How do I register for IRBNet?
To register, go to www.irbnet.org.At the top right of the screen, under the log-in box, click on the link that says “New User Registration” and fill in the information requested. NOTE: This log-in is NOT RELATED to your RAM ID or NETID. You may create any username and password that you like.
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Where are all my old projects?
For projects in RAM2.0, you will still have access to RAM2.0. When these projects expire, you will be required to copy & paste them into a word document and resubmit as a "Continuing Review" using IRBnet.
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How can I access my documents that were submitted through RAM?
Please log into RAM2.0 as you have done in the past. RAM2.0 is only available as a read only archive.
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When is a project ready to submit in IRBNet?
A project is ready to submit in IRBNet when the following has been completed:
1) All application forms have been completed (Exempt, Expedited/Full Board Review or Continuing Review)
2) All appendices have been uploaded to IRBNet.
3) All signatures have been obtained (PI and Department Representative for Initial Applications, PI for Continuing Review and Amendments)
Please DO NOT submit before each of these items have been satisfied. If you submit an incomplete application, we will unlock your project and the review process will be delayed until you address the modifications and mark your revisions complete. Turning in an incomplete application will slow down the review process.
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Where can I find Exempt or Expedited/Full Board Review Application?
You can find all Applications under the “Designer” section of IRBNet. NOTE: To access the Designer page, you must be within your project on IRBNet (click the title of the project under My Projects) for the Project Administration menu to appear on the left side of your screen. Once in the Designer section, click "Add New Document" at the bottom of the page. Under the second box titled "On-Line Document," select the appropriate IRB Application (Exempt or Expedited/Full Board/ or Continuing Review) and click “add” and follow the prompts to complete the form.
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When and why do I need an Exempt or Expedited/Full Board Review Application (IRB Application)?
You need an Exempt or Expedited/Full Board Review Application when:
1. You are submitting a new project to the IRB committee for review.
2. If your project existed before the switch to IRBNet, you will need to submit Continuing Review in IRBNet when it has expired.
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What is a Waiver of Consent and where do I find this in IRBNet?
A Waiver of Consent is a request to waive/alter some or all of the informed consent elements. If you wish to do this, please refer to Section 17 - Consent/Assent Process and Documents on the IRB Application.
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration;
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation. You may request a waiver of informed consent by including responses, in your application, to the above listed waiver criteria.
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My project was approved by the IRB Committee and now it's coming up for a renewal. How do I get my consent forms?
Please use the most recently approved consent form. This will supersede the previous submission.
To obtain consent forms, go to the Designer Page and locate the list of Documents in the package. Click on the “paper icon” next to the consent form to download a copy and print.
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What is the Lock Status? What does “locked” and “unlocked” mean?
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Lock Status
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Color of Lock
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What does it mean?
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“Locked”
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Grey
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A project has been submitted and is currently under review by the IRB.
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“Unlocked – Revisions Pending”
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Red
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The IRB has decided that revisions must be made to a project. By unlocking, the IRB has stopped their review until the edits are complete.
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“Locked – Revisions Complete”
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Green
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The investigators have addressed the requested modifications and the IRB can continue their review.
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What are Messages & Alerts in IRBNet?
The Messages & Alerts function, located at the bottom of the left side toolbar, presents a complete history for each individual protocol. Any messages that are sent between investigators or between investigators and the IRB office can be found here. If modifications are requested, a copy of the requested adjustments can also be found here. This is a useful tool in projects that have multiple team members to help keep track of the actions taken on your project.
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Modifications have been requested by the Office of Research Administration. How do I change documents previously submitted?
When making modifications to documents within IRBNet, we request that you remove the old documents and upload and rename the new ones. This will accelerate the process if the changes are clear to our reviewers.
For example, you need to make a change to Section 6 of your Initial Application. Go to your hard drive, make the necessary modifications, and upload the document onto IRBNet. Title the document "Initial Application REVISED." Remember to delete the original application to avoid confusion.
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I have completed the modifications requested. How do I Mark Revisions Complete?
Once you have completed the modifications requested by, you must Mark Revisions Complete to notify the IRB that they may continue the review of your application. To do so, go to the Designer page, located under the Project Administration menu on the left hand side. At the top of the page, you will see “This package is” followed by the lock status; the status will read “Unlocked – Revisions Pending” and the lock will be red. To Mark Revisions Complete, click the second link to the right of the Lock Status, “Mark Revisions Complete.” The lock will then turn green and read “Locked – Revisions Complete.”
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Glossary of Terms in IRB Net
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IRB Net Term
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Meaning
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Mark Revisions Complete
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Term used when making modifications to a protocol that is currently being reviewed by the IRB. This link can be found next to the Lock Status on the Designer Page.
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Submission is Locked
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Refers to the Lock Status function. When your submission is locked, you cannot make any edits to your project as it is under review by the IRB.
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Submission is Unlocked
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Also refers to the Lock Status function. Your submission may be unlocked by the IRB office because modifications are needed or upon request of the Principal Investigator.
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Package
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Each project submitted to IRB Net is a package. Each package has its own unique package number. Each time a new submission is made, you submit it under the same package number, but the submission number will change.
For example “123456-1” is an Initial Application. If you submitted an Amendment, the number would change to “123456-2.”
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Internal Reference Number
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This function is completely optional. If your department has their own numbering system, separate from the IRB, this is where you could include your own project number. This number cannot be seen by the IRB, only the investigators.
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Local Board Reference Number
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If you are submitting an Amendment or Continuing Review, this will be your previous IRB approval number. This will help the IRB Office link your IRBNet submission with your previously approved transactions.
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Amendment
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This is the new term for Addendum.
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Continuing Review/Progress Report
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This is the new term for Renewal.
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Department Representative
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This is the new term for IRB Liaison.
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What does it mean to Share a Project? How do I share my projects with other investigators?
Sharing a project in IRB Net gives others access to your research. There are three levels of access when sharing:
Signature Only (Read): Users whose ONLY role is to sign off on project documentation should be granted "Read" access. Users with Read access can view project documentation, communicate with the project team and add their signature. NOTE: Read access should be provided to ALL IRB Liaisons.
Write: Users that are granted "Write" access can view and edit project documents, collaborate with other users and add their signature, but MAY NOT grant access to other users, submit packages for review or perform any other administrative functions.
Full: Users that are granted "Full" access can perform all functions without restriction. This includes editing project documents, sharing the project with other users, submitting document packages for review and deleting document packages. NOTE: ONLY Project Owners with day-to-day responsibility for the project should be granted Full access. Users with Full access will receive automatic email copies of all project notifications and alerts that are sent to the Project Owners.
To share your project, find “Share My Project” under the Project Administration menu. Then, click the first blue link titled “share.” Select the Oakland University as the organization. Then, at the bottom of the page you will see a search box to search for users by last name. If you cannot find a researcher, please see Question 17.
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17) I want to Share My Project with someone and cannot find them when I search for them. What do I do?
If you cannot find someone within IRBNet, this means that they have not yet registered with IRBNet. Every member at the Oakland University – MUST have their own unique username and password. The IRB Office will not create a username/password for any member of our research community.
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18) How do I Sign a Project within IRBNet?
To Sign a Project, go under the Project Administration menu and click “Sign This Package.” Then, in the drop down box next to your name, select your affiliation with the project (i.e. Principal Investigator, Co-Investigator, Department Representative) and click “sign” at the bottom of the screen. NOTE: You must be shared on the project in order to view the project and sign. For instructions on sharing, see Question 16.
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How do I submit a project on IRB Net?
To submit a project on IRB Net, find the Project Administration menu and click “Submit This Package.” Then, under Search for Organization, find Oakland University. Now, you should see two different options for Oakland University. Please select “Oakland University- IRB.” Then, select your Submission Type (i.e., new project, amendment, continuing review) and any comments you wish to include. Finally, click “submit.”
NOTE: Please be careful when selecting where to submit your project to as there are two review boards at the Oakland University, the IRB (human subjects only) and the IACUC (animal research only). Selecting the incorrect board will require your application to be withdrawn and then will need to be resubmitted to the correct board. This will DELAY your REVIEW and APPROVAL.
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