Student Submission Information

• Student IRB Submission Guidelines
  • Independent Student Summer Research Projects
• Students Receiving Funding from HMS/HSDM (ex. SMO)
  who are joining IRB Approved Research Project

• The IRB Process

Student IRB Submission Guidelines

Independent Student Summer Research Projects
Submission Deadline: April 1

HMS and HSDM Student Submissions to the CHS should include:

• Cover letter.
• Initial Application Materials signed by student and mentor.
• A copy of the grant, contract, and/or Scholars in Medicine Office (SMO) or research fellowship application.
• Informed Consent Forms or request for waiver (also HIPAA authorization or request for waiver of same).
• Research materials: recruitment fliers, survey instruments, questionnaires, telephone scripts, focus group questions, etc.
• Human Subjects Protection Training certificate for student and HMS mentor.
• Resumes/CVs or biosketches for student and HMS mentor.
• IRB approvals from other institutions/sites.
• Mentor letters from HMS faculty and on-site supervisor.

 

Students Receiving Funding from HMS/HSDM (ex. SMO) who are joining IRB Approved Research Projects not already reviewed by the CHS
Submission Deadline: April 1

Submissions to the CHS should include materials to request that the CHS consider ceding review:

• Designation Request Form or Online Catalyst Cede Review Request Form
• A copy of the grant, contract, and/or Scholars in Medicine Office (SMO) or research fellowship application.
• IRB approval letter from the reviewing IRB (if ceding review is requested)

Students planning to work on a research project (as a research assistant/associate) that has CHS approval and who are or will receive funding from the Faculty of Medicine must submit materials to amend the existing project.

For students conducting research at Massachusetts General Hospital or Brigham and Women's Hospital, please read the Partners Sponsored Staff Onboarding Process and the Partners Policy Regarding Non-Employees

The IRB Process

• Your IRB Application is logged into the IRB's database.
• The IRB Administrative Director divides submissions among the CHS staff.
• The CHS Staff thoroughly pre-review applications and may contact you for clarifications.
• Student research must meet minimal risk exemption or expedited review criteria (though, some minimal risk studies may require full CHS review depending on the research topic, activities, population and/or location).
• The application and supporting materials are forwarded for final review (Exempt, Expedited or Full Committee) and approval.
• There may be additional questions from IRB members.
• FINAL IRB approval is then documented by Report on Action (ROA) letter sent to the Principal Investigator by IRB staff.
• YOU MUST HAVE A SIGNED ROA (or exemption letter) before starting any work with human participants!
• Due to strict adherence to Federal Regulations, protocols take approximately 8 weeks from the time they are submitted, to the time they are approved.
• Full Committee meetings are generally held the last Tuesday of the month (Please see the Committee Meeting Schedule for details).

 

Updated: 09-Dec-2011