What Every Harvard LMA Student Investigator Should Know Alyssa Speier, MS, CIP 1

Agenda 2 2 2 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 Host-Country Ethical Review What to Submit Plan Ahead! Tips Questions? 2 2 2

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 3 3 3 3

Types of IRB Review 4 4 Not Human Subjects Research Exemption Any HLMA school affiliate can act as PI Exemption Expedited Review Full Board Review Non-Committee Review Occurs on a rolling basis No submission deadlines Performed by one or more designated & experienced IRB members department-assigned IRB Review Specialist Occurs at scheduled monthly meetings Submission deadlines approx. 3 weeks prior to meeting Performed by the convened IRB which is made up of scientists, non-scientists, Harvard-affiliated and non-affiliated members. 4 4

Is Your Project Human Subjects 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 -IRB review/determination not required for NHSR -To obtain a formal written determination, complete “Not Human Subjects Research Request Form” -If investigators have questions about whether an activity is Human Research, contact the OHRA -Any HLMA School affiliate (including students) can submit a request and serve as PI 5 5 5 5 5

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 Identifiers include: voice recording (unless large sample) medical record numbers 6 6 6 6

Common Examples Human Subjects Research Not Human Subjects Research Animal research Literature search Exercises solely to fulfill course requirements or to train students Program evaluation not intended to be generalizable beyond the specific program Analyses of anonymized or de-identified data (i.e., data set obtained includes no identifiers) Clinical trial designed to evaluate the safety/efficacy of an investigational product (IND/IDE study) Interviewing community members to evaluate the reception of a new bicycle pathway in the community Medical record/chart review

Is Your Project Exempt? Investigators MUST obtain an exemption determination from the IRB prior to conducting Human Research Exempt from certain requirements of other non-Exempt Human Research (e.g., signed consent form and annual review) Study procedures must fit within Exemption category(ies) Research conducted with prisoners is not eligible Research regulated by FDA is not eligible No long-form consent document required; however, process to obtain consent must be in place 8 8 8 8 8

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 No minors unless purely public observation of behavior with no intervention or interaction Collection of existing data, documents, specimens If publicly available If no identifiers are recorded 9 9 9 9 9

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 An HLMA school faculty member must act as the PI on Non- Exempt Human Research IRB submissions 10 10 10

Host-Country Ethical Review Non-exempt human research conducted abroad Secure local IRB/ethical review committee (ERC) approval No human subjects research activities can occur onsite until approval in place For non-HHS funded research, in the absence of an FWA holding ERC, form a Community Advisory Board (CAB) For exempt human research, check with local collaborators/institution to see what, if any, review is required Best Practice: submit to local IRB/ERC or Community Advisory Board for review or comment CAB Minimum of 3 members Membership includes personal and/or professional experience with the target population, and/or study methodologies Reviews recruitment, consent process, and study interventions/interactions to ensure they are culturally-appropriate 11 11 11

What to Submit (when applicable) Electronic IRB Submission System (ESTR) under Study Scope page: https://irb.harvard.edu NHSR - Upload NHSR Form All other submissions - Upload Research Protocol For Exemptions use Appendix F of the Investigator Manual when filling out the 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. 12 12

Plan Ahead! 13 13 13 Submit as soon as possible. Average review times You cannot begin research with human subjects or identifiable data before obtaining HLMA 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 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- Submit 21 Days prior to lapse date 13 13 13

Tips 14 14 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 Submit to HLMA IRB first, then Local (if time allows) Most often we have the resources to be quicker Most often we will defer to any changes the local IRB feels are culturally appropriate Contact QIP for Submission Assistance Investigator Manual (at http://www.hsph.harvard.edu/ohra/investigator-manual/) ESTR Submission Guide and other resources here: http://estrsupport.fss.harvard.edu/icb/icb.do Make sure to have the PI hit “submit” in ESTR. 14 14

Questions? 15 15 15 15 Quality Improvement Program Staff Lisa Gabel, lgabel@hsph.harvard.edu, 617-432-5842 Scott Meyers, scmeyers@hsph.harvard.edu, 617-432-2143 Alyssa Speier, aspeier@hsph.harvard.edu, 617-432-2140 Department Assigned Review Specialist: https://www.hsph.harvard.edu/ohra/department-assignments/ Resources OHRA Website: http://www.hsph.harvard.edu/ohra Investigator Manual: http://www.hsph.harvard.edu/ohra/investigator-manual/ ESTR Support and Training: http://estrsupport.fss.harvard.edu/icb/icb.do 15 15 15 15