On January 15, 1994, U.S. President Bill Clinton established the Advisory Committee on Human Radiation Experiments (ACHRE). The purpose of the ACHRE was to investigate how human subjects during the Cold War had undergone radiation experiments without their knowledge or informed consent. In October 1995, the ACHRE published its final report and disbanded.
The ACHRE determined that not only were there “significant deficiencies in some aspects of the current system for the protection of human subjects,” but also that many informed consent forms were “flawed in morally significant aspects.” As a result, the ACHRE recommended the adoption of a uniform Federal policy that would require informed consent in all research — including research that did not receive Federal funding and was otherwise exempt from the Common Rule (i.e., 46 CFR 45).
Senator John Glenn, Jr., Introduces Bill S. 193
On January 22, 1997, U.S. Senator John Glenn, Jr., introduced the Human Research Subject Protections Act before the 105th Congress. The Act was designed to protect “individuals who are the human subject of research.”
In presenting Bill S. 193, Senator Glenn recounted how he had been asked by his Ohio constituents to look into abuses surrounding human experimentation research. As a former astronaut, Senator Glenn admitted that he “had research conducted on me because of my past activities . . . in the space program.” The difference, however, was that he knew he was being experimented upon and had given free consent for testing.
“No Law on the Books” Requires Informed Consent
When he began studying the issue, Senator Glenn was confident that there must be some Federal regulation that prohibited “experimenting on people without their informed consent.” After all, the Nuremberg Code (1947) had been in existence for half a century. Instead, Senator Glenn was shocked to discover that there still was “no law on the books requiring that informed consent be obtained” before a clinical trial could begin.
According to Senator Glenn, “What it comes down to is there are no criminal fines or penalties for violating the spirit or the letter of that Nuremberg Code.” Therefore, Bill S. 193 was necessary as a matter of law to protect human subjects from research abuses, especially those funded under the provisions of the Common Rule.
Three Shortcomings of the Common Rule
In 1991, the Common Rule was adopted in order to put all Federally-funded research under a single set of guidelines. Any institution that sought Federal funding for research had to guarantee that it was complying with all known Federal regulations, including informed consent principles. But there were three loopholes in the Common Rule.
First, no Federal agency is required to adopt the Common Rule. Of the nearly 1,200 Federal agencies in existence, only 16 comply with Common Rule provisions. The U.S. Department of Labor and the Nuclear Regulatory Commission are two Federal agencies that fund research, but do not subscribe to the Common Rule.
Second, Common Rule provisions are voluntary. Even though Federally-funded institutions are legally required to register clinical trial information in a database (e.g., ClinicalTrials.gov), voluntary observance is inconsistent, compliance scattered, and enforcement of research violations nonexistent. According to Zarin et al. (2005), although 91% of all National Institutes of Health (NIH) clinical trials are appropriately registered, the same is not true for other funding areas. For example, only 48% of Federally-funded industry research is reported annually. There are no penalties for violations.
Third, privately-funded clinical trials are not required to disclose any research information, including data about compliance with informed consent guidelines. As a result, the total number of U.S. research abuses is unknown.
Purpose of Bill S. 193
Bill S. 193 was intended to close all three loopholes in the law. The bill was “read twice and referred to the Committee on Labor and Human Resources” for consideration. Bill S. 193 did not receive a proper hearing, died in Committee, and was never acted upon by the 105th Congress.
Since 1997, the U.S. Congress has tried on nine separate occasions to pass more stringent legislative measures guaranteeing the right to informed consent and the protection of human research subjects. To date, all proposals have been blocked from further consideration.
Why is Research Protection Not a Basic Human Right?
Informed consent is often agreed upon by medical researchers in principle, but rejected in practice. The major stumbling block to reform comes from pharmaceutical companies that resist efforts to limit how research is conducted. These companies possess enough resources to hire lobbyists to put pressure on politicians to prevent unwanted legislation from being entered into law.
In 2007, for example, the U.S. House of Representatives passed a bill that would have required private pharmaceutical companies to post the results of all clinical studies in open forums so that patients, other researchers, and independent physicians could evaluate the research. Under existing laws, such companies can conduct research in private — publishing favorable data to push the sale of a new drug, and withholding unfavorable safety information in order to forestall bans on manufacture or distribution.
U.S. President George W. Bush immediately moved to block the legislation. According to Adams (2007), the reasons given were not only that the Food and Drug Administration (FDA) was unable to assess the accuracy of any disclosed information, but also that the general public would be incapable of understanding the technical information released.
Until basic human rights are adopted, reform will never become reality.
References
Adams M. 2007. Bush/Big Pharma conspiracy? White House to oppose open disclosure of clinical drug trials. Natural News Network.
Glenn Jr., JH. 1997 (January 22). Introductory remarks on S.193. Washington, D.C.: U.S. Congressional Record.
Zarin DA, Bergeris A, Ide NC, et al. 2005. ClinicalTrials.gov; A Report to the Board of Scientific Counselors. Technical Report No. LHNCBC-TR-2005-003. Bethesda, MD: U.S. National Library of Medicine.
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