The InfoEd IRB Module has been updated!
See the InfoEd Updates page for more information. User Guides are also available.
NEW studies with external funding and studies with more than 2 external collaborators/study personnel for which single IRB review (by UConn/BRANY) is being requested are now submitted to BRANY IRB.
Please visit the BRANY IRB tab under IRB Reliance for more information. |
IRB Submission Platform
Applications to the IRB, including requests for review by BRANY IRB, requests for other external IRBs to serve as the reviewing IRB, and Human Subjects Research Determinations and requests are submitted using the Human Subject/IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu. The platform has undergone significant updates, users are strongly encouraged to consult the new User Guides before using the system.
Migration of Existing Studies to the New Application Form
The IRB module of InfoEd was updated on December 16, 2024, The system does not allow for an automatic migration of documents and information from existing InfoEd records. Additionally, the upgraded system includes questions built into the application that were not previously captured electronically. As such, currently approved studies will need to be manually transitioned by the investigator to the upgraded version. Please see the Migration of Study Information guide for details.
Adding Undergraduate Students to InfoEd
Undergraduate students are not auto-populated into InfoEd. Each undergraduate student must be manually added to the system. Click here to add undergraduate students to InfoEd prior to adding these students as personnel on a study. Adding the students before completing the application form will result in less time and effort completing the form as it can take 20 minutes for the student’s name to become available in the system.
Uploading CITI training completion reports to InfoEd
Please follow these instructions for uploading CITI completion reports.docx as part of your IRB protocol submission. Completion reports are only required when (1) adding UConn personnel who completed training elsewhere or (2) adding non-UConn personnel.
Submission Forms
The new IRB application form in InfoEd will ask you to upload certain supplemental forms and materials. Be sure to check this page to ensure that you are using the current versions, most of our forms and materials have been updated or will be updated soon. For assistance with preparing your IRB submissions, contact the IRB Office at irb@uconn.edu to schedule a help session. If you experience technical issues with InfoEd, please contact era-support@uconn.edu.
Human Subjects Research (HSR) Determination
Investigators who are unsure if their proposed activity constitutes “human subjects research” according to federal regulations, may submit a request for a Human Subjects Research (HSR) Determination through InfoEd. Investigators are especially encouraged to submit for a determination when there are plans for dissemination as requests for IRB documentation are increasingly common. Based on the information provided, the IRB Office will determine if the proposed activity meets the regulatory definitions of “human subjects” and “research” and either grant a Not Human Subjects Research (NHSR) letter or advise as to next steps regarding the need to secure formal exemption or approval from the IRB.
This form is also used for 45 CFR 46.118 certifications (aka Approval in Principle, Development Only, Delayed Onset). A grant or contract may require certification of IRB approval as a condition of submitting for or releasing funds but before definitive plans for the involvement of human subjects have been fully developed (e.g., measures or tools need to be developed, animal studies are needed). Refer to 4.1.15.2 in the NIH Grants Policy Statement or the NSF Proposal & Award Policies and Procedures Guide (PAPPG), Chapter II: proposal Preparation Instructions, Section E(5) for information. Note that 45 CFR 46.118 certifications are not limited to proposals submitted to Federal Agencies.
Human Subjects Research (HSR) Determination Form
IRB Reliance Forms
Please see the IRB Reliance pages (IRB Reliance – General, BRANY IRB) for instructions and information about requests for external IRBs to serve as the IRB of record for a study and for requests for the UConn IRB to serve as the IRB of record for other entities (including UConn Health). Requests to cede review to an external IRB, including BRANY IRB, are initiated in InfoEd. Requests for UConn to serve as the IRB of record for other entities are initiated outside of the system using the Request for UConn to Serve as the IRB of Record Form on the IRB Reliance – General webpage.
BRANY IRB template forms are available on the BRANY IRB webpage.
Request for UConn to Serve as the IRB of Record
Protocol Templates
A study protocol must be included with all applications to the IRB for expedited or convened board review. Protocols for exempt studies are optional at this time, but may be requested by the IRB staff when the application alone doesn’t provide sufficient detail.
Ethnographic Protocol Template
Supplemental Forms
Based on study specifics, the IRB Application Form may guide you to upload one or more supplemental forms. A Data Security Assessment Form (DSAF) is required for all exempt, expedited, and convened board submissions.
International Research Supplement
IRB Conflict of Interest (COI) Disclosure Form
Language Translation Certification Form
Request for HIPAA Waiver or Alteration
Sample Demographic Worksheet – for Continuations
Consent/Authorization Templates
Informed Consent Resource for Secondary Research with Data and Biospecimens: https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf
Consent Checklist for Investigators.docx
For Non-exempt (Expedited, Full Board Review) Studies:
Adult Consent Form Template.docx
Simplified Consent Form Template.docx This template may be used in conjunction with the template for the adult consent form for people with communication disorders. Emily Myers, Ph.D. developed this form for research participants with communication disorders, such as aphasia, and generously provided permission for its use by others. This form or another method may be proposed when enrolling individuals with communication disorders where the process will help facilitate comprehension and enable participants to make informed decisions about research participation.
Parent Permission Form Template.docx (for participants under 18 years old)
Assent Form for Minor Participants.docx (under 18 years old) Federal regulations do not dictate how minor assent is documented. This template is designed to be used with younger children with the content of the Adult Consent or Parent Permission Form used as a guide. The assent process should convey the information noted in the assent template using age-appropriate language. Use of this template is not required; Investigators should develop assent processes and forms that are appropriate for the population that they will enroll. For example, when enrolling teens, it may be more appropriate to have an assent form that is similar to the Adult Consent or Parent Permission Form.
HIPAA Authorization Form Template.docx (A HIPAA Authorization Form is needed in addition to a research consent form when the research includes the access, use, or disclosure of Protected Health Information (PHI) unless a waiver of the requirement for authorization is approved or another exception applies (e.g., use of a Limited Data Set with a Data Use Agreement).
For Exempt/Limited Studies:
Exempt Study Adult Prospective Agreement/Consent Form Template.doc
Exempt Study Parent Prospective Agreement/Permission Form Template.doc (for participants under 18 years old)
Exempt Study Assent Form for Minor Participants.docx (under 18 years old) Federal regulations do not dictate how minor assent is documented. This template is designed to be used with younger children with the content of the Adult Consent or Parent Permission Form used as a guide. The assent process should convey the information noted in the assent template using age-appropriate language. Use of this template is not required; Investigators should develop assent processes and forms that are appropriate for the population that they will enroll. For example, when enrolling teens, it may be more appropriate to have an assent form that is similar to the Adult Consent or Parent Permission Form.
Recruitment Flyer Template
Important! When preparing an announcement for the Daily Digest, Lifeline or similar, please be reminded that online platforms often have character limits that could impact study postings; tag lines and headings should provide information about the study and should not emphasize that subjects are paid for participation. The IRB study number is required on any announcement.