Helpful Links & Resources

Cambridge Health Alliance:

• 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
• The Vancouver Group (The International Committee of Medical Journal Editors)
• Council for International Organizations of Medical Sciences Guidelines (CIOMS)
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• The National Bioethics Advisory Commission (NBAC)

US Food and Drug Administration (FDA):

• FDA homepage
• FDA regulations search
• 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
• FDA FAQs about Form FDA 1572
• FDA Informed Consent Elements, 21 CFR 50.25(c), Questions and Answers

Office for Human Research Protections (OHRP):

• OHRP homepage
• 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 Department of Public Health
• Massachusetts Controlled Substances Registration (MCSR)

Consent:

• OHRP ICF Checklist
• FDA: A Guide to Informed Consent
• OHRP Tips on Informed Consent
• Research Participant Brochures (Harvard Catalyst) - a variety of brochures (available in more than 15 languages) that provide useful information to prospective participants on a range of research topics, including:

• Should I be a research subject?
• Research Subject Bill of Rights
• Social and Behavioral Research
• CT Scans for Research
• MRI Scans for Research
• PET Scans for Research
• Surrogate Decision-Making in Health Research

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