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Date:
9/17/2001 10:50:00 AM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
Amici do not ask the Court to reverse its decision in these cases. As the Court held, these cases should return to the circuit court for proceedings consistent with the Court’s holding that KKI owed a duty to the plaintiffs. In those further proceedings, the issues to be resolved include the precise contours of KKI’s duty, whether the duty was violated, and, if so, what injuries plaintiffs suffered as a result of any breach. While those proceedings should go forward, the Court should review, reconsider, and rescind that portion of its decision which would have a devastating impact on health and human developmental research.
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Date:
3/1/2001 10:55:00 AM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
Dear Mr. Pascal: Thank you for your invitation to comment on the Office of Research Integrity's draft guidelines for assessing possible research misconduct in clinical research and clinical trials. As you know, the Association of American Medical Colleges (AAMC) represents the nation's 125 accredited medical schools, over 400 teaching hospitals, and 91 academic and scientific societies. We are joined in these comments by the Council on Governmental Relations (COGR), a nonprofit organization representing 143 of the most research-intensive universities in the United States. The guidelines touch on two themes that are fundamentally important to our memberships: the promotion of clinical research, in all its forms, to improve public health and the paramount responsibility to conduct this research ethically.
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Date:
5/30/2003 10:55:00 AM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
The Association of American universities welcomes the opportunity to comment as requested on the draft "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection" AAU represents 60 leading public and private research universities in the United States and two in Canada. AAU works to ensure that research conducted on our campuses meets the highest ethical standards and promotes public health, and in recent years has issued reports of human research protections and on financial conflict of interest.
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Date:
2/2/2001 11:10:00 AM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
Dear Dr. Federman, This letter presents comments of the Association of American Universities (AAU), the Council on Governmental Relations (COGR) and the National Association of State Universities and Land-Grant Colleges (NASULGC) on the proposed Public Responsibility in Medicine and Research (PRIM&R) accreditation standards for the protection of human subjects research on which the Institute of Medicine has sought commentary.
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Date:
9/17/2001 01:15:00 PM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
On the day the mandate in this case issues, hundreds of fully accredited medical research projects now conducted in Maryland will terminate. These projects, involving the dedicated efforts of countless scientists, are conducted by institutions of international renown. The projects give hope not only to the thousands who participate in the research, but to countless others who hope to reap the benefits of these studies. Each of these research projects was initiated only after careful review by Institutional Review Boards of the sponsoring institutions and, in most cases, only after review by other accrediting and funding agencies such as The National Institutes of Health. The design of each project complied with federal regulations developed over an extended period after intense scrutiny and debate in a process involving the most experienced scientists and most respected bioethicists in the world. The cost to the State of Maryland and its citizens, and the damage done to the institutions as a result of terminating these projects, will be incalculable. Significantly more important than this damage will be the devastating curtailment of medical research directed to understanding, treating, and curing diseases that impact our most vulnerable populations, the young and the disabled. And upon issuance of the mandate, the reputation of one of these sponsoring institutions will be indelibly and undeservedly tarnished in a way that no trial on remand can overcome.
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Date:
9/21/2000 01:20:00 PM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
Dear Mr. Pascal: This letter presents comments of the Association of American Universities (AAU), the Council of Graduate Schools (CGS), the Council on Governmental Relations (COGR) and the National Association of State Universities and Land-Grant Colleges (NASULGC), on the proposed PHS Policy on Instruction in the Responsible Conduct of Research published by the Office of Research Integrity on July 17, 2000. The AAU is an organization of research universities devoted to maintaining a strong system of academic research and education, and consists of 59 U.S. universities and 2 Canadian universities. COGR is an association of 143 research-intensive universities that concerns itself with the influence of government regulations, policies and practices on the performance of research conducted at colleges and universities. NASULGC, with roots back to 1887, is the nation's oldest nonprofit higher education association with 210 members from all 50 states, the District of Columbia and the U.S. territories.
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Date:
9/18/2001 01:20:00 PM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
Washington, September 18, 2001—The Association of American Medical Colleges (AAMC), and the Association of American Universities (AAU), announced today that they have joined with two individual institutions, the University of Maryland Medical System, and The Johns Hopkins University, to file an amicus brief supporting the appellant's motion for reconsideration of the opinion issued by the Maryland Court of Appeals in Grimes v. Kennedy Krieger Institute, Inc. The brief does not ask the court to reverse its decision that the two cases at issue should return to the circuit court for adjudication. Instead, it strongly urges that the Court review, reconsider, and rescind only that portion of its decision "that would have a devastating impact on health and human development research.”
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Date:
9/21/2000 01:30:00 PM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Human Subjects Research
Agencies of the Public Health Service (PHS) strongly believe in promoting the responsible conduct of research and preventing research misconduct, and other violations of responsible research, through education and awareness. Since 1990, NIH has required recipients of National Research Service Award research training grants to develop a program of instruction in the responsible conduct of research for trainees. With this policy, PHS extends the requirement beyond trainees to all research staffto all staff at at extramural institutions engaged in research or research training with PHS funds., or who work on PHS-supported research projects. A similar requirement will cover PHS intramural staff engaged in research or research training.
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Date:
2/21/2002 02:35:00 PM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Animals in Research
Dear Senator Helms: On behalf of the 61 U.S. research universities in the Association of American Universities, I am writing to thank you for attaching an amendment to the Senate Farm Bill that would maintain existing protections for animal care but prevent the creation of counterproductive new regulations. Your amendment to codify the existing enforcement definition of rats, mice, and birds in the Animal Welfare Act will help ensure that federal and university research funds can remain focused on finding future medical diagnoses, treatments, and cures, rather than diverted to costly and duplicative paperwork.
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Date:
7/24/2000 10:00:00 AM
Folder Path:
\Policy Issues\Research Administration and Policy Issues\Costs of Research\Reports and Presentations
http://www.ostp.gov/html/00727_3.html
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