eIRB

Reference Guide for Students and Trainees

This guide contains reference information for Duke students and trainees about creating and submitting human subjects research studies to the Duke Medicine IRB. All projects must be submitted electronically using the eIRB at: http://eIRB.mc.duke.edu.

For a general introduction to the eIRB software, including how to navigate the different workspaces, please see the General Reference Guide.

For detailed information about how to create and submit new studies, see the Study Staff User Guide.

TABLE OF CONTENTSHUMAN SUBJECTS PROTECTION (HSP) CERTIFICATION.........................................................................................2

STUDENT AND TRAINEE RESEARCH................................................................................................................................2

HOW TO USE THE EIRB.........................................................................................................................................................3

HOW TO LOG IN........................................................................................................................................................................3HOW TO CREATE A NEW STUDY APPLICATION........................................................................................................................5

How to Complete an Application for Trainee Research While Away from Duke...............................................................9How to Complete an Application for Exemption from IRB Review...................................................................................12How to Complete an Application for Regular IRB Review...............................................................................................14

HOW TO SUBMIT A NEW STUDY APPLICATION......................................................................................................................15HOW TO RESPOND TO REVIEWER REQUESTS.........................................................................................................................18

GETTING HELP......................................................................................................................................................................22

TECHNICAL SUPPORT..............................................................................................................................................................22eIRB Home.........................................................................................................................................................................22eIRB Email.........................................................................................................................................................................22DHTS Help Desk................................................................................................................................................................22

RESEARCH SUPPORT...............................................................................................................................................................23IRB Office..........................................................................................................................................................................23Clinical Research Support Office (CRSO) Email..............................................................................................................23

Human Subjects Protection (HSP) Certification

In order to receive IRB approval of your research, you must complete the Human Subjects Protection (HSP) training modules. This is also part of the School of Medicine’s third-year requirements.

The required modules are available on the Collaborative Institutional Training Initiative (CITI) web site, www.citiprogram.org.

For step by step instructions for how to register for and complete the training modules:1. Go to the School of Medicine Human Subjects Protections (HSP) training web site:

http://medschool.duke.edu/modules/som_research/index.php?id=10 2. Scroll down to the “For instructions for CITI module completion” link.

Student and Trainee Research

To obtain IRB approval of research while away from Duke, or new research you will be doing while at Duke, you will create and submit a new study application in the eIRB.

o If research will continue past the IRB approval expiration date, submit a Continuing Review.

o When research is complete, submit a Final Progress Report. o You must submit the Final Progress Report or Continuing Review at least 30 days before

the expiration date.

To obtain IRB approval to be added to an existing study with IRB approval, the study team will submit a Personnel Change Request to add you to the Other Key Personnel list. When your role on the research ends, the study team must submit a Personnel Change Request to remove you from the study.

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How to Use the eIRB

How to Log In1. From your internet browser, go to the eIRB Home page: http://eIRB.mc.duke.edu .

2. Type your NetID in the NetID field, tab to the password field and type your NetID password. Press the Enter key or click the Login button.

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Your personal workspace displays. The task list shows you any items that are awaiting your action.

To return to the task list at any time, click the white My Home link at the right of the top blue banner.

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How to Create a New Study Application1. Click the New Study Application button under the Create heading in the column at the left.

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The first page of the application displays.

2. Type your study information. Complete all the required fields marked by *. Under SBR select “NO” to all questions.

a) From the Study Organization drop down list, select Office of Curriculum.b) In the Principal Investigator field:

o For study while away from Duke, select Pat Thibodeau as Principle Investigator

o For study while at Duke, select your Duke Mentor or Principle Investigator of the project.

c) In the Primary Study Coordinator field, select yourself.d) In the Primary Regulatory Coordinator field, select Sherry Burton.

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3. Click the light gray Save link at the top of the page.

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The study is created with a unique Protocol number, Pro000xxxxx showing at the top right of the study page.

4. Click Continue to save the current page and proceed.

At any time, if you want to exit the study pages to return later, click the Exit link at the top of the page, and click Yes to confirm you want to save changes if applicable.

5. On page 02. Outside Duke Personnel, add information as needed, and click Continue to proceed.

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How to Complete an Application for Trainee Research While Away from Duke

1. On page 03. Protocol Application Type, select Trainee Research While Away from Duke and click Continue.

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2. On page 03.2 Trainee Research While Away from Duke, attach and enter the requested information.

For detailed instructions about attaching documents, please see the General Reference Guide.

3. Click Continue to save the current page and proceed.

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4. Click Finish to save the current page and return to the study workspace.

Important Note: You have created and saved the application. You must submit the application, and the PI must electronically sign it, to route it to the IRB for review.

For instructions, see the How to Submit a New Study section of this document.

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How to Complete an Application for Exemption from IRB Review

1. On page 03. Protocol Application Type, select Application for Exemption from IRB Review and click Continue.

If you are unsure whether your study would qualify for exemption, please talk with your research mentor.

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2. On page e(1) Exempt Application, attach and enter the requested information.

3. Click Finish to save the current page and return to the study workspace.

Important Note: You have created and saved the application. You must submit the application and the PI must electronically sign it, to route it to the IRB for review.

For instructions, see the How to Submit a New Study section of this document.

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How to Complete an Application for Regular IRB Review

1. On page 03. Protocol Application Type, select Regular Study Application and click Continue.

2. Click Continue through all pages of the regular new study application.

At any time, if you want to exit the study pages to return later, click the Exit link at the top of the page, and click Yes to confirm you want to save changes if applicable.

Important Note: You have created and saved the application. You must submit the application nd the PI must electronically sign it, to route it to the IRB for review.

For instructions, see the How to Submit a New Study section of this document.

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How to Submit a New Study Application1. From the study workspace, click the Submit Study button in the column at the left.

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2. Click the checkbox to confirm and click OK.

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The study is submitted to the PI for electronic signature and an email is sent notifying the PI that a study is awaiting his or her signature.

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How to Respond to Reviewer RequestsWhen changes are needed to a study application, responding to requests for changes is a two-step process. The first step is to make the changes to the application. The second step is to submit the changes to notify the reviewer that your changes are complete and ready for review.

1. To view your Tasklist, click the My Home link in the top blue banner.

2. Click the link to the study under the “Name” column to open the study.

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The reviewer comments display in the History tab.

3. If changes to the study are needed, click the View/Edit activity in the column at the left.

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The first page of the application displays for editing.

4. Go the appropriate study page and make the changes and/or attach revised documents on the page. Save the pages and exit the application. Changes to the study pages appear as entries in Change Log in the History folder. For more information about these steps, see the General Reference Guide.

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5. When your changes are complete, click the Send Comment to Reviewer activity in the column at the left.

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6. To explain your response, enter comments and/or attach documents and click OK.

Getting Help

Technical Support

eIRB Home

See http://eIRB.mc.duke.edu for help logging in to the eIRB, User Guides, and Frequently Asked Questions (FAQ).

eIRB Email

Email eIRB@mc.duke.edu to contact IRB IT staff for help using the eIRB.

DHTS Help Desk

Call the DHTS Help Desk at 684-2243 for help with network connectivity, NetID and NetID password.

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Research Support

IRB Office

See http://IRB.mc.duke.edu for guidance and information from the IRB Office.

Clinical Research Support Office (CRSO) Email

Email CRSO.Help@notes.duke.edu if you have questions about the CITI training modules.

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