IRBNet Submission Instructions
IRBNet Submission InstructionsThe purpose of this document is to provide instructions for submitting to the IRB using IRBNet. Please contact the Officeof the IRB for assistance:irb.unm.edu 505.277.2644 IRBMainCampus@unm.eduAll submissions to the UNM IRB are submitted through IRBNet. Should you need additional assistanceusing IRBNet, the OIRB offers workshops and consults. Please see the website for more information.Reference the IRB Submission Checklist to ensure that all required documents are submitted.Instructions for:DescriptionIRBNet New User Registration &ProfileCreating your IRBNet Account and uploading your CITI completionreport and CV to your user profile.2Uploading your CITI training and CVto your IRBNet user profileInstructions on uploading your CITI completion report and CV to youruser profile in IRBNet.4First IRBNet SubmissionHow to submit a new project in IRBNet.Granting or removing IRBNet accessHow to grant or remove IRBNet access for project teammembers.Signing a packageHow to sign a package.Submitting a packageHow to submit a package in IRBNet.Responding to an‘Unlocked’ PackageHow to respond to an ‘unlocked’ package that requiresclarifications as requested by the OIRB.Creating a new package for a‘Locked’ IRBNet ProjectHow to create a new submission (package) for a ‘locked’ project.Attaching New documents usingVersion trailsHow to attach new documents and upload revised documents to showa version trails.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 1 of 17Page5-117910121516
IRBNet New User Registration & ProfileAll UNM Main and Branch Campus Investigators that need to submit an IRB application must create an IRBNet Account inorder to utilize the system.Instructions to complete new user registration:1. Go to www.irbnet.org and click on the New User registration link.Continue2. Follow the on-screen instructions to create a new user account and click on the In the ‘Username’ text field, enter your preferred username. In the ‘Password’ text field, enter a password that is 8 characters long.3. Read the “IRBNet: Individual User Terms of Use” and click on the Accept button.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 2 of 17button.
4. Follow the on-screen instructions to add your affiliation with UNM and click on the Continuebutton.a. In the ‘Search for an organization’ text field, type “Mexico.”b. Make sure that ‘Research Institutions’ is the only box checked.c. Click on the Display button.d. In the ‘Your Organization’ box, select “University of New Mexico, Albuquerque NM.”University of New Mexico, Albuquerque, NM5. Follow the on-screen instructions to enter your contact information and click on the Continue button. In the Telephone Number field, please enter a number that the IRB can use to reach you. Often times theIRB calls to address urgent concerns like “fast track” requests. In the ‘Email’ text field, enter an e-mail address that you check regularly as the IRB communicates primarilythrough email. This does not have to be your UNM email.6. Review your information and edit as necessary. Click on the Register button. IRBNet will send an e-mail to yourUNM e-mail address that you provided in step 5. You will need to open this message and click on the linkprovided to activate your account. After you have successfully activated your IRBNet account, log into the IRBNetsystem to manage your user profile and submit IRB submissions.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 3 of 17
Uploading CITI training and CV to your IRBNet user profile1. Go to http://www.irbnet.org and log in using your IRBNet account username and password.2. Click on the User Profile link (upper-right of screen next to logout).3. Review and edit your IRBNet user account and affiliations as necessary.4. Scroll down to the ‘Training & Credentials’ section and click onAdd a New Training & Credentials Record5. You will see a table that shows any trainings that you have previously uploaded. Click on the radial button next toany training that you wish to update. If you are uploading a new training click none of these and continue.6. To upload a CV/Resume:a. In the ‘Document Type’ drop-down menu, select ‘CV/Resume’.b. In the ‘Effective Date’ field, click theCalendar icon and select the date that your CV/Resume wasupdated.c.Click on the Choose File button and search your computer for your current CV/Resume to upload intoyour user profile.d. When you are satisfied with the information provided, click on the Attach button.7. To upload CITI training:a. In the ‘Document Type’ drop-down menu, select ‘CITI – Human Subjects Research.b. In the ‘Effective Date’ field, click on the Calendar icon and select the date that you passed the course.c. Click on the Choose File button and search your computer for your current CITI Completion Report toupload into your user profile. Please upload the completion report that lists the module titles.d. When you are satisfied with the information provided, click on the Attach button.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 4 of 17
First IRBNet SubmissionThe initial submission of a project in IRBNet is called a New Project. Follow the IRB Submission Checklist to ensureall necessary documents are attached. The submission checklist can be found on the IRB website: irb.unm.edu.Instructions to submit your first IRBNet submission:1. Go to http://www.irbnet.org and log in using your IRBNet account username and password.2. Click on the Create New Project button (left of screen). This will direct you to the ‘Project Information’ page.3. Enter the pertinent study information and click on Continue . The ‘Research Institution’ is “University of New Mexico, Albuquerque, NM.” In the ‘Title’ text field, enter title of your project. The title listed in IRBnet should be consistent with thetitle listed on your project information form and protocol. In the ‘Local Principal Investigator’ text fields, enter the First and Last Name and degrees of the UNMPrincipal Investigator of Record1. Please note, the UNM Faculty should be listed as the PrincipalInvestigator in IRBnet and on all IRB forms. In the ‘Keywords’ text field, enter words that will help you quickly identify your project, if any. In the ‘Sponsor’ text field, enter the organization that is providing funding, if any. Leave ‘Internal Reference Number’ text field blank. Click continue. This will take you to the designer page.1Theindividual that is identified as the UNM Principal Investigator must meet the criteria for PI eligibility. Please referto the IRB’s policy on Principal Investigator Eligibility.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 5 of 17
4. Step 1 of the “Designer’ page, provides copies of IRB Forms and Templates that you can download and save toyour computer. Please note that the same forms are available on the IRB website irb.unm.edu on the submissionforms and templates tab. If you have completed some or all of the required forms as noted in the OIRBSubmission Checklist, skip this step and go to step 5 to attach your documents.5. In Step 2 of the ‘Designer’ page, you will upload your completed IRB documents from your computer. Followthe IRB submission checklist to upload the required IRB forms and project documents and also to help identifyand label documents.Click the attach new document button.Search your computer for the documents you would like to upload.In the ‘Document Type’ drop-down menu, select the appropriate document type. The document type thatshould be chosen is listed in the middle column of the IRB submission checklist. If you are unsure of whatto use for a document type, select other.6. Documents that you have attached will appear in the “Documents in this Package” section of the ‘Designer’ page.Review the documents that you have attached to this project and revise information as needed.a) To change the ‘Document Type,’ click the arrow to the left of the document and select theappropriate document type in the dropdown menu.b) You can update the document ‘Description,’ by clicking the text in the description column to edit as needed.c) To download a copy of the document, click the paper icon.d) To edit a document, click the pencil icon.e) To remove/delete a document, click the X icon. IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 6 of 17
7. Click on thebutton to grant permission levels to project team members that have an activeIRBNet account and need to edit, review, and sign project packages. Please note that this does not replace theProject Team Form. Principal Investigator of Record (UNM Faculty) – should be granted full access to edit, review, and sign allIRBNet packages.8. Click on thelink (center-left of screen) In the ‘Search for an organization’ text field, type “Mexico” to quickly find the University of New Mexico. Make sure that ‘Research Institutions’ is the only box checked. Click on the Display button. In the ‘Your Organization’ box, select “University of New Mexico, Albuquerque NM.” Click on the Select Organization button.9. A search box will appear. Type the last name of the individual you would like to grant access. Please notethat the individual must have an active IRBnet account or they will not appear. Locate the individual user. Click on the Radio button next to the ‘Access Type’ you would like to grant them. In the ‘Your Comments’ text field, you may choose to include comments for the individual(s). Click on the Save button.Principal & Lead InvestigatorsProject CoordinatorResearch AssistantRandom IRBNet UserIRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 7 of 17
10. Click on the Project Overview Button to review and edit this package as necessary. Click on the Edit Link to Edit project information such as the Title of the project or Principal Investigator. Click on the designer tab, or link in the center of the screen to review and edit the “documents in thispackage”. Click on the shared link in the center of the screen or the Share this project tab on the left side of thescreen to add or remove project access for a project team member.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 8 of 17
11. Once the Principal Investigator of Record is satisfied with the information provided in this package, the PrincipalInvestigator of Record will need to sign this package. Click on the Sign this Package button (left of screen). Read the attestation and select ‘Principal Investigator’ from the drop-down menu. Click on the Sign button. You will see a pop-up window that will ask you to provide your IRBNetusername and password. Enter your IRBNet Username and Password. Click on the Continue button.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 9 of 17
12. Submitting the package for IRB processing- Submitting the package will lock it to edits or additions; ensurethat your submission is complete before submitting for processing. Follow the OIRB Submission Checklist toensure all necessary documents are attached. Click on the Submit this Package button (left of screen).13. Follow the on-screen instructions to submit this package for IRB review. The default board in the ‘Select a Board’ field will list ‘University of New Mexico IRB, Albuquerque, NM.’ Click on the Continue button. In the ‘Submission Type’ drop-down menu, select the appropriate submission type for this package.In the ‘Your Comments’ text field, you may specify any additional comments to be included in thenotification to the Office of the IRB. Any funding deadlines should be listed here.Click on the Submit button.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 10 of 17
14. You can verify that your new project was submitted but clicking on theProject Overviewtab. The ‘Board Action’ and ‘Project status’ will now say pending review rather than ‘work in progress notsubmitted’. Once your new project has been submitted, you will want keep an eye out for emails sent from IRB staff.To view messages that have been sent click the messages and alerts button. You can view submitted documents by clicking on the designer tab.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 11 of 17
Responding to an ‘Unlocked’ IRBNet Submission PackageThe OIRB staff will ‘unlock’ an IRBNet package for the following situations: The OIRB staff has sent an email noting items are either missing from the package or more information isneeded before sending the package for IRB review. The Principal Investigator has contacted the OIRB Staff requesting to make changes to the package prior to prereview.If any of the above situations are true for your package, follow the instructions below to respond to an unlocked IRBNetsubmission package.Instructions to respond to your unlocked IRBNet submission package:1. Go to http://www.irbnet.org and log in using your IRBNet account username and password.2. Click on the My Project button (left of screen) to go to the ‘My Projects’ page.3. Locate the package that is unlocked and click on the Red Unlocked icon (right of screen). This will take you tothe ‘Designer’ page.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 12 of 17
4. In the ‘Designer’ page, click theView Historylink (upper-center of screen). This will show you themessage that was sent by IRBNet staff outlining what is needed.5. Review the message to see what needs to be edited or added in the ‘Designer’ page. If you need to add a new document, click the ‘attach new document’ button (bottom of screen). To change the ‘Document Type,’ click the arrow to the left of the document and select theappropriate document type in the dropdown menu. To update the ‘Description,’ click the text in the description column and edit as needed. To download a copy of the document, click the paper icon. If you are uploading a revised version of a document that is already listed in the bottom table, click thepencil icon next to the old version in the bottom table, to upload the new version. This will upload thedocument with a version trail. To remove/delete a document, click the X icon.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 13 of 17
a. To confirm that a document has been uploaded to show a version trail, click on the stacked piece of papericon next to the document.b. You will see the new version that you just uploaded (using the pencil) is now connected to the old version. Fordetailed instructions on uploading documents to show a version trail, see page 16.6. When you are satisfied with your revisions, click on the Mark Revisions CompleteLink (upper-center of screen).a. You will see a pop up window. In the ‘Message’ text field, add your message to the OIRB.b. Click on the Continuebutton to ‘lock’ your package.You will see that the package goes from a red unlocked padlock to a green locked padlock and will say ‘Locked – RevisionsComplete.’ OIRB staff will now continue processing the submission.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 14 of 17
Creating a new package for a ‘Locked’ IRBNet ProjectThe Principal Investigator will need to create a new package for the following situations:o Modification Response: Respond to an IRB determination letter to secure approval.o Response: IRB has requested more information prior to making a determination.o Appeal: Submission has been disapproved and the PI would like an appeal for IRB reconsideration.o Continuing Review: The expiration date of the project is approaching and the IRB approval period needs to beextended. Requires a continuing review application form.o Continuing review/progress report: Project has expired and PI wishes to re-activate the project to commenceresearch activities. Requires a continuing review application form.o Amendment: PI intends to make changes to the project. Requires an amendment application form.o Event Report: A reportable event has happened and needs to be reported. Requires an event report form.Instructions to create a new package for a ‘locked’ project:1. Go to http://www.irbnet.org and log in using your IRBNet account username and password.2. Click on the My Projects button (left of screen) to go to the ‘My Projects’ page.3. Locate the project that you want to create a new submission for and clickon the Title of Project . This will take you to the ‘Project Overview’ page.4. Click the Create New Package tab on the left side of the screen.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 15 of 17
Attaching New Documents Using Version Trails1. Attach new documents to this package.a. If the document you are attaching is a new document and not shown in the bottom table on thedesigner page, click attach new document.2. If you have revised a document from a previous package and it is already listed in the bottom table, you willneed to upload the revised document to show a version trail. To do this, click on the pencil icon, next tothe old version in the bottom table (documents from a previous package), to upload the revised version.In the example shown, we will upload a revised version of the project team form to show a version trail byclicking on the pencil next to the project team form in the bottom table.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 16 of 17
3. Once you click on the pencil next to the old version of the project team form in the bottom table,Click choose file to browse your computer to find the revised version that you have saved on yourcomputer. When you have the file chosen, click update.a. The project team form will now move to the top table and will appear in the “Documents inthis Package.” To verify your revised document has been uploaded correctly, (to show aversion trail) click on the stacked piece of paper icon next to the project team form. You willsee the new version that you just uploaded (using the pencil) is now connected to the oldversion.4. Once the Principal Investigator of Record is satisfied with the information provided in this package, thePrincipal Investigator of Record will need to sign this package. Please see instructions for signing apackage on page 9.5. The last step is submitting your package. Submitting the package will lock it to edits or additions.Ensure that your submission is complete before submitting for processing. Please see instructions forsubmitting a package on page 10.IRBNet Submission Instructions v5.5.21UNM Office of the Institutional Review BoardPage 17 of 17
IRBNet Submission Instructions v5.5.21 UNM Office of the Institutional Review Board Page 1 of 17 . IRBNet Submission Instructions . The purposeof this document is to pr
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