Information for researchers regarding IRBNet submission and IRB protocols in general.
A: Your project is your initial submission to the IRB. You will have a separate project covering each protocol. The project includes not only your protocol submission form and related documents, but also includes information on your co-PIs, submission history, and other general information related to the project. You will only create a new project once for each protocol. Upon initial submission, the project is assigned a six digit project number followed by a hyphen and another number, such as 877632-1. The number after the hyphen is the package number (explained below).
A package is a subcomponent of your project. The initial submission is the first package of the project. After that, you will create a “New package” for all subsequent submissions. Packages can contain revisions to secure approval, continuation requests, or modification requests. Each request should be submitted as a separate package. While the six digit project number remains the same, the package number will increase sequentially for each package submitted. For example, if your initial package had a number of 877632-1, the second package would be numbered 877632-2 and so forth.
Your protocol is the actual document(s) that describes your plan for conducting your research and how to carry it out. The protocol includes the protocol submission form and all related consent documents, appendices, instruments, etc. Your protocol must be followed by all members of the research team.
Q: What are the basic steps to submit a project in IRBNet?
A: The initial submission of the project creates the first package of the project. Each revision/modification/continuation after the original submission requires a new package for the project. To create a new package to submit your revisions, select “Project History” from within the project and click “Add new package” to create a new package. (You will see that the number after the hyphen has increased by one.) From the new package, select the “Designer” tab to add or revise documents, link your CITI training to the package, sign the new package, and then submit the new package. Select “Revisions” as the submission type. Please make sure that the package status shows as having been “submitted” instead of as a “work in progress.” To view step by step instructions and screen shots, click here.
Q: How do I link my CITI training to my User Profile?
A: In your User Profile, scroll down to “External Accounts.” Click “add an external account.” Then enter your CITI Member ID number, not your completion report ID number. Then click “Continue” to finish. Once you add your CITI account to your IRBNet profile, you will be sent an email at the address or record to verify your ownership of the external account. To do this, you will open the verification e-mail and click on the activation link. Training will show as unverified until you click on the activation link in the email. Once you verify the account, CITI importation will take approximately 24 hours to complete. IRBNet will now pull your information directly from CITI and your CITI reports will be available in the Designer tab after the importation has occurred.
Linking your training to your user profile does not link it to each project.
Q: What is the difference between waiver of informed consent and a waiver of the documentation of informed consent?
A: Waiver of informed consent means that the IRB may approve a consent procedures that either doesn't include, or which alters, some of all of the elements of informed consent. 45CFR46.116.
Waiver of the documentation of informed consent means that the consent process is still required, but a signed consent form might not be. An example might be an online survey where the participant signifies consent by clicking a button to proceed to the survey.
Q: How do I request a waiver of informed consent documentation for my survey questionnaire?
A: The Code of Federal Regulations (45 CFR 46.117) allow only two scenarios under which the IRB can waive the requirement of a signed consent form. In Section B.2.b.ii of your protocol, choose the statement below that is the most appropriate for your protocol:
“I am requesting a waiver of documentation of informed consent since the signed consent form will be the only record linking the subject and the research and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.”
“I am requesting a waiver of documentation of informed consent since the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.”