Post on 28-Dec-2016
transcript
USF Research Integrity & Compliance
Before you begin
• Register for an ARC account – https://arc.research.usf.edu/prod – Complete all the fields on the registration form
• Complete your human subjects protections education requirement
• Draft the protocol document • Draft the informed consent document
ARC Homepage
Where should I start? • Login Home Institutional Review Board
Human Subjects Protection Education
Consent Form Templates
Regulation and Guidance
ARC Training Materials
Create a New Application Login New IRB Study
Create a New Application
Create a New Application
Create a New Application • Study Staff
– Principal Investigator • Access to complete all activities in ARC
– Primary and Secondary Coordinators • Access to complete all activities, except first submission
of initial application – Co-investigators/Faculty Advisors
• Access to respond to comments and revise application – Key Personnel
• View only All individuals listed on the application must
be affiliated with USF
Create a New Application
Create a New Application • Back will take you to your previous page, but will not save
your work. • Save will save your work. • Exit will take you back to the main workspace, and prompt
you to save • Hide/Show Errors will show you sections that still need
completion • Jump To will take you to anywhere in the application
• Required sections are in bold, not required gray and current page red.
• Continue will take you to the next page of required questions and will save your work.
Create a New Application
Create a New Application Popup Help
Create a New Application 1. Click Browse to find your document 2. Name your document
– Include version # and version date • This should also be in the document itself (i.e. footer)
– Example: Protocol_v1_7.24.13
3. Click OK
Create a New Application
Create a New Application
• Protocol • All Informed Consent
documents/scripts • Surveys/Questionnaires • Interview Scripts • Focus Group Questions • Recruitment Materials (flyers,
emails, brochures) – Requirements USF HRPP Policy 708
• Video scripts • Letters of support from Non-USF
sites • Approval letters from host country
for transnational research • Any other study instruments being
used
Required Documents
Create a New Application
Create a New Application Enrollment
Create a New Application
Create a New Application Informed Consent
Create a New Application Informed Consent
45 CFR 46.116; 45 CFR 46.117; USF HRPP Policy No. 601
Create a New Application
• Risks – Address all risks, no matter how minor.
• Records reviews – breach in confidentiality
– Indicate risks in the informed consent document
• Benefits – Consider the direct benefit to the participants and society – Compensation is not a benefit
Risk/Benefit – Section 8
Create a New Application Privacy & Confidentiality – Section 9
Create a New Application Privacy & Confidentiality – Section 9
Create a New Application Privacy & Confidentiality – Section 9
PHI = Identifier(s) + Health Information
…If yes
Create a New Application • Continue through the SmartForm completing all required questions • Selecting Exit or Finish in the SmartForm brings you to the Application’s Workspace • Clicking Finish does NOT submit your study
Create a New Application
Sends email to study staff requesting they “agree to participate”
Submits study
Withdraws/closes study before submitting to IRB Receives copies of emails – NOT RESEARCH STAFF
Read only access – NOT RESEARCH STAFF
Uploads CV/resumes of study staff
Uploads hsp certificates for study staff (IRB Staff adds dates of certification)
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Let’s Review… IRB Submission Checklist
• Draft protocol and consent documents • Complete IRB application and supporting
documents • “Agree to Participate” completed • All study staff members and PI have current
human subjects protections education • All study staff and PI have a CV/resume uploaded • PI submits application
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Application Workflow
• All Applications follow the same basic workflow • The Study Team will receive email notifications if action is
required • Applications under review will not appear in the study
team’s Inbox and cannot be edited
Approval Pre Submission
IRB Pre Review
Board/Chair Review
Revisions Requested
Department/Affiliate
Revisions Requested
Revisions Requested
Requested Revisions
• Reviewers may request revisions or additional information
• The study team will receive an email and the application will be back in their Inbox
• Study teams respond to revisions by: 1. Correcting the SmartForm 2. Responding to the Reviewer Note 3. Submitting back for review
Requested Revisions
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Select the application link from an email notification.
Requested Revisions
1. Correct
2. Respond
Requested Revisions
3. Submit (PI or Study Coordinator)
What is the status of my submission?
• Top left, main study workspace
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I have approval...now what? • Study workspace
1. Expiration Date 2. Approval Letter
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• Stamped Informed Consent documents
I have approval...now what?
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I have approval...now what? • I need to make a change to my research
study – Submit an Amendment
• My IRB approval is expiring in 60 days – Submit a Continuing Review
• No later than 45 days from expiration date
• I’m done with all research Activities – Submit a Final Review
• I have something I need to tell the IRB – Submit a Reportable Event
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Important Stuff
• ARC Help Desk – (813) 974-2880 / rsch-arc@usf.edu
• Policies – http://www.research.usf.edu/dric/hrpp/policy-
procedure.asp
• IRB Website – http://www.research.usf.edu/dric/hrpp/irb-hrpp.asp
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