both passionate and eloquent at the same time, and had a razor-sharp wit. Some of his comments, though subtle, could make me laugh out loud. Always gracious, his irony and sarcasm never drifted into ad hominem attacks. Most of all, there was a spiritual ebullience that directed his readers toward the Savior. His deep faith lifted his prose to musicality.

Though I have never personally met Father Richard John Neuhaus, I will deeply miss him.

Associated Press