Forms

Subrecipient Information and Compliance Form – To be provided along with subaward proposal documentation (scope of work, detailed budget and budget justification, additional documents required by proposal guidelines) when forwarded to Pre-Award Services (as part of an initial prime application/proposal) or in support of requests to sponsor for post-award addition of subaward/subcontract

Subrecipient Profile Questionnaire – Requested from subrecipients who are not members of the Federal Demonstration Partnership (FDP) to collect information used during required SPS risk assessment

Other Resources

The IBC is actively recruiting new committee members!

If you are interested in joining an exciting committee that oversees biological research at UConn, email ibc@uconn.edu or the IBC Program Director at danielle.delage@uconn.edu.

 

---

 

Compliance with the NIH Guidelines is a requirement for every institution that conducts rsNA activities and receives NIH funding. Since UConn receives NIH funding, compliance is a term and condition of funding for all labs handling rsNA constructs at UConn. It should be noted that the NIH Guidelines may be applicable to experimental activities, regardless of the project’s funding source.

 

Section IV-B-2-a of the Guidelines requires an institution to maintain an IBC that comprises of no fewer than five members, two of which must include community members unaffiliated with the institution. The UConn IBC consists of faculty, staff, and community representatives, all of whom contribute to the professional competency necessary to review the broad scope of research and teaching activities at the university.

 

---

 

Dual Use Research of Concern (DURC) &
Potential Pandemic Pathogen Care and Oversight (P3CO)

 

Research involving biological agents and toxins is essential to the scientific advances that improve national and global health and safety. Such research does not come without potential biosafety and biosecurity risks. Work with pathogens and toxins must be carefully considered. Appropriate risk mitigation strategies must be implemented to protect personnel and public health and safety.

Current regulations, policies, and guidelines regarding oversight for such work are as follows:

1. 2012 Federal DURC Policy
2. 2014 Institutional DURC Policy
3. 2017 OSTP Potential Pandemic Pathogen Care and Oversight (P3CO)
4. 2017 HHS P3CO Framework

 

*Pending Updates to Federal Policy*

 

USG Policy for Oversight of DURC &
Pathogens with Enhanced Pandemic Potential (PEPP)

 

In May of 2024, the United State Government issued the Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (herein referred to as the DURC/PEPP Policy). DURC/PEPP Policy will supersede previous DURC and P3CO Framework Policies. The policy includes new oversight roles for researchers, applicants, recipients, and federal funding agencies. The DURC/PEPP Policy addresses the identification and mitigation of biosafety, biosecurity, and information risks associated with manipulation of certain pathogens that could cause significant harm to society, be it accidental or intentional. Updates reflect the evolving nature of scientific and technological risks.

Implementation Guidance was released alongside the Policy, which comprises a set of explanatory materials and tools designed to aid PIs, research institutions, institutional review entities (IREs), and federal funding agencies with implementation.

NIH issued a notice on January 10, 2025. NIH intends to implement the DURC/PEPP Policy effective May 6, 2025. NIH will provide additional details and requirements, including applicable grant and cooperative agreement activity codes, specific implementation timelines, and information regarding implementation for other NIH funding mechanisms, in future Guide Notices.

 

Overview of Changes

1. Applicable to federal funding agencies that sponsor covered research, and non-federally funded research at institutions that receive federal funding, via term and condition awards.
2. Responsibilities:
   • Principal Investigators (PIs) – Assess research to identify covered research, and report to sponsor and IRE. Work with IRE to draft risk benefit analysis, and risk mitigation plans.
   • Research Institutions – Established and implement policies to fulfill role of IRE.
3. Expands scope of covered research – two categories:
   • Category 1 = DURC
     • Current DURC covers 15 agents. New policy includes all BSAT, RG4 pathogens, and subset of RG3 pathogens listed in NIH Guidelines.
     • Current DURC covers 7 experimental outcomes. New policy increased to 9 experimental outcomes.
   • Category 2 = PEPP
     • Any pathogen modified in such a way that is reasonably anticipated to result in a PEPP. Includes the development of new PPPs from non-PPPs, enhancement of existing PPPs, as well as work with eradicated or extinct PPPs.
     • Covers 4 experimental outcomes.

 

The InfoEd Human Subjects module supports the submission and review of human subjects research protocols and related activities.

Major updates to the Human Subjects Module were implemented on December 16, 2024.  The User Guides below apply to the updated application form and procedures.  The How To Materials apply to those who are still working with the old forms and procedures.

Most active studies will need to be migrated to the new form for the system to work as intended. Information and instructions, including important deadlines, are available in the Study Migration Guide.

USER GUIDES – NEW

• User Guide for Researchers
• User Guide for Department Reviewers
• User Guide for Ancillary Reviewers

HOW TO MATERIALS – OLD

• Show or list my existing human subjects IRB protocol applications.pdf Updated
• Search for an existing human subjects IRB protocol application.pdf Updated
• Create a new re-approval (continuation), amendment, protocol deviation, or adverse events submission for an existing approved human subjects IRB protocol.pdf
• Respond to a human subjects IRB protocol application that requires modifications to secure an approval determination.pdf
• Add institutional forms and upload supporting documents for a human subjects IRB protocol – All Submission Types.pdf
• Review and approve human subject IRB protocol routing submissions.pdf

 

For technical issues with InfoEd, please email era-support@UConn.edu.

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.

Cede Application Form

External Personnel Log

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.

Standard Protocol Template

Ethnographic Protocol Template

Repository 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.

Data Security Assessment Form

IND Assessment Worksheet

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.

Sample Recruitment Flyer Template (with tabs).docx

InfoEd IRB module updates were implemented on December 16th!

The IRB Office is pleased to announce that the long-awaited updates to the IRB module of InfoEd were implemented on December 16^th. The updated system will help streamline IRB submission and review processes, making it easier to keep track of your protocols and communications with the IRB staff, and streamline the review process.

IS TRAINING AVAILABLE?  Research Integrity & Compliance will offer weekly training opportunities both in-person and online via WebEx or Teams. They are open to all UConn faculty, staff, and students. A recorded session will be made available for those unable to attend in person. Sign-up links for both in-person and online training sessions are located on our InfoEd Training session webpage.

WHAT IS DIFFERENT?

• Consolidated Smart Forms: With this update, the application forms (e.g., IRB-1, IRB-5, IRB-7, IRB-9) have been consolidated into a single Main Application form that uses logic to drive your experience. If the IRB determines that a different level of review is required, you will not need to start from scratch, you will simply modify the review type and answer the additional questions that populate.
• Updated Protocol Templates: Comprehensive protocol templates have been introduced with enhanced instructions to help research teams understand what the IRB is looking for up front with the goal of reducing back and forth during the review process and reducing the time from submission to approval.
• Responding to IRB Feedback: System enhancements make it easier for study teams to respond to IRB feedback. IRB staff will add comments directly into the electronic form for study team review and response. Modified e-forms and the documents uploaded within them can be compared against historical versions within the system. These enhancements will greatly reduce the need for submitting clean and tracked changes versions of documents.
• Routing: Routing is automated; submitters will not have to add the PI and Department Head to the route for review and sign-off. Automated emails will inform study teams as the submission moves through routing and when it arrives to the IRB.
• Personnel Roles: Personnel roles (i.e., PI, Co-I, Student Investigator, Correspondent) drive who on a study team is able to edit, manage, and submit submissions to the IRB and who will be included on system messages and IRB correspondence. All submissions other than personnel changes and reportable events will be automatically routed to the PI for review and sign-off.
• Amendments: There are three types of amendments: Personnel Changes, Transition Amendments (for transitioning to the new form), and regular Amendments (for changes to the study itself or study materials). Only one amendment can be in process at any given time. Differentiating the amendment types will allow the IRB office to identify personnel changes and transition amendments at a glance so that they can be processed.
• Ancillary Reviews:  In the updated system, there are questions built into the application form that will determine the need for most ancillary reviews (e.g., Privacy, Information Security) and automatically inform the responsible office that a review is needed. This upfront process will help streamline review times.
• Reportable Information/Events: All reports of issues that arise during research or information that is required to be reported to the IRB will be reported using a single smart form. There will no longer be separate forms for Adverse Events and Protocol Deviations.
• Administrative Check-Ins: Exempt studies, studies that do not require submission of a continuing review application, and studies overseen by external IRBs will receive periodic notices to either complete an administrative check-in or a study closure. This will allow the University to have current information about studies and to be able to accurately report.
• IRB Reliance: Requests for UConn to cede IRB review to another IRB, including BRANY IRB, will now be 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. Please see the IRB Reliance pages (IRB Reliance – General, BRANY IRB) for additional information.

WHAT DOES THIS MEAN FOR EXISTING STUDIES?

Most existing studies will need to be migrated to the updated application form for the system to work as intended. Migration will be required before continuing review (starting on March 16, 2025) or with the next submission to the IRB (for studies without continuing review). A study migration guide is forthcoming.

The following studies will need to be migrated:

• Studies that received approval or exemption determination from UConn Storrs IRB prior to the system updates;
• Studies that were approved by an external, non-UConn IRB, that have a record in InfoEd.

The following projects do not need to be migrated:

• Research studies that are closed;
• Determinations that a project is not research or projects that are determined not to involve human subjects (aka NHSR determinations);
• Projects for which data collection is complete and the only remaining activities are data analysis;
• Projects that can be closed because they no longer involve human subjects.

Investigators are encouraged to close studies that are eligible for closure as soon as possible. Studies are eligible for closure when:

1. Enrollment is closed,
2. Interactions and Interventions with participants are complete,
3. Data collection is complete, and
4. Analysis of identifiable information and/or identifiable biospecimens for the purposes of the current research is complete.
5. When the UConn IRB is serving as the IRB of record for other sites, the study may be closed when all sites meet the above criteria.

Simply maintaining identifiable data/biospecimens without using, studying, or analyzing the data/biospecimens does not require an open protocol with the IRB.

WHERE CAN I LEARN MORE? 

The IRB Office (irb@uconn.edu) is always available to answer any questions you may have.

User Guides with step-by-step instructions are available including:

• User Guide for Researchers
• User Guide for Ancillary Reviewers
• User Guide for Department Reviewers

Keep visiting these dedicated InfoEd Update webpages for updated information.