• Research Home Page
• IRB Members Only
• Contact Us
  • irb@ihs.gov
• Division of Planning, Evaluation & Research
• Medical & Professional Programs
• IHS Home
• NIH Home
• DHHS Home

IHS Research Program Resources

Human Subjects Protection Resources

• Human Research Participant Protection and FDA Regulation of Pharmaceuticals and Devices [PPT - 308KB]
  • A presentation on 8/23/2007 by Jean Toth-Allen, Ph.D., Good Clinical Practice Program

    Office of Science and Health Coordination
    Office of the Commissioner
    Food and Drug Administration (FDA)

• Saver RS: MEDICAL RESEARCH & INTANGIBLE HARM. UNIVERSITY OF CINCINNATI LAW REVIEW 2006 [Vol. 742] 941-1011 [PDF - 380KB]

• Public Health Practice vs. Research [PDF - 567KB]
  Including Cases and Guidance for Making Distinctions

  • By James G. Hodge, Jr., J.D., LL.M., Lawrence O. Gostin, J.D. and the Council of State & Territorial Epidemiologists (CSTE) Advisory Committee
• The importance of ethically-sound health research to improvements in Aboriginal health [WORD - 455KB]
  by Doris Cook
  • Doris Cook is Project Manager at the Ethics Office of the Canadian Institutes of Health Research (CIHR) and is working on the development of the CIHR Guidelines for Health Research Involving Aboriginal Peoples. Doris Cook
• 45 CFR 46 POLICY AND PROCEDURE FOR USE AND DISCLOSURE OF
• NIH Grant Guide
• OHRP Renewal Page
• OHRP Main Page
• Certificates of Confidentiality (NIH)
• Human Subjects Research Tutorial (NIAID)
• IRB Guidebook (OHRP)
• Research Ethics Training Curricula from Family Health International (FHI) Any Media (slides, overheads, text or on-line, including IRB module)
• Human Subjects Decision Tree (OHRP)
• IRB member Training from NIH
• Human Subjects Protection Training from NCI
• IRB MEMBER LIABILITY INFORMATION SHEET
• CITI Collaborative IRB Training Initiative at U of Miami
• the On-Line UCI Research Tutorials website. These tutorials review core concepts for the responsible conduct of research involving human research participants. This is a Q&A format that can serve as a useful test of members' knowledge.
• University of Minnesota Web-Based Instruction on Informed Consent
• Bioethics Resources on the Web
• Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan (PHS398)
• Certificate of Confidentiality Application
• UC Irvine on-line Human Subjects Research Training
• U Minn on-line Informed consent training
• Collaborative IRB Training Institute (CITI) on-line Human Subjects Training
• NIH Certificate of Confidentiality Application
• Office of Research Integrity (ORI) Model Procedures
• NIAID Human Subjects Research Page (including curriculum)
• HRSA IRB Training Video
• U of Washington Research Ethics Page
• Report on the Lasker Forum on Ethical Challenges in Biomedical Research & Practice
• UC San Diego Responsible Conduct of Research (RCR) resources
• Federal Policy on Research Misconduct
• Resources for Teaching Research Ethics at Indiana U.
• Ethical issues in international Health Research from Harvard
• IRB Reform In North America: Challenges And Opportunities
• Samford U. IRB page-nicely laid out procedures and forms
• ORA Institutional Review Board (IRB) Tutorial Introduction
• IRB Training Modules (MS Word) at Kansas Wesleyan U.
• Basic IRB Training at Penn
• Web-based Training Provided by other Institutions (great list of resources)
• VA IRB page - Good References & Resources
• James Madison U. IRB Training modules
• FDA Page & Resources for IRBs - Great references, good for comparison sake, but some differences from ours
• Great HIPAA materials and training from the VA
• Research & HIPAA from (OCR)
• UCLA Investigator’s Manual for Protection of Human Subjects
• Slide Presentations and Other Resources (extensive) from Columbia U.
• VA Web-based Courses in Human Subjects Protection & etc. -open to IHS
• Harvard Web-based Course on Human Subjects Protection w/good case-question format
• Is This Human Subjects Research-Checklist/Decision Tree from U. of Wisconsin
• Good forms & info sheets from Seattle Childrens'
• Responsible Conduct of Research (RCR) Education Resources-Online Resources for Instructors
• GAO Report on Human Subjects Research
• IRB Forum-Links & Resources
• IRB Member Training Modules from Penn State
• Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) offers accreditation to institutions that conduct or review research with human participants.
• Respecting Cultural Knowledge and Traditions
• CDC IRB forms, policies & etc.
• The Applied Research Ethics National Association (ARENA)
• NIH page on HIPAA and Research
• Research Integrity and Related Training Modules @ Eastern Michigan U.
• U of VA On-line Training for IRB members (Behavioral & Social Sciences)
• Hopkins Research Compliance Website w/many training modules
• UC Riverside Tutorial on HIPAA and Human Subjects Research
• Jaeb Center Tutorial & Resources on IRB, includes HIPAA
• AAMC Research Compliance Resources
• IRB Training and other Resources from IRC
• Updating Protections for Human Subjects Involved in Research
  • Jonathan Moreno, PhD; Arthur L. Caplan, PhD; Paul Root Wolpe, PhD; and the Members of the Project on Informed Consent, Human Research Ethics Group.  
    JAMA. 1998;280:1951-1958.
• Protecting Human Beings: Institutional Review Boards and Social Science Research
  • A White Paper from the American Association of University Professors
• NIH Glossary of Human Subjects Protection Terms
• HIPAA for Researchers (online slide presentation from UCSF)
• The Program for Research Integrity Development & Education (PRIDE) is a new VA office whose mission is to protect participants
• Research Integrity Resources from ORI
• NIH Resources for Responsible Conduct of Research (RCR)
• Ethics Web (of Canada) general ethics including health
• Great Procedures, Investigator and IRB step-by-step instructions and FORMS in rtf (easily edited) from WVU
• Training in Responsible Conduct of Research (RCR) from NIH
• UNIVERSITY OF NEW MEXICO Human Subject Research forms, manual, training, HIPAA, etc.
• HIPAA Policy @ IHS (including IRB responsibilities for waivers)
• NIH Presentation and Resources on HIPAA and Research
• NIH Decision Trees for Human Subjects Research
• NIH Glossary of Human Subjects Protection Terminology
• NIH Bioethics Program
• CITI International
• NIH Bioethics Resources
• NIH Department of Clinical Bioethics, including course on Clinical Bioethics
• Bioethics Course webcasts from NIH Dept. of Clinical Bioethics
• IOM Report: Ethical Conduct of Clinical Research Involving Children
  • Also has links to other Institute of Medicine Reports on Research Ethics. 
• U Mass Worcester IRB & HIPAA Forms in .doc format-might be good models
• VA Office of Research Oversight-Good Policy (VA Handbook) Documents & IRB Manual
• Great Human Subjects Webpage at U. Washington Med Ctr.
• Iowa Health systems IRB Policies & Procedures, Fully Accredited by AAHRPP
• Code of Ethics of the American Anthropological Association
• ETHICAL PRINCIPLES OF PSYCHOLOGISTS AND CODE OF CONDUCT
• Application of the DHHS Regulations for the Protection of Human Subjects at 45CFR46, Subpart A, to Oral History Interviewing
• American Sociological Association Code of Ethics
• Medical Ethics from the AMA
• AMA Ethics Journal: Theme Issue on Research Ethics, 11/2004
• AMA Extensive list of Bioethics Resource Links
• Health Information Privacy and Security (HIPAA/HIPS) Training modules from U. Miami (CITI provider)
• VA Research & Development Program & Resources
• International Ethical Guidelines for Biomedical Research Involving Human Subjects
• 1991 INTERNATIONAL GUIDELINES FOR ETHICAL REVIEW OF EPIDEMIOLOGICAL STUDIES
• VA Policies by Topic: Scroll Down for Research-Related Policies
• Guided tour of HIPAA (training for Privacy Officers) from CITI/U Miami
• University at Buffalo SUNY Human Subjects Protection Program
  • This is where the spreadsheet submission form came from. 
• Human Subjects Assurance Training (web-based) from OHRP
  • In order to qualify for an Assurance, the OHRP strongly recommends that the Institutional Official complete Module 1. The Human Protections Administrator (Primary Contact) and IRB Chair should complete all three modules.
• Childrens Hospital Los Angeles IRB-Good Conflict of Interest (financial) Policy and Forms
• OHRP Related Links Page
• AATCHB resources for Tribal IRBs
• Excellent, detailed report of the Havasupai vs. U. Arizona case
• Proposal Submission for IRB review Checklist/Guidelines
  • This site is a guide for researchers who wish to submit a protocol for IRB review
• Suggested Guidelines for Writing a Research Protocol from the Western IRB (WIRB)
  • This is a good ref for someone who'd writing their first protocol. 
• World Medical Association Medical Ethics Manual (including chapter on research ethics)
• Human Subjects Resources from PRM&R and ARENA
• FDA Laws and Regs
• U of Minn IRB web site-Good guides
• USC Training Guides
  • IRB Teaching Guide (PDF) (PPt)
    Protecting Human Research Subjects. A Guide for Student Investigators (PDF)
    Are You Conducting Research Using Human Subjects? A Guide for Principal Investigators
    Reportable Events Lecture (PowerPoint) Presented By CHLA
    Violating the Rights and Welfare of Research Subjects (PowerPoint) Presented By CHLA
    Retrospective Studies and Case Reports (PowerPoint) Presented By CHLA
    Is Your Project Human Subjects Research? A Guide for Investigators (Word) (PDF)
    Tip Sheets
    Glossary
• The Illinois Whate Paper - Improving the System for Protecting Human Subjects: Counteracting IRB "Mission Creep"
• When is BSSR human subjects research?
  • Guidance from the NIH Ofc. of Behavioral & social Science Research
• Bioethics Resources on the Web (from Georgetown)
• Kennedy Institute Bioethics Info Resources (Georgetown)
• President's Council on Bioethics
• Southcentral Foundation (ALASKA) Research Page w/IRB forms
• Tips: What If a Cooperative Extension Professional Must Work with Native American Institutional Review Boards?
  • Tips: What If a Cooperative Extension Professional Must Work with Native American Institutional Review Boards?
• Website that’s designed with the prospective subject of human research in mind (http://www.getresearchsmart.org/)
• Official NAGPRA Website
• NYU Wagner IRB Initiative: online resource for educators and researchers in policy and management
• Online-research-ethics list run by asb at cc.gatech.edu
• Online Course in Bioethics
• Ethics of Research on the Internet
• Research Ethics Resources on the Internet
• IRB Glossary from the University of Illinois at Urbana-Champaign (UIUC),
• 2006 Course on Ethical and regulatory aspects of clinical research from the NIH Department of Clinical Bioethics (w/videocasts & slides)
• CITI on HIPAA and Research
• CDC Guidance on Research vs. non-Research
• Good Courses on Human Research Protections and on HIPAA for Researchers from UCLA
• AAMC-ORI Responsible Conduct of Research (RCR) Program for Academic Societies-Web-based resources
• The Journal of Empirical Research on Human Research Ethics (JERHRE) publishes empirical research and reviews of empirical literature on human research ethics.
• National Reference Center for Bioethics Literature at Georgetown U.
• Phoenix New Times 2004-05-27/Havasupai Case "Indian Givers"
• When Two Tribes go to War (Havasupai case) Nature 430, 500-502(29 July 2004) | doi:10.1038/430500a; Published online 28 July 2004
• Tribe blasts 'exploitation' of blood samples (Nootka case) Nature 420, 111 (14 November 2002) | doi: 10.1038/420111a
• Proceedings and Other Materials (Slides, handouts, readings, etc) from the PRIM&R 2006 Annual HRPP Conference in Washington, DC
  • Great Resource! some presentation recordings and no passwords needed
• PRIM&R 2006 Handout Center - PW=washington06
  • Site lists PDFs by Day of Conference, need password (PW) ot download/open the documents. Password is "washington06"
• Links Related to Conducting Responsible Research in Indian Country from the National Congress of American Indians (NCAI) Policy Research Center
• Harvard Program on Ethical Issues in International Research
  • Cases and lots of great teaching material
• Teaching the Course in Responsible Conduct of Research in Humans (RCRH) utilizing a Case Study Approach
  • by Dr. Stanley Korenman skorenman@mednet.ucla.edu
    310-794-1818; funded by ORI
• http://bioethics.net/ Emphasis on Neuroscience & bioethics
• Alden March Bioethics Institute (AMBI) is a multi-institutional bioethics research organization based at the Albany Medical College
• NIH Human Subjects Research Policies and Procedures (PDF- 618KB)
• NHLBI Clinical Research Guide Consent Form Tools, Templates and Other Human Subject Protection Resources
• Research on Human Specimens Brochure from NCI
• NIAID PAge on Human Subjects, Clinical Research
• Indigenous Peoples' Council on Biocolonialism
• Educational Conference Call Series on Institutional Review Boards (IRBs) and Ethical Issues in Research
  • Jointly sponsored by:
    Community-Campus Partnerships for Health (CCPH) and the Tuskegee University National Center for Bioethics in Research and Health Care (the Bioethics Center)
• Tuskegee University National Center for Bioethics in Research and Health Care
  • www.tuskegee.edu/bioethics

ˆ Top of Page

For further information please feel free to contact:
Indian Health Service
Office of Public Health Support
Division of Planning, Evaluation, and Research

Dr. Alan Trachtenberg (301) 443-0578
801 Thompson Avenue, TMP, Suite 450
Rockville, Maryland 20852
Fax: (301) 443-0114