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The Perfect Protocol Submission

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  1. The Perfect Protocol Submission Cathleen Montano, JD, CIP IRB Manager Jan Hewett, JD, BSN HRPP Director November 20, 2013

  2. Roadmap • What we need from you before submitting the application • What we can do to help before the application comes in • Top 10 problem areas encountered by IRB Office/Committees • Expectations • Top 10 takeaway tips • Resources

  3. What We Need From You Before Submitting the Application 1. PI training in HSPT and HIPAA 2. PI COI disclosure on file with University COI office 3. Approvals from other University committees as applicable: PRC (oncology studies), PPRC (children), YCCI (use of HRU or CRU) 4. Signature of PI and dept. chair (if paper); will be held up in routing if not approved electronically 6. Identification of PI’s business manager

  4. What We Need From You Before Submitting the Application • Current IRB application(s) and/or template(s) – see website for most up-to-date version • The right form is used for the submission • All documents are proofread for spelling, typographical errors and correct answers to the questions • Everything is together – nothing missed from the complete submission

  5. What We Can Do To Help You • Keep our website up-to-date with policies, procedures, guidance documents and application forms that contain embedded just-in-time education • Be available for “consultation” services prior to, during and after a submission has gone to the full committee or single-member for expedited review • Review the submission and send back minimal (if any) modifications or clarifications during the regulatory review stage • Send the submission to the fully convened IRB (or expedited reviewer) with everything ready to go so that the outcome review and discussion (full committee) leaves very few post-committee member/committee changes • Protocol is approved and research can begin!

  6. Top Ten Trouble Areas Protocol Specific: 1. Full Consent waivers – be sure to state why it is impracticable to get consent 2. HIPAA section – describe (in words) what health information is needed (minimum necessary) 3. Recruitment/screening procedures must describe what health information is collected – may attach telephone screening script 4. Data and Safety Monitoring Plan section is often incomplete. Follow link to template language and personalize to the study. 5. Information in application & consent form do not match.

  7. Top Ten Trouble Areas – cont’d 6. Coeus access but no training 7. Protocol is created in Coeus but not submitted. 8. Person listed as PI on the protocol does not meet University qualifications to serve as PI 9. Special Permission request to serve as PI does not include CV 10.Protocol includes research staff who are not affiliated with any institution, or visiting students

  8. Expectations • Expectations for researchers and study personnel are high – but the review stakes are equally higher: • IRB members (faculty and others) expect high quality submissions • Federal agencies look for well crafted applications and appropriate IRB review • Expectations for IRB staff and members are equally high!

  9. Poll: Current resources? • 1. PI • 2. Other co-workers or colleagues • 3. HRPP website • 4. HIC staff • 5. YCCI website • 6. YCCI staff • 7. Other • 8. None

  10. Top Ten Tips 1. Always go to HRPP website to download most recent forms – many specific applications (e.g., initial, industry-sponsored, pediatric, humanitarian use, medical record review, exemption) and forms 2. Anticipate time needed to secure additional approvals (PRC, PPRC, YCCI, MRRC) so submission is not urgent by the time it gets to the IRB 3. Consult posted instructions under Getting Started or contact IRB staff 4. Consult the posted application instructions document 5. Read and answer the questions – put N/A if not applicable but don’t leave blank

  11. Top Ten Tips – cont’d 6. Communicate with your PI! 7. List all current funding sources with institutional numbers assigned by G&C (we need to look these up and compare to the protocol for congruency) 8. Know your G&C manager: http://www.yale.edu/grants/contacts/index.html 9. Confirm that PI and all study staff have current HSPT and HIPAA training 10. Confirm that PI has current COI disclosure on file with University: http://coioffice.yale.edu/

  12. Poll: What resources would you like to have (more) available? 1. Electronic protocol submission system 2. IRB staff consultations 3. More FAQs and links to documents/resources 4. Instructional videos on website 5. In-services, workshops 6. Collegial resources – fellow experienced coordinators/mentors 7. Make a decision tree for selecting right form from the info on the getting started document 8. Model applications and consent documents

  13. Resources • Human – IRB staff, YCCI staff • HRPP website – FAQs, Getting Started sections particularly directed to newcomers: http://www.yale.edu/hrpp/responsibility/start.html • YCCI YCCI’s Protocol Development and Regulatory Support unit (Kelly A and Theresa K): http://ycci.yale.edu/researchers/ors/protocol.aspx