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Category Archives: International and National Clinical Research

Too Many Research Products. Too Few Research Volunteers. Ethical Implications

August 3, 2016

The financial and infrastructure investment in clinical research over the past several decades has resulted in major benefits to the health of individuals in both wealthy and poor countries. The ability to identify the cause of disease and develop treatments to control and even eradicate disease is a testimony to the investment in clinical research …more»

An Ethical Collision Course

June 6, 2016

Physicians in Clinical Research and Physicians in Clinical Care Research physicians dedicated to finding the cause, prevention, and treatment of diseases may find themselves in a position of conflict of interest when conducting research in income poor countries. As new and exciting treatment discoveries proliferate and are coupled with dramatic increases in funds for clinical …more»

The VRC01 Study Must Be Stopped Now

April 11, 2016

Modified April 24, 2016 First Tuskegee, then Guatemala, and now VRC01 In April, 2016 NIH initiated a study of the HIV broadly neutralizing monoclonal antibody (bNAb) VRC01. The study mimics two infamous studies, Tuskegee and Guatemala, universally declared unethical for withholding effective treatment from sexually transmitted infections in disadvantaged populations. (1-3) As if the memory …more»

Ethical Oversight and Exclusion of Opinions.

December 8, 2015

One would think that the first revision of the Common Rule since 1991, protecting human research subjects, would allow widespread and detailed input to be certain that vulnerable subjects in resource poor countries are protected from exploitation. Comments on the rule were solicited in the Federal Register Vol 80 No 173 Sept 8, 2015 to …more»

A Hollow Victory

June 24, 2015

A Hollow Victory. Ethics, Science, and the NIH PROMISE Study. On the night of June 16, 2015 I received an email message from Washington DC stating, “Because of START results, they [NIH sponsored researchers] will be offering HAART to all mothers in all [research] arms in the PROMISE study.” First an explanation of the acronyms: …more»