1. Common Questions Answered: What every (Harvard LMA) Student Investigator Should know Paul Hryvniak, MS, CIP Alyssa Speier, MS, CIP QIP Student Education Session October 1, 2015

2. Agenda Office of Human Research AdministrationOffice of Human Research Administration FAQs AnsweredFAQs Answered Case StudiesCase Studies Question/AnswerQuestion/Answer 2

3. OHRA 3 Office of Human Research Administration Harvard Longwood Medical Area (Harvard Chan School, HMS, HSDM) Director - Leslie Howes Institutional Review Board IRB Administrative Chair – Julie Kaberry Department-assigned IRB Review Specialists: Jada Dixon Paul Hryvniak Keren-Nicole Insalaco Kim Serpico Keisha Turner IRB Coordinator – Grace Bullock Quality Improvement Program QA/QI Specialists: Stanley Estime Lisa Gabel Alyssa Speier

4. Types of IRB Reviews & Determinations Non-Full Board Review – on a rolling basisNon-Full Board Review – on a rolling basis Not Human Subjects Research determinationNot Human Subjects Research determination Exemption determinationExemption determination Expedited approvalExpedited approval Full Board (Convened IRB) Review - monthlyFull Board (Convened IRB) Review - monthly 4 Most common for student protocols

5. Am I conducting Research with Human Subjects Research is defined as a…Research is defined as a… “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” Human Subject is aHuman Subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention/interaction with the individual, orData through intervention/interaction with the individual, or Identifiable private information”Identifiable private information” 5

6. DE-identified vs. Coded 6 TermAs 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. Such 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 is de-identified, or Data provider gives PI attestation that s/he will not release identifiers or key

7. What should I submit to the IRB? When activities don’t meet the definitions of research with human subjects… IRB review & approval is not required but recommendedIRB review & approval is not required but recommended Investigators may obtain a formal NHSR determinationInvestigators may obtain a formal NHSR determination To do so, prepare a Not Human Subjects Research Request Form (non-SMO)To do so, prepare a Not Human Subjects Research Request Form (non-SMO)Not Human Subjects Research Request FormNot Human Subjects Research Request Form available in ESTR and on our website at http://www.hsph.harvard.edu/ohra/formsinstructions/n ew-submissions/available in ESTR and on our website at http://www.hsph.harvard.edu/ohra/formsinstructions/n ew-submissions/ 7

8. Is my human subjects Research Exempt from IRB approval? 1.Research conducted in established or commonly accepted educational settings, involving normal educational practices 2.Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior 3.Surveys, interviews, observation of public behavior if participants are public officials 4.Collection of existing data, documents, specimens If publicly available OR If publicly available OR If no identifiers are recorded If no identifiers are recorded 5.Evaluation of public benefit or service programs, etc. subject to approval of Department or Agency heads 6.Taste and food quality evaluation and consumer acceptance 8

9. Category #2 Up Close Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior Caveats: Sensitive information collected must be anonymousSensitive information collected must be anonymous Doesn’t apply to research with minors unless activities are limited to observation of public behavior and investigator doesn’t manipulate the environmentDoesn’t apply to research with minors unless activities are limited to observation of public behavior and investigator doesn’t manipulate the environment Doesn’t apply to research with prisonersDoesn’t apply to research with prisoners 9

10. Category #4 Up Close Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Caveats: Data must be existing, on the shelf, at the time of submission to the IRBData must be existing, on the shelf, at the time of submission to the IRB “Publicly available” means anyone could access it“Publicly available” means anyone could access it Identifiers cannot be recorded if not publicly availableIdentifiers cannot be recorded if not publicly available 10

11. What should I submit to the IRB? When conducting human research activities that are exempt-eligible… IRB review (& determination) is requiredIRB review (& determination) is required A consent process must be in place, when applicable. It should discloseA consent process must be in place, when applicable. It should disclose That the activities involve “research”That the activities involve “research” The research proceduresThe research procedures That participation is “voluntary”That participation is “voluntary” The PI’s name & contact informationThe PI’s name & contact information Prepare Exemption Request Form obtained through QIP consultation (non-SMO)Prepare Exemption Request Form obtained through QIP consultation (non-SMO) 11

12. Expedited and Full Board Review Non-exempt human research is reviewed either…Non-exempt human research is reviewed either… Expedited basisExpedited basis Rolling basis, first come-first servedRolling basis, first come-first served Activities pose minimal risk and fit into one or more Expedited Review CategoriesActivities pose minimal risk and fit into one or more Expedited Review CategoriesExpedited Review CategoriesExpedited Review Categories Convened IRB aka “Full Board”Convened IRB aka “Full Board” Monthly meeting (submit at least 30 days prior)Monthly meeting (submit at least 30 days prior) Activities pose greater than minimal risk and/or don’t fit into Expedited Review CategoriesActivities pose greater than minimal risk and/or don’t fit into Expedited Review Categories Note: A faculty member must serve as PI. Students are not eligible to be PI for Non-Exempt Human Research 12

13. How do I submit My IRB Application? 13 ESTR: E lectronic S ubmission, T racking, & R eporting ESTR: E lectronic S ubmission, T racking, & R eporting Harvard’s IRB electronic submission system, available at irb.harvard.eduHarvard’s IRB electronic submission system, available at irb.harvard.eduirb.harvard.edu Login using HUID & PIN or eCommons loginLogin using HUID & PIN or eCommons login Click “Create New Study” and follow system prompts to complete electronic SmartformClick “Create New Study” and follow system prompts to complete electronic Smartform Upload relevant study materials where prompted, e.g., Not Human Subjects Research Request form; Exemption Request form; Research Protocol; local IRB approval, etc.Upload relevant study materials where prompted, e.g., Not Human Subjects Research Request form; Exemption Request form; Research Protocol; local IRB approval, etc. For SMO projects, upload PIM proposal with Human Research Addendum to the Study Scope Page in lieu of other forms on that pageFor SMO projects, upload PIM proposal with Human Research Addendum to the Study Scope Page in lieu of other forms on that page Available trainingAvailable training http://estrsupport.fss.harvard.edu/icb/icb.do?keyword=k93454&pageid=i cb.page570759http://estrsupport.fss.harvard.edu/icb/icb.do?keyword=k93454&pageid=i cb.page570759http://estrsupport.fss.harvard.edu/icb/icb.do?keyword=k93454&pageid=i cb.page570759http://estrsupport.fss.harvard.edu/icb/icb.do?keyword=k93454&pageid=i cb.page570759 One-on-one support, contact QIPOne-on-one support, contact QIP ESTR helpdesk: estrhelp@harvard.eduESTR helpdesk: estrhelp@harvard.edu

14. Do I need IRB Training? OHRA policy requires human research training of the following:OHRA policy requires human research training of the following: Any PI, Co-Investigator, Key Personnel as defined by NIH, andAny PI, Co-Investigator, Key Personnel as defined by NIH, and Anyone with direct contact with human subjects or access to their identifiable dataAnyone with direct contact with human subjects or access to their identifiable data Ways to satisfy the requirement for trainingWays to satisfy the requirement for training CITI: https://www.citiprogram.org/CITI: https://www.citiprogram.org/https://www.citiprogram.org/ Attend 3 OHRA Education series offerings/academic yearAttend 3 OHRA Education series offerings/academic year 14

15. When will I Hear back? 15 Type of Determination or Review Average review turnaround times Not Human Subjects Research Determination 1 week Exemption Determination 1 week Expedited2-3 weeks Full Board1 month

16. Considerations/Tips Conducting research abroad?Conducting research abroad? Discuss project with local collaboratorsDiscuss project with local collaborators Obtain local review and approvalObtain local review and approval If your plans change, submit modifications/clarifications to the IRB before implementation in the fieldIf your plans change, submit modifications/clarifications to the IRB before implementation in the field Plan Ahead – things always take longer than anticipatedPlan Ahead – things always take longer than anticipated Obtain QIP consultation prior to IRB submissionObtain QIP consultation prior to IRB submission 16

17. Additional Resources Office of Human Research Administration websiteOffice of Human Research Administration website www.hsph.harvard.edu/ohrawww.hsph.harvard.edu/ohrawww.hsph.harvard.edu/ohra www.hms.harvard.edu/ohrawww.hms.harvard.edu/ohrawww.hms.harvard.edu/ohra Department-AssignmentsDepartment-Assignments SMO: Grace Bullock ∙ 617-432-3071 ∙ gbullock@hsph.harvard.eduSMO: Grace Bullock ∙ 617-432-3071 ∙ gbullock@hsph.harvard.edu gbullock@hsph.harvard.edu All other departments: http://www.hsph.harvard.edu/ohra/department-assignments/All other departments: http://www.hsph.harvard.edu/ohra/department-assignments/ http://www.hsph.harvard.edu/ohra/department-assignments/ Quality Improvement Program staffQuality Improvement Program staff Stanley Estime ∙ 617-432-2164 ∙ sestime@hsph.harvard.eduStanley Estime ∙ 617-432-2164 ∙ sestime@hsph.harvard.edusestime@hsph.harvard.edu Lisa Gabel ∙ 617-432-5842 ∙ lgabel@hsph.harvard.eduLisa Gabel ∙ 617-432-5842 ∙ lgabel@hsph.harvard.edulgabel@hsph.harvard.edu Alyssa Speier ∙ 617-432-2140 ∙ aspeier@hsph.harvard.eduAlyssa Speier ∙ 617-432-2140 ∙ aspeier@hsph.harvard.eduaspeier@hsph.harvard.edu 17

18. CASe Study #1 Dr. Kim plans to analyze SAT scores from 2006 to 2015 from 10 Boston-area schools. The schools will provide Dr. Kim with a de-identified data set and neither Dr. Kim nor the schools will be able to link the scores back to the students. She will collect basic demographics about the school from their websites. What should Dr. Kim submit to the IRB? 18

19. Case Study #2 Dr. Smith has a freezer of blood samples that were originally collected for a research study which ended several years ago. Patient codes (which can be linked to patient medical records) remain on the samples. The consent form originally signed by the subjects indicated whether or not their stored blood could be used for future research. A student advisee of Dr. Smith has requested access to the samples to conduct his own secondary data analyses. Dr. Smith agrees. What next? 19