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Promoting Integrity in Research
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Education - RCRCommittee CorrespondenceFebruary 5, 2001 Mr. Chris Pascal, J.D. Director Office of Research Integrity Office of Public Health and Science Department of Health and Human Services 5515 Security Lane Rockville, MD 20852 Dear Mr. Pascal: Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee on Energy and Commerce has been reviewing the adequacy and appropriateness of federal regulation and oversight over public health research. In the course of our review, the Committee has learned that on December 1, 2000, the Office of Research Integrity ("ORI") on behalf of itself and various Public Health Service ("PHS") agencies issued a final policy under your name that would impose new requirements on our nation’s research institutions. The policy requires research institutions to assure that all research staff involved in PHS funded research successfully complete a core curriculum covering nine areas (e.g., data sharing, mentoring practices, authorship practices, recordkeeping) as may be relevant. The purpose of the policy is to promote the ethical practice of science. While we strongly support federal efforts to encourage responsible and ethical scientific research practices, we are troubled by ORI's process in implementing such efforts. Based on the Committee staff’s review, we are concerned that a policy aimed at improving the ethics of those outside government may have been issued by a government agency in apparent disregard of federal law. According to the Committee staff’s analysis, ORI's December 1, 2000 policy appears to be a final substantive rule, within the meaning of the Administrative Procedure Act (APA), 5 U.S.C. §§ 551 et seq. and as such, ORI should have complied with the notice-and-comment provisions of the APA, and the various statutes designed to ensure sound regulatory decisionmaking, such as the Regulatory Flexibility Act, 5 U.S.C. §§ 601 et seq., the congressional presentment provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 ("SBREFA"), 5 U.S.C. §§ 801 et seq., and the Paperwork Reduction Act, 44 U.S.C. §§ 3501 et seq. In issuing its final policy, it appears ORI did not comply with any of these laws or requirements. Indeed, the texts of both proposed policy and final policy were never published in the Federal Register, as required by the APA. Instead ORI announced the existence of the policy on its website through a document in the Notice section of the Federal Register. Not publishing the text in the Federal Register raises the question of whether ORI purposely so acted to avoid having to confront the various requirements that the Office of the Federal Register would impose on ORI before it publishes a rule or proposal (e.g., OMB approval, Secretarial sign-off, statement of legal authority for rule, Regulatory Flexibility Act analysis, federalism analysis). Given the importance of adhering to federal law, especially in the case of an agency whose mission is ethical conduct, please provide the following by February 7, 2001: 1. All records relating to documents, clearances, or signoffs, including but not limited to memoranda from the Office of the General Counsel, discussing, mentioning or referencing directly or indirectly the propriety or legality of issuing the above noted policy without going through notice-and-comment rulemaking or without adhering to the provisions of the laws outlined above. 2. Any legal authority that you would rely upon to support the notion that ORI did not violate any of the above-noted laws in issuing the policy referenced above. Please note that, for the purpose of responding to these requests, the terms "records" and "relating" should be interpreted in accordance with the Attachment to this letter. Furthermore, it may be necessary for Committee staff to interview ORI employees. Accordingly, we request that this letter serve as a general request that you make available to us ORI employees for interviews. No ORI personnel other than the interviewee will be permitted at the interview. The ORI employee has the option to appear alone, with private counsel, or with a counsel from the Department's Office of General Counsel who has no reporting relationship with the ORI or any individual at ORI. The purpose of these interviews would be to allow for more open and candid discussions between ORI personnel and Committee staff. Thank you for your assistance. Sincerely, W.J. Billy Tauzin Chairman James Greenwood Chairman-designate Subcommittee on Oversight and Investigations cc: The Honorable John D. Dingell, Ranking Member |
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This page last was updated on January 12, 2005
 U.S. Department of Health and Human Services Office of Research Integrity • 1101 Wootton Parkway • Suite 750 • Rockville, MD 20852 Directions to ORI Office Questions/suggestions about this web page? Contact ORI |
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