In some cases, achieving our strategic goals and objectives may be impeded by factors that are beyond the control of the Department of Health and Human Services (HHS). For example, national or local economic conditions can influence whether we are successful in helping families on welfare become economically independent. In some cases, there may b
External ethical oversight provides additional protection for research subjects. Prime examples in the U.S. are the Institutional Review Boards (IRBs) that supervise human-subjects research conducted under Federal jurisdiction, which is very broad. IRBs are carefully constituted boards that conduct independent oversight of research. 73
Basic research develops the fundamental science that underpins all applied research. It uses every experimental approach possible, every kind of instrumental observation, every epidemiological and other analytic technique. It uses social-scientific methods where these can illuminate basics. It studies simplified "model" systems, in search of insig
The ethos surrounding research on humans was recast and codified after World War II, as the world coped with the revelation of the medical atrocities perpetrated by the Nazis. The resulting "Nuremberg Code"—the opening sentence of which was, "The voluntary consent of the human subject is absolutely essential"—established principles having to d
The Federal Common Rule and other laws and regulations require many protections for human subjects of research. The main social instruments are informed consent of the data- subject, and Institutional Review Board (IRB) supervision. Both of these mechanisms have served society well. But both now need to be renewed.
HHS Strategic Goals and Objectives - FY 2001 . Objective 6.7 - Strengthen Mechanisms for Ensuring the Protection of Human Subjects in Research and the Integrity of the Research Process.
We will strengthen mechanisms for ensuring protection of human subjects by: increasing and enhancing the educational opportunities for clinical investigators and Institutional Review Board (IRB) members and staff to facilitate their understanding and application of federal requirements for the protection of human subjects.
Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Increasing Use of Interconnected Electronic Information Systems
Until recently, health information was recorded and maintained on paper and stored in the offices of community-based physicians, nurses, hospitals, and other health care professionals and institutions. In some ways, this imperfect system of record keeping created a false sense of privacy among patients, providers, and others. Patients' health info
Health Care in Transition: Technology Assessment in the Private Sector Prepared by: Richard Rettig of the RAND Corporation Office of the Assistant Secretary of Planning and Evaluation Agency for Health Care Policy and Research. July, 1996.
HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. Endnotes
1 In general, grantees own the data generated by or resulting from a grant-supported project. Special terms and conditions of the award may specify alternative rights, e.g., under a cooperative agreement or if there are shared rights to data. Except as otherwise provided in the terms and conditions of the award, the grantee is free to copyright
HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. C. HHS Responsibilities
In accordance with the OMB Guidelines, agencies subject to the Paperwork Reduction Act (44USC 3502(1)) are required to:
HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public
This site describes the HHS Information Quality Guidelines as well as the supporting administrative mechanisms to request correction of information covered under the guidelines. The HHS Guidelines were developed in accordance with the provisions of P.L. 106-554 and OMB government-wide requirements directing all federal agencies to issue guidelines
Developing a Framework to Guide Genomic Data Sharing and Reciprocal Benefits to Developing Countries and Indigenous Peoples: A Colloquium
The O'Neill Institute for National and Global Health Law invited twelve thought leaders with extensive experience in the conduct of biomedical research among indigenous peoples and developing countries to a colloquium at Georgetown University on January 7-8, 2009. The colloquium addressed a basic question: as genomic science develops across the w
Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange
Identifying Opportunities To Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange Meeting Summary Andrew Dorfmann and Jessica Nadler 10/15/2009
Information Needs Associated with the Changing Organization and Delivery of Health Care: Summary of Perceptions, Activities, Key Gaps, and Priorities. 2. Structure II: Resources -- Training and Financing
Information on resources involves questions and concerns that are central to the development and financing of the system and its components over time (see Table 3 for illustrative issues). Interviewees were especially concerned about training for providers, especially physicians, given the fact that there is already an oversupply nationwide. Many
Information Needs Associated with the Changing Organization and Delivery of Health Care: Summary of Perceptions, Activities, Key Gaps, and Priorities
This report summarizes the insights and conclusions drawn from a project to asses unmet needs for supply-side information on the health system. The project focused on identifying how information needs associated with a changing health care system are perceived by providers, insurers, purchasers, consumers, and government at various levels. The proj
Performance Improvement 2013-2014. What is the Impact of the National Cancer Institutes' Career Development Awards on Participant Career Outcomes?
The National Cancer Institute Career Development (NCI K) awards program includes a broad range of funding mechanisms that provide scientists and clinicians with support to develop their cancer research careers and transition to independence, expand their existing research programs, or mentor junior investigators. The evaluation sought to define th
Performance Improvement 2013-2014. Does the Research on Research Integrity Program Support a Diverse Research Community?
The Research on Research Integrity (RRI) program supports research on the responsible conduct of biomedical research. This study was commissioned to better understand the success of the program's efforts to promote research on responsible research, improve future research integrity-related funding opportunity announcements, and diversify the commu
Performance Improvement 2011-2012. Does the Director's Pioneer Award Program Result Stimulate Pioneering Research?
The National Institutes of Health (NIH) commissioned a study to assess whether the short-term outcomes of the NIH Director's Pioneer Award (NDPA) program were consistent with its original goals, and to evaluate the impact of the NDPA on NIH and its funding of high-risk research. The NIH launched the NDPA program in 2004 to support individual scie
Performance Improvement 2011-2012. Does the Interdisciplinary Research Consortium Program Encourage Greater Interdisciplinary Collaboration?
The Interdisciplinary Research (IR) Program is one of eight National Institutes of Health (NIH) Common Fund initiatives developed to overcome barriers to medical research that are inherent in single discipline approaches.