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IRB Submissions, Forms & Templates

NEW studies with external funding and studies with more than 2 external collaborators/study personnel are now submitted to BRANY IRB.

 

Please visit the BRANY IRB tab under IRB Reliance for more information.

IRB Submission Software 

Human Subject applications, protocols and associated supplemental materials are submitted to the IRB using the Human Subjects/IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu. See the How To Guides for more information on using InfoEd, including step-by-step instructions for creating initial and other types of IRB submissions (amendments, requests for continuation/closure, and reportable information or events including protocol deviations or adverse events). For technical assistance using InfoEd, email era-support@uconn.edu or call 860.486.7944. The eRA Help Desk is staffed Monday-Friday, 8:00 a.m. to 4:30 p.m.

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 key personnel on the Appendix A Personnel form. Adding the students before completing the Appendix A form will result in less time and effort completing the form.

Uploading CITI training completion reports to InfoEd

Please follow these instructions for uploading CITI completion reports as part of your IRB protocol submission. Completion reports are required only when (1) adding UConn personnel who completed training elsewhere or (2) adding non-UConn personnel.

Submission Forms

For assistance with preparing your IRB submissions forms, contact the IRB Office at irb@uconn.edu to schedule an individual help session.

Human Subjects Research (HSR) Determination

Investigators who are unsure if their proposed activity constitutes “human subjects research” according to federal regulations, may submit a Human Subjects Research (HSR) Determination Form through InfoEd. The IRB Chair and/or their designee will determine if the proposed activity meets the regulatory definitions of “human subjects” and “research” and advise as to next steps regarding 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 not been developed.  A sponsor may require this certification if the specific activities of the research have not yet been determined because there is significant activity needed prior to involving human subjects (i.e., development of measures, animal studies).  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

For help submitting the HSR determination form using InfoEd see this help guide.

Submission Components

For initial submission to the IRB, please submit the following components listed below. The IRB may request additional forms or information that are specific to the research and will assist the IRB review of the submission. Please note that students may not serve as PI, a faculty PI must be named and oversee student-initiated research.

Exempt & Limited Submissions:

  1. IRB-5 electronic application form. This form is located in InfoEd;
  2. IRB-5 Word document Study Protocol;
  3. Appendix A Personnel form for studies with key personnel in addition to the PI (or student and faculty advisor). This form is located in InfoEd;
  4. Data Security Assessment Form;
  5. Consent Forms, Assent Forms, Parental Permission forms (as applicable), Consent Scripts and Information Sheets;
  6. Recruitment materials, including advertisements intended to be seen or heard by potential study participants;
  7. Letter(s) of permission from any non-UConn-Storrs sites; or, when applicable, documentation of IRB approval or exemption from the external site;
  8. Any other participant-facing materials (e.g., questionnaires, surveys, diaries, instructions, screening, etc.);
  9. Internal UConn grant application, when applicable;

Quick Tips for Exempt Submissions

Expedited & Full Board Submissions:

  1. IRB-1 electronic application form. This form is located in InfoEd;
  2. Study Protocol (see templates below);
  3. Appendix A Personnel form (unless study involves only PI or student and faculty advisor). This form is located in InfoEd;
  4. Data Security Assessment Form;
  5. Consent Forms, Assent Forms, Parental Permission forms (as applicable), Consent Scripts and Information Sheets;
  6. Recruitment materials, including advertisements intended to be seen or heard by potential study participants;
  7. Letter(s) of permission from any non-UConn-Storrs sites; or, when applicable, documentation of IRB approval or exemption from the external site;
  8. Any other participant-facing materials (e.g., questionnaires, surveys, diaries, instructions, screening, etc.);
  9. Details (e.g., investigator brochure, labeling, instructions for use, diagrams, etc.) concerning any test articles being evaluated

Study Protocol Forms

Standard Protocol Template

IRB-5 Study Protocol for Exempt and Limited IRB Review

IRB-9 — Ethnographic Protocol Template

Repository Protocol Template

Data Security Assessment Form

Supplemental Forms

dbGaP Access Assurance Form

Faculty Review Sheet, to aid in the review of student projects

Templates

Consent 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

For Non-exempt (Expedited, Full Board Review) Studies:

Adult Consent Form Template

Simplified Consent Form Template 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 (for participants under 18 years old)

Assent Form for Minor Participants (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.

For Exempt/Limited Studies:

Exempt Study Adult Prospective Agreement/Consent Form Template

Exempt Study Parent Prospective Agreement/Permission Form Template (for participants under 18 years old)

Exempt Study Assent Form for Minor Participants (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)