B-303689, National Institute of Environmental Health Sciences--American Chemistry Council Donation, September 30, 2005
The Honorable Bart Gordon
Ranking Minority Member
Committee on Science
House of Representatives
The Honorable Mark Udall
House of Representatives
The Honorable Eddie Bernice Johnson
House of Representatives
Subject: National
Institute of Environmental Health Sciences—American Chemistry Council Donation
This responds to your request for our opinion regarding the
authority of the National Institute of Environmental Health Sciences (NIEHS)[1] to
accept a conditional gift from the American Chemistry Council (ACC), a nonprofit
organization that represents the
Under 42 U.S.C. sect. 328, the Secretary of the Department of Health and Human Services (HHS) and his delegates may accept gifts, including conditional gifts. Our review of the MOU, the Request for Applications (RFA) that NIEHS issued in conjunction with the MOU, and applicable law does not establish that NIEHS agreed to any conditions that would be inconsistent with its responsibility to make final determinations on grant awards. To effectuate the overall collaborative NIEHS/ACC objective to stimulate mutually desired research, NIEHS, in the MOU, agreed to provide ACC the opportunity to review grant applications for responsiveness to the RFA, provide input to NIEHS in the negotiation and award of the grant applications, and monitor the progress of the awarded grant projects. We do not read the provisions of the MOU to provide ACC with anything more than the opportunity to provide advice and input to NIEHS as NIEHS implements its statutory authority consistent with the mutually agreed upon research objectives.
To ensure transparency in the grants process, and to avoid any appearance of a conflict of interest between future donors and NIEHS’s statutory responsibilities, we suggest that NIEHS develop formal policies and procedures regarding the level of participation a donor may have in the grants process and articulate these policies and procedures clearly in the RFA and MOU. We also suggest that NIEHS work with donors to ensure that before making a donation, the donor has adequate knowledge of the grants process and how NIEHS may use its donation, so that the donor can consider all of the restrictions and other conditions it might wish to place on its donation before it provides the donation to NIEHS.
BACKGROUND
NIH’s mission is to improve human health by increasing
scientific knowledge related to disease and health. NIH
Grants Policy Statement,
In July 2001, ACC, a nonprofit trade organization that
represents most major
The RFA for Developmental Toxicology Exploratory Research
Grants, NIEHS RFA-ES-01-006, June 14, 2001, states that the overall objective
of the research initiative to study environmental developmental toxicants is “to
stimulate research on the mechanism of action of developmental toxicants using
the state of the art tools of genomics, proteomics and model organisms
including transgenic and gene knock out genetic animal models.” RFA at 1.
“The new information obtained . . . will be used to accelerate research
in developmental toxicology, advance new approaches in molecular epidemiology
and improve qualitative and quantitative risk assessment processes for
evaluating the potential for exposure induced developmental defects.”
“[t]he present initiative RFA addresses the mutual research goals of the NIEHS and the ACC to improve the quantity, quality, and timeliness of data from investigations on the mechanisms of developmental toxicants. Thus, this jointly sponsored RFA represents a unique collaboration of Government and Industry to support novel, high potential research that will contribute to the improvement of the health of the American people by improving the quantity and quality of the data on developmental toxicants that is available for use in the risk assessment process.”
Pursuant to NIH/NIEHS policy, after grant applicants submit
applications in response to the RFA, NIEHS staff review all submitted grant
research applications to determine whether they are complete, conform to
administrative requirements, and contain the information necessary for a
detailed review. NIH Grants Policy Statement,
The MOU states that both ACC and NIEHS “will review all
[grant] applications received for responsiveness to the purpose and intent of
the RFA” prior to the acceptance of the application, and that “[t]hose
applications judged responsive will be accepted by the NIH/NIEHS for
peer-review evaluation.” MOU at 3. The MOU also provided ACC “the
opportunity . . . to provide input to
the NIEHS in the negotiation and award of the grant applications, and to assist
in the monitoring of progress of the awarded grant projects.” MOU
at 4. According to the Deputy NIH Legal Advisor,
ACC, in fact, did not exercise its opportunity to review applications prior to
acceptance to determine if they were responsive to the purpose and intent of
the RFA. Letter from Patricia A.
Kvochak, Deputy NIH Legal Advisor, to Susan A. Poling, Managing Associate General Counsel, GAO,
ACC, however, did review the grant proposals subsequent to review and recommendation by an independent peer review panel. Kvochak letter. After review by the peer review panel, NIEHS presented to ACC a funding plan and a copy of each grant proposal. At that point, ACC requested that NIEHS not use its donation to fund two of the research proposals. NIEHS agreed to ACC’s request and chose to use its fiscal year appropriations to cover the full cost of the two proposals.[8] Kvochak letter.
ANALYSIS
ACC provided a gift to NIEHS that was conditioned on joint review by NIEHS and ACC of grant applications for responsiveness and that was conditioned on providing ACC both the opportunity for input in the award of grants and the opportunity to assist in monitoring the progress of grant proposals.
Without statutory authority, an agency may not accept gifts of goods or services for its own use (i.e., for retention by the agency or credit to its own appropriations). B-286182,
Congress provided the Secretary of HHS the authority to
accept conditional gifts. 42 U.S.C. sect. 238(a). The statute provides that “[t]he Secretary of
Health and Human Services is authorized to accept on behalf of the
The research initiative on environmental developmental toxicants was a collaborative project between ACC and NIEHS. The gift instrument—the MOU—placed certain conditions on the gift ACC made to NIEHS to ensure that the gift was used consistently with the aims and goals that ACC and NIEHS jointly developed:
· Both ACC and NIEHS “will review all [grant] applications received for responsiveness to the purpose and intent of the RFA” prior to the acceptance of the application, and that “[t]hose applications judged responsive will be accepted by the NIH/NIEHS for peer-review evaluation.” MOU at 3.
· ACC will have “the opportunity . . . to provide input to the NIEHS in the negotiation and award of the grant applications, and to assist in the monitoring of progress of the awarded grant projects.” MOU at 4.
NIEHS is responsible for awarding grants and administering them per statutory requirements and may not delegate its grant award authority to nongovernmental entities. We read the conditions in the MOU as providing ACC only with the opportunity to provide advice and input to NIEHS as NIEHS implements its statutory grant award authority and not as delegating decision authority to ACC.
As explained in the background section above, pursuant to
NIH/NIEHS grants policy, after grant applicants submit applications in response
to the RFA, NIEHS staff review all submitted grant research applications to
determine whether they are complete, conform to administrative requirements,
and contain the information necessary for a detailed review. NIH
Grants Policy Statement,
If the research application is complete, the next step in
the process is peer review. NIEHS is
required by statute and policy to conduct scientific and technical peer review
of all grant applications. 42 U.S.C. sect.
284(b)(2)(B). The purpose of the peer review panel is to provide a fair and objective
review process in the overall interest of science. NIH
Grants Policy Statement,
After the peer review process, ACC requested that NIEHS not
use its donation to fund two grant proposals recommended by the peer review panel. ACC requested that NIEHS not use its donation
for the first project because it involved research on primates. It requested that NIEHS not use its donation
for the second project because it involved a chemical related to the ACC
industry, and ACC was concerned that funding this research might look like a
conflict of interest. Kvochak letter,
and subsequent conversation with the
Deputy NIH Legal Advisor,
The MOU and NIEHS only permitted ACC to advise and provide input to NIEHS in its grants award process, not to overrule NIEHS’s grant award decisions. However, to ensure transparency in the grants process, and to avoid any appearance of a conflict of interest between future potential donors and NIEHS’s statutory responsibilities, we suggest that NIEHS develop formal policies and procedures regarding the level of participation a donor may have in the grants process and articulate these policies and procedures clearly in the RFA and MOU. We also suggest that NIEHS work with donors to ensure that before making a donation, the donor has adequate knowledge of the grants process and how NIEHS may use its donation, so that the donor can consider all of the restrictions and other conditions it might wish to place on its donation before it provides the donation to NIEHS.
CONCLUSION
The Secretary of HHS and his delegates have authority to accept gifts, including conditional gifts. The conditions articulated in the MOU did not delegate to ACC any of NIEHS’s statutory grant award authority but only provided ACC with the opportunity to provide advice and input to NIEHS in the review and award of grant applications. In order to avoid any appearance of a conflict of interest in the future, we suggest that NIEHS develop formal policies and procedures regarding donor participation in the grants process, and that it work with donors to ensure they consider all of the conditions they might wish to place on their donation before they provide the donation to NIEHS.
Anthony H. Gamboa
General Counsel
DIGEST
The Secretary of the Department of Health and Human Services and his delegates have authority to accept gifts, including conditional gifts, so long as they do not offend existing statutory or regulatory provisions. NIEHS may not delegate its grants award authority to nongovernmental entities. While the MOU provides ACC the opportunity to advise and provide input, it does not delegate to ACC any decision authority. To avoid any appearance of a conflict of interest, we suggest that NIEHS develop grants policies and procedures regarding the level of participation a donor may have in the grants process and work with donors to ensure that they consider all of the restrictions and other conditions they might wish to place on their donation before providing the donation to NIEHS.
[1] NIEHS is a research institute within the National Institutes of Health, Department of Health and Human Services.
[2] See also NIH Grants Policy Statement, March 2001, at 36. The NIH Grants Policy Statement that was in effect when ACC donated funds to NIEHS for the research projects studying environmental developmental toxicants was dated March 2001. The policy statement was revised in December 2003.
[3]
ACC “is committed to improved environmental, health and safety performance
through Responsible Care [the industry’s initiative to improve participating
companies’ environmental health and safety performance], common sense advocacy
designed to address major public policy issues, and health and environmental
research and product testing.” http://www.americanchemistry.com
(last visited
[4] The general purpose of NIEHS is the conduct and support of research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly. 42 U.S.C. sect. 2851. The Applied Toxicological Research and Testing Program, a program within NIEHS, conducts applied research and testing regarding toxicology. 42 U.S.C. sect. 2851-1. The directors of the national research institutes, acting on behalf of the Secretary of NIH, have the authority to enter into grants, contracts, and cooperative agreements to encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences relating to causes, diagnosis, treatment, control, and prevention of physical and mental diseases. 42 U.S.C. sections 241, 284(b)(1).
[5] See also NIH Grants Policy Statement, March 2001, at 35.
[6] See also NIH Grants Policy Statement, March 2001, at 34.
[7] See also NIH Grants Policy Statement, March 2001, at 38.
[8] In total, NIEHS obligated $3.7 million from its annual appropriations for the research initiative studying environmental developmental toxicants. Of this amount, NIEHS used $2.5 million for these two grant awards. Kvochak letter, p.3.
[9] In 1966, the functions of Surgeon
General of the Public Health Service were transferred to the Secretary of
Health, Education, and Welfare. Reorg.
Plan No. 3 of 1966 sections 1, 3; 42 U.S.C. sect.
202 note. In 1979, the Department of
Education Reorganization Act, Pub. L. No. 96-88, 93 Stat. 668 (Oct. 17, 1979), redesignated
the Department of Health, Education, and Welfare as the Department of Health
and Human Services. 20 U.S.C. sect. 3508.
[10] See also NIH Grants Policy Statement, March 2001, at 35.
[11] See also NIH Grants Policy Statement, March 2001, at 34.
[12] See also NIH Grants Policy Statement, March 2001, at 34.