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Table of Contents Introduction 2 IRBNet User Registration 2 IRBNet ID Number 2 Training and Credentials 3 IRB Meetings and Deadlines 4 IRB Approval Letters and Board Documents 5 IRB Forms, Templates, and Guidance 5 IRBNet Actions 6 My Projects 6 Create New Project 6 Project Overview 6 Designer Revise an Existing Document 7 Add a New Document 8 IRB Documents 10 View/Update/Delete 11 Create New Package 12 Lock Status 12 Share this Project 12 Sign this Package 13 Submit this Package 13 Send Mail 14 Delete this Package 15 Submission Types 16 New Project 16

Sharing a project 19 Signing the Package 21 Submitting the Package 22

Revisions (modifications required) 22 Reportable Events 23 Non-Compliance 23 Protocol Deviation 23 Unanticipated Problems Involving Risk 24 Amendments 24 Contact Information 25

Introduction Effective November 8, 2014, Florida A&M University Institutional Review Board (IRB) will only accept new submissions electronically through IRBNet. The next step is to utilize IRBNet for IRB protocol amendments and extensions and we anticipate requiring use of IRBNet for such activities by December 2, 2014 (see Guide for Submitting Amendments and Extensions for Old Projects in IRBNet)

The purpose of this document is to provide guidance for processing IRB submissions electronically through IRBNet. Step-by-step instructions as well as snapshots are provided for each IRBNet transaction. Additionally, each instruction will include a list of required study documents and forms to be attached with a submission in IRBNet. These documents are necessary to facilitate your IRB reviewers’ knowledge of your study. Finally, this document will also provide some instructions on how to complete each of the FAMU IRB forms. Additional guidance, forms and information can also be found on the FAMU IRB website. The following transactions are to be submitted electronically through IRBNet: New Study Continuing Review/Extension Modification/Amendment Close/Final Report Reportable Events Response/Follow-up to IRB requests IRBNet User Registration To register as a new user, open the above IRBNet webpage. This is what the homepage will look like:

Web Address: www.irbnet.org 

Click onComplet IRBNetIRBNet project.

n the “New User te the registration

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IRB Forms, Templates, and Guidance Some FAMU IRB forms are available on IRBNet for download and use. The FAMU – IRB Protocol application is available in this library and must be completed and adjusted on the Designer page in IRBNet (see the IRBNet FAQs for more information). More information about new submissions is included below. If you would like to access the forms and templates library, you can do so at any time by clicking on “Forms and Templates” option on the left-hand side of your screen under “Other Tools.”

IRBNet Actions This section will describe each IRBNet function. My Projects

Please note that the information in the picture shows multiple documents available when you access the library through IRBNet. You can access any document on the list by clicking the name of the document or the paper icon for each document. If you do not access the forms and templates library prior to beginning your submission, you will have another opportunity to download documents when you create a New Project.

IRBNet will automatically open to the My Projects page after you have logged in. This section allows you to view all studies that you have created or to which you have been shared access. You may sort the list of submissions by clicking on any of the heading options (e.g., Study Title, Status, IRBNet ID).

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age appears oncelinks to other funhe My Projects p

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you have submig., modifications vised documentsents or add entireent history propeyou may be requctly from IRBNe

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nt to be revised b

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by clicking on the

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Add a New Document: Use the "Add New Document" option when the document you are adding is not a revised or updated version of an existing project document. The "new" document will not be tied to the Document History of any existing document, and it will not have any Document History of its own since it is a completely new addition to your project.

If you will use a template to generate your new document, you must first access the template in the forms and templates library. On the left-hand side of your screen, select “Forms and Templates.” Click on the name of the document or the paper icon for the template or form you wish to download. Save the template or form to your computer for completion. Complete downloaded forms or create documents to be submitted. Make sure you save your finished product. After your document is saved, you can now upload it to the package. Back on the designer page in IRBNet, use the “Add New Document” button to upload the completed document into the package. It will not have a revision history (stack of paper icon) at this time because it is new.

If you have already generated the document and it is saved on your computer, you do not need to download a template from the forms and

template library. You can go straight to the “Add New Document” button to upload the new document into the package. It will not have a revision history (stack of paper icon) at this time because it is new.

What about copies of existing documents? Committee members and administrators often need to access copies of existing project documents, such the previously approved Consent Form, when reviewing your new or revised documents. You do not need to attach these older, unchanged project documents to your current package. Committee members and administrators can automatically access these older documents as needed from the "Documents from Previous Packages" list. If you are unsure about the documents you are required to submit, you should contact your local research integrity administrator for more information.

1. You have a modified Consent Form that replaces the current version of your Consent Form from a previous package. What To Do: Access the designer page for your project by clicking the “my projects” button on the left-hand side of the screen. From there you can click on the title of the project you are revising. This will bring you to the project overview page where you can click “designer.” Locate your Consent Form in the "Documents from Previous Packages" list and click the "Revise this Document" icon which will look like a pencil. This will allow you to include a new version of your document in your current package while retaining your complete Document History. 2. You have a completely new document that is not a revised or updated version of any existing project document. What to Do: From the designer page, click the "Add New Document" button. This will allow you to add the new document to your current package. Please note that there are multiple ways that the Designer can be accessed:

1. Clicking on the “Continue” icon when creating a new project 2. Clicking on the “Designer” icon from the Project Administration menu 3. Clicking on the blue “Designer” link while in the “Project Overview” page 4. Clicking on the blue package type hyperlink while previewing the “Project History”

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Create New Package Please note that creating a new package is different than creating a new project. Another package may be prepared while a package or multiple packages are pending review. However we strongly recommend that you avoid doing this as it may delay the review of your protocol documents. Only an individual with Full access to the project can create a new package. To create a new package:

1. Log into IRBNet 2. Click into your project in IRBNet by clicking the title of the project. 3. Click the “Project History” button the left-hand side of your screen. 4. Click the “Create New Package” button in the middle of the page. 5. Click “Work in progress (Not submitted)” to access the Designer page for your new package (also may be called “New Document Package” in some instances).

IRBNet will now default to this package when you re-enter the project. Alternatively, a new package can be created from the “Designer” when you try to add a new document. Simply accept the warning to create a new package. Lock Status The IRB administrator may unlock a package if it is missing documents required for review or if requested by a PI (as long as the package is not already under review by an IRB member) Contact an IRB administrator via email to request the project package be unlocked. Please provide an accurate IRBNet ID and package # and a brief reason for the request in the message. Please note: your project will only be unlocked if no IRB action has occurred and the package is not being reviewed by the IRB at the time of the request. If the package is being reviewed, the package may not be unlocked.

Permissions Full: User may manage all aspects of the project. The user may give and change permissions associated with the project. You may have more than one manager to a project. Write: User may co-edit the project with owner, but not give or change permissions. Any changes a person with "write" access makes to a document using the project designer will automatically transfer across to the owner's copy. Read: User may only access a read-only PDF of the project. All other management features are disabled. Use this level of permission if you only need that person to sign the project.

Although any individual can sign the project, only an individual with Full access may submit the project to the IRB. The individual creating a new project will automatically be assigned Full permissions. Shared access for research team members can be changed at any time. Only individuals with full access may share a project with others. New staff should be entered as soon as they have met the FAMU IRB requirements for new research staff conducting research (e.g., CITI training). Departing staff should be removed promptly. The addition/removal of research staff share permissions does not involve review by the IRB if the project is exempt. However, if the project has been approved as expedited or full board, the addition of new personnel will require IRB review and approval. The PI should ensure share permissions are current and accurate to ensure unwarranted access by non-research team individuals. More information about project sharing is included below in the New Study section. Sign this Package The Principal Investigator must sign the initial package for each new project. If you are a researcher unaffiliated with FAMU, it will be necessary for you to designate a FAMU full time researcher for your project. This researcher will need to sign the package before it can be submitted to the FAMU IRB. If you are a student, it will be necessary for your faculty advisor to sign the package. If the principal investigator is different than the faculty advisor on a student project, both the PI and the faculty advisor must sign the package. Packages that have not received the proper signatures will be returned without review. More information about project sharing is included below in the New Study section of this document. Submit this Package A research team member with Full share access may submit the transaction to the IRB after the necessary individuals have signed the submission. To submit a project package: 1. Click on “Submit this Package” from the Project Administration menu options or click on the “here” hyperlink on the Project Overview page. 2. Ensure that the Florida A&M University, Tallahassee, FL IRB, IACUC or IBC is highlighted and then click the “Continue” icon. 3. Select the Submission Type from the drop down menu. If it is an entirely new submission, please select “New Project.” If you are responding with revisions based on a review memo, please select “Revisions” as the submission type. 4. Write a message if you would like to do so. However, there is no need to send comments when you submit. 5. Click on the “Submit” icon.

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Research Institution: Florida Agricultural and Mechanical University, Tallahas

Title:

*

Local Principal Investigator:

First Name:*Last Name:* Degree(s):

Keywords:

Sponsor:

You may specify an internal account number, billing identifier or reference number for this project.

Internal Reference Number:

Continue

Cancel

* required fields

13. The principal investigator (PI) is the individual who will be responsible for the conduct of the project. Although we strongly recommend that the PI be the individual generating the project paperwork, this is not a requirement. If project paperwork is being completed by someone other than the PI (e.g., research coordinator), please "share" this document with the PI so that both parties have full access. Directions on how to share are outlined below. Only faculty, are permitted to be PIs on IRB submissions.

14. In the keywords field, please specify keywords that can be used in a search to find this project. In the sponsor field, list the name of the funding agency sponsoring the project (if applicable) and upload the funding application and approval (when appropriate). If the project is unfunded, leave the sponsor field blank. Finally, we ask that you leave the institutional reference number field blank. After you have completed all the appropriate fields, click “Continue”. Clicking continue automatically saves your data. 15. On the next page (designer page), you will be able to download documents from the UNF documents library (step 1). Step 1 is optional and most researchers do not use it because they already completed the documents prior to accessing this page. If you use step 1, be sure to select the University of Florida Agricultural and Mechanical University in the “select a library” field. The documents library contains informational how-to documents, forms, templates, and checklists. Download any document that you will use in your submission. The Florida Agricultural and Mechanical University – IRB Protocol application cannot be accessed from the documents library. The application will be available electronically within IRBNet in the next section and outlined in Step 2 below. If you have generated your own supplemental documents (e.g., recruitment, consent, measurement tools), it will only be necessary to download the “Attachment A: Study Details for Expedited or Full Board Projects” document or the “Attachment B: Study Details for Exempt Projects” document for completion. Documents downloaded from the library should be saved to your computer, completed, resaved, and then uploaded into IRBNet. Please refer to the guides below for information about what documents are required to be included for a new project:

Documents Checklist - For Expedited or Full board projects Documents Checklist for Exempt Projects - Use only if you believe your project will be declared exempt from further review

16. after you have completed all of the supplementary documents (e.g., Attachment A or Attachment B, recruitment materials, informed consent documents, permiss[929200-1] IRBNet training test of submission process

Step 1: Download blank forms, document templates and reference materials to assist you in assembling your document package.

Select a Library:

Florida Agricultural and Mechanical University IRB, Tallahassee, FL

Select a Document:

Dow nload

Step 2: Assemble your document package. In addition to adding project documents to your package, IRBNet also allows you to link your project team's Training & Credentials to yo

Documents in this Package:

Document Type Description Last Modified

Consent Form Consent Letter 016-26.pdf 06/29/2016 11:47 AM

There are no Training & Credentials records linked to this package. | Link / Un-Link Training Records |

Add New Document

 

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‐ Click “Submit” when you are done. IRB Projects generally take between four to six weeks between the time of submission and the time of approval. If you are required to submit multiple revisions or if a large volume of projects have been submitted, the timeline for review and approval may be elongated.   

Modifications Required: Revising your Project Documents: The IRB may request modification(s) to the protocol application or supplementary documents (e.g., attachment A or attachment B, recruitment materials, informed consent documents, CITI training). You will receive an email notification within IRBNet from the IRB informing you that a board document has been published in IRBNet. The board may publish a response to your submission by making a document available for you to review. This letter may ask you to make modifications or it may indicate that your project has been approved or disapproved. It is the responsibility of the research team to log into IRBNet to view these documents and address any modifications requested. To view the IRB’s determination and modification request: 1. Log into IRBNet 2. Select the project (click title of project) 3. Select the “Reviews” from the administrative menu (left-hand side of page) 4. Click on the blue hyperlink for the Decision Letter or other board documents from the IRB. This will download a copy of the letter to your computer. To make revisions: 1. Complete your revisions as requested. Save the revised documents to your computer. 2. Sign into IRBNet and select the correct project from the My Projects page. Do this by clicking on the title of the project you are revising. 3. On the toolbar on the left-hand side of the screen click on the “Project History” button. This will allow you to see all the packages that have been started for your project. 4. From the project history page, click “Create New Package.” 5. You should see a new entry in the list of packages. This entry should be titled “Work in progress (Not submitted).” Click on the link for “Work in progress (Not submitted)” to begin your new package. 6. Attach a revised document or add new project documents to the new package by following the instructions for adding new documents in the Designer section of this document. 7. Submit the documents to the IRB by following the Submit this Package instructions and designating the submission type as a “Revision.”  

ReportaNon-Cofederal oNon-com

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able Event ompliance: any aor state regulatiompliance reports

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ol Deviation: Anment, informed ces the stamped and a stamped and dg that the study dcipant. The PI mocol prior to consion Type during

action or activityns or institutionashould be desig

action or activityns or institutionashould be desig

n alteration/modiconsent, and datand dated approvadated approval fr

does not deviate fmust report any p

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y associated withal policies and prnated as an “Oth

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protocol deviationation. Non-comp

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RB approved pronot permitted witthin IRBNet. Thease contact a respproved protocolns or violations apliance reports sh

oversight of resening human subjvent” when sele

oversight of resening human subjvent” when sele

otocol that is not thout final IRB ae approval lettersearch integrity a, except in such and when possibhould be designa

earch involving hject research or tcting the Submis

earch involving hject research or tcting the Submis

approved by theapproval. Final IRr will outline the administrator forcases where it is

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human subjects tthe requirementsssion Type durin

e IRB prior to itsRB approval wilconditions of yo

r more informatis necessary to avest permission froer Reportable Eve

that fails to comps or determinationg submission.

that fails to comps or determinationg submission.

s initiation or impll be confirmed wour approval. If yion. The PI is resvoid an immediatom the IRB to deent” when select

ply with ons of the IRB.

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Unanticipated Problems Involving Risk: any incident, experience, or outcome that meets the following criteria: a) Event is unanticipated, unforeseen, or unexpected b) There is a reasonable possibility that the problem is related or caused by the research, AND c) Participants or others are at an in increased risk of harm An Unanticipated Problem Involving Risk to Participants or Others could result from a protocol deviation. However, an Unanticipated Problem could also involve the loss of study forms, consents or a participant complaint. An Unanticipated Problem also needs to be reported to the IRB. The submission type for an unanticipated problem involving risk will be “Unanticipated Problem (UP)”. To submit a reportable event: 1. Download the event report form and save the form to your computer for completion. 2. Complete the form and save it to your computer. 3. Sign onto IRBNet and click on My Projects to access the project for which you are reporting 4. Select the correct project by clicking on the project title 5. Create a new package for your project 6. Go to the Designer page of your new package 7. Click the “Add New Document” icon and add the Event Report Form you completed along with any supporting documents, as applicable. Please see the Designer section of this document for more information about navigating through the Designer page. For document type select either “Reportable Event (Non-AE)” or “Unanticipated Problem Report” from the drop down list. 8. Have the PI sign the package by following the Sign this Package instructions 9. Submit the package to the IRB following the Submit this Package instructions, designating the submission type as either a Other Reportable Event or an Unanticipated Problem (UP) as applicable. In addition to the event report, you may be asked to submit additional documentation. For example, if you will revise any of your protocol procedures, it will be necessary to submit a revised protocol application with your report. If you will make changes to your informed consent documents, it will be necessary to submit those documents for review. Any additional or pertinent information should be submitted with your report as applicable. Modification/Amendment If your project has been approved and you would like to change your procedures or materials, it may be necessary to submit an amendment before engaging in the revised activities. Any change to an expedited or full board project must be submitted as an amendment. That amendment will need to be reviewed and approved before you begin your revised activities. If you plan to make changes to an exempt project, please note that only substantive changes will need to be submitted for exempt projects. Please refer to the FAMU Standard Operating Procedures for more information about changes to exempt projects that might necessitate an amendment. If you are unsure of whether your project requires an amendment, please contact a research integrity administrator before beginning your revised activities. The investigator is responsible for promptly submitting protocol amendments to the IRB. Amended procedures may not be implemented until the amendment has been reviewed and approved by the IRB unless the change is necessary reduce or eliminate harm. 1. Download the Amendment Request Form. Save the form to your computer for completion. 2. Complete the form and save it to your computer. 3. Sign onto IRBNet and click on My Projects to access the project that you would like to amend

4. Select the correct project by clicking on the project title 5. Access the designer page for the project 6. Click the “Add New Document” icon 7. Add the required amendment documents (see list below) 8. Have the PI sign the package by following the Package Signing instructions 9. Submit the package to the IRB following the Submit this Package instructions, designating the submission type as Modification/Amendment The following documents must be submitted for modification/amendment of expedited or fill board projects. Amendments to exempt projects are not required unless the change could increase risk to participants:

Amendment Request Form Updated protocol application New or revised materials (e.g., informed consent document, measurement tool) – anything that will be affected by the changes you are proposing in

your amendment Additional sections of this guidance document will be added as needed. If you have questions about information in this document or about research integrity in general, please contact one of the research integrity administrators.

Research Integrity Contact Information

Phone: (850) 412-5246 Email: IRB@famu.edu Mail: Office of Animal Welfare and Research Integrity Florida Agricultural and Mechanical University 1515 South Martin Luther King Room 308H Science Research Center Tallahassee, FL 32307 i Information in this guide was obtained from many sources including but not limited to the Code of Federal Regulations (45 CFR 46), the Office for Human Research Protections (http://www.hhs.gov/ohrp), the IRBNet forum, and the Anne Arundel Medical Center IRBNet User Manual.