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WE NEED UNIFORM FEDERAL REGULATIONS TO PROTECT HUMAN RESEARCH SUBJECTS

Charles, David MD

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Dr. Charles is the Chairman of the National Alliance of Medical Researchers and Teaching Physicians and Director of the Movement Disorders Clinic and Neurology Residency Training Program at Vanderbilt University Medical Center.

The opinions expressed in this column are those of the author only and do not necessarily reflect the views of the AAN or this publication. Readers should feel free to respond, in writing, to the Viewpoints column by writing to NeuroToday@lww.com.

Clinical research is the branch of medical science where the discoveries of the laboratory meet the realities of the human body – and no other discipline stirs as much anxiety and ambivalence in the public's mind.

On one hand, everyone who takes a prescription drug or undergoes a surgical procedure wants to know that the safety and effectiveness of their treatment have been thoroughly tested and independently verified. That is the clinical researcher's responsibility.

Figure. Dr. David Ch...
Figure. Dr. David Ch...
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On the other hand, no drug, biologic, or medical device can be adequately tested unless it has been tested on humans – and that's where the public, and even public policy makers, become squeamish.

That's understandable. We're still in the shadow of the abominable Tuskegee Syphilis Study that ended 30 years ago. More recently, the tragic death of an 18-year-old college student during a gene transplant study in 1999 renewed calls for more safeguards on testing with human subjects.

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SAFETY CONCERNS

Those calls have reached the US Senate. The Subcommittee on Public Health is looking into the issue of safety precautions for human test subjects, as well as the handling of potential conflicts of interest between the drug companies that finance clinical research and the researchers who conduct it.

As a clinical researcher myself, I would support any constructive effort to make the human testing process safer and to reassure the public that research results are not tainted by conflict of interest. At the same time, some perspective is needed.

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CONFLICTS OF INTEREST

A handful of failures don't negate a century's worth of success. The 20th century was a pivotal time for advances in the treatment of diseases and relief of suffering. Almost all of the advances involved some degree of human testing before they could help society. As to conflicts of interest between researchers and research sponsors, keeping the two groups in strict isolation from each other is not the answer. Successful research demands a close level of cooperation between the manufacturer of a medical device or prescription drug, for instance, and the clinical researchers whose work will verify or challenge the value and safety of the new treatment.

The key to avoiding conflict of interest problems is in the full and uniform disclosure of information. That's the best protection for all concerned.

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GUIDELINES ON DISCLOSURE

Any new federal legislation on clinical research should include strong guidelines governing potential conflicts of interest and clear requirements for full disclosure of any financial interest linking the researchers and producer of the drug, biologic, or medical device they are evaluating.

No evaluation of a research protocol by an Institutional Review Board (IRB) should be considered complete unless the researchers have disclosed the arrangements made for their compensation. Similarly, researchers should disclose up front any proprietary interest they or their immediate families have in the outcome of their research.

Armed with timely and complete information, IRBs can evaluate for themselves whether a research-threatening potential for conflict of interest exists in any given research project. And the clarity of reporting requirements is essential to getting that information. In fact, that holds true for all federal regulations governing clinical research.

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CLARIFY REGULATIONS

I had the privilege of testifying to the Senate committee on behalf of the National Alliance of Medical Researchers and Teaching Physicians. I told the senators that we don't need more regulations as much as we need clarification of the regulations already in effect and much clearer responsibility for enforcing them.

The reality today is that badly needed clinical research is being delayed or not done at all because of the dense regulatory thicket that any researcher has to pass through before a new trial can be launched. Time that should be spent in research is wasted on paperwork, much of it duplicative, to satisfy the sometimes conflicting requirements of 17 federal agencies and departments.

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CREATE UNIFORM LAWS

If Congress wants to minimize the risks for human test subjects, make it easier to avoid conflicts of interest, and make the clinical research process more efficient, it can start by codifying the myriad regulations on clinical research into one set of uniform federal laws. That same set of laws should give clear enforcement responsibility to the IRBs that already exist around the country.

No one in the medical community challenges the government's obligations to act as an extension of the public and look over our shoulder, especially in an area as crucial as clinical research. The joint challenge of the medical profession and public policy makers is to strengthen the safeguards without creating new regulations so burdensome that they make vital research impossible.

©2002 American Academy of Neurology

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