Web Resources

Educational Resources for Human Subjects Protections, Scientific Integrity, and the Responsible Conduct of Research
Government Resources and Federal Regulations
Developing a Data and Safety Monitoring Plan
University Websites and Centers for Bioethics
Of Interest to Principal Investigators and Research Teams
International Human Subject Research
Of Interest to Human Subjects of (participants in) Biomedical Research

 


 

Educational Resources for Human Subjects Protections, Scientific Integrity, and the Responsible Conduct of Research:
HHS, NHLBI, NIH: Who Needs Human Subject Protections Training?
Collaborative Institutional Training Initiative (Registration Required)
NCI: Human Participant Protections Education for Research Teams (Registration Required)
UCLA: Stanley G. Korenman book: Teaching the Responsible Conduct of Research
AAAS / NAS: Scientific Integrity Program
UTMB CRC CREO: Tools and Techniques for Clinical Research: Ethics Module
UTMB Data & Safety Monitoring Planning Computer-Based Course


Government Resources and Federal Regulations:
Institutional Review Board Guidebook
NIH Common Fund
Clinical Trials.gov
RegSource Regulatory Page
HHS Code of Federal Regulations: Browser
HHS Code of Federal Regulations: Protection of Human Subjects
HHS: Office for Human Research Protections
HHS: Office of Research Integrity
HHS: HIPAA regulations
FDA: Regulations Related to Good Clinical Practice
FDA: Protection of Human Subjects
FDA: Good Clinical Practice in FDA-Regulated Clinical Trials
FDA: Guidance for Institutional Review Boards and Clinical Investigators
NIH: Bioethics Resources on the Web
NIH: Office of Human Subjects Research
NIH: HIPAA regulations
NIH: Office of Biotechnology Activities - Recombinant DNA and Gene Transfer


Helpful Websites for Developing a Data and Safety Monitoring Plan:
UTMB Procedure for Developing a Data Safety Monitoring Plan
Adverse Event Reporting on Patient Safety at UTMB
Adverse Event Reporting of Events with Human Subjects at UTMB
UTMB Data & Safety Monitoring Planning Computer-Based Course
HHS OHRP: Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
NIH Guidelines for Adverse Event Reporting
NIH Guidelines for Data and Safety Monitoring
Further NIH Guidance on Data and Safety Monitoring for Phase I and Phase II Trials
National Center for Complementary and Alternative Medicine
National Cancer Institute
National Cancer Institute Guidance for Conducting Clinical Trials
National Heart, Lung and Blood Institute
National Institute on Aging
National Institute on Aging – Sample DSMP
National Institute of Allergy and Infectious Diseases
National Institute for Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke

 

University Websites and Centers for Bioethics:
Baylor College of Medicine – Center for Medical Ethics and Health Policy
MD Anderson Cancer Center – Integrated Ethics
University of Houston Law Center – Health Law & Policy Institute
Johns Hopkins University Bioethics Institute
Washington University Medical Center: Human Studies Committee
University of Toronto Joint Centre for Bioethics
Michigan State University Center for Ethics and Humanities in the Life Sciences
University of Pennsylvania Center for Bioethics
The Hastings Center: An Independent Bioethics Research Organization
The Medical College of Wisconsin Center for the Study of Bioethics
Kennedy Institute of Ethics at Georgetown University

 

Websites of Interest to Principal Investigators and Research Teams:
NIH: Human Participant Protections Education For Research Teams (Registration Required)
National Library of Medicine: Gateway Search Page
Public Responsibility in Medicine and Research
Centerwatch Clinical Trial Listing Service
Drug Information Association
BioSpace: Web Solutions for the Life Sciences
The National Academies Institute of Medicine
The National Academies: Science, Engineering and Medicine
National Institutes of Health Homepage
American Medical Association Ethics Program
Society of Research Subject Advocates
Canadian Institute of Health Research: Ethics Publications
The Greenwall Foundation Faculty Scholars Program in Bioethics
Friends Research Institute
Kluwer Online: research related publications
National Academies Press: Institute of Medicine publication "Integrity in Scientific Research."
NORD: National Organization for Rare Disorders
Association of American Medical Colleges
NIH: National Center for Research Resources
Society for Research Subject Advocates: Bioethics Reading List
Society for Research Subject Advocates: Useful Links
MedicineNet: Medical Dictionary
Stanford RCO: Glossary of Lay Terms for Use in Preparing Consent Forms
HHS OHRP: Frequently Asked Questions About Research with Children
HHS OHRP: Frequently Asked Questions about Human Subject Research
UTMB Research Listserv

International Human Subjects Research:
Canadian Institute of Health Research
International Conference on Harmonization
The World Medical Association
Office for Human Research Protections

 

Of Interest to Human Subjects of (Participants in) Biomedical Research:
National Institutes of Health / National Library of Medicine: Information about Clinical Trials
Centerwatch Clinical Trial Listing Service
Public Responsibility in Medicine and Research
National Institutes of Health Homepage
DHHS: Office for Human Research Protections
FDA: Protection of Human Subjects
National Library of Medicine: Gateway Search Page