Investigators at HMS and HSDM often participate in collaborative research projects that involve multiple research sites. To help Investigators understand their responsibilities to HMS and affiliated institutions or institutions providing or receiving prime or subcontract awards, the following guidelines were developed:

A. Where an Investigator is the recipient of the primary funding award (regardless of the source) and the research is conducted at HMS/HSDM and additional sites are coordinated by the HMS/HSDM Investigator

1. The CHS is responsible for the initial and continuing reviews of the main study, the grant, all research materials and activities, and participant safety.
2. The CHS is responsible for receiving copies of IRB approvals, approved consent documents and research materials (including language translations) from all sites and, for DHHS sponsored research, assuring that research is taking place at institutions holding a current FWA
3. The CHS will review plans for circulating approved protocols and data collection instruments to the sites, for communicating changes to the protocol to those sites, and for data distribution from those sites back to the Investigator and/or between sites.
4. The CHS is responsible for ensuring that there are adequate provisions for monitoring the data to ensure the safety of participants and for ensuring an adequate plan of informing additional sites of these issues in a timely manner.
5. The CHS is responsible for reviewing requests for changes to the protocol and the Investigator’s plan to disseminate information about approved changes to the additional sites, and also is responsible for receiving amendment approvals (and approvals of any revised documents) from the IRBs at those sites.
6. The CHS is responsible for reviewing any protocol deviations or issues of non-compliance with federal regulations at the HMS/HSDM site, and for reviewing any such reports to/from the additional site’s IRBs. The CHS will review the Investigator’s plans for reporting such issues to the other sites and will itself report such issues to the other site IRBs.
7. The CHS will collaborate and communicate with other IRBs reviewing or ceding review of the research, as necessary.

B. Where an Investigator is the recipient of a primary funding award and whose primary appointment is at a Harvard-affiliated institution where the research will be solely taking place

1. The CHS will either confirm its use of a Cooperative Agreement with the Institution or will attempt to enter into an Authorization Agreement with the IRB of the Harvard-affiliated institution.
2. If the CHS is unable to enter into an authorization agreement with the IRB of the Harvard-affiliated institution, then the CHS remains responsible for the items in Section E(a), above.
3. The CHS will collaborate and communicate with other IRBs reviewing or ceding review of the research, as necessary.

C. Where an Investigator is the recipient of a subcontract funding award and the research is taking place at HMS or HSDM

1. The CHS is responsible for the initial and continuing reviews of the research indicated in the subcontract for the research taking place at HMS or HSDM, and for participant safety at the HMS or HSDM sites.
2. The CHS is responsible for ensuring that the Investigator enters into a material transfer agreement (MTA) or a clinical trials agreement (CTA), as appropriate, before the research begins. The CHS is responsible for reviewing the CTA with the Office of Technology Licensing.
3. The CHS is responsible for receiving a copy of the approval document from the IRB of the institution receiving the primary funding award.
4. The CHS is responsible for ensuring that there are adequate provisions for monitoring the data to ensure the safety of participants and the plan for (i) reporting events to the main/overall Investigator, and (ii) receiving information on events from the other research sites, and/or the DSMB.
5. The CHS is responsible for reviewing requests for changes to a protocol at the HMS site.
6. The CHS is responsible for reviewing any reports of protocol deviations and/or non-compliance with federal regulations.
7. The CHS will collaborate and communicate with other IRBs reviewing or ceding review of the research, as necessary.

D. Where an Investigator with a primary appointment at a Harvard-affiliated institution is the recipient of a subcontract funding award and the research is taking place solely at the Harvard affiliated institution

1. The CHS will either confirm its use of a Cooperative Agreement with the Institution or will attempt to enter into an Authorization Agreement with the IRB of the Harvard-affiliated institution.
2. If the CHS is unable to enter into an authorization agreement with the IRB of the Harvard-affiliated institution, then the CHS remains responsible for the items in Section C, above.
3. The CHS will collaborate and communicate with other IRBs reviewing or ceding review of the research, as necessary.

E. Where there is no external funding and the HMS/HSDM Investigator is the Principal Investigator and additional sites are coordinated by the HMS/HSDM Investigator

1. See Section A, above.

F. Where an Investigator with a primary appointment at a Harvard-affiliated institution receives no external funding and the research is taking place solely at the Harvard-affiliated institution

1. The research should be approved by the IRB of the Harvard-affiliated institution.

 

Updated: 22-Oct-2009