Sunday

IRB-Human Research Participant/Subject Protection


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)

Sharepoint NARCH

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 Investigator̢۪s 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

http://www.rcr.emich.edu/module5/e1_objectives.html

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.

http://www.ihs.gov/PublicInfo/Publications/IHSManual/Circulars/Circ03/Cir03_02/circ03_02.htm

NIH Presentation and Resources on HIPAA and Research

NIH Decision Trees for Human Subjects Research

NIH Glossary of Human Subjects Protection Terminology
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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)


Notes

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 Reserach 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 that̢۪s 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),

New Corasworks DPER Page

Old Sharepoint NARCH Page

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
http://workgroups.ihs.gov/sites/ophs-dper-IRBz/Lists/Links/AllItems.aspx?Paged=TRUE&p_ID=102&p_Order=10200%2e0000000000&View=%7b2E187955%2d68CA%2d4E24%2dAC00%2d8D8CF3363E29%7d&PageFirstRow=101# 310-794-1818; funded by ORI

http://bioethics.net/

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 (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

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