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 InvestigatorsReportable Events Lecture (PowerPoint) Presented By CHLAViolating the Rights and Welfare of Research Subjects (PowerPoint) Presented By CHLARetrospective Studies and Case Reports (PowerPoint) Presented By CHLAIs Your Project Human Subjects Research? A Guide for Investigators (Word) (PDF)Tip SheetsGlossary
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),
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 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 (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
Institutional Review Boards (IRB) for Indian Health Research (Romero/Freeman Slide presentation)
Alliance for Human Research Protection
OHRP Draft Guidance on "Engagement" in Human Subjects Research
CDC Guidelines for Defining Public Health Research and Public Health Non-Research
NIH Offic for Human Subjects Research (OHSR) Information Sheets/Forms
IRB Member Training at NIH
Navajo Nation Human Research Review Board (NNHRB)
financial conflicts of interest (COI) toolkit from FASEB
The Alliance for Human Research Protection (AHRP)
A national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected. Perhaps somewhat over-skeptical of psychiatric pharmacotherapy.
Aberdeen Area Tribal Chairmens' Health Board IRB Resources
RESEARCH ETHICS AND INSTITUTIONAL REVIEW BOARD (IRB) RESOURCES FOR TRIBES AND RESEARCHERSResource for Tribes: How to Review Research to Benefit Tribal Communities including How to Build and Sustain a Tribal IRBResource for Researcher: How to Conduct Research in AI/AN communities
University of Minnesota Web-Based Instruction on Informed Consent
Friends Research Institute IRB Reviewer Forms
Very nice and easy to use templates for IRB members
Friends Research Institute IRB Submission Forms for Investigators
Very Nice & Simple forms, good for IHS use.
American Educational Research Association (AERA) Working Group on Human Research Protections
The Social and Behavioral Sciences Working Group on Human Research Protections is an interdisciplinary group of scientists established to examine and suggest ways to enhance the protection of human subjects in the social and behavioral sciences. The Working Group receives support for its activities from the National Institutes of Health's Office of Social and Behavioral Sciences Research.
NIH/CSR Resources for Applicants
NCAI Policy Research Center: Gathering Our Stories, Setting a Roadmap for the Future
Resources for tribal communities exploring and developing research and evaluation policies and procedures; Tribally-Driven Research Agenda;
National Congress of American Indians (NCAI)
NCI Participant's Guide to Informed Consent
http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide
Online Ethics Center (OEC) at the National Academy of Engineering (NAE)
Group Mentoring in Responsible Research Conduct from OEC/NAE
A modular sequence of activities in the responsible conduct of research for faculty, trainees and staffThese Web resources for exploration of issues in the responsible conduct of research among students, faculty, postdoctoral fellows and research staff have been greatly expanded under grant PHS-NIH# T15 AI07592 A Modular Short Course in Research Ethics.
PRIM&R Educational Handout Center Archive
2006 Password is "washington06"2007 Password is "hrpp!07"
Family Health International (FHI) Research Ethics Training Curriculum for Community Representatives (RETC-CR)
FHI's Office of International Research Ethics (OIRE) has developed a dynamic and innovative curriculum to empower community representatives through training and education to act as a competent voice for research participants worldwide. Developed and field-tested in eight countries, the Research Ethics Training Curriculum for Community Representatives (RETC-CR) helps community representatives to understand the research process and their roles and responsibilities as partners of the research team. The Curriculum also explains the corresponding roles and responsibilities of Ethics Committees/IRBs and Researchers. The RETC-CR addresses universal principles of research ethics, informed consent, ethics committees and other important issues. The RETC-CR was recipient of The 2005 Distinguished Award of the Society for Technical Communication.
Native Health Data Base
HSLIC Native American Health Information ServicesHealth Sciences Library and Informatics CenterMSC09 51001 University of New MexicoAlbuquerque, NM 87131-0001Phone: (505) 272-0664
FDA Device Advice
Device Advice is CDRH`s self-service site for medical device and radiation emitting product information. Device Advice is an interactive system for obtaining information concerning medical devices.
IND/IDE Contact Information
Questions about medical devices (other than gcp questions)www.fda.gov/cdrh/dsma/dsmastaf.html Manufacturer's assistance: 800-638-2041Consumer assistance: 888-INFO-FDAQuestions about whether a product is subject to IDE regulations: call 240-276-4040Questions about drug products (other than gcp questions)301-827-4570Druginfo@fda.hhs.gov Questions about whether a product is subject to IND regulations: call 301-827-4570Questions about biologics (other than gcp questions)301-827-2000Octma@cber.fda.gov (consumer oriented)Matt@cber.fda.gov (manufacturers's assistance)Questions about whether a product is subject to IND regulations: call 301-827-2000
Good Clinical Practice in FDA-Regulated Clinical Trials
Humanitarian Use Devices
OP-1 Putty- H020008
Part 1 - Approval OrderPart 2 - Summary of Safety and Probable BenefitPart 3 - Professional LabelingPart 4 - Patient LabelingOther Consumer Information
H010002 - OP-1™ Implant-long bones
Approved Device Data Bases @ FDA
New Device Approvals that include some of the newest medical technology available.Monthly listings of Premarket Notification [510(k)] and Premarket Approval (PMA) decisionsInformation on Humanitarian Device Exemption (HDE) approvalsSearchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.Frequently asked questions about recently approved devices.
***First 100 old Links:::
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URL
Notes
IHS IRB Research Program
The Philosophy of the I H S Research Program is:Good research discovers important new knowledge and answers questions to pressing and serious problems. Good research is needed by, useful for, and acceptable by American Indians and Alaska Native (AI/AN) communities and people. It should be conducted in partnership with them.
45 CFR 46 POLICY AND PROCEDURE FOR USE AND DISCLOSURE OF
Code 44: What do I do?
If you see a code 44, a bar to award, on your summary statement, call your program officer to learn what it's about, and then send him or her the following information. See webiste information.
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)
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 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)
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