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Human Subjects Research and IRBs

bullet Ethics Codes and Standards
bullet Regulations, Policies and Guidance
bullet IRB Resources
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Ethics Codes and Standards

bullet Declaration of Helsinki

bullet Nuremberg Code

bullet Belmont Report

bullet International Conference on Harmonization – Guideline for Good Clinical Practice

bullet CIOMS International Ethical Guidelines

bullet Canadian Tri-Council Policy Statement

bullet Indian Council of Medical Research [PDF]


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Regulations, Policies and Guidance

bullet The Department of Health and Human Services (DHHS) issued Regulations governing research with humans that is conducted or supported with DHHS funds - Title 45, Part 46 of the Code of Federal Regulations (45 CFR-part 46 – revised 2005).  Several Federal agencies have adopted uniform Regulations known as The Common Rule.

bullet A Guidance document, Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, was issued on May 12, 2004 by the Secretary of DHHS. It is directed at  Institutional Review Boards, investigators, research institutions, and others involved in research with human subjects

bullet The Office for Human Research Protections(OHRP) provides leadership on human research subject protections and implements a program of compliance oversight for DHHS regulations for the protection of human subjects. The OHRP site contains Federal Regulations for the Protection of Human Subjects, policy guidance on a wide variety of topics and a set of Human Subject Regulations Decision Charts to assist IRB's, investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the Regulatory requirements. It also includes Procedures for Registering Institutional Review Boards IRBs and Filing Assurances of Protection for Human Subjects.

bullet The National Institute of Health (NIH) Human Subjects site has information and NIH policies and guidance concerning research with human subjects including research with vulnerable populations (Human Subjects Website). These are in addition to the Regulatory and other DHHS requirements and policies. The site links to notices published in the NIH Guide to Grants and Contracts that are relevant to research with human subjects.

Policy documents:

Guidance documents:

bullet The NIH Office of Intramural Research (OIR) has an Office of Human Subjects Research to serve investigators who conduct research on the NIH campus and/or are intramural scientists. This site includes links to training in research with humans, NIH intramural program assurance documents, and links to other resources.  Information for IRB Members includes protocol review standards, orientation material for IRB members, and information about liability for NIH IRB members.  Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health  and  A Guide to Preventing Conflicts of Interest in Human Subjects Research at NIH (Jan. 4, 2005) are designed for  NIH intramural scientists. These resources may be helpful to all investigators.

bullet Stem Cell Information -- policy and guidance from the NIH.

bullet Research on Human Specimens: Are You Conducting Research Using Human Subjects? - provided by the National Cancer Institute (NCI) of the NIH
bullet Guidance for Institutional Review Boards and Clinical Investigators (1998) - provided by The Food and Drug Administration (FDA). Topics include, among others: answers to FAQs, informed consent guidance, list of various regulations and their differences, and information on continuing review.

bullet Information for Clinical Investigators - provided by the Center for Drug Evaluation and Research of the FDA.

bullet The Department of Energy (DOE) Protecting Human Subjects - page has links to human subjects policies and regulations, educational information and resources, genome research resources, a national conference calendar, computer-based training for human subjects researchers, as well as links to the DOE Human Subjects Working Group, Research Projects Data Base, Worker Health Related Studies, the Human Radiation Experiments, and soon, a site for Scientific Integrity.

bullet Centers for Disease Control and Prevention Human Subjects Research - Provides human subjects regulating documents, ethical guidelines for the protection of human subjects, and IRB checklists and forms. Click on Legislation and Regulation.

bullet The National Science Foundation's Interpreting the Common Rule for the Protection of Human Subjects in Behavioral and Social Science Research -- a set of frequently asked questions and vignettes.

bullet Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials - Principles and standards to guide institutions and investigators on reporting clinical trial results.

bullet AAMC Research Compliance Resources - Provides resources on oversight agencies, web based training, and model policies and procedures.

bullet FDA Regulations for Protection of Human Subjects: CFR21Part50.

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Institutional Review Board (IRB) Resources

bullet The IRB Forum - A forum sponsored by the Medical College of Wisconsin that promotes the exchange of ethical, regulatory, and policy concerns of human subjects research

bullet Public Responsibility in Medicine and Research (PRIM&R) - A national organization dedicated to providing a multidisciplinary forum for addressing biomedical and bioethical issues. Conducts training courses for IRB administrators, members and for for investigators and disseminates materials.

bullet Institutional Review Board (IRB) Guidebook Online – Produced by DHHS, provides introductory material, regulatory and compliance requirements and information on IRB review of types of research.

bullet The NIH Office of Human Research - Site has information on training for investigators and IRB members as well as standards for protocol review used by the NIH intramural program and lnks to other resources.

bullet Videotape "Protecting Human Subjects" – an OHRP resource covering the history of concern about protecting human research subjects, balancing society’s mandates, and the Belmont principles and their application.

bullet Almost all universities have IRB Handbooks or Guidelines online. Although these were developed to guide administrators, faculty, students and staff in their institutions, they are available on-line and are excellent resources. Google IRB Handbook or IRB Guidelines to access them or go to the institution’s homepage and search within it for Protection of Human Subjects or IRB. The IRB Forum links to many IRB Home Pages

bullet University of California San Francisco (UCSF) Human Research Protection Program - links to information on the consent process, federal regulations, training, outside resources and more.

bullet The Medical School IRB of the University of Michigan - this site contains links to human subjects research pages, federal regulatory policies, and key ethics source documents

bullet Stanford University Research Policy Handbook - on the use of human subjects.

bullet University of California Los Angeles (UCLA) Office for the Protection of Research Subjects - includes their comprehensive Investigator Manual for the Protection of Human Subjects

bullet Fred Hutchinson Cancer Research Center Institutional Review Office- site provides extensive information about the purpose and necessity of IRB review.

bullet University of Minnesota Research Subjects' Protection Programs -- links to IRB and IACUC websites.
University of Miami IRB Home Page- site contains information on the protection of human subjects in research, as well as necessary forms and guidelines for conducting such research.

bullet Models of IRB Review - Site has information on non-local IRB review of research. 

bullet National Conference on Alternative IRB Models: Optimizing Human Subjects Protections (2006). A report summarizing the proceedings of a national conference that was suggested by the Secretary's Advisory Committee on Human Research Protections to explore perceived barriers to use of alternative IRB models and to develop means for addressing them. The conference was sponsored by the NIH, the Office for Human Research Protections, the Veterans Administration, AAMC, and the American Society of Clinical Oncology.

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Last updated: 5/19/11 11:05 AM