Educational Resources

Human Subjects Research Regulations

45 CFR 46 (HHS Human Subject Regulations, aka The Common Rule)
Revised 2018 Common Rule
21 CFR PART 50 (FDA Protection of Human Subjects)
21 CFR PART 56 (FDA IRB Regulations)
International Conference on Harmonization

Assistance in Interpreting the Regulations

HHS Guidance Documents Listing
FDA Information Sheets for Investigators and IRBs

Codes of Research Ethics

Belmont Report
The World Medical Association (WMA) - Declaration of Helsinki
Nuremberg Code

Government Agencies/Offices

DHHS Office for Human Research Protections (OHRP)
DHHS Office of Research Integrity (ORI)
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Biologics Evaluation and Research (CBER)
FDA Center for Devices and Radiological Health (CDRH)
FDA Laws, Regulations, Policies and Procedures for Drug Applications
National Cancer Institute (NCI)
NIH Inclusion of Children Policy Implementation
NIH Inclusion of Children: Case Studies

Pediatric Research Ethics Guidelines

American Academy of Pediatrics Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
Guidelines for Adolescent Health Research: A Position Paper of the Society for Adolescent Medicine - Journal of Adolescent Health: 2003.
FDA Division of Pediatric and Maternal Health (DPMH) - Pediatric Guidances
Advisory Committee on Human Radiation Experiments (ACHRE) Report, Chapter 7: The Context for Nontherapeutic Research with Children

Association Websites

Public Responsibility in Medicine and Research (PRIM&R)
WCG CenterWatch Clinical Research and Drug Information

International Research Ethics Guidelines

Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans
Nuffield Council on Bioethics (UK)
World Health Organization (WHO) Ethics Publications
Listing of International Bioethics Organizations

Additional Ethics Information

NIH Bioethics Resources
National Library of Medicine, Current Bibliographies in Medicine: Ethical Issues in Research Involving Human Participants

Boston Area IRBs

Partners Health Care - Human Research Office/IRB
Harvard Longwood Medical Area (LMA) Office of Human Research Administration (OHRA)
Harvard University Area (FAS) Committee on the Use of Human Subjects (CUHS)
Dana-Farber Cancer Institute - Office for Human Research Subjects (OHRS)
Boston University Medical Campus - Boston Medical Center IRB
Boston University Charles River Campus

Information for Families

NIH: About Clinical Trials

Other Information

Harvard Academic Research and Integrity (ARI): Integrity in Science Policies
NIMH: Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers
Improving the Informed Consent Process at Children's Hospital (Katz-Fox Report)
NIH: Guidelines for Developing a Data Safety Monitoring Plan

Additional Boston Children's Hospital Resources

Harvard Catalyst Regulatory Foundations, Ethics, and Law Program
Biostatistics and Research Design Center (BARD)
Technology and Innovation Development Office (TIDO)