Issues Concerning Informed Consent and Protections of Human Subjects in Research

experimental medication for schizophrenia, she had been taken off the
medication because the drug company funding the research would no longer
pay for her to receive the medication. Consequently, she is now desperately
searching for a new protocol which she can participate in to receive the
medication until it is approved by the FDA.
Unfortunately, sad stories like these are all too common for persons with
severe mental illnesses. While drug companies frequently try to make
experimental medications available free of charge to people who have
successfully completed trials for fixed periods of time, the time limits
established by these companies, coupled with the lengthy drug approval
process, result in many people suffering relapses after being terminated from
these drugs for lack of funding.
In view of the sacrifices made by people who voluntarily participate in trials
of experimental medications, NAMI believes that all individuals should have
continuing access to medications they have benefited from until alternative
sources of funding are found. This, we believe, would be reasonable
compensation for the contributions made by individuals who participate as
human subjects in research.
Conclusion
NAMI supports the critical need for biomedical research on severe mental
illnesses. I know first hand the benefits of such research. My daughter and
other family members have participated in and benefited from NIMH funded
research on new medications. NAMI is eager to play a role in strengthening
protections of human subjects and ensuring ongoing improvements in
research on severe mental illnesses through open dialogue with the scientific
community. As the ultimate beneficiaries of research on brain disorders,
NAMI members appreciate the interests of this Committee on these
important issues.
The complete NAMI policies are attached as an appendix to our written
testimony. I look forward to any questions you may have.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,
"The Belmont Report", April 18, 1979; President's Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research, "Protecting Human Subjects", Dec. 1981.
i 45 C.F.R. 46.116

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