This Investigator Manual (IM) is designed to guide investigators and study staff through policies and procedures related to the conduct of Human Research that are specific to the Harvard Longwood Campus (HLC) Office of Regulatory Affairs and Research Compliance (ORARC). Additionally, the manual serves as a guide for the HLC research community when preparing and submitting materials to the HLC IRBs.
General information regarding Human Research protections, as well as relevant federal regulations and guidance, has been incorporated throughout this manual where applicable.
The complete Investigator Manual is available in PDF format here. Otherwise, click on the links below to go directly to each section. Please note: because the links below arrive at the top of each page, you may need to scroll down to find the beginning of the section.
IRB Determinations & Modes of Review
Determining when an IRB Application is Required
Reporting Financial Interests to the IRB
Conducting Research with Non-Harvard Collaborators
Cede Review (Designating a single IRB)
Submitting an Application in ESTR
Appendix A Prompt Reporting Requirements
Appendix B Additional Regulatory Requirements
Appendix C Principal Investigator Responsibilities and ESTR Assurance Statement
Appendix D Principal Investigator Responsibilities as Overall Site PI for sIRB Study
Appendix E Principal Investigator Responsibilities When Relying on an External IRB
Appendix F Additional Consent Form Language Requirements Relating to Conflict of Interest
Appendix G Additional Consent Form Considerations
Appendix H Preparing the Research Protocol General Requirements
Appendix J Identifiable/Coded/De-Identified/Anonymous Data and/or Specimens
Appendix K Guidance on Information and/or Biospecimen Repositories
