Consult with your area IRB to determine if your research needs to be reviewed by the IRB.  Special considerations for research with human subjects, human material, or human-related data include the following:

• Tissues, specimens, or data coming in may require a Material Transfer Agreement (MTA) or a Data Use Agreement (DUA).
• The use of fetal tissue in research, even if it is considered Not Human Subjects Research, may need IRB review.
• Research that involves the use of biological, chemical, or radioactive materials in humans may require the approval or signoff from the appropriate area in Lab Safety or may require an MTA.
• Research performed in collaboration with another institution may require review/approval from the collaborating institution.  Alternatively, participating institutions may execute an IRB Reliance Agreement whereby one institution relies on another for IRB review and oversight.
• Research in foreign countries may require government and/or local research ethics committee approval.  (See helpful resources from the DHHS Office for Human Research Protections.)
• For research collaborations with members of the European Economic Area (EEA), the General Data Privacy Regulation (GDPR) may apply.
• Research involving genomic data and sharing should comply with the Harvard Genomic Data Sharing Policy and Procedures
• Use of stem cells requires the review and approval of the Embryonic Stem Cell Research Oversight (ESCRO) Committee.
• Research must comply with the University’s Research Data Security Policy.
• Research involving protected health information, e.g., identifiable medical record information, requires compliance with HIPAA.