Investigator Manual

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.

Key Definitions & Terms

IRB Determinations & Modes of Review

Determining when an IRB Application is Required

IRB Decisions

Principal Investigator

Human Research Training

Reporting Financial Interests to the IRB

Conducting Research with Non-Harvard Collaborators

Cede Review (Designating a single IRB)

ESTR Record Access

Submitting an Application in ESTR

Consent Considerations

Record Retention

IRB Submission Assistance

Quality Improvement Program


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 I Single IRB Studies

Appendix J Identifiable/Coded/De-Identified/Anonymous Data and/or Specimens

Appendix K Guidance on Information and/or Biospecimen Repositories

Appendix L ORARC Tip Sheets

Appendix M Harvard Ancillary Reviews