Educational Resources

Human Subjects Research Regulations
45 CFR 46 (HHS Human Subject Regulations, aka The Common Rule)

Revised 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
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

DHHS Office for Human Research Protections (OHRP)
DHHS Office of Research Integrity
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)
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: 1995;
Pediatric and Maternal Health Product Development
Advisory Committee on Human Radiation Experiments (ACHRE) Report, Chapter 7: The Context for Nontherapeutic Research with Children

Association Websites
Public Responsibility in Research and Medicine (PRIMR)
Centerwatch Clinical Trials Network

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
Harvard Longwood Medical Area (LMA) Office of Human Research Administration (OHRA)
Harvard UniversityArea (FAS) Committee on the Use of Human Subjects (CUHS)
Dana-Farber Cancer Institute - Office for the Protection of Research Subjects
Boston University Medical Campus - Boston Medical Center: Office of the Institutional Review Board

Boston University Charles River Campus

Information for Families
NIH: About Clinical Trials

Other Information
Harvard Integrity in Science Policies
NIMH: Issues to Consider in Intervention Research with Persons at High Risk for Suicidality
Improving the Informed Consent Process at Children's Hospital
NIH: Guidelines for Developing a Data Safety Monitoring Plan

Additional Boston Children's Hospital Resources

Harvard Catalyst

Translational Research Program

Technology and Innovation Development Office