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October 10, 2008


October 10, 2008

ATS Comments on OHRP Human Subject Research Training and Education

The ATS recently submitted comments to the Office of Human Research Protections
(OHRP) on whether Institutional Review Board (IRB) members should receive training
and education on human subject research protections. In a letter to OHRP Director Ivor
Pritchard, ATS President Jo Rae Wright, Ph.D., encouraged the agency to develop
education programs and requirements that enhance IRB oversight of human subject
research without over-burdening members with administrative obligations. In particular,
the ATS highlighted the risk to research generated by small institutions if IRB's have to
focus extensive effort on new administrative requirements.

Dr. Wright also took the opportunity to reiterate a point made in a letter that the ATS and
its sister organizations jointly submitted to the OHRP at an earlier date: some OHRP
regulations lack clarity and do not establish a clear distinction between quality
improvement initiatives and quality improvement research. Specifically, the ATS and its
sister organizations recommend that the OHRP develop a more exact definition of
human research and evaluate research and quality improvement projects based on the
risks to human subjects.


Physician Supply: Congress Extends and Expands Conrad 30 Program

In September, the House and Senate passed legislation to extend and expand the
Conrad 30 J-1 visa waiver program, which allows states to sponsor up to 30 international
medical graduates residing in the U.S. and waive their J-1 visa requirement, provided
that they return to their host nation, in exchange for agreeing to work in either medically
underserved areas or areas designated as those with the greatest shortages of health

The legislation also increases from five to 10 the number of flex spots, which allow
states and healthcare facilities to sponsor non-primary care specialists to serve in areas
that are not medically underserved or in health professional shortage areas, so long as
the facilities serve patients from underserved or health professional shortage areas.


Tobacco: Supreme Court Hears Preemption Tobacco Case

This week, the U.S. Supreme Court heard oral arguments in Altria Group vs. Good
regarding individuals' ability to sue tobacco companies under state law regarding
deceptive labeling practices. In the case, three U.S. Maine plaintiffs sued Altria, the
parent company of Phillip Morris tobacco, for labeling selected tobacco products "light"
and "low-tar." The plaintiffs claim that these terms imply a reduced health risk and that
industry documents prove the tobacco industry knew that even "light" and "low-tar"
cigarettes are just as dangerous to human health as other tobacco products.

Altria counters that it met all federal labeling requirements in using the terms "light" and
"low-tar." The company argued that it should be shielded from this lawsuit, as well as
future litigation in state courts, because the products labeled as "light" and "low-tar"
passed a test sanctioned by the Federal Trade Commission.

A lower court initially sided with Altria, but its decision was overturned by a federal
appeals court. While the case involves tobacco, most legal scholars believe that its
outcome will depend on federal preemption of state law and the level to which it should
shield corporations from liability. The U.S. Supreme Court will issue a decision on the
coming months.

Points of Contact

Gary Ewart Senior Director, Government Relations
Nuala Moore Senior Legislative Representative
Joe Kirby DC Office Administrator