• Student IRB Submission Guidelines
  • Independent Student Summer Research Projects
• Students Receiving Funding from HMS/HSDM (ex. OEP)
  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
• CHS application signed by student and mentor.
• A copy of the grant, contract, and/or Office of Enrichment Program (OEP) 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. OEP) who are joining IRB Approved Research Projects
Submission Deadline: at least two weeks prior to start date

Students who wish to work on an already existing (or soon to be approved), research project and are receiving funding from HMS/HSDM must submit:

• A cover letter explaining the student’s role in the research project.
• A copy of the Office of Enrichment Program (OEP) application.
• Human Subjects Protection Training certificate.
• A copy of the IRB approved research protocol that includes the student as research personnel, or an amendment documenting the addition of the student to the research protocol, and IRB approval documentation.
• If the student will be performing additional research activities involving human participants not included in the original IRB protocol, then the student or PI must submit an amendment to the appropriate IRB to include this work. Documentation of the amendment and the IRB approval must be submitted to the HMS/HSDM IRB office.

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

The IRB Process

• Your IRB Application is logged into the IRB's database.
• The IRB Administrator divides submissions between three coordinators.
• IRB coordinators thoroughly review applications and may email you with questions prior to IRB approval.
• The application and supporting materials are forwarded for review (depending on level of risk - 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: 22-Oct-2009