Initial Review of Human Subject Research
The Initial Review of Human Subject Research (Initial IRB Application) is required for all research that requires a human subject component (exempt, expedited, and full convened IRB review).
Submission Process
The IRB uses two applications forms for initial review of human subject research proposals.
- For research requiring full board or expedited review, use the Initial Review of Human Subject Research (Initial IRB Application).
- For research requiring exempt review, use the Exempt IRB Review Application.
In addition to the application, there are many appendices to the Initial IRB Application. Most Principal Investigators (PIs) will seldom use more than a handful of these. These forms are designed to streamline the review process so all information required for review is submitted at time of application.
The Parts of your Application
The IRB Application form is required. There are related application documents, which include a number of application appendices depending on the type of research. Additionally, there are study-specific documents that must be included with the application.
In addition to the required application form and relevant appendices, study-specific documents must be included with the application. [Link to Human Subjects forms page]
Informed Consent
The IRB is responsible for stamping all approved informed consent documents with the URI logo, project reference number, and approval/expiration information. When submitting an informed consent document, be sure to leave the bottom right corner of the document BLANK as this is the location where we upload our stamp. The IRB has developed the templates that the IRB recommends using.
- Informed Consent
- Low Risk Survey Informed Consent
- Child Assent
- Parental permission
Protocol Submission
All information must be submitted through IRBNet.
learn more and access irbnetProtocol Review Process
The length of the approval process is influenced by several varying factors, such as the complexity of a protocol, the risk of the project to the research subjects, and the completeness of documentation. In all circumstances, early submission combined with accurate documentation will result in an expedited approval.
The IRB application process starts with your submission of the application form, consent forms and other required appendices/materials. The ORI staff pre-reviews your application to make sure all of the necessary materials are there for IRB review. The ORI staff will contact you by email if your application or forms are not sufficient and will let you know what needs to be done to get your application ready for review by the IRB.
Submissions are typically reviewed within 10 business days of submission (note the entire review process, including time to make IRB requested revisions may take 5-6 weeks). The most common decisions are approve; approve pending revisions; or assignment to a convened Board (which occurs monthly). Note that only a small percentage of submissions require review by the convened Board. Even so, we encourage you to submit your item as soon as possible. For applications that require review by the convened Board, all application materials must be submitted to the IRB at least three weeks prior to the date of the scheduled IRB meeting.
irb meeting schedule and deadlinesModifications to an Approved Study
Modifications to an approved study require the completion of the amendment form, a revised application with changes highlighted, and any associated appendices. Also required are any new or revised study-specific documents required. Some common examples include:
- New consent form
- New grant application
- New questionnaire
- New recruiting letter
Continuing Review to an Approved Study
Studies that require continuing review are typically approved for one year. Prior to the expiration date, notifications will be sent asking that investigators submit a continuing review for your project. Typical documents that are required for a continuing review are:
- Continuing Review Form
- The most recently used consent document that has been signed, whited out so that all personal information so that it is no longer visible.
- A new, clean copy of the consent document with the bottom right corner BLANK.
Failure to submit a continuing review prior to the expiration date and/or date of the next IRB meeting, will result in the suspension of the protocol.
When completing the continuing review form, evaluate whether your study continues to need IRB Approval. Research where there is no further data collection (including long term follow-up or recontact) or analysis of identifiable/coded data is complete can be closed via the Study Closure Form instead of the continuing review.
Collaborative Research involving Multiple Institutions
The URI IRB must review all URI research unless a formal agreement has been established between ORI and another organization that will conduct the IRB review. For some research activities involving multiple organizations, the URI IRB may be willing to conduct review for the other organizations involved or allow another organization to be the reviewing IRB. This is determined on a case-by-case basis. To ask whether the URI IRB will conduct review for other involved organizations, contact the IRB for more information before submitting your application to the URI IRB. To expedite the IRB review process for collaborative research, URI has joined the SMARTIRB Reliance Agreement.