Learn about regulatory requirements
- Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. GCP standards for conducting human studies are detailed in the International Conference on Harmonization (ICH) GCP Guidelines which incorporate U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations governing human research studies.
- The principal investigator (PI) is responsible for the conduct of human subjects research in accordance with the investigational plan and all applicable regulations. The PI may delegate duties to co-investigators and other members of the study team, but cannot delegate his/her responsibilities.
- FDA regulations apply to all studies involving agents regulated by the FDA. HHS regulations apply to behavioral, observational and social science studies which do not involve FDA regulated agents.
- The Partners Human Research Committee (PHRC) commonly referred to as the Institutional Review Board or IRB, ensures the protection of human subjects in all clinical research projects. All Partners-affiliated investigators must obtain PHRC approval prior to initiation of a clinical research study. Investigators conducting studies involving FDA approved agents being evaluated for unapproved indications or involving unapproved route of administration, doses, etc. may be required to complete the FDA’s Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application.
▪ Federal Regulations
▪ Harvard Catalyst Regulatory Knowledge and Support Program
▪ HHS Protection of Human Subjects (45 CFR 46)
▪ International Conference of Harmonization (ICH) Good Clinical Practice (E6) Guidelines
▪ Partners Human Research Committee (IRB) website
▪ Partners IRB Help Line Mailbox
▪ Partners QI Program
▪ US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) Approval Process
▪ US Food and Drug Administration (FDA) Investigational New Drug (IND) Application
▪ Good Clinical Practice and Study Management Basics
▪ HIPAA training via HealthStream [search 'PHE HIPAA']
▪ Submitting your Medical Records/Health Information Research Protocol to the IRB
▪ A Hands-On Introduction to eIRB
▪ A Potpourri of FDA Related Issues
▪ CRP Spotlight Series: Managing and Reporting Unanticipated Problems Including Adverse Events
▪ Ethics and Clinical Research Protocols
▪ FDA Inspections, 483's and Warning Letters: How to Avoid and Survive Them
▪ Genetics and Clinical Research: Points to Consider
▪ Good Clinical Practice in Research at an Academic Research Institution
▪ Guidance for Obtaining Surrogate Consent
▪ IND/IDEs: Beyond the Basics of Investigational Product Applications
▪ Introduction to Survey Design
▪ IRB and QI Roundtable Series: Session I: Part I: New Submissions: Initial Full Board Review
▪ IRB and QI Roundtable Series: Session I: Part II: New Submissions
▪ IRB and QI Roundtable Series: Session II: Part I: Continuing Review and Amendments
▪ IRB and QI Roundtable Series: Session II: Part II: Source Documentation
▪ IRB and QI Roundtable Series: Session III: Part I: Amendments and Reporting to the IRB
▪ IRB and QI Roundtable Series: Session III: Part II: Protocol Adherence and Reporting Requirements
▪ IRB and QI Roundtable Series: Session IV: Part I: Consent Form Writing
▪ IRB and QI Roundtable Series: Session IV: Part II: Informed Consent Process
▪ IRB Issues for the Bench and Desk Scientist
▪ Maintaining Research Subject Privacy and Information Security
▪ Medical Device Development (Harvard Catalyst)
▪ Meet the Protocol Administrators and Managers of the Partners Human Research Office
▪ Reporting Results: Should Subjects Be Told Clinical Research Results?
▪ Research Misconduct
▪ What Constitutes a Minimal Risk Study?
▪ What Does the IRB Really Want? How to Write a Human Studies Protocol
▪ Who Tells the IRB What to Do?: The Effects of Case Law on Research Regulations and Oversight