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To: Stand Watch Listen
The Federal Office of Research Integrity

Ahem... Who are these people. If their job is to review these studies/watch our $$$ then where have they been?

24 posted on 01/07/2002 6:01:26 PM PST by sistergoldenhair
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To: sistergoldenhair
The Federal Office of Research Integrity....Ahem... Who are these people. If their job is to review these studies/watch our $$$ then where have they been?

ORI HISTORICAL BACKGROUND

Scientific misconduct became a public issue in the United States in 1981 when then Representative Albert Gore, Jr., chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, held the first hearing on the emerging problem. The hearing was prompted by the public disclosure of scientific misconduct cases at four major research centers in 1980. Some twelve cases of scientific misconduct were disclosed in this country between 1974-1981. Congressional attention to scientific misconduct was maintained throughout the 1980s by additional allegations of scientific misconduct and reports that the National Institutes of Health (NIH), universities, and other research institutions were inadequately responding to those allegations.

Congress took action in 1985 by passing the Health Research Extension Act. The Act, in part, added Section 493 to the Public Health Service (PHS) Act. Section 493 required the Secretary of Health and Human Services to issue a regulation requiring applicant or awardee institutions to establish "an administrative process to review reports of scientific fraud" and "report to the Secretary any investigation of alleged scientific fraud which appears substantial." The Section also required the Director, NIH, to establish a process for receiving and responding to reports from institutions. This legislation complemented existing authority under which the PHS pursued scientific misconduct in the 1970s and early 1980s. Guidelines were published in the NIH Guide to Grants and Contracts in July, 1986; the Final Rule, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science", was published in the Federal Register on August 8, 1989. This regulation is codified at 42 CFR Part 50, Subpart A.

Before 1986, reports of scientific misconduct were received by funding institutes within PHS agencies. In 1986, the NIH assigned responsibility for receiving and responding to reports of scientific misconduct to its Institutional Liaison Office. This was the first step taken to create a central locus of responsibility for scientific misconduct within the Department of Health and Human Services.

In March 1989, the PHS created the Office of Scientific Integrity (OSI) in the Office of the Director, NIH, and the Office of Scientific Integrity Review (OSIR) in the Office of the Assistant Secretary for Health (OASH). The sole purpose of these offices was to deal with scientific misconduct; the creation of OSIR also began the process of removing responsibility for scientific misconduct from the funding agencies. In May, 1992, OSI and OSIR were consolidated into the Office of Research Integrity (ORI) in the OASH. Later that year, HHS established a hearing opportunity for all scientists formally charged with research misconduct.

In June 1993, the process of removing responsibility for handling allegations of scientific misconduct from the funding agencies was completed when President Clinton signed the NIH Revitalization Act of 1993. This Act established the ORI as an independent entity within the Department of Health and Human Services (HHS).

Organizationally, ORI is located within the Office of the Secretary of Health and Human Services in the Office of Public Health and Science which is headed by the Assistant Secretary for Health.

In October 1999, HHS announced several changes designed to improve its processes for responding to allegations of research misconduct and promoting research integrity. The final definition was published in the Federal Register on December 6, 2000. First, HHS will adopt the proposed government-wide definition of research misconduct developed by the National Science and Technology Council after it is finalized by the Office of Science and Technology Policy. The proposed definition was published in the Federal Register on October 13, 1999. Second, extramural institutions and intramural research programs have the primary responsibility for responding to allegations of scientific misconduct. The Office of Inspector General, HHS, rather than ORI conducts any fact-finding required by the federal government. ORI continues to conduct oversight reviews of all investigations. Third, the Assistant Secretary for Health, upon recommendations from ORI, makes the final decisions regarding scientific misconduct and administrative actions, subject to appeal. Fourth, the HHS Departmental Appeals Board continues to hear appeals, but the hearing panels include two scientists rather than one or none. Fifth, all extramural research institutions are required to provide training in the responsible conduct of research to all research staff who have direct and substantive involvement in proposing, performing, reviewing, or reporting research, or who receive research training, support by PHS funds or who otherwise work on PHS-supported research projects even if they individual does not receive PHS support. The PHS Policy on Instruction in the Responsible Conduct of Research was published n the Federal Register on December 1, 2000 and suspended on February 20, 2001 pending review of the substance of the policy and whether the document should have been issued as a regulation rather than a policy. Sixth, HHS published a notice of proposed rulemaking on the protection of whistleblowers in the Federal Register on November 28, 2000; comments were due by January 29, 2001.

To answer "where they have been" you have to look to the underlined parts of the above. You'll notice a change that occured in 1993, that internalized the independancy of the agency and placed it under the control of HHS. You should also notice the sly way that they fixed it, to possibly take effect after/if they were ousted from power.

30 posted on 01/07/2002 7:16:50 PM PST by PeaceBeWithYou
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