NIH Statement Regarding House Hearing on Human
Tissue Samples Attribution: John Burklow, NIH spokesman
NIH’s position on ethics is clear: any conflict of interest
resulting in an individual personally profiting from official government
research activities cannot be tolerated. We are committed to maintaining
the public’s trust in NIH and its scientists as an unbiased
source of biomedical research guidance and advice. The case under
consideration concerns events that began in 1998 — after the
NIH ethics rules concerning outside activities were relaxed —
and that ended before the new rules were put in place. NIH has previously
referred this case to the relevant authorities for appropriate action.
It is important to note that the specific consulting arrangements
in question, had they been known to NIH, would not have been approved
under the present or previous ethics regulations. Outside consulting
connected to an NIH employee’s official government duties
has always been prohibited at NIH.
NIH has undertaken a comprehensive review of its activities and
conflict of interest policies in the last few years. As a result
of that process, on August 25, 2005, NIH implemented comprehensive
ethics rules that make it clear what NIH scientists can and cannot
do in regard to outside activities. These new rules removed any
ambiguity about what is allowed or not allowed. Here are two important
points:
- Under new NIH regulations, all NIH employees are now prohibited
from engaging in outside employment with pharmaceutical companies
and biotechnology companies in their private capacities —
period.
- Collaboration and partnership with industry can nonetheless
be very valuable in scientific pursuits and NIH rules allow such
activities, as long as they are undertaken through an officially
approved Cooperative Research and Development Agreement (CRADA).
Although we cannot discuss this particular case because it remains
under investigation, we can speak to the relevant issues that it
raises.
Collaborations among scientists that involve human tissue samples
are common and essential for science. There are, however, stringent
rules in place to protect the participants who donated their samples,
and to ensure that there is full informed consent.
We share the Committee’s concerns in regard to the ethical
management of human tissue samples and the development of rigorous
and uniform policies to protect the public’s trust and interests,
while advancing science to address important public health problems.
The thousands of scientists who work at NIH have always been and
remain committed to these principles.
The Office of the Director, the central office at NIH, is responsible for
setting policy for NIH, which includes 27 Institutes and Centers. This involves
planning, managing, and coordinating the programs and activities of all NIH
components. The Office of the Director also includes program offices which
are responsible for stimulating specific areas of research throughout NIH.
Additional information is available at http://www.nih.gov/icd/od/.
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U.S. Department of Health and Human Services. It is the primary federal
agency for conducting and supporting basic, clinical and translational medical
research, and it investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit www.nih.gov. |