Are human research subjects safe enough? - Ethical Aspects

Physician Executive, July-August, 2003 by Richard E. Thompson

* Are conflicts of interest acknowledged? Is the purpose of the clinical trial or double-blind study to confirm the efficacy of a new treatment or the safety of a new treatment known to be efficacious? Or is the purpose to lend credence to a new device, drug or procedure that a company wants to market or that the investigator wants to use in his or her practice?

* How is the progress of approved studies monitored? Don't ask for periodic routine reports as a government agency might. Rather, insist on exceptions reporting. Insist that clinical investigators report adverse incidents and unexpected results and document them immediately.

* How are IRB members oriented? Are IRB members impressed with the importance of their obligation? Or are they told, "Don't worry, this won't take too much of your time. It's just another requirement we have to meet."

More regulation of human research can be expected. Some provisions of HIPAA regarding uses of personal medical information are an example. And a brand new accrediting program, the Partnership for Human Research Protection, Inc. (PHRP) Accreditation Program is just starting to take applications and do surveys. PHRP is a collaborative effort of the Joint Commission on Accreditation of Healthcare Organizations and National Committee for Quality Assurance.

If red tape and alphabet soup worked, safety of human subjects would have been assured years ago. Things won't truly get better until clinical researchers themselves re-discover the true meaning of clinical research.

References

(1.) Harris Interactive Poll, February, 2002. cited in "At Your Own Risk," Time magazine, April 22, 2002. p. 49.

(2.) Nuremberg code, 1946. In Encyctopedia of Bioethics, Volume 4. Edited by Warren T. Reich. The Free Press. New York. 1978. Pages 1764-1765.

(3.) Declaration of Helsinki: Ethical principles for medical research involving human subjects. World Medical Association. June 1964, last revised October, 2000. http://www.wma.net/e/policy/b3.htm.> (4.) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. National commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, D.C., U.S. Government Printing Office, 1978.

(5.) Code of Federal Regulations 45 Part 46. U.S. Department of Health and Human Services (HHS). 1974. Revised June 18, 1991, reprinted March 15, 1994.

(6.) http://ohrp.osophs.dhhs.gov

(7.) http://ohrp.osophs.dhhs.gov/irb

(8.) Karen Maschke. Editor IRB: Ethics and Human Research. The Hastings Center, Garrison, N.Y (www.thehastingscenter.org). Personal communication.

Richard E. Thompson, MD, is president of Thompson, Mohr and Associates in Springfield, Mo. Previously, he was an adjunct instructor of ethics at the Ethics Institute St. Petershurg College, St. Petershurg, Fla. He can he reached by phone at (417) 889-8853 or by e-mail at tmaret@shcglobal.net