Who must apply?

All UConn faculty, student (graduate and undergraduate), and staff planning to conduct “research with human participants” must file an application and receive IRB approval BEFORE starting to advertise, recruit or conduct research procedures. See When Submission to the IRB is Required and Pilot Research and Protocol Development in the IRB Policies and Procedures document.

Is it human subject research?

Human Subject Research is defined by the Federal Regulations and determined by the IRB Chair or the Chair’s designee. See Human Participant Research Determination in the IRB Policies and Procedures document.

What is CITI Training?

All researchers, including students and key personnel such as study coordinators or individuals obtaining consent must complete the online CITI Training course for the protection of human participants in research before the IRB will approve a study. Training is required of all key personnel regardless whether the study qualifies for exempt, expedited or full board review.  Research personnel must renew their training every three years.  See Training for more information.

Can I submit my application electronically?

Yes. Read about electronic submission using UConn InfoEd.

Initial Approval

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.

What 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:

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

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.

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.

 

Re-Approval

Expedited  or Full Board Protocol Applications

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. 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. 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) Protocol 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

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.