Refer to HRPP SOPs for UConn-Storrs (in process) for full detail on the UConn Human Research Protection Program.
Who needs to comply with the requirements of UConn’s Human Research Protection Program (HRPP)?
All UConn University faculty, staff, and students must comply the HRPP Policy and associated Standard Operating Procedures (SOPs) of the UConn HRPP. These documents are available on the Policies and Procedures page of the HRPP website.
Which activities require submission to the HRPP/IRB before beginning a proposed activity?
According to the Federal Policy for the Protection of Human Subjects (“Common Rule;” 45 CFR 46):
Activities that meet the specific definitions of “research” involving “human subjects/ participants” are covered under the requirements of the HRPP and require prior exemption or approval through the HRPP/IRB.
Research is a systematic investigation (an activity that involves a prospective plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a question) including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [i.e., designed to obtain new information that would be applicable beyond the system (e.g., UConn)] in which it will be conducted/implemented and beyond the target population who will participate in the activity.
(i) the activity must meet both bolded ‘parts’ of the definition in order to be considered ‘research’.
(ii) There are activities that are specifically deemed not to be research. One relevant example:
Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
A human subject (or participant) is “A living individual about whom an investigator conducting research obtains:
(1) information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens, or
(2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens”
According to Food and Drug Administration (FDA) regulations (21 CFR 50, 56, 312, 812):
If your study is evaluating what FDA considers to be a test article, i.e., biologic, drug (which may include dietary supplements, foods, and other substances), or device (which may include certain software, wearable technology, exercise devices, and other products), your research will be subject to FDA regulation. Proceed here for further details: https://ovpr.uconn.edu/services/rics/irb-2/research-subject-to-fda-regulation/
If you are unsure, complete the ‘Human Subjects Research (HSR) Determination Form’ available here: https://ovpr.uconn.edu/services/rics/irb-2/irb-forms-templates/ and submit in InfoEd for review (see FAQ below “How do I apply…” for more information on InfoEd).
NOTE: If your activity does not constitute research involving human participants subject to the UConn HRPP, it does not mean you can initiate the activity; other institutional policies may apply/permissions may be necessary.
OK, my proposed activity constitutes research involving human participants. What’s next?
First of all, you need to know what type of review your activity is going to need. It will either qualify for exemption, expedited, or convened/full board review.
Exemption Review: If all proposed activities fall within 1 or more exemption categories defined in the Common Rule (see 45 CFR 46.104(d)), most reviews will be conducted by an IRB specialist on behalf of the institution (unless the study qualifies for limited IRB review, in which case an IRB member will conduct the review). There are restrictions when the activity involves children and prisoners, so contact the IRB Office (firstname.lastname@example.org) if these populations are proposed for use. Exempt research is exempt from most of the requirements of the Common Rule, but it is not exempt from the ethical requirements of the Belmont Report, and will be reviewed to ensure that appropriate protections are in place.
Expedited Review: If all proposed activities involve minimal risk, and fall within the federally-defined expedited review categories, the activity is subject to all requirements of the Common Rule, including IRB review. However, since the activity is ‘minimal risk,’ the IRB review can be conducted by one IRB member (as opposed to the full committee). All federally-mandated approval criteria for nonexempt research will need to be met in order for the study to be approved.
Convened/Full Board Review: If the proposed activity does not qualify for exemption or expedited review, the study will be placed on the agenda for the next scheduled IRB meeting. Generally, the board meets on the second Tuesday of each month (with the exception of July and August). Studies determined to require full board review that are received by the first Tuesday of the month will be placed on the agenda. As with studies undergoing expedited review, all federally-mandated approval criteria for nonexempt research must be met in order for the study to be approved.
How do I apply for exemption or approval for my research involving human participants?
The specific materials that must be submitted depend on the type of review required.
For Exemption Review: See Section 5.4 of the SOPs (HRPP SOPs for UConn-Storrs (in process))*
For Expedited and Full Board Review: See Section 11.2.4 of the SOPs (HRPP SOPs for UConn-Storrs (in process)*
The online application is available in UConn’s IRB e-system, InfoEd. All submissions to the HRPP/IRB are done via the Human Subjects/IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu. See the How to Guide for more information on using InfoEd, including step-by-step instructions for creating initial IRB protocols and other types of protocol submissions (modifications, requests for continuation/closure, and protocol deviations or unanticipated problem reports). For technical assistance using InfoEd, email email@example.com or call 860.486.7944. The eRA Help Desk is staffed Monday-Friday, 8:00 AM – 4:30 PM.
Once I submit my application, what are the possible outcomes of review?
Approval. No further action is needed. You may begin your study.
Modifications Required for Approval. Certain prescriptive conditions must be satisfied before you will receive approval and the ability to begin your study. These conditions can be reviewed by IRB Specialists.
Deferral. This action is taken by the IRB when substantive conditions must be satisfied, or additional information is required in order to render the study approvable. If this outcome is a result of a full/convened IRB review, your response will need to be reviewed by the convened IRB at a subsequent meeting.
Disapprove (Full Board only). This action is taken when the convened IRB determines that the proposed research activity does not satisfy the criteria for approval and that it cannot be modified to render it approvable.
Tabled (Full Board only). This action is taken when the convened IRB cannot review a study on the meeting agenda. For example, quorum for the meeting is lost, or the primary and/or secondary reviewer are not present, or a study document is missing and review cannot be conducted without it (e.g., consent form, protocol, etc.).
Do I need to complete any training before the IRB can approve my submission?
Yes. All study team members must complete training in human research protections before exemption or IRB approval may be granted. Please see https://ovpr.uconn.edu/services/rics/irb-2/citi-training/ for additional information. Training is valid for a period of three years from the date of completion.
What are my responsibilities after I receive IRB approval?
You have several reporting responsibilities after you obtain IRB approval (besides requests for continued approval, where applicable--see FAQ “How long is my exemption or IRB approval good for?" below for details):
- Since you must conduct your study as it was approved by the IRB, any changes you want to make to it must first receive approval from the IRB before you implement that change. This is accomplished by following procedures outlined in Section 11.6.1 of the HRPP SOPs for UConn-Storrs (in process). The only exception to this requirement is if you must deviate from the protocol to eliminate apparent immediate hazards to the subject. If this occurs, you must report this event to the IRB as soon as possible.
- If an incident, experience, or outcome occurs, or new information comes to light during the conduct of the research that may be an ‘Unanticipated Problem Involving Risk to Subjects or Others’ (UAPs), the event must be reported within five working days following procedures outlined in Section 17.2 of the HRPP SOPs for UConn-Storrs (in process). These are events that meets all of these three criteria:
- Is unexpected (incident, experience or outcome is not expected (in terms of nature, severity, or frequency); and
- Is related or possibly related to participation in the research (“reasonable possibility”); and
- Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
UAPs can be very important signals regarding promised protections and safety of research subjects. Remember, it may not just be that a previously unknown event has happened; It could be that the event was expected, but it is occurring more severely, and/or at a higher rate, than previously expected. Also note that UAPs do not just encompass physical issues; a stolen laptop that has study data on it may constitute a UAP in that there is an unexpected risk of a breach of confidentiality.
If you are unsure if an event constitutes a UAP, please feel free to email firstname.lastname@example.org and we will set up a time to discuss the event.
- Finally, if you deviate in any way from the study protocol as it was approved by the IRB (e.g., use of the wrong consent form, not conducting all screening procedures before enrollment, skipping or adding study procedures, etc.), you need to submit the details to the IRB within 5 working days following reporting procedures detailed in the HRPP SOPs for UConn-Storrs (in process), Section 18.2.
When you submit any of the reportable events above, the IRB will conduct a review to ensure that the rights and safety of subjects remain protected, and the integrity of the study remains intact. You will be notified of the outcome of the review, and any actions that need to be taken as a result.
How long is my exemption or IRB approval good for?
If your study qualifies for exemption, you will receive reminders to complete a short study status report every year by the anniversary of the initial exemption. If you do not reply to these reminders by that anniversary date, your study will be administratively closed, and no further activity involving human participants (including analysis of identifiable data or biospecimens) may be conducted.
If your study qualifies for expedited review and is not DoJ-funded or subject to FDA regulations, you will receive reminders to complete a short study status report every year by the anniversary of the initial exemption. If you do not reply to these reminders by that anniversary date, your study will be administratively closed, and no further activity involving human participants (including analysis of identifiable data or biospecimens) may be conducted.
If your study qualifies for full board review, or qualifies for expedited review but is DoJ-funded or subject to FDA regulations, you will receive an approval period that is no longer than one year, and must complete the continuing review process before the expiration date noted on your approval letter. You will receive reminders regarding the need for continuing review, but it remains the Principal Investigator’s responsibility to maintain continued approval with the IRB. If your approval lapses, even if you’ve submitted your continuing review materials before the expiration date, you must immediately stop all activity involving human participants (including analysis of identifiable data or biospecimens). See Section 220.127.116.11 of the HRPP SOPs for UConn-Storrs (in process) for details concerning management of enrolled subjects during approval lapse.
What should I do if my proposed activity involves non-UConn personnel and/or an external institution?
Complete the UConn External Reliance Intake Form (found under Supplemental Forms on the InfoEd Submissions, Forms, & Template IRB webpage), then email the completed form to email@example.com to initiate IRB assistance with developing a reliance plan tailored to your study. For studies that will include external involvement, it is recommended that researchers contact the IRB as soon as possible in the development stage of the research to minimize delays in the review process.