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Environmental Factor

June 2011

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Council updated on several NIEHS research initiatives

By Ernie Hood
June 2011

David Balshaw, Ph.D.

Balshaw had good reason for elation, as the Council approved the concept clearance to extend development work on research pioneered in the GEI. (Photo courtesy of Steve McCaw)

Pat Mastin, Ph.D.

DERT Deputy Director Pat Mastin, Ph.D., briefed the Council on the new NIH appeals process, which applies to grant applications submitted for the January 25, 2011 due date and thereafter. (Photo courtesy of Steve McCaw)

NIEHS/NTP Director Linda Birnbaum, Ph.D.

Birnbaum alerted Council to the latest edition of the journal Health Affairs (see related story(, which for the first time was devoted entirely to articles on environmental health science, including contributions by Birnbaum and her Chief of Staff, Paul Jung, M.D., former NIEHS Director Kenneth Olden, Ph.D., and several NIEHS grantees. (Photo courtesy of Steve McCaw)

133rd National Advisory Environmental Health Sciences Council meeting

The 133rd meeting of the Council was held May 19-20 at NIEHS. (Photo courtesy of Steve McCaw)

Joan Packenham, Ph.D.

According to Packenham, NIEHS currently has 61 active clinical protocols subject to Institutional Review Board oversight. (Photo courtesy of Steve McCaw)

At its meeting May 19-20 at NIEHS, the National Advisory Environmental Health Sciences Council( was briefed on the progress of a number of NIEHS initiatives. In its only voting action, the panel approved a sweeping concept clearance (see text box) designed to provide for continuation of the research work conducted by the NIH Genes, Environment and Health Initiative (GEI) through NIEHS funding.

Advancing clinical research

Joan Packenham, Ph.D., director of the NIEHS Office of Human Research Compliance (OHRC), updated Council on NIEHS efforts to protect human research subjects. She noted that to provide an integrated approach to human research subjects' protection as the institute was beginning its clinical research program, in 2008 the institute established the OHRC, which manages the NIEHS Human Research Protection Program (HRPP). Packenham mentioned that NIH is preparing for accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The accreditation process is under the leadership of the NIH Office of Human Subjects Research Protections, under the direction of Michael Gottesman, M.D., NIH Deputy Director for Intramural Research.

As Packenham explained, the NIEHS role is to make sure that NIEHS has a high quality HRPP that meets the goals, principles, and standards outlined by AAHRPP and is in compliance with NIH HRPP regulations. NIEHS serves as a leader in this process and has been invited to participate on several trans-NIH committees as NIH refines its HRPP policies and procedures. NIH will submit the application for accreditation sometime in 2011. The Association for the Accreditation of Human Research Protection Programs, the gold seal for human research protection programs, "gives assurance to research participants, research organizations, researchers, sponsors, and the general public that an organization's HRPP is focused first and foremost on excellence, safety, and ethically sound research."

Exploring the epigenome

NIEHS extramural investments in research on environmental epigenetics and epigenomics were the subject of a presentation by Fred Tyson, Ph.D., of the Cellular, Organ, and Systems Pathobiology Branch of the Division of Extramural Research and Training (DERT). He explained that research investments are growing rapidly because of increasing recognition that “the epigenome serves as the interface between the genome and environment in common complex human diseases.” Extramural investments have expanded exponentially since 1998, he said, and have included several targeted solicitations, including two still in development; many investigator-initiated grants; grants within the NIH Roadmap Epigenomics Program, specifically funding Epigenome Mapping Centers; and a variety of well-attended international meetings and workshops.

Confronting the epidemic of autism

Autism is another relatively new frontier for environmental health research, and DERT Health Science Administrator Cindy Lawler, Ph.D., who specializes in autism research, provided Council with a guided tour of the investments that NIEHS has made in addressing this very urgent public health concern. She pointed to the many significant developments in recent years, such as establishment of the Interagency Autism Coordinating Committee( Exit NIEHS, which is comprised of both public members and federal officials, including NIEHS/NTP Director Linda Birnbaum, Ph.D., and NIH Director Francis Collins, M.D., Ph.D. The NIEHS autism portfolio now includes large-scale human studies such as CHARGE( Exit NIEHS and EARLI( Exit NIEHS, which will enable reliable identification of environmental risk factors and gene-environment interplay involved in the development of autism.

Addressing climate change and health issues

Senior Advisor for Public Health John Balbus, M.D., briefed Council on NIEHS efforts to integrate human health with research endeavors on global climate change and sustainability. He noted that it had been precisely one year since Council had approved the NIEHS Human Health Impacts of Climate Change (HHICC) program the first within NIH. “Through our research grant-making, we are taking a major step to build [a] community of climate change researchers who will ultimately be informing policy both in this country and around the world,” said Balbus.

Shaping a vision for NIEHS

NIEHS Deputy Director Richard Woychik, Ph.D., reported on recent developments in the Institute's strategic planning process. With its first phase aimed at gathering broad-based stakeholder input, the first mechanism to do so was the opportunity to submit visionary ideas to the New Strategic Plan website( Woychik called the response “wildly successful.”

Woychik also noted that nearly 600 nominations had been received for the stakeholder community workshop in July. The process of selecting, inviting, and securing attendance commitments from 200 individuals representing a cross-section of the global environmental health sciences community should be completed by the end of May, he said.

The panel was also briefed on recent NIEHS and DERT activities and accomplishments by NIEHS/NTP Director Linda Birnbaum, Ph.D. and DERT Director Gwen Collman, Ph.D., and met in closed session to consider grant applications. The members also enjoyed a scientific presentation by NIEHS Principal Investigator Carmen Williams, M.D., Ph.D. (see related story)(

The Council will meet again September 1-2.

(Ernie Hood is a contract writer for the NIEHS Office of Communications and Public Liaison.)

Mary Lee, M.D.

Council member Mary Lee, M.D., from the University of Massachusetts Medical School, made a point about strategic planning during Council discussion. (Photo courtesy of Steve McCaw)

Fred Tyson, Ph.D.

Frederick Tyson updated Council on NIEHS/DERT investment in environmental epigenetics and epigenomics, a hot area of scientific activity. (Photo courtesy of Steve McCaw)

Council approves next steps for gene-environment efforts

David Balshaw, Ph.D., a program administrator in the DERT Center for Risks and Integrated Sciences who has been one of the administrators of the Exposure Biology Program - the environmental side of the GEI led by NIEHS - told Council that, although the GEI has had tremendous successes, its four-year timeline was not sufficient to accomplish its lofty goal of comprehensively integrating genetics and environmental exposures (see related story ( He said there is more work to be done before the integration can truly be accomplished. As fellow DERT Health Science Administrator and co-presenter Kimberly McAllister, Ph.D., put it, "The ultimate goal of the new proposed activities is to try to demonstrate the value of putting together the genetics and the environmental factors for disease risk."

The team proposed six initiatives, all to be conducted and funded in partnership with sister NIH institutes that were also involved with the GEI. The projects address three identified gaps in the research: continued development of tools for exposure biology (such as sensors and biomarkers), proof of principle studies designed to integrate genetics with environmental studies and vice versa, and functional analysis of gene-environment interactions. Collman pointed out that the projects would probably span five to ten years, so that the activities would build upon each other and establish continued momentum.

Oregon Health and Science University professor and Council member Stephen Lloyd, Ph.D., left no doubt about how he felt about the proposal. "This is a long-term but extremely important commitment by this institute... It's so integral and germane to the NIEHS mission [that] it's something we can't possibly punt on." His Council colleagues agreed, voting unanimously to approve the concept.

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