Clinical Research Support

Office for Human Research Studies (OHRS)

The Office for Human Research Studies (OHRS) supports and manages the Scientific Review Committees and the Institutional Review Boards (IRB) for Dana-Farber/Harvard Cancer Center and Dana-Farber Cancer Institute. OHRS provides regulatory guidance and resources to the review committees, the investigators, and the research teams.

Contacts
Phone numbers and email information for OHRS staff

Information for Sponsors
Sponsor information, such as the certification letter

Submitting a New Protocol
All forms required for new protocol submissions

Single Patient IND / Emergency Use of a Test Article
Information about submitting a single patient IND protocol as well as emergency use of a test article without IRB review.

Consent Documents
All model consent documents

After Activation Forms
Forms for post-activation events including adverse events, amendments, deviations, and continuing reviews

HIPAA
Forms relating to HIPAA such as waivers of authorizations

OHRS Information Sheets
Regulatory guidance on issues relating to Scientific and Institutional Review Board reviews

External Regulatory Guidance
Outside regulatory agency and federal regulations

OHRS News Updates
Archive of all OHRS office updates

Oncology Protocol System and OHRS Submit
Learn how to obtain access to these systems

Presentation and Training Materials
Powerpoint presentations and other training resources

Partners Policy and Guidance
Information about Partners policies and guidance