Submission Guidelines

All applications submitted to the CHS office receive a pre-review by a CHS staff member. The staff member will communicate to the Investigator any issues or recommended changes to the study or study documents based on the regulations or CHS policies. The staff member who pre-reviews a research proposal sees that proposal through the initial approval and any subsequent submissions (such as continuations and amendments) to the office. And, the CHS staff member who reviews one research proposal for an Investigator will review all subsequent proposals for that Investigator.

Submission Guidelines For New Applications
Please submit one original copy (including requisite signatures) of the CHS application to the CHS office along with the following materials, as applicable:

• CVs/Biosketches for the Investigator and research personnel with human studies responsibilities (including members of the team who interact with participants or handle data/specimens containing participant identifiers);
• HETHR or equivalent human subjects protection certification (such as CITI or NIH) for all research personnel with human studies responsibilities (including members of the team who interact with participants or handle data/specimens containing participant identifiers);
• IRB approvals from appropriate institutions, or letter of support if the institution does not require IRB review, as applicable;
• All funding application/s (including grants, subcontracts and clinical trial agreements) supporting the research;
• The full protocol;
• The sponsor protocol (when one exists);
• The complete DHHS-approved protocol (when one exists);
• Recruitment materials (cover letters, fliers, brochures, email notices);
• Study materials (telephone scripts, question guides, written questionnaires and surveys);
• Educational materials (information sheets, study guides);
• Consent materials, including any requests for waivers;
• HIPAA materials (including any waiver requests and proposed authorizations);
• Investigator’s Brochure (or package insert or pages from the Physicians Desk Reference, if a marketed drug).

Students will also need to submit:

• Mentor letters (HMS faculty and on-site supervisor).
• Application should be signed by student and mentor
• HMS faculty mentor's Human Subjects Protection Training certificate

Additional Information
IRB Guidelines
Federal and State Guidelines
Harvard University Guidelines
Policies and Procedures

Updated: 04-Sep-2007

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For questions or comments about this website, please email: orsp@hms.harvard.edu