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Bioethics and the NIH

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Bioethics Resources on the Web

Bioethics and the NIH

This page is an effort to bring together web-based resources at the NIH having to do with bioethics.

bullet Offices and Programs - NIH organizations that deal directly bioethical issues
bullet Research Resources - starting points for bioethics research provided by NIH
Bioethics Documents and Publications - guidelines, FAQs, fact sheets, position statements, and reports

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Offices and Programs

bullet Trans-NIH Bioethics Committee (T-NBC) - Contributes directly to the agency's policy development and decision-making processes by providing an ongoing, coordinated approach to the consideration of DHHS policies as they impact on the ethical, legal, and social implications of NIH-funded clinical research. T-NBC is coordinated by the Office of Science Policy.

bullet NIH Inter-Institute Bioethics Interest Group - A discussion group of scientists, ethicists, IRB members, policy makers, and others interested in bioethics. Established in 1997, the group has monthly meetings for the discussion of a wide range of topics in bioethics, especially in research ethics. Although primarily intended for the NIH community, the Interest Group has a large public membership. 

bullet Office of the Director (OD) - The administrative locus of the NIH. The OD coordinates the activities of the institutes and centers in both the intramural (on site) and extramural (off site) research programs. Offices within the OD that deal with bioethical issues are:

bullet Office of Science Policy (OSP) - Advises the NIH Director on science policy issues that affect the medical research community, develops new policies, particularly policies that promote the safe and ethical conduct of research.

bullet Office of Science Policy Analysis (OPSA) - The OSPA coordinates activities and is a resource of activities in science policy analysis and planning for the NIH.

bullet Office of Biotechnology Activities (OBA) - Monitors scientific progress in human genetics research in order to anticipate future developments, including ethical, legal, and social concerns, in basic and clinical research involving Recombinant DNA, Genetic Testing, and Xenotransplantation. It also manages the operation of the NIH Recombinant DNA Advisory Committee (RAC) and the DHHS Secretary's Advisory Committee on Genetic Testing (SACGT).

bullet Clinical Research Policy Analysis and Coordination (CRpac) - Harmonizes and coordinates policies and requirements for the conduct and oversight of clinical research. Issues being addressed include clinical trials design, data and safety monitoring in clinical trials, informed consent, adverse event reporting, models of IRBs, human subjects protections and issues related to human specimen and data repositories.

bullet The NIH Ethics Program - Information on conflict of interest for NIH employees and standards of ethical conduct for federal employees. The NIH Ethics Program includes the central NIH Ethics Office and the ethics programs in each of the Institutes. The site includes information on outside activities and management of conflicts of interest.

bullet Office of Human Subjects Research (OHSR) - This Office operates within the NIH Office of Intramural Research and was established to help intramural investigators within the NIH understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects. The site provides the federal regulations for the protection of human subjects, the text of the Belmont Report, and a computer-based training program: Protecting Human Subjects in the Intramural Research Program, NIH.

bullet Office of Extramural Research (OER) - NIH devotes 80-85 percent of its total budget) to extramural research. Grants support biomedical and behavioral research and research training at universities, research institutions, and medical centers across the United States and abroad. OER's site provides resources on human subjects protection and grants policy and guidance.

bullet Office of Laboratory Animal Welfare (OLAW) - NIH site providing guidance, tutorial, news flashes, policies and laws, and useful links.

bullet Office of Legislative Policy and Analysis (OLPA) - The principal office within the Office of the Director (OD) for providing legislative analysis, policy development, and liaison with the Congress. Web page provides reports, a listing of legislation in which the NIH is involved, and information on NIH participation in congressional hearings.

Some NIH Institutes have posted bioethics resources on their websites. These include:

National Human Genome Research Institute (NHGRI) - Covers current issues in genetics and genomics research.

bullet Policy and Ethics (NHGRI) - This page has resources regarding critical issues and legislation surrounding genetics research, genetic testing, intellectual property and genomics and other biomedical research issues.

bullet Ethical, Legal, and Social Implications (ELSI) Program (NHGRI) - ELSI was established in 1990 to identify, analyze, and address the ethical, legal, and social implications of the Human Genome Project (HGP) at the same time the basic science issues are being studied. The web site provides background information, press releases, links to genome ethics policy and legislation and research funding priorities for genome ethics research.

bullet National Institute of Environmental Health Sciences (NIEHS) Bioethics Web Site - Provides a colloquium on research ethics, a directory of resources in genetics and ethics, and contains the NIEHS IRB web page.

bullet Department of Bioethics (DB) of the Walter Grant Magnuson Clinical Center - Conducts research on ethics of research with human subjects; ethics of health policy; and ethical issues in genetics. It provides ethics-related services for the Clinical Center, as well educational courses and seminars. The DB serves the NIH community.

bullet John E. Fogarty International Center (FIC) - Serves as the organizational locus for NIH international activities. It hosts an annual Global Forum on Ethics in Research. The Center fosters research partnerships between American scientists and foreign counterparts and explores the ethical issues of international clinical trials and in bioethics education and career development through its International Research Bioethics Initiatives.

bullet National Cancer Institute (NCI)  - The NCI conducts and supports basic and clinical research on cancer. Biospecimens are valuable research resources.  The NCI has published guidance on Legal and Ethical Issues relating to Biospecimens.

bullet National Heart, Lung and Blood Institute (NHLBI) - The NHLBI conducts and supports research on diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders.  The NHLBI a webpage on Ethics, Populations Data Safety and Integrity, and Funding Issues.  


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Research Resources - This web site, maintained by the National Library of Medicine at the NIH allows the public to search for clinical trials by title and funding organization.

bulletThe National Library of Medicine - Provides several search engines including PubMed, MEDLINE, and Grateful Med. It provides access to the bioethics literature in conjunction with the Kennedy Institute of Ethics at Georgetown University. The library has a Bioethics Information Resources site that accesses journal articles. Ethical Issues in Research Involving Human Participants is an archived (1989-1998) bibliography that may be helpful to those searching for historical references.


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Bioethics Documents and Publications

bulletELSI Publications and Products - Between 1990 and 2001, the ELSI program supported 235 research and education projects and conferences. These ELSI grants and contracts have resulted in 550 peer-reviewed journal articles, books, newsletters, Web sites and television and radio programs. Those products are listed, arranged by the principle investigator's (PI) last name. For further project descriptions, use the ELSI Research Program Abstracts and Activities Database.

bulletPublications of the NIH Department of Bioethics - A bibliography of publications by the faculty, fellows and staff of the Department of Bioethics is posted on this page that describes the Department’s research projects.. .The link is a useful resource to scholars.

Research Portfolio Online Reporting Tools (RePORT) – The NIH RePORT database provides access to reports, data and analyses of NIH research activities.

bulletAnnotated Compendium of NIH Resources on Informed Consent (2007) – This compilation includes informed consent resources from the NIH Institutes and Centers.  Among the resources are informed consent templates, frequently asked questions, guidance created by specific ICs, and other materials.  The topics include general guidance on the informed consent process, tools for the development of informed consent forms, and materials designed to navigate users through challenges in informed consent, such as working with populations that may present special considerations relative to communication or decision-making capacity.

bulletFinal NIH Statement on Sharing Research Data (2/26/2003) - NIH's policy statement supporting timely release and sharing of research data for use by other investigators.

bulletNHLBI Data Sharing Policies and Resources - This site lists policies and procedures for use of available datasets. New datasets are added as they become available.

bulletPublic Health Service Policy Relating to Distribution of Unique Research Resources Produced with PHS Funding  (1999) – This site states the policy requiring the sharing of biological specimens/resources produced with public funds with other investigators in order to advance scientific knowledge.

bulletPolicies and Guidance for Sharing of Resources and Data for Studies on the Genetics of Alzheimer’s Disease –  NIA.  A policy document of the National Institute on Aging requiring specimen and data sharing in studies of Alzheimer’s genetics.

bulletNIH Policy on Sharing Model Organisms for Biomedical Research (5/7/2004) - NIH's policy to support sharing of research resources among investigators.

bulletGenome-Wide Association Studies (GWAS) (2007) – A genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits, or the presence or absence of a disease or condition. This site includes background information and policies for (1) data sharing procedures, (2) data access principles, (3) intellectual property, and (4) issues regarding the protection of research participants through all phases of GWAS.  The site also includes implementation guidance for sharing and for the creation of a centralized NIH GWAS repository.

bulletReport of the NIH Working Group on Research Tools (1998) – A report advising the Director, NIH on the dissemination of research tools for access by other investigators. Includes recommendations about Material Transfer Agreements.

bulletNIH Stem Cell Information - Basic information, research topics, federal policy and news and information related to stem cells

bulletHIPAA Privacy Rule: Information for Researchers - From the NIH. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. This web site provides information on the Privacy Rule for the research community.

bulletInformation Sheets, Forms, and Checklists (2000 and later, revised as needed) - Provided by the Intramural Office of Human Subjects Research at the NIH.

bulletResearch Involving Individuals with Questionable Capacity to Consent: Points to Consider - A report by the Office of Extramural Research (March, 1999).

bulletQuestion and Answers about the NIH Policy and Guidelines on the Inclusion of Children in as Participants in Studies Involving Human Subjects (03/19/1999) - Site links to policy on inclusion of children as participants in research.

Research on Human Specimens: are you conducting research using human subjects? - Provided by the National Cancer Institute (NCI) of the NIH.

bulletNCI Best Practices for Biospecimen Resources (2007) – This document outlines the operational, technical, ethical, legal and policy best practices for NCI-supported biospecimen resources.
bulletProtecting human subjects in genetics research –NHGRI (1993) -  Issues for investigators and IRBs to consider when undertaking sensitive genetics research.

bulletNamed Populations in Genetic Studies (2005) – A document that advocates community consultation for genetic studies involving individuals and the  named communities to which they belong. Recommends that by being open with communities about the goals and process of their research before it is conducted, scientists can better design studies to yield meaningful data while working within distinct social and cultural contexts.

bulletProtection of Third Party Information in Research (2001) – This report addresses questions about whether the Common Rule (regulations governing the protection of human subjects in Federally-funded research that are codified by the DHHS at 45 CFR 46 Part A) applies to third parties in research and whether third parties are human subjects or can become human subjects during the course of research.

bulletConsidering Usual Medical Care in Clinical Trial Design: Scientific and Ethical Issues (2005) - Report of a conference that addressed situations in which it is unclear whether a usual care comparison arm should be used at all, as well as cases where there is a lack of consensus about what interventions should be provided to a usual care comparison group

 bulletInformed Consent for Gene Transfer Research. (2002) – This site provides guidance intended to serve as a resource and learning tool for individuals involved or otherwise interested in gene transfer studies. It is designed to help those preparing, using and reviewing consent forms for gene transfer protocols and to potential participants when deciding whether to participate in a gene transfer study.

bulletNIH Public Access Policy (2008) - The Public Access Policy requests that investigators funded by the NIH submit an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to the NIH National Library of Medicine's PubMed Central (PMC).


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