MARYWOOD UNIVERSITY

Institutional Review Board & Exempt Review Committee

Immaculata Hall, 2300 Adams Avenue, Scranton, PA 18509

(570) 348-6211, x. 2418 or


http://www.irbnet.org

IRBNET INSTRUCTIONS FOR RESEARCHERS

IRBNet is Marywood University’s research submission and management system, and it must be used when applying for review of human or animal research. No hardcopy or email submissions will be accepted under any circumstances. Please thoroughly review this document to ensure that your materials are submitted correctly.

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Revised: 1/9/2018

I.  How to Register with IRBNet

II. How to Upload Training Reports

III. How to Build a New Research Project

IV. How to Share Your Project

V. How to Sign Your Project

VI.  How to Submit Your Project

VII.  How to Access Decision Letter

VIII.  How to Submit Follow-up Materials

IX.  Other Features in IRBNet

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Revised: 1/9/2018

I.  How to Register with IRBNet

1.  Visit http://www.irbnet.org and click the New User Registration link at the upper right.

2.  Enter your name, create a user name and password, and click Continue.

3.  Review the terms of use and click Accept.

4.  For organization, enter Marywood, click Search, and click on Marywood University. Click Continue.

5.  Enter your telephone number and email address, verifying your email address. Click Continue.

6.  Review your information and click Register. Check the email account you had provided. You must activate your registration by clicking a link provided to you via email.

7.  We recommend that you use your Marywood email account, Yahoo or Gmail, as some systems have aggressive spam-blocking protocols. If you do not receive an activation email, check your spam filter/junk box. You may need to add to the contacts section of your email account. If you still do not receive an activation email, log into IRBNet and click USER PROFILE at the upper right. At the bottom of the next screen, where you see Affiliations, click Edit. Change your email address if it is incorrect. Enter a new or different fax number, and hit Save. This will trigger a new activation email that will be sent to your account. If you still have difficulty, send a request to .

8.  If you forget your password, click on the Forget Your Password link in the upper right portion of IRBNet’s home page and follow the instructions. Should you wish to change your username or password, log into IRBNet and click on User Profile in the upper right portion of the screen. Please do not create multiple user accounts.

II.  How to Upload Training Reports
All principal and co-investigators, research assistants, and advisors/sponsors (of students, PT employees or unaffiliated individuals) must complete two online training courses through CITI at www.citiprogram.org.

1.  Human Research Course (HRC) – Choose the Social/Behavioral or Biomedical learner group based on your discipline. Do not select Members/Staff, which is for board members or research office staff only. Those involved with clinical trials must also complete the course for Clinical Trial researchers.

2.  Responsible Conduct of Research Course (RCR) – There is just one basic course.

Download your FULL REPORTS (showing grades; not certificates) at www.citiprogram.org. After logging in, click View-Print-Share to the right of the appropriate course (under Completion Record column). Then, click the blue link under Completion Reports and save as a .pdf to your computer.
Reports must be uploaded into your IRBNet user profile one time and may be linked to multiple projects so that they do not need to be uploaded with every new project.

Important Notes:

·  Do not click “Add an external account,” as we do not subscribe to this service.

·  Do not upload another individual’s certificates into your own IRBNet user profile. Each team member must add them to their own IRBNet profile, or they may be added to a submission package.


To upload training reports to IRBNet:

1.  Visit www.irbnet.org. Click USER PROFILE at the top right portion of the screen.

2.  Scroll to the bottom of the page under Training and Credentials and click Add New Record.

3.  For Document Type, click the drop down and scroll to Marywood University in bold. Select the appropriate label.

4.  For Effective Date, enter the date of completion.

5.  Click Browse and locate the file on your computer. Select document and click Open. Click Attach. You will be returned to the User Profile page.

6.  Scroll to the bottom where your training document has been added and click Submit on the right side (blue link). Type Marywood and click Search. Click on the appropriate board’s name and click Continue.

7.  Click Submit. Repeat for each report or document.

To link training reports to a particular project (OPTIONAL):

1.  If you upload reports to your IRBNet user profile and submit, we will see them even if you do not link, so this is optional.

2.  Once you have created your project, ensure that other individual have shared access to your project if required (see Section IV.).

3.  Click on the My Projects button on the left menu, and then click the title of the first package within the project.

4.  On the left menu, click the Designer button. Under the documents that have been uploaded, click Link/Un-link Records.

5.  A list of available documents will be displayed. Select the boxes corresponding to the appropriate training or credentials you wish to link, and then click Save.

III.  How to Build a New Research Project in IRBNet
Note: You may log out of IRBNet at any time while building your package. Documents will not be sent to a board until you click submit. You may log in again at a later time to complete or submit your package. Your project will appear by clicking on the title of your study to view your package, and then clicking on the “Designer” tab (at left) to resume the process of assembling your package.

  1. Visit www.irbnet.org. Log in and click the Create New Project button on the left menu.
  2. Project Information Page:
  3. Fill in required information – Title, first and last name, funding sponsor (if applicable), highest degree attained, etc.
  4. Internal Reference Number – Leave blank, as a number will be assigned by office staff.
  5. Click Continue.
  6. Designer Page – Under Step 1:
  1. Select a Library – IMPORTANT – If your research qualifies for exempt review, be sure to click on the drop-down menu and select Marywood University Exempt Review Committee. If your project is expedited or full, choose Marywood Institutional Review Board. Choosing the incorrect library will provide incorrect forms and templates.
  2. Select a document – Download all required forms and templates for the project here. A checklist of what to submit may be found on the IRB and ERC Checklist webpage. Save documents to your computer where they will be easy to find and edit. Alternatively, you may find forms and templates on the IRB or ERC websites.
  1. Upload All Project Documents – Under Step 2:
  2. Click on Attach New Document – For document type, select a descriptor from the drop down menu. If something is not listed or you are unsure, select other and provide the description in the description field (e.g., permission letter, flyer, etc.).
  3. Click Browse to search for the file on your computer, click on the document and then click Open.
  4. Click the Attach button.
  5. Continue until all forms are uploaded to your package as needed.

IV. How to Share Your Project
Note: All Principal Investigators (PIs) must share their projects with any co-investigators (if applicable). Student researchers, adjunct/part-time faculty or staff, or individuals not affiliated with Marywood University must share their projects with an advisor/sponsor.

  1. Verify with your co-investigator(s) or your advisor/sponsor that they have registered with IRBNet.
  2. Click the Share this Project button on the left menu.
  3. Click the word Share.
  4. Type Marywood University in the search box and click Search.
  5. Click Marywood University and click Select Organization.
  6. Type the last name of the individual and search for their name.
  7. Once located, under Permission Access, designate the level of access you are granting.

·  Give co-investigators “read” access, as the Principal Investigator (PI) should be the only one allowed to edit documents.

·  Give advisors/sponsors “full” access because they will then receive auto-notices from IRBNet whenever actions are taken by the Board or Committee.

  1. You may add comments at the bottom of the screen which will be shared with all individuals with whom you have granted access to your project.
  2. Click the Save button.
    Your Share Project page will now show the names of the individuals who’ve been granted access to your project. You may edit this list at any time by clicking on the individuals’ names.

V.  How to Sign Your Project Electronically


All Principal Investigators (PIs) must electronically sign every package within their project. Co-investigators and sponsor/advisors must sign the initial application and any renewals (if applicable).
To add a signature:

1.  Click Sign this Package on the left menu.

2.  Click on the drop down menu and select your role.

3.  Click the Sign button.
The Sign Package page will now show the names of all individuals who have signed the package. Be sure that co-investigators and advisors sign the package before submitting it. Otherwise, review will be delayed.

If you are the Principal Investigator, co-investigator or advisor/sponsor, your e-signature on a given project means that the research described in your submission will be conducted in full compliance with Marywood University’s policies, as well as Federal, state and local regulations governing research with human participants.

VI.  How to Submit Your Project

1.  Click the Submit this Package button on the left menu.

2.  IMPORTANT: There are 3 boards in the IRBNet system (IRB, ERC and IACUC). The Institutional Review Board (IRB) will be highlighted as the default, which is only correct for applications requiring expedited or full review. If your study qualifies for exempt review, be sure to select Exempt Review Committee by clicking the down arrow button on the right side of the Select a Board box where it lists all board names. Scroll down. The Exempt Review Committee (ERC) is listed directly under the IRB’s name. Click on Exempt Review Committee to highlight it. Failure to select the correct board may delay the review of your application.

3.  Click Continue.

4.  Click the Submission Type drop down menu arrow and choose the appropriate type:

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Revised: 1/9/2018

New Application = “New Project”

Board-Requested Change =“Amendment/Modification”
6-month Status Report = “Other”

PI-Requested Change After Approval = “Revision”

Renewal = “Continuing Review/Progress Report”

Closing Study = “Closure/Final Report”

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Revised: 1/9/2018

5.  Leave the comment box blank. Critical information must be contained within your package.

6.  Click Submit.
Clicking the Submit button will send your package to the IRB, ERC, or IACUC. Once a project is submitted, it cannot be retracted or deleted from IRBNet. Should you realize that you have forgotten something after submitting, please contact the individual shown at the bottom of this document so that your package may be unlocked. NOTE: Once an individual package within a project has been submitted one time, it cannot be submitted again. However, when you create an additional package within a project at a later date, you will have to click Submit this Package for that package. All packages must be submitted one time.

7.  After you submit, IRBNet will automatically assign your project an IRBNet number, consisting of a base number, followed by a suffix (12345-1, 12345-2, 12345-3, etc.). When you upload any packages in the future, they must be submitted under the same project’s base number. Please see How to Submit Follow-up Materials in section VIII, below.

VII.  How to Access Decision Letter


When a decision has been made by the IRB or ERC, the Principal Investigator and all others who have been granted full access to the project will receive an automatic e-mail message from IRBNet stating that an action has been taken on IRBNet. It will look something like this:

PleasenotethatMarywoodUniversity’sIRBhastakenthefollowingactiononIRBNet:

Submission: [37382‐1] Title oftheStudy

Action: ModificationsRequired

EffectiveDate: 09/07/2011

AdditionalinformationisavailableinIRBNet.Shouldyouhaveanyquestionsyoumaycontact______.

How to Access a Decision Letter or Other Materials:

1.  Log into IRBNet at www.irbnet.org and click on your existing project’s title, which will take you to the Project Overview page.

2.  Click on Review Details which is a blue link halfway down the page.

3.  Scroll down to Board Documents at the bottom of the page.

4.  Click on the document’s name or the paper icon on the right side of the section. Save it to your computer.

5.  See the next section on how to respond.

VIII.  How to Submit Follow-Up Materials
Follow-up materials may include modifications requested by the board, revisions to previously approved research, reports (status, final, deviation/violation, and adverse event), continuing review applications, etc. DO NOT CREATE A NEW PROJECT (e.g., 12345-1) when submitting follow-up materials! When submitting modifications or revisions, MAKE SURE YOU ENABLE TRACK CHANGES IN YOUR WORD PROCESSING SOFTWARE (see tracking instructions)!
To submit follow-up materials:

1.  Log into IRBNet at www.irbnet.org and click on your existing project’s title. If you have multiple projects, use the search box. If you cannot see the study, be sure to click the My Projects button on the left menu first.

2.  On the Project Overview page, click on the Project History button on the left menu. Ignore the notice that the package has been locked. It must remain locked to maintain a submission trail.

3.  Click the Create New Package button at the bottom of the page.

4.  You will land on the Project Details page. On the left menu, click the Designer button.

5.  You can build your new package here. There’s a library under step 1 (IRB, ERC, or IACUC), and an Attach New Document button under step 2. Documents from previous packages will be shown at the bottom, but will not automatically be uploaded to your new package.