US Senator John Glenn

Reply to Pat Mougey about
Human Subjects Research

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Note from Pat Mougey:

I am not enclosing the material he referred to. Hope to get it typed up later...but did want you to see this since it contains his request of contacting the Senate Committee on Labor and Human Resources in the near future.

I wrote his several letters and included different material in each letter. I also sent EMails to his office, and in at least one letter included copies of the EMail.

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The Letter

 

11-7-97
   

Thank you for writing me about the Human Research Subject Protections Act of 1997, S. 193. I appreciate your support for this very important legislation to protect people from being subject to experimentation without their informed consent.

I first became aware of the gap in our legal system which allows the government to perform experiments without the knowlede and consent of those involved in 1993 when the Governmental Affairs Committee conducted an investigation into the Cold War radiation experiments. One of the most infamous of these experiments took place in my own state of Ohio, where scores of patients at the University of Cincinnati were subjected to large doses of radiation during experimental treatments without their informed consent. During the course of this investigation, I began to ask the question, what protections are in place to prevent such abuses from happening again? What law prohibits experimenting on people without their informed consent?

On an international level we have the Nuremberg Code, a list of ten ethical research principles created as part of the judment against Nazi physicians who engaed in truly heinous medical experiments during World War II. The first principle of the Nuremberg Code states that the voluntary consent of the human subject of research is absolutely essential. Unfortunately, as we look back through our history since the late 1940s, it appears that researchers in America may not have taken the Nuremberg lesson completely to heart and thre is no law on the books requiring researchers to obtain informed consent. This must be remedied and I hope to do this through S. 193.

The Human Research Subject Protections Act of 1997 would require informed consent and independent review for all research involving human subjects. Protections would apply to classified research as well as to research conducted in the open. It would defintiely prevent abuses such as the ones you have described. I have enclosed a fact sheet to give you more information on the bill.

The bill has been referred to the Senate Committee on Labor and Human Resources and will remain there until the committee reports it out. There are no changes being made to the legislation at this time, but it is possible that it may be altered and amended as it continues through the legislative process. I suggest that you contact the Labor and Human Rsources Committtee and urge them to move quickly on S. 193 so that Congress can have an opportunity to vote on it early in 1998.

I am very sorry to hear of your personal troubles and you may count on my continual commitment to legislation to protect every American from abuses in our research system.

Thank you again for contacting me about this very important issue. I apprecite your support and please let me know if I can be of assistance to you in the future.

Best regards,
Sincerely,

John Glenn
United States Senator

JG:aa
Enclosure