As I surfed the Web this past month I came across an article titled “Naval Center Halts Research During Inquiry About Ethics” that appeared in the New York Times online several weeks ago. Apparently the National Naval Medical Center suspended all orthopedic and radiology research on patients in September while it investigates a violation of standard ethical practice.

The doctors involved in the study failed to submit a detailed scientific outline and study design that was required by the IRB. The study involved injecting a chemical dye into 48 subjects who then underwent an MRI. It appears that the doctors did not realize that they had to follow protocol.

The study was never published or presented because the number of enrolled subjects was too small to be statistically significant. Navy officials have since ordered training of doctors and health workers in the “ethics of human experimentation.”

How did the investigator or his medical facility not know this? Can I trust all those federally mandated rules and regulations devoted to subject protection and human rights?

My interest was heightened and I decided to continue my review of the regulations that would disqualify a study. Failure to obtain IRB approval and comply with IRB regulation (21 CFR 54) stands right out there as a basis for disqualification. How did the investigator miss this?

I continued to read further down the basis for disqualification list and came across one of my favorite regulations — 21 CFR 50 — failure to obtain informed consent. Obtaining informed consent is a delicate issue. It involves the initial visit, communicating the purpose of the study and insuring that the subject understands what he/she is signing. This includes a consent form that is readable and addresses language and cultural issues. It should then follow that if the study subjects understand what the trial is about from the initial contact, retention rates will increase, as reported in several studies (see ACT Subject Recruitment Supplement, November 2003).

And, as the European and Asian markets open up to clinical trials, with language and cultural challenges, it is even more important that subject protection policies are followed more rigorously. I was pleased to hear similar concerns voiced by the clinical research community at two recent conferences I attended.

ACT always welcomes your concerns, thoughts and ideas about issues related to this topic or any other through our Letters to the Editor, Features, Notes From the Field or ACT 101.

Toby Jane Hindin, Editor-in-Chief

fax: (732) 596-0003 email: thindin@advanstar.com