Author: Eva Pastor
Date: 09-28-09 22:03
Source: Arizona Daily Star
URL: http://www.azstarnet.com/sn/hourlyupdate/310586.php
Date published: September 28th 2009
By Adrian A. Shelton
Special to the Arizona Daily Star
Tucson, Arizona | Published: 09.28.2009
In a recent guest opinion ("Human-research oversight is too lax," Sept. 21), Washington and Lee University law professor Robin Wilson leaves the lay reader with the impression that human-subjects research in the United States is either unregulated or only lightly so; that it "rests on little more than trust"; and furthermore, that "not much has changed in the intervening decade" since Jesse Gelsinger's death as a participant in gene research at the University of Pennsylvania in September 1999.
All of this is completely inaccurate.
Significant federal regulation of human-subjects research began in the 1970s, and the drive to improve ethical understanding and performance in human-subjects research has been continuous.
Within months of Gelsinger's death, the federal government, through the National Institutes of Health, began a series of actions to address oversight weaknesses identified in the course of investigating the Tucson teen's death, starting with establishment in 2000 of an NIH requirement that all persons who perform in any substantive way in a human-subjects research project must be certified to have had human-research ethics training prior to their involvement.
In the ensuing 10 years, extensive new human-subjects-research ethics and conflict-of-interest management programs, policies, and review and monitoring processes have been established by federal agencies and also within research universities and other entities that perform human-subjects research.
As just one example of the comprehensiveness and complexity of the human-subjects protection programs, the Association for the Accreditation of Human Research Protection Programs, or AAHRPP, was established in 2001.
AAHRPP accreditation is actively sought by research universities, and AAHRPP standards are very detailed operational prescriptions that encapsulate the aspirations and daily work of human-subjects-research oversight programs across the country.
The fact is that human-subjects research in the United States is heavily regulated by multiple federal powers. It is monitored by extensive research-compliance programs within research organizations themselves. It is continually scrutinized by federal agencies, by active researchers on related topics and by professional organizations focused on best practices for informed consent, for identification and control of potential conflicts of interest, and for risk assessment and review of each proposed and each ongoing human-subjects-research activity.
What we must all lament is that however comprehensive our systems of research oversight, we can never be assured that we have banished the possibility of a tragedy compounded of human error. But research administrators across the country have comprehensive research-oversight programs and work every day to reduce risk to human-research subjects and make informed consent as truly informed as is humanly possible.
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