Dear Dr. Menikoff:
Thank you for the opportunity to provide input in response to the Advanced Notice of Proposed Rulemanking (ANPRM) entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Notice Number HHS-OPHS-2011-0005), published in the July 26, 2011 Federal Register (76 FR 44512).
Attached please find a joint response to the ANPRM from the Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU).
On behalf of the Association for American Universities (AAU) and Association of Public and Land-grant Universities (APLU), please accept this request for an extension of the deadline for submission of comments in response to the Department of Health and Human Services (HHS) Advanced Notice of Proposed Rulemaking (ANPRM) titled, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” We request an extension of at least an additional 30 days.
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.
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.”
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.
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.
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.
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.
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.
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.
Dear Colleagues: The AAU Task Force on Research Accountability has just completed its report on the protection of human beings who are the subjects of research. Its purpose is to ensure that the research university community takes strong action to ensure the safety and dignity of human subjects as new treatments and therapies are developed and tested. We urge your prompt attention to this important report and hope that you will find the recommendations useful as you evaluate the policies and practices of your institution.
The Association of American Universities believes it is vital for leaders of the academic community to ensure that research conducted on our campuses meets the highest ethical standards and promotes the public health. AAU therefore established the Task Force on Research Accountability in March, 2000. The Task Force’s first assignment was to assess university research management challenges related to the protection of human subjects; its second will be to examine issues that arise from the increasing collaboration between industry and our research universities. In both areas, the Task Force is charged with developing recommendations for providing appropriate accountability and oversight of university research and regulatory compliance. This is the report on human subjects research.
The Association of American Universities, which represents 61 leading North American research universities, today released a report laying out specific recommendations for bolstering protections of human subjects in university-based research. The association is urging its members to adopt the recommendations. The recommendations call for the following:
We applaud the steps announced today by Secretary Shalala. Our association and other, similar organizations are working to strengthen the protection of human research subjects on our campuses, and more vigorous, coordinated federal oversight and enforcement will assist that effort.
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