Here are some of the most frequently asked questions that our staff receives. Click on a question to see the corresponding answer.
Which level of review is required: exempt, expedited or full board review?
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:
How do I submit my application?
IRB submissions are made electronically via InfoEd. Read about electronic submission using UConn InfoEd.
Which form should I use?
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.
Which Consent Form template should I use?
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.
How long does a review take? When will I receive approval?
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.
What is the policy with regard to students serving as principal investigators for human subject protocols?
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 http://policy.uconn.edu/?p=975).
How do I add Undergraduate Students to InfoEd?
Click here to add undergraduate students to InfoEd prior to adding these as key personnel on the Appendix A form.
What if an external investigator is involved with the study?
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.
How often does the IRB review an approved study?
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.
Protocols requiring full IRB review must be submitted 8 weeks before the expiration date.
Expeditable protocols must be submitted 4 weeks before the expiration date.
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.
What is the difference between “anonymity” and “confidentiality”?
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 Confidential Data, Information Technology Policy.
How long am I required to retain records?
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.
How do I get help or support?
Please contact the IRB Office for help.