10.04 Office for Research Subject Protection

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10.04 Office for Research Subject Protection

The Harvard Medical School Office of Human Research Administration is responsible for the approval and oversight of research conducted at HMS. All research must receive approval from the appropriate Institutional Review Board (IRB) prior to the start of the study. Details about policy and procedures can be found at http://hms.harvard.edu/departments/office-human-research-administration.

Important links

Information and forms for submitting applications for research are available at http://www.irb.harvard.edu.

IRB Investigator Manual: http://hms.harvard.edu/departments/office-human-research-administration/investigator-manual

Guidelines for Approval of Research Studies

To apply for IRB approval of research

All students who are leading research studies (either independent research or research for their scholarly project) must receive approval from the Scholars in Medicine Office (SMO) before applying for IRB approval. See Section 3.08 or the SMO website (http://hms.harvard.edu/departments/medical-education/md-programs/scholars-medicine-sim).

To begin the application for IRB approval, go to irb.harvard.edu to access ESTR, the Electronic Submission, Tracking, and Reporting System, and use your Harvard ID and password to sign on to the system. Click on “create new study,” and you will see a blank “SmartForm” that includes a series of questions related to your study (Study Title, Personnel, etc.). Depending on your answers, the SmartForm will direct you to fill out additional forms or answer more detailed questions relevant to your study. A research protocol template will also be provided for you to describe the study design, methods, recruitment, and consent process. While you are working on your research protocol document, you can save it on your computer or flash drive, and upload it to your ESTR account when it is completed. Other study documents (such as consent forms, survey instruments, and recruitment material) must also be uploaded to ESTR. When your study documents are ready to go, you will click “submit” and the IRB will begin the intake process.

Research in medical education (e.g., curricular studies, student attitudes, knowledge, behavior related to teaching, learning, or career development) requires the additional approval of the HMS Academy. See the Academy research webpage for instructions on this process at http://hms.harvard.edu/departments/academy/academy-office-education-research/educational-research-review-process.

Guidelines for Research with Students as Participants

Students may participate in any study for which they are eligible; however, in order to prevent any coercion (or perception of coercion) or undue pressure for students to participate, investigators should not specifically recruit students who work directly or indirectly for them, students who work with or for them, or students for whom investigators have any, even indirect, educational oversight, such as grading or assessment.

Participation in a research study may never be a condition of employment, insurance, grades, promotion, or any other benefits or bonuses. The Office of Human Research Administration is particularly mindful of situations that may put undue pressure on students to participate in research projects, and thus recommends that investigators refrain from directly soliciting students as participants. Students with questions or concerns related to participation in a research study should contact the Harvard Office of Human Research Administration. Contact information can be found at http://hms.harvard.edu/departments/office-human-research-administration/contacts-location.

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