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
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
U of Minn IRB web site-Good 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
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?
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
Ethics of Research on the Internet
Research Ethics Resources on the Internet
IRB Glossary from the University of Illinois at Urbana-Champaign (UIUC),
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
National Reference Center for Bioethics Literature at Georgetown U.
Phoenix New Times 2004-05-27/Havasupai Case "Indian Givers"
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"
Harvard Program on Ethical Issues in International Research
Cases and lots of great teaching material
by Dr. Stanley Korenman skorenman@mednet.ucla.edu
310-794-1818; funded by ORI
http://bioethics.net/ Emphasis on Neuroscience & bioethics
NIH Human Subjects Research Policies and Procedures (618KB)
Research on Human Specimens Brochure from NCI
NIAID PAge on Human Subjects, Clinical Research
Indigenous Peoples' Council on Biocolonialism
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
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
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 RESEARCHERS
Resource for Tribes: How to Review Research to Benefit Tribal Communities including How to Build and Sustain a Tribal IRB
Resource 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/
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 staff
These 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"
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.
HSLIC Native American Health Information Services
Health Sciences Library and Informatics Center
MSC09 5100
1 University of New Mexico
Albuquerque, NM 87131-0001
Phone: (505) 272-0664
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.
Questions about medical devices (other than gcp questions)
www.fda.gov/cdrh/dsma/
Manufacturer's assistance: 800-638-2041
Consumer assistance: 888-INFO-FDA
Questions about whether a product is subject to IDE regulations: call 240-276-4040
Questions about drug products (other than gcp questions)
301-827-4570
Druginfo@fda.hhs.gov
Questions about whether a product is subject to IND regulations: call 301-827-4570
Questions about biologics (other than gcp questions)
301-827-2000
Octma@cber.fda.gov (consumer oriented)
Matt@cber.fda.gov (
Questions about whether a product is subject to IND regulations: call 301-827-2000
Good Clinical Practice in FDA-Regulated Clinical Trials
Part 1 - Approval Order
Part 2 - Summary of Safety and Probable Benefit
Part 3 - Professional Labeling
Part 4 - Patient Labeling
Other 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) decisions
Information on Humanitarian Device Exemption (HDE) approvals
Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.
Frequently asked questions about recently approved devices.
Havasupai article from Indian Country Today
Research Regulation in American Indian/Alaska Native Communities: Policy and Practice Considerations
By Puneet Chawla Sahota, posted at NCAIPRC.org
Special Thematic Issue: Participatory Ethics
Health Care Quality Improvement: Ethical and Regulatory Issues
Edited by Bruce Jennings, Mary Ann Baily, Melissa Bottrell, and Joanne Lynn, Hastings Center: This new edited volume is a collection of original papers providing in-depth discussion of important ethical and regulatory aspects of quality improvement.
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