IRB approval must be obtained prior to initiating any research activity that meets either the DHHS definition of research involving human participants or the FDA definition of clinical investigation involving human participants and prior to implementing amendments to previously approved research (except when necessary to eliminate apparent immediate hazards to participants).  The IRB will publish submission deadlines for studies requiring review by the convened board at the start of each semester.  New submissions requesting expedited review or exempt status can be submitted at any time and are reviewed on an on-going basis.

All forms required for an IRB submission are available on the IRB website.  The PI is responsible for submitting complete forms and required supporting documentation.  The PI must sign all submissions.  Students are required to sign the submission when the research is student initiated (research is related to the doctoral dissertation or master’s degree).  The signature of the Department Head or Dean is required for all submissions unless the research is funded by an external grant or contract.  The signature of the medical monitor is required for interventional studies that are monitored by a physician.  The IRB staff and reviewer reserve the right to return any submission that is incomplete or on out-dated forms.

Determination of Level of 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 PI’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.

When Submission to the IRB is Required

A protocol application must be submitted to the IRB for any study for which research is the intent and the researcher proposes to use or involve any of the following:

• identifiable data collected for non-research purposes (e.g., academic or medical records);
• interaction (communication or interpersonal contact between investigator and participant) through interviews, surveys, and other forms of communication;
• intervention (physical procedures by which data are gathered and manipulations of the participant or the participant’s environment that are performed for research purposes);
• student research projects conducted as part of Research Methods Courses;
• access to medical records and data through the medical information systems;
• pathological specimens (directly identifiable or identifiable via codes);
• diagnostic specimens (directly identifiable or identifiable via codes).

The IRB reviews projects when the research:

• is sponsored by the institution;
• is conducted by or under the direction of an employee or agent of the institution in relation to his/her institutional responsibilities;
• is conducted by or under the direction of an employee or agent of the institution using resources of the institution; or
• involves the use of the institution’s non-public information (i.e. alumni, students, staff, etc.) to identify or contact human research participants or prospective participants.

 

Pilot Research and Protocol Development

Per 45 CFR 46.102, Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

In some cases, the UConn IRB must review pilot research and protocol development, including but not limited to the following activities:

• • Development and testing of instruments or measures on human subjects* (even if it is just one subject);
  • Testing of research procedures on human subjects*;
  • Procedures done on human subjects* for the purpose of refining research design.
  • Data collected that will be used solely or in combination with other data for purposes of publication, reports or presentation;
  • Development and testing procedures on human subjects* involving needles, catheters, radiation, drugs or devices that are swallowed or inserted in an orifice require IRB approval.

*Please note that the Office for Human Research Protections (OHRP) considers the Principal Investigator as well as all research personnel to be human subjects if testing procedures are to be conducted on them.  Therefore, even when pilot tests are conducted on study personnel, the protocol must be reviewed and approved by the IRB prior to initiation.  Please refer to the policy on the Involvement of UConn Students and Employees in Research.

Pilot studies should be identified as such in applications to the IRB. The informed consent process must explain to subjects that the research is a pilot study.

 

Procedures that are not considered to be pilot research and do not need to be reviewed by the IRB include, but may not be limited to, the following:

• Training programs designed to teach proven methods that will be used during the conduct of research (i.e., blood drawing training, interview techniques training);
• Refining data collection procedures or preparation of an instrument, such as a survey.  For instance, “How could this survey question be misunderstood?”, or “In what order should survey instruments be distributed?”  This type of study development does not contribute to generalizable knowledge, and therefore is not considered research and does not require IRB review.  Such data cannot be used in publications or reports.

 

Meeting Schedule and Submission Deadlines

The meeting schedule and submission deadlines are posted on the web.  Adjustments to the meeting schedule may be made due to holidays or other issues.  Adjustments will either be noted in the published meeting schedule (when known in advance) or announced via e-mail.  The submission deadline for full board reviews is 10 working days prior to the meeting date.

Material requiring full-board review must be submitted by the published submission deadlines to provide sufficient time for screening and review prior to the meeting date.  The IRB staff will send the agenda and material to IRB members via hand delivery or express mail within 2 – 3 working days after the submission deadline to allow members to have at least 7 working days for review of the material prior to the meeting date.

Under unusual circumstances, the Chair may call an emergency meeting of the board.  However, such a meeting will not be called due to the negligence of the investigator to submit material on time.  An emergency meeting may be called, for example, when a quorum for the originally scheduled meeting was not met and review is required to prevent lapse of a study, or if an investigator is faced with a situation beyond his/her control.  If not already distributed, material must be distributed to members as soon as possible to allow for sufficient review.  The investigator may be asked to attend the meeting to address questions, or provide additional information or clarification.

Under unusual circumstances, the IRB staff, in consultation with the Chair, may also add an item to the agenda after the submission deadline.  Such circumstances generally involve situations in which an investigator is faced with a situation beyond his/her control and an amendment must be made to the protocol.  The material must be distributed (via hand delivery, e-mail or express mail) to members as soon as possible to allow for sufficient review.