Scholars in Medicine 2015 Student Projects IRB Submission Process Winter/Spring 2015 Workshops Tel: 617-432-2140 E-mail: gbullock@hsph.harvard.edu Website: www.hsph.harvard.edu/ohra 1

All Research Must Be Reviewed by the IRB Before it Begins All research involving human subjects, or human subjects data, must be reviewed by the IRB and issued a determination before the project begins. IRB Application Deadline for SIM Projects: April 15, 2015 2 2 2 2

Types of IRB Review Not Human Subjects Research Exemption Student can act as PI Exemption Expedited Review Full Board Review 3 3

De-identified vs. Coded Term As defined by the IRB… Research with Human Subjects? Anonymized/ De-identified Samples or data that may have identified human subjects at one time, but all identifiers or codes have since been removed and destroyed. No; no collection of identifiable data/specimens. Coded/ Indirectly Identifiable Samples or data labeled with a code (e.g., a number), rather than a person’s name or other personal identifier. This code can be traced or linked back to sample donor/data provider by an investigator, who retains key, e.g., coding system/crosswalk. Yes, unless.. Data de-identified, or Data provider provide PI with attestation that s/he will not release identifiers or key.

What to Submit To The IRB Office ESTR Application - https://irb.harvard.edu - Don’t forget to list your Faculty Sponsor on the Basic Information page! HMS SMO 2015-2016 Funding Application (PIM proposal) Appendix 3 – IRB Questionnaire (part of the SMO application for funding) Human Subjects Training Certificate (CITI) https://www.citiprogram.org Any related study documents: recruitment materials, consent or assent forms, surveys, interview or focus group questions, etc. SEE website to sign up for ESTR training sessions and clinics 5 5

IRB Questionnaire – Appendix 3 Will the data that you obtain be recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants? Will children or other vulnerable populations be included? How are participants recruited? Will you obtain local IRB approval (for research conducted outside of the US)? Will you interact with participants?

What if there is an existing IRB determination? If you, or your mentor/PI, has an existing IRB approval at HMS/HSDM/HSPH only, please contact Grace directly. If there is an existing approval at ANY OTHER SITE (including Partners), the standard process still applies. You still need to submit your proposal through ESTR.

Type of Determination or Review Average review turnaround times Plan Ahead! Submit as soon as possible You cannot begin research with human subjects or identifiable data before obtaining LMA and Local IRB approval, even if you’ve booked your flight! Be sure to discuss your project with local collaborators to check on any special approvals or permissions. When will I hear back from the IRB? Type of Determination or Review Average review turnaround times Not Human Subjects Research Determination 1 week Exemption Determination Expedited 2-3 weeks Full Board 1 month 8 8 8

Questions? Office of Human Research Administration: http://www.hsph.harvard.edu/ohra   OHRA’s Student FAQs: http://www.hsph.harvard.edu/ohra/for-hsph-student-researchers/ SMO Contact: Grace Bullock, IRB Administrator (gbullock@hsph.harvard.edu) Julie Kaberry, IRB Administrative Chair (jkaberry@hsph.harvard.edu) Kim Serpico, IRB Review Specialist (kserpico@hsph.harvard.edu) Quality Improvement Program (QIP) (qip@hsph.harvard.edu) ESTR Resources: http://estrsupport.fss.harvard.edu/ The Student Submission Guide for the ESTR system is available from Scholars in Medicine Office or IRB website. 9 9 9 9