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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.

IMPORTANT: Sign up for the DF/HCC Research Listserv by requesting access to OncPro and OHRS Submit. This will ensure you receive important communications from OHRS, QACT and CTEO.


IRB Policies and Procedures for the Protection of Human Subjects [11.20.14]

Telephone numbers and email addresses for OHRS staff
Office Hours: [Schedule]

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 Initial Submission Forms
Forms for post-activation events including adverse events, amendments, deviations, and continuing reviews

Forms relating to HIPAA such as waivers of authorizations

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

Resources for Biospecimen and Biobanking Research
Policies, forms and guidance on biospecimen and biobanking research

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

Central IRB Related Documents
Guidance for Central IRB Review Process [Track-changes]
Guidance for Registering Investigators for the NCI CIRB Review Process
New Project Application - CIRB [Track-changes]
Amendment Form - CIRB [Track-changes]
Application for Continuing Review - CIRB
Consent Addendum Model for NCI IRB Protocols
CIRB Approval for DFCI with Consent Boilerplate Language

Guide to Human Research Activities [GHRA Revisions 11.20.14]
The Guide to Human Research Activities outlines the current practices and guidelines involved in conducting human subject research at Dana-Farber/Harvard Cancer Center (DF/HCC). The guide is directed to all staff who are, or will be, directly involved with conducting research. New research staff will find the material particularly useful as they become acquainted with their roles.


Informed Consent Language (ICL)

This resource has been created to assist researchers and clinical operations personnel with writing and amending informed consents for study participants.

Informed Consent Language (ICL) Database