Investigators make an initial determination for which type of review is appropriate for their study (full board, expedited, or exempt) and submit the required number of copies of the protocol and supporting documentation.  Upon receipt, the IRB staff, in consultation with the Chair or an IRB member, screens the protocol to verify the investigator’s initial determination.  The protocol is then placed into the appropriate queue for review.  The Chair, or his/her designee, makes the final determination of the type of review required and the appropriate expedited or exempt category. For more information on each type of review, please see:

• Exempt Procedures (New Protocol Submissions)
• Initial Review by Expedited Procedures
• Initial Review by the Full Board

IRB submissions are made electronically via InfoEd. Read about electronic submission using UConn InfoEd.

Form IRB-1: Protocol Application for the Involvement of Human Participants in Research: for Expedited or Full Board Review. Expedited and Full Board studies require the same level of review, so the same form is used for both types of review.  See the next section to determine which level of review is required.

Form IRB-5: Request for Exemption from Continuing IRB Review. The IRB makes exemption determinations.  This category requires initial IRB review, but the study is then exempt from continuing review.  See the next section to determine which level of review is required.

Form IRB-7: Protocol Application for Research Methods Courses (RMC). Course Instructors must submit an application for IRB approval of the types of research projects to be conducted by students in the class.  The IRB-7 protocol will receive expedited review.

Form IRB-9: Protocol Application for Ethnographic/Naturalistic Research.  Ethnographic/naturalistic research activities may require expedited or full board review.  The same form is used for both types of review.  See the next section to determine which level of review is required.

The consent discussion that takes place between an investigator and participant must be captured in a document called an “informed consent form”, or “consent form.”  Ordinarily, all research participants must indicate in writing their willingness to participate in research by signing the consent form. However, signed consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research, or in research where the participants are to remain anonymous. In these cases, the IRB gives an investigator permission to alter the consent process (waiver of signed consent), and the investigator should prepare an information sheet appropriate for the study. Federal regulations identify certain specific elements required for informed consent.  Depending on the nature of the research, the IRB may require additional elements. For more information, see Standard Consent and Documentation section of the IRB Policies and Procedures documentation.

Several factors affect the amount of time a review will take.  These factors include how many other applications were received ahead of yours, whether all investigators on the application have completed the CITI training program, and whether the application is complete or if there is missing information required.  The IRB reviews application in the order in which they were received.  When a new application is received, the IRB Cover Page is stamped, and an IRB protocol number is assigned.  The IRB Cover Page is returned to the Principal Investigator (or Correspondent) to verify receipt.  From the date of receipt, the amount of time a review takes is as follows:

• Exempt reviews generally  take one to two weeks.
• Expedited reviews  generally take two to three weeks, depending on the time of year.  The heaviest submission period is at the  beginning of the semester.
• Full  Board reviews are dictated by the Meeting Dates/Deadlines. IRB determination letters are sent to  investigators within one week of the meeting.   If a protocol determination is deferred, the study must be revised and  be returned to the full board for review.   If the IRB approves the protocol contingent upon minor modifications  being made, the study can be approved as soon as the modifications are made and  approved by the IRB Chair or his/her designee.

For the purposes of submitting protocols through InfoEd, students are now permitted to submit the protocol under their own name. However, the protocol must be routed to the faculty advisor for internal review and approval. Also, when completing the personnel section of the protocol application, the student researcher must change the role automatically assigned by InfoEd when the submission is created. The student must change the role from principal investigator (PI) to student researcher. When adding the faculty advisor to the list of key personnel, that faculty member must be given the PI role. Finally, it is important that the student researcher add the faculty member PI as a delegate to the student’s InfoEd user profile so that the faculty member can, at any time, access the protocol record. Please note: The designation of the student researcher as PI in InfoEd is solely to facilitate the online application process. In accord with UConn policies, the official PI may not be the student researcher (refer to the Eligibility for Principal Investigator Status Policy at https://policy.uconn.edu/2022/12/22/principal-investigator-eligibility-on-sponsored-projects-policy-on/).

Click here to add undergraduate students to InfoEd prior to adding these as key personnel on the Appendix A form.

IRB approval must be obtained from each collaborating institution that has an IRB before research is initiated at those sites. Investigators should identify all collaborating sites in the protocol application and indicate which aspects of the research will take place at each site. The protocol will not be approved until each individual IRB has granted approval. In some circumstances, it is possible to designate one IRB as the IRB of record, whereby one institution’s IRB has responsibility for reviewing the study and the collaborating institutions agree to accept those determinations. UConn Storrs has formal collaborative agreements with several institutions. This decision is made by the IRBs involved, but the PI may request which IRB he/she prefers to be the IRB of record. Generally, the IRB of record will be at the institution where most or all of the research activities will be conducted. Contact the IRB office for more information.

Any investigator listed as a collaborator on a protocol application that is not affiliated with UConn Storrs, with a collaborating institution with an approved  FWA, or otherwise covered by a contract between UConn and a sponsor, will be required  to submit an Individual Investigator Agreement form which will be modeled on  the template provided by the OHRP. The form will  commit the investigator to comply with all relevant IRB determinations, federal, state and local regulations, and UConn policies pertaining to the  prospective review of research studies and the protection of human participants  in research.  Independent investigators  will also be asked to complete the same disclosure of conflict of interest form  that employees of the institution are required to complete.  The conflict of interest committee will be  asked to review such disclosures and determine if a conflict exists, if it is  manageable and if so what actions must be implemented for that management. For additional information about conflict of interest, see FCOI.

Researchers who are unaffiliated with the University but wish to recruit participants on the UConn Storrs campus, the four regional campuses, the School of Social Work, or the School of Law, must request permission from the IRB before recruiting students or employees on UConn campuses (via poster, flyer, email announcement or newspaper ad).  Unaffiliated researchers must submit to the UConn IRB Office,  one copy of the full packet of materials they submitted to the IRB of their own institution, including the letter of IRB approval for the project.  The packet should include, but may not be limited to, the IRB protocol application, consent form or information sheet, recruitment flyer or ad, instruments or measures to be used, and any supporting documentation.  The IRB Chair or his/her designee will review the request and issue a letter of permission to recruit on campus.  The IRB reserves the right to have requests for permission to recruit on campus go to the full board for review and approval, should the Chair or Vice Chair decide that the nature of the study requires the independent scrutiny of the IRB to protect its students and employees.

Expedited or Full Board Applications

Unless the IRB exempts a protocol from continuing review, approved protocols  must periodically be re-reviewed to allow the IRB to assess the continued participation of subjects in the research. The reapproval period is set by the  IRB depending on the nature of the study and risks to the subjects, but in all cases, the reapproval period may not be longer than one year. This means that it is the investigator’s responsibility to submit a request for reapproval on  the IRB-2 form  to the IRB in time for the IRB to review and approve the protocol before its  approval period has expired. The expiration date is stamped on the front of  each approved IRB application and Consent Form.

Please Note: The “Re-approval/Completion form (IRB-2) for re-approvals will be returned to investigators if the “Findings” section is not updated annually. Copying prior information onto the IRB-2 will not be accepted, since duplicating the findings information from a prior year does not provide an explanation for the last year’s research activities.  This also applies to studies that are in data analysis.

If the protocol’s approval  expires subjects may not be enrolled nor may research procedures continue until the PI receives the reapproval letter from the IRB Chair. If research continues beyond the expiration date, it is considered to be unapproved research.  As a courtesy, the IRB staff sends reapproval reminders to investigators, but the investigator is responsible for submitting  the reapproval on time.

• See Lapse in Approval

Protocols  requiring full IRB review must be submitted 8 weeks before the expiration date.

• See Meeting Dates and Deadlines.
• See Continuing Review by the Full Board.

Expeditable protocols must be submitted 4 weeks before the expiration date.

• See Continuing Review by Expedited  Procedures.

Research Methods Course (RMC) Applications

Approved RMC protocols also must be periodically re-reviewed. It is the course instructor’s responsibility to submit a request for reapproval on Form IRB-8 to the IRB before the protocol’s approval expires.

Amendments to Approved Research

Any change to an approved protocol must be approved by the IRB before being implemented. This includes changes that reduce risks to subjects as well as administrative changes such as adding or removing investigators. Amendments are to be reported to the Institutional Review Board using the Amendment request form (IRB-3).

• See Submission of Request for Amendment
• See Review of Amendments by  Expedited Review
• See Review of Amendments by Full Board  Review

The IRB only recognizes one exception to this rule, specifically where the change is necessary to eliminate apparent immediate hazards to the subjects. In such cases, the investigator must submit a report to the IRB explaining the event as a protocol deviation on Form IRB-6.

Research studies cannot be both confidential and anonymous.  "Anonymity" means that no one, not even the researcher, will be able to connect the participant’s responses to his or her identity.  Identifiable information should not be collected from research participants unless it is essential to the study protocol.  "Confidentiality" means that the researcher will be able to connect the participant's responses to his or her identity, but that the information will not be released to anyone else.  Researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses.

For example:  A study is considered to be “anonymous” if it is not collecting specific identifiable information (such as names, social security numbers, etc.) or the study is not collecting information in such a way that the answers that someone gives to the questions could be tied together to allow for identification (this is called deductive disclosure).

Here are some ways to protect confidentiality:

• Use study codes on data documents (e.g., completed questionnaire) instead of recording identifying information and keep a separate document that links the study code to subjects’ identifying information locked in a separate location and restrict access to this document (e.g., only allowing primary investigators access);
• Encrypt identifiable data;
• Remove face sheets containing identifiers (e.g., names and addresses) from survey instruments containing data after receiving from study participants;
• Properly dispose, destroy, or delete study data / documents;
• Limit access to identifiable information;
• Securely store data documents within locked locations or University Servers; and
• Follow the University’s Data Classification Policy.

The Federal regulations on human subject protection in research require that all research-related records be retained for at least 3 years after the study has been completed. Individual funding sources, federal or private, may have increased record retention periods; check your funding source for this information. All research records at the University shall be accessible for inspection and copying by the IRB, the IRB Monitor, Research Compliance Services and applicable federal agencies or research sponsors. For externally funded studies, information about financial record retention requirements is provided by the Records Compliance.

Per FDA regulations for investigational new drugs (21 CFR 312.62) investigators must retain records for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it was investigated; or, if no application is to be filed, or if the application is not approved for such indications, until 2 years after the investigation is discontinued and the FDA is notified.

Per FDA regulations for investigational devices (21 CFR 812.140) an investigator or sponsor shall maintain the study records during the investigation and for a period of 2 years after the latter of the following two dates: the date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.  An investigator or sponsor may withdraw from the responsibility to maintain records for the period required and transfer custody of the records to any other person who will accept responsibility for them ( including the requirements of § 812.145). Notice of a transfer must be given to FDA no later than 10 working days after transfer occurs.

IRB Study Records

IRB staff will retain records in accordance with Federal regulations. Connecticut currently has no required retention period for IRB records. The IRB will maintain complete files of all active studies on site. The IRB staff arranges to have closed study files moved to a permanent, secure location in the basement of the Whetten Graduate Center for archiving.  Files may not be destroyed until after Federal retention requirements are met. A list of closed files is available from the InfoEd database. Files are retrievable immediately for future reference to allow for inspection and copying by regulatory agencies, including the OHRP and FDA, at reasonable times and in a reasonable manner.

IRB Meeting Documentation

The IRB staff maintains a hard copy of the agenda and meeting minutes in 3-ring binders. Hard copies of the approved list of exempt and expedited protocols, a status report of protocols previously reviewed at IRB meetings, and educational materials are also attached to the minutes and retained in the binder.  A hard copy of the minutes is also provided to the Institutional Official. The IRB staff also maintains electronic copies of the agendas and minutes for a given calendar year in a folder shared by RICS and IRB staff. The IRB staff maintains hard copy files of meeting documentation on site for at least three years. The IRB staff may archive these files as dictated by space needs. Files are not destroyed. Files are retrievable immediately to allow for inspection and copying by regulatory agencies, including the OHRP and FDA, at reasonable times and in a reasonable manner.

• Assistant/Associate/Full Professors in a tenured/tenure-track position
• Clinical and extension faculty
• Assistant/Associate/Full Professors-in-Residence
• The SFF is open to faculty who do not have access to any investigator accounts with balances over $500.00
• Storrs and Regional campus faculty only. UConn Health faculty are not eligible

• UConn-hosted conferences, symposia, seminars, colloquia or workshops (support for planning and implementation but not attendance; events funded under this category must have a faculty facing research/scholarship focus; professional development/teaching development workshops are not eligible).
• Small start-up/pilot data projects in support of applications to external sponsors
• Test new procedures/methodologies
• Creative/scholarly projects in support of gallery shows or exhibitions
• Library/archival research leading to book/monograph
• Costs to bring book-length manuscripts to publication (textbooks not eligible)
• Publication costs (including open-access journal costs, copy-editing, etc.)
• Sabbatical projects
• Contractual services (including statistical consulting, graphic artists, website design, etc.)
• Other categories: any activity that does not fall under one of the categories above may be considered, provided a sufficient rationale is given.

Requests for SFF support must be submitted through the UConn Quest Portal’s online application form, and should include:

• Project Description (Limit: 2000 characters/250 words). Describe the activities you wish to undertake in the project, the scholarly products (publications, grant applications etc.) that these activities will enable, and your proposed timeline for these activities.
• Budget and Justification (Limit: 2000 characters/250 words). Break down (itemize) the costs related to this project and provide justification as to why each is necessary and reasonable for the work described in the project description.  It is important to list each cost separately and provide information regarding how cost estimates have been reached.
  • The following items cannot be requested: faculty, clerical or administrative personnel salaries, including personnel whose primary purpose is to explore funding sources and/or prepare grant applications; service/maintenance contracts on equipment; laboratory renovations, or other infrastructure renovations; institutional memberships in professional organizations; travel to professional meetings to present the results of research; travel to explore extramural funding opportunities. SFF budgets must specify how funds will be used to advance/complete a specific aspect of a faculty project; SFF funds will not be granted solely to provide support or gap funding for personnel.
• Funding Need (Limit: 2000 characters/250 words). Please detail your efforts in finding other sources of funding for this project and include all other sources of funding you may have available for this project. You should include external funding earmarked for this project, available start-up or IDC funds, and any cost-matches that have been offered by department or school/college. Please also describe the importance of SFF funding for the continuation/success of the project. Providing some level of explanation of the funding need (even if there are no other resources available) is critical for contextualizing SFF requests.  Requests that do not address funding need will have lower funding priority.
  • Detail your efforts in finding other sources of funding for this project
  • Include external funding earmarked for this project and what it will cover
  • Discuss existing start-up or IDC funds and what they will cover or why they are not available for the project
  • Describe any cost-matches that have been offered by department or school/college. The effort by the PI to request funding from and the willingness of other units to contribute to the costs of the project will be viewed as a positive factor when evaluating SFF requests
  • Describe the importance of SFF funding for the continuation/success of the project.

• Requests are generally for a 1 year period, however, funds will be deposited into the PI’s IDC account, and will not expire. It is expected that funds will be used as described in the original application. Major changes to how the funds are to be used should be discussed with the OVPR before proceeding. Small amounts of leftover funds (after the SFF project is complete) may be used by PIs for other research-related costs at their discretion.
• Additional documentation may be required such as evidence of manuscript acceptance, book contract, exhibition date, etc. prior to award being made.
• SFF budgets must specify how funds will be used to advance/complete a specific aspect of a faculty research/scholarly project
• Salary support for faculty members (AY or summer) is generally not an allowable cost on SFF awards.
• Student-led research projects are not eligible for SFF funding.
• Projects focused on curriculum development or teaching are only eligible if they contribute to a program of pedagogical research and lead to appropriate scholarly products.
• SFF funds will not be granted solely to provide support or gap funding for personnel.
• Funds will not be granted retroactively (i.e. for activities that take place before the award period)
• If your project is approved, a project report must be submitted by the PI at project completion, and the OVPR will request annual updates on project outcomes for a few years following the award.

Awards are made based on the strength/completeness of the project description/budget, the applicant’s existing funding resources, imminent need, and recent internal funding history. Applications from early career investigators are given slight priority over applications from more established faculty members.

Reporting requirements:

• Reporting requirements: PIs will need to prepare a brief report, using this Award Report Template to summarize project progress within one month of posting final expenses unless an extension from the OVPR has been received.
• Further reports on project outcomes may be requested in the future to track return on investment.