1. Leslie Howes, MPH, CIP Alyssa Speier, MS, CIP September 24, 2014 Investigator Manual: http://www.hsph.harvard.edu/oh ra/investigator-manual/ http://www.hsph.harvard.edu/oh ra/investigator-manual/ OHRA’s Investigator Manual and Updates: The Investigator’s Best Friend

2. 2 Agenda I.M. Table of Contents Human Research Protection Program (HRPP) Human Research Training Online Submission (ESTR) Research Protocol Reporting Financial Interests Classifications of Review and Determinations Investigator’s Responsibilities Informed Consent Continuing Review Considerations Services Available to Assist Investigators: QIP Study Closure Questions?

3. 3 I.M. Table of Contents What is the purpose of this manual? What is the Human Research Protection Program? What is Human Research? Exempt Human Research Who can be Principal Investigator (PI)? What training do investigators and study staff need to conduct Human Research? How to submit a new Human Research Application Online Who has access to my ESTR record and submission to the IRB? How to write a Research Protocol What financial interests have to be reported to the IRB? How to create a consent/assent document? What are the different regulatory classifications that research activities may fall under? How does the IRB decide whether to approve Human Research? Review Using the Expedited Procedures Review by the Convened IRB What will happen after IRB office receives a submission? What are the decisions the IRB can make when reviewing proposed research? What are the Investigator's obligations after IRB approval?

4. 4 I.M. Table of Contents (continued) How to document consent? How to submit a modification? How to submit continuing review? How to get help for an IRB submission? Are there any services available to assist investigators with ensuring regulatory compliance? How to close out a study? How long should records be kept? How to get additional information and answers to questions? Appendix A: Prompt Reporting Requirements Additional Requirements for DHHS- Regulated Research Additional Requirements for FDA- Regulated Research Additional Requirements for Clinical Trials (ICH-GCP) Additional Requirements for Department of Defense (DOD) Research Additional Requirements for Department of Energy (DOE) Research Additional Requirements for Department of Justice (DOJ) Research Additional Requirements for Department of Education (ED) Research Additional Requirements for Environmental Protection Agency (EPA) Research

5. 5 Human Research Protection Program (HRPP) Not just the IRB Comprised of : – Institutional leadership – Institutional Review Board (IRB) – Quality Improvement Program (QIP) – Investigators and Study Staff – Relevant Departments and Units

6. 6 Human Research Training Read HRPP Plan IRB approval may not be granted for proposed research in which investigators have not completed human research protections training – CITI Training – Check with ORARC Coordinator to find out if OHRA has current training on file Staci Landis at scushman@hsph.harvard.edu or 617-432-2157scushman@hsph.harvard.edu Additional Training Available for staff – For training offerings visit: http://www.hsph.harvard.edu/ohra/education-2/ http://www.hsph.harvard.edu/ohra/education-2/

7. 7 Online Submission (ESTR) Electronic, Submission, Tracking and Reporting (ESTR) - http://irb.harvard.eduhttp://irb.harvard.edu – University-wide system – Dedicated support available at ESTRhelp@harvard.edu Study Submission Guide – Provides step-by-step instructions

8. 8 Research Protocol Every section’s requirements are explained in detail Some highlights: – Inclusion and Exclusion Criteria – Procedures involved in the Human Research Include ALL HS Research vs. Standard of Care HLMA staff vs. others Describe what data will be collected and duration of research – Privacy It involves consideration of whether the participants will be comfortable with the research procedures – Confidentiality of Data Describe where data will be stored, who will have access to the data, measures taken to secure the data, how long data will be stored, and, when applicable, how data will be archived and/or destroyed Data security plans must comply with protection requirements described in the Harvard Research Data Security Policy (HRDSP) Data Management and monitoring

9. Reporting Financial Interests 9 Who “All individuals involved in the design, conduct, or reporting of the research” and their immediate family (anyone on the personnel information form and some not on it, too) “Immediate family” means spouse, domestic partner, children, and dependents. What Any amount over $0 must be reported E.g., Ownership interest, Compensation of any amount, Proprietary interest of any value, Board or executive relationship regardless of compensation When Initial and Continuing Review Report any change to the IRB within 30 business days How Upload Financial Interest Disclosure Form in ESTR

10. 10 Classifications of Review & Determinations Types of Review – Not Human Research – Exempt – Expedited – Convened IRB Determinations – Approval – Requires Modification(s) – Deferral/Disapproval

11. 11 Investigator’s Responsibilities Secure IRB approval prior to implementation Conduct study according to IRB approved protocol – Submit Continuing Review, Modifications (including study staff changes) to IRB Ensure adequate facilitates, equipment on site Ensure study staff are qualified Report “new information” (see Appendix A) Do not accept or provide “finder’s fees” or “bonus payments”

12. 12 Informed Consent Consent Templates available online with signature blocks and check boxes, e.g., written long form vs. child assent If alternative format, submit justification Include all required elements Other considerations, e.g., HIPAA authorization Documentation, e.g., signature and date fields

13. 13 Continuing Review Considerations If involves modifications submit a separate modification request If not received by submission deadline, will be restricted from submitting new Human Research until the completed application has been received If expires, all HR Study procedures must stop – If stopping will harm participants, provide these on a clinical basis – If such procedures not available on a clinical basis, contact IRB Administrative Chair, Julie Kaberry (jkaberry@hsph.harvard.edu or 617-432-2149) and provide a written list of enrolled participants and explanation as to why they would be harmed if procedures were stoppedjkaberry@hsph.harvard.edu

14. 14 Services Available to Assist Investigators: QIP IRB Submission Assistance Routine On-site Reviews Education/Additional Training – IRB Clinic – In-Service – New Investigator/Research Coordinator Orientation – Scheduled Education Series Floating Research Coordinator/Assistant Study Management Tools

15. 15 Study Closure Retain all records for seven years after study completion, i.e., closure of the Human Research protocol, or longer if required by the sponsor Including signed and dated consent documents

16. 16 Questions?  Leslie Howes, OHRA Director (lhowes@hsph.harvard.edu)lhowes@hsph.harvard.edu  Julie Kaberry, IRB Administrative Chair (jkaberry@hsph.harvard.edu)jkaberry@hsph.harvard.edu  QA/QI Specialists  Alyssa Speier (aspeier@hsph.harvard.edu)aspeier@hsph.harvard.edu  Stanley Estime (sestime@hsph.harvard.edu)sestime@hsph.harvard.edu  Lisa Gabel (lgabel@hsph.harvard.edu)lgabel@hsph.harvard.edu  OHRA: www.hsph.harvard.edu/ohrawww.hsph.harvard.edu/ohra  See OHRA web site for department-assigned IRB Review Specialist and contact information