NIH responds to PharmedOut open letter calling for more research on ethics

The following was received in response to this letter, which PLoS was one of the co-signers of:

Dear Dr. Fugh-Berman:

Thank you for your November 17, 2009 letter requesting that the National Institutes of Health (NIH) promote the highest ethical standards and practices in the translation of biomedical advances from bench to bedside through its funding of ethics-oriented research.  I appreciate your concerns and share your commitment to research and clinical environments that place public safety, trust, and well-being before personal gain.

The NIH has a long history of promoting the highest ethical standards and practices through its funding mechanisms, in addition to its role in  promoting management of conflicts of interest and assuring Federal requirements associated with receipt of NIH awards.  The NIH regularly supports a variety of research and training opportunities related to identifying and resolving bench-to-bedside ethical issues.  Among the many on-going programs, some examples include: the Clinical Research Ethics component of the Clinical and Translational Science Awards (CTSAs), Fogarty International Center’s “International Research Ethics Education and Curriculum Development Awards”, and the National Human Genome Research Institute’s “Ethical, Legal, Social Implications of the Human Genome Project” Program.  Also, the “Ruth L. Kirschstein

National Research Service Award (NRSA) Institutional Research Training Grant” (T32), which trains scientists and shapes the next generation moving through the scientific pipeline, requires that participants receive training in the responsible conduct of research. In addition to these programs, NIH has issued funding opportunity announcements (FOAs) to support bioethics research.

Examples of these include:

*        The NIH Challenge Grants in Health and Science Research (RC1). This FOA included Bioethics as a Challenge Area and specifically identified commercialization and conflict of interest, and blurring between treatment and research as areas of concern.

*        The NIH periodically issues FOAs as part of a series focused on “Research on Research Integrity”, the most recent of which was RFA-RR-09-004 (an Exploratory/Developmental Grant R21).

*        The NIH currently has three FOAs as part of a series active since 1999 that specifically focus on “Research on Ethical Issues in Human Subjects Research”, including research on conflicts of interest:

o       PA-07-277 (a Research Project R01)

o       PA-06-367 (a Small Research Grant R03)

o       PA-06-368 (an Exploratory/Developmental Grant R21)

These FOAs exemplify the NIH’s on-going commitment to funding research that enhances interpretation and application of ethical principles and regulatory requirements. While NIH has a long history of promoting bioethics research, we recognize that we must be continually vigilant and responsive to the evolving context of science and clinical practice.  The NIH convened a Task Force on NIH’s Role and Investment in Bioethics Research, Training and Translation in May 2009.  The Task Force is completing its proposal to further strengthen the NIH investment in bioethics research and training.  I look forward to receiving their recommendations in the near future, and to furthering the NIH’s commitment to fundamental research promoting the highest ethical standards in the translation of research from bench to bedside.

Sincerely,

*SALLY J. ROCKEY, Ph.D.*

Acting Deputy Director for Extramural Research National Institutes of Health