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Subject:   The NIH Roadmap and Lack of Training in Ethics
Date:   2003-11-24

On September 30th, Dr. Elias Zerhouni, Director of the National Institutes of Health, announced the NIH Roadmap, a plan which will cost $2.1 billion for the next five years. The purpose of the plan is to coordinate and accelerate the conversion of basic science into therapy for patients by increasing clinical trials and patient recruitment, especially in community settings. We share the desire of Dr. Zerhouni that more effective treatments be made available in health care. We especially commend his proposal for doctors not ordinarily engaged in clinical research to be trained in research ethics in order to protect the safety of volunteers. (See Bor. J., The Baltimore Sun, Wednesday October 1, 2003. P.A1.)

CIRCARE, however, has two concerns. Firstly, Dr. Zerhouni appears to be making the case that a higher percentage of patients for a given disease be enrolled in experimental treatment. For instance, he cites how most leukemia patients are enrolled in clinical trials, while only 1% of Parkinson's disease and 4% of adults with cancer are enrolled in clinical trials. It is only appropriate that a small percentage of persons with a given disease be in clinical trials because the rest of patients are presumably receiving the standard of care.

Secondly, CIRCARE is concerned that the expansion of the current system for training in research ethics will not work, for the present system that trains the tens of thousands of clinical researchers is wholly inadequate.

  1. Currently, NIH only mandates that individuals on training grants receive instruction on ethics – representing only a few percent of all graduate students in biomedical sciences and even less for all other researchers.
  2. For all other researchers, it is only recommended that they be trained by some method – many of whom may choose to use the internet for an hour or two to satisfy the voluntary requirement. This level of training is wholly inadequate to address the complex ethical issues that may arise in research and the sensitivity needed to insure the safety of the research subject.

CIRCARE would like to offer specific reforms, which should be part of a roadmap for the future of research that is seeking to expand to larger numbers of persons and settings.

  1. Mandate that each NIH grantee receive a three credit hour course or its equivalent (and not internet-based) in research ethics and practice with case studies. Fund the resources for such an endeavor.
  2. Increase funding to the federal oversight Office for Human Research Protections (OHRP) to accommodate the increase in clinical trials.
  3. Increase training and education of foreign researchers conducting clinical trials overseas for use in the United States. These researchers have even less training and education in research ethics and practices than their counterparts in the states.
  4. Involve advocacy groups for the protections of human subjects in the planning of training and education of researchers in research ethics. To our knowledge, the large NIH group consulted by Dr. Zerhouni did not include a member of any advocacy group interested in greater human research protections. The making of a roadmap might benefit from those well experienced in the hazards of the road.

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327


Link:   To create an HTML link to this InfoMail cut and paste the following:

<a href="http://www.circare.org/im/im24Nov2003.htm">The NIH Roadmap and Lack of Training in Ethics</a>. CIRCARE InfoMail (2003-11-24)

Last Updated: 2006-04-25

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