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Clinical Research Support

Office for Human Research Studies (OHRS)

The Office for Human Research Studies (OHRS) is responsible for the scientific and Institutional Review Board review processes for all cancer relevant research conducted by the five Harvard clinical institutions under the umbrella of Dana-Farber/Harvard Cancer Center. These institutions are: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Children's Hospital Boston; Dana-Farber Cancer Institute; and Massachusetts General Hospital. OHRS is responsible for ensuring the administrative and regulatory management, implementation, and operation of the (1) Protocol Review and Monitoring System under the Cancer Center Grant; (2) the system for the institutional review board review of research; (3) the Health Improvement Portability and Accountability Act as it relates to research; and (4) Activation of Research Protocols.

Contacts
Telephone numbers and email addresses 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

Food & Drug Administration Information
FDA guidance, forms and links

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

Citations to Recent FDA Warning Letters
  • September 20, 2010