Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel: URL:

2222 Agenda The IRB’s Function Types of IRB Review Is your Project Human Subjects Research Is your Data Identifiable Is your Project Exempt Expedited and Full Board Studies What to Submit Plan Ahead! Tips

33333 IRB’s Primary Function To Ensure: - Participant Protection: Rights and Welfare Safety Privacy and Confidentiality – Compliance with IRB-approved protocol, Institutional policies, and federal regulations

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

55555 If student is acting as PI List Faculty Advisor under Basic Information in ESTR (irb.harvard.edu) Faculty Advisor will automatically receive a message and need to provide their sign-off before the project comes to the IRB

66666 Refer to flow chart to see if your advisor has signed off Dark blue oval would move to IRB Review when Faculty Advisor has signed-off

Is Your Project Human Subjects Research? Research: A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human Subjects: A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information

88888 Is your Data Identifiable? Coded data is identifiable unless: – Codes can be stripped prior to analysis – The PI gets an attestation from the data provider De-identified/Anonymized data – Cannot contain participant codes/IDs if there is a link to identifiable information in existence unless the PI gets an attestation

99999 Is Your Project Exempt? Study procedures must fit within Exemption category(ies) – Research conducted with children cannot be exempt under b(2) unless activities are limited to observation without investigator interaction – Research conducted with prisoners is not eligible – Research regulated by FDA is not eligible Investigators MUST obtain an exemption determination from the IRB prior to conducting Human Research No long-form consent document required; however, process to obtain consent must be in place 9

10 Exemption Categories, examples – Surveys, interviews, observation of public behavior If identifiers are not recorded OR If risk is not increased should responses be disclosed outside of research – Collection of existing data, documents, specimens If publicly available OR If no identifiers are recorded

11 Expedited and Full Board Review If your study does not meet the criteria for “not human subjects research” or “exemption,” it will be reviewed expedited (in office) or at the Full Board Meeting (monthly) – Expedited Research: All study procedures must meet into one or more of the expedited categories (see handout) AND must be less than minimal risk – Full Board: Activities not under the expedited criteria OR Greater than minimal risk *Note: A faculty member from your affiliated school (HMS, HSPH, or HSDM) must act as the PI – students are not eligible to be PI on Non-Exempt Human Research 11

12 What to Submit (when applicable) IRB Electronic Submission, Tracking & Supporting system (ESTR) under Study Scope page: – SMO - upload your PIM proposal including IRB Addendum – All other NHSR - Upload NHSR Form – All other submissions - Upload Research Protocol *English version of consent documents *English version of recruitment materials *English version of study tools – E.g. questionnaires, focus group and interview guides, data collection sheets, etc. *Include version date and/or version number within each document.

13 Plan Ahead! Submit as soon as possible. – You cannot begin research with human subjects or identifiable data before obtaining HSPH and Local IRB determination, even if you’ve booked your flight! – Allow sufficient time for review(s) Review times dependent on completeness of submission Average HLMA review times – Exemptions/NHSR-5 business days – Expedited-2 to 3 weeks – Full Board-see submission deadlines online (about a month prior to the meeting) – Expedited Continuing Review-21 Days prior to lapse date

14 Tips Discuss project with local collaborators – Do you need local review or permission? Once you submit your application sit tight and let the reviewers do their jobs – If the status of your submission hasn’t been changed to “assigned” within 48 hours check in. If things change submit a modification request Contact the Quality Improvement Program (QIP) for Submission Assistance Investigator Manual (at ESTR Submission Guide and other resources here: Make sure to have the PI hit “submit” in ESTR.

15 Questions?  OHRA’s Student FAQs: researchers/#FAQ13http:// researchers/#FAQ13  Leslie Howes, OHRA Director  Julie Kaberry, IRB Administrative Chair  QA/QI Specialists  Alyssa Speier  Stanley Estime  Lisa Gabel  SMO Contact: Grace Bullock  OHRA:  See OHRA web site for department-assigned IRB Review Specialist and contact information  ESTR Resources: