navigating the irb application

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

How to Create a New Application

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

Complete the rest of Section 9

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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