THE PERFECT PROTOCOL
SUBMISSION
Cathleen Montano, JD, CIP
IRB Manager
Jan Hewett, JD, BSN
HRPP Director
November 20, 2013
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
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
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
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 singlemember 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 postcommittee member/committee changes
Protocol is approved and research can begin!
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.
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
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!
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
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
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/
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
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