So you’ve received IRB approval…what now?

1. So you’ve received IRB approval…what now? Alyssa Speier, MS, CIP Paul Hryvniak, MS, CIP QIP Hot Topic Session April 22, 2014

2. Agenda • Office of Human Research Administration • Considerations and Tips • Modifications • Continuing Review • Reportable New Information • Regulatory Documentation and Participant Files • Additional Resources

3. OHRA

4. Considerations/Tips • Types of Review • Rolling Review • Not Human Subjects Research determination • Exemption determination • Expedited approval of non-exempt study • Full Board (Convened IRB) Review - monthly • Conducting Research Abroad • Discuss project with local collaborators • Obtain local review and approval before beginning Human Research Activities (including recruitment)

5. Considerations/Tips (cont.) • Plan Ahead – things always take longer than anticipated • Obtain QIP consultation prior to IRB submission • Submit all applications in ESTR (Electronic Submission, Tracking, & Reporting): irb.harvard.edu • Consult Investigator Manual (http://www.hsph.harvard.edu/ohra/investigator-manual/)

6. Modifications • Submit any changes via ESTR and receive determination PRIOR to implementing change in the field • NHSR, Exemptions, Expedited, Full Board • Submit Personnel Changes (for those conducing Human Research Activities) • Update Research Protocol if necessary • Submit track change and clean copies of materials being changed • Update version dates/numbers on documents being changed • Use the “update” function in ESTR to replace docs already there • If time sensitive, email/call Review Specialist in advance of submitting and/or put a comment in ESTR regarding the timeframe

7. Continuing Review • Expedited and Full Board Protocols must be reviewed “not less than once per year” • “Create Continuing Review” and submit in ESTR • Full Board: By deadline for applicable meeting (make sure study doesn’t lapse) • At least 21 days in advance of expiration date • Include Enrollment numbers under item #1 of CR screen (for secondary data/samples, include the number of data/samples obtained) • Explain any breakdowns of numbers in Summary of Study Progress document attached under item #7 • Anyone consented is considered “enrolled”

8. Continuing Review (cont.) • Under item #7 of CR Screen, upload any: • Progress Reports that have been submitted to funder/sponsor that year • Summary of Study Progress document (see template in ESTR) • Local/other reviewing institutions’ approval notices for that year • No changes can be requested through the CR application, you must submit a modification request in ESTR separately • If a study lapses, stop all Human Research Activities (including analysis of identifiable data) immediately until the project has been reapproved.

9. Reportable new information (RNI) • Things that that happen during the course of the study that should be reported to the IRB • There are a specific categories of RNIs: Increased risk, unexpected harms that are possibly related to the study, protocol deviations, study lapses, etc. (See complete list in Investigator Manual) • Examples • Investigator does not conduct a blood draw approved as part of the IRB protocol • Corrective Action Plan: Design a study procedures checklist to be used for each subject • A drug manufacturer reports new side effects for a study drug • CAP?? • Lap top is stolen with identifiable participant data on it • Updated data confidentiality plan to

10. Reportable New Information (Cont.) • If HHS funded, serious/continuing non-compliance must be reported to OHRP • If you classify the information incorrectly in ESTR, don’t worry, the IRB will make the correct determination. • Submit RNIs in ESTR • If related to an existing protocol, make sure to select that protocol under item #5 on the RNI screen • Propose any corrective actions to avoid this happening again under item #3 • You will receive an Acknowledgement or hear back as to any corrective actions • Contact IRB or QIP if there is something you are not sure whether to submit

11. Regulatory Documentation and Participant files • Maintain for 7 years after IRB study closure (unless longer, as required by Sponsor) • Regulatory Documentation • IRB Documentation • Study Team CVs, Training, Licensure • Sponsor/funder documentation • Logs (updated in real time) • Etc. (request a Regulatory Binder from QIP) • Participant files • Keep original signed consents, if applicable • Keep source documentation (e.g., questionnaires, transcripts, etc.) • Ensure that you are keeping documents as outlined in approved Research Protocol (i.e., locked file cabinet, password protected computer with fire wall, etc.)

12. Additional Resources • OHRA Investigator Manual: http://www.hsph.harvard.edu/ohra/investigator-manual/ • Office of Human Research Administration website • www.hsph.harvard.edu/ohra • www.hms.harvard.edu/ohra • Department-Assignments • http://www.hsph.harvard.edu/ohra/department-assignments/ • Quality Improvement Program staff • Stanley Estime ∙ 617-432-2164∙sestime@hsph.harvard.edu • Lisa Gabel∙617-432-5842∙lgabel@hsph.harvard.edu • Alyssa Speier∙617-432-2140∙aspeier@hsph.harvard.edu