• Cambridge Health Alliance (CHA)
• Historical Research Ethics Links
• US Food and Drug Administration (FDA)
• Office for Human Research Protections (OHRP)
• National Institutes of Health (NIH)
• Other Federal Links
• Massachusetts
• Consent
• Professional Societies

CHA:

• Policy: High Risk Medication Management
• Policy: Investigational Drug Service Functions
• Policy: Investigational Drug Service Fee Schedule
• Policy: Reporting of Adverse Events to the IRB
• Policy: CHA Institutional Conflict of Interest
• Policy: Conflict of Interest in Public Health Service Funded Research
• Policy: Conflict of Interest in Research
• Policy: Research versus Quality Improvement
• Policy: Informed Consent for Research and Authorization for the Use and Disclosure of Patient Health Information

Historical Research Ethics Links:

• The Nuremberg Code
• The Declaration of Helsinki
• The Belmont Report
• Henry Beecher paper (page 3): Ethics and clinical research
• The Vancouver Group (The International Committee of Medical Journal Editors)
• Council for International Organizations of Medical Sciences Guidelines (CIOMS)
• International Conference on Harmonisation (ICH)
• The National Bioethics Advisory Commission (NBAC)

US Food and Drug Administration (FDA):

• FDA homepage
• FDA regulations search
• FDA Guidance: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
• FDA IRB Information Sheets
• FDA Guidance on Subject Recruitment
• FDA Drug Guidance: “Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
• FDA Drug Guidance: Treatment Use of Investigational Drugs
• FDA Investigational New Drug Application
• FDA Device Guidance: Significant Risk and Nonsignificant Risk Medical Device Studies
• FDA Device Guidance: FDA FAQ About Medical Devices
• FDA Device Guidance: FDA Office of Combination Products
• FDA Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative

Office for Human Research Protections (OHRP):

• OHRP homepage
• OHRP ListServ
• DHHS Code of Federal Regulations 45 CFR 46: Protection of Human Subjects
• OHRP Human Subject Regulations Decision Charts
• OHRP Guidance: Engagement of Institutions in Human Subjects Research
• OHRP Guidance: Research Involving Coded Private Information or Biological Specimens
• OHRP Guidance: Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• International Compilation of Human Research Standards

National Institutes of Health (NIH):

• NIH homepage
• NIH Office of Human Subjects Research
• NIH Office of Extramural Research: Research Involving Human Subjects
• NIH Human Subjects Protection and Inclusion of Women, Minorities, and Children: Guidelines for Review of NIH Grant Applications
• NIH: Children and Clinical Research
• NIH Certificates of Confidentiality
• NIH: Bioethics Resources

Other Federal Links:

• Office of Research Integrity
• ClinicalTrials.gov

Massachusetts:

• Massachusetts General Laws
• Massachusetts Department of Public Health
• Massachusetts Fetal Research Statute
• Massachusetts Controlled Substances Registration (MCSR)

Consent:

• OHRP ICF Checklist
• FDA: A Guide to Informed Consent
• OHRP Tips on Informed Consent

Professional Societies:

• Society of Clinical Research Associates (SoCRA)
• Public Responsibility in Medicine and Research (PRIM&R)
• Regulatory Affairs Professionals Society (RAPS)
• Association of Clinical Research Professionals (ACRP)
• IRB Forum
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• CenterWatch Clinical Trials Network
• The Hastings Center