uconn

IACUC Training

Initial IACUC Training is a requirement for everyone working with live vertebrate animals at the University of Connecticut in accordance with the policies and guidelines set forth in the “Public Health Service Policy on Humane Care and Use of Laboratory Animals” (PHS 1986), the “Guide for the Care and Use of Laboratory Animals” (ILAR 2011), the USDA Animal Welfare Regulations (CFR 1985) and the “Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.”

Retraining is required for faculty PIs on a triennial basis (once every three years). All other animal users (staff, post-doctoral fellows, graduate students and undergraduates) must complete IACUC retraining on an annual basis.

Initial IACUC Training

The University’s Institutional Animal Care and Use Committee (IACUC) requires that all faculty, staff and students who work with live vertebrate animals attend an initial IACUC training session.   This will provide an overview of federal, state and University regulations, policies and procedures as well as general information related to the care and use of animals at the University.

ALL INITIAL IACUC TRAINING IS PROVIDED ONLINE VIA SYNCHRONOUS WEBEX EVENTS. Please navigate through the links provided below to sign up for an IACUC training session. When using the sign-up link, please use the Register link on the associated page.  You should receive an “Approval” email after signing up.  If you have any questions or concerns regarding sign-up, please contact iacuc@uconn.edu.

Presentation Dates and Times:

Please note: Sessions start promptly. Latecomers risk not receiving credit.

Day Time Session Name Presenter Sign-Up Link
Tuesday, January 7, 2025 10:30 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Wednesday, January 22, 2025 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, February 6, 2025 10:30 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Wednesday, February 19, 2025 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, March 6, 2025 10:30 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Wednesday, March 26, 2025 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, April 10, 2025 10:30 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Wednesday, April 23, 2025 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx

Retraining Options

The IACUC requires retraining for all animal users.  Within a year (for Faculty who are Principal Investigators, three years) after the initial classroom training session, animal users must complete one of the following retraining options in order to receive approval for continued animal use:

  1. Completion of an animal subjects web-based exam on the Collaborative Institutional Training Initiative (CITI) Program website (www.citiprogram.org). Please login to the CITI Program site using your Institutional Login credentials (Log In Through My Institution) and selecting University of Connecticut – Storrs & Regional Campuses so that you can enter your UConn NetID username and password to access the CITI Program website. Depending on the course one selects, it may take approximately 1-6 hours to complete.  Please note that completion of any of the web-based courses can be spread over a period of time.  They do not have to be completed in a single session.  Currently, the course modules available include:
    • UConn IACUC, A Review
    • Working with the IACUC
    • Essentials for IACUC Members
    • Post-Procedure Care of Mice and Rats in Research
    • Working with Amphibians in Research Settings
    • Working with Fish in Research Settings
    • Working with Mice in Research Settings
    • Working with Rats in Research Settings
    • Working with Gerbils in Research Settings
    • Working with Hamsters in Research Settings
    • Working with Guinea Pigs in Research Settings
    • Working with Rabbits in Research Settings
    • Working with Cats in Research Settings
    • Working with Dogs in Research Settings
    • Working with Swine in Research Settings
    • Working with Non-Human Primates in Research Settings
    • Working with Zebrafish (Danio rerio) in Research
    • Wildlife Research
    • Working with Reptiles in a Research Setting
  2. Documented attendance at or participation in one of the sessions offered by the Biological Health & Safety section of Environmental Health & Safety. This training is designed for laboratory personnel who work with research animals.  Topics include principles/concepts of biosafety, agent classes and safety levels, engineering controls, personal protection equipment, work practices, biological agent use and transport information and biological waste management issues.
  3. Documented repeat attendance at the in-house classroom session presented by ACS/IACUC.  The session lasts approximately 1.5  hrs.
  4. Documented attendance at any special seminar session that may be specifically offered by Research Compliance Services or Animal Care Services in the future to fulfill this training requirement.
  5. Documented attendance at a training session offered by a recognized scientific society or organization that addresses animal use in research and/or animal welfare concerns.  Please consult with Research Compliance Services in advance to determine whether the session you would like to attend meets this retraining requirement.

IACUC Resources

IACUC Membership

The IACUC has members whose backgrounds & experience are relevant to the Committee’s responsibilities, including veterinarians, non-scientists, and scientists representing schools and colleges that use animals, as well as members who are not affiliated with the University in any way other than as a member of the IACUC.

The Institutional Official appoints the IACUC members.

Chair: Randall Walikonis, PhD, randall.walikonis@uconn.edu 860.486.9031

Institutional Official: Michael Centola, MHS, CIP, Associate Vice President for Research Integrity centola@uchc.edu

Attending Veterinarian: Curtis Schondelmeyer, DVM, CPIA, DACLAM, curtis.schondelmeyer@uconn.edu

Assurance

The University of Connecticut/Storrs has an Assurance of Compliance #D16-00077/A3124-01.  It was most recently renewed and approved by the Office of Laboratory Welfare (OLAW) effective March 1, 2020 and is valid for a period of four years, expiring on February 29, 2024.

Those affiliated with animal research may access the University of Connecticut/Storrs PHS Assurance by going to this password protected link.

IACUC Policies

University Policy: Animal Use in Research, Teaching and Testing

AW-01-2011: Reporting Animal Welfare Concerns and Incidents of Non-Compliance

AW-02-2012: Animal Transportation

AW-03-2012: Acclimation of Newly Arrived Research and Teaching Animals

AW-04-2011: Animal Adoption

AW-05-2011: Use of Non-Pharmaceutical Grade Compounds in Animals

AW-06-2011: Single Housing of Social Species

AW-07-2018: Housing Rats and Mice in Shared Spaces

AW-08-2018: Animal Housing Areas

AW-09-2018: Guillotine and Scissor Maintenance

AW-10-2018: Environmental Enrichment

BP-01-2010: Use of Full Committee Review (FCR)

BP-02-2012: Use of Designated Member Review (DMR)

BP-03-2012: Responsibilities of the Primary Reviewer

BP-06-2010: Requires Modifications to Secure Approval

BP-07-2012: Responsibilities of Full Voting Members

BP-08-2013: Biomedical vs. Agricultural Use of Agricultural Species

BP-09-2011: Veterinary Review of Protocols

BP-10-2011: Program Responsibilities: Attending Veterinarian

BP-11-2012: Annual Review of Protocols

BP-12-2012: Animal Welfare Investigation and Reporting

BP-13-2012: Post Approval Monitoring of Protocols

BP-14-2012: Semiannual Inspection of Facilities

BP-15-2012: EHS Review of Protocols

BP-16-2012: Pre-Review of Protocols

BP-17-2012: Administrative Changes to Protocols

BP-18-2012: Withholding Approval of Protocols

BP-19-2012: Holding Protocols

BP-20-2012: IACUC Emergency Business Practices

BP-21-2013: Suspension of Approved Animal Activities

BP-22-2012: IACUC-Safety Committee Coordination of Protocol Review

BP-23-2012: IACUC By-Laws

BP-25-2013: Grant Review

BP-26-2018: Modifications to Approved Animal Activities

BP-27-2022: Assessing and Reporting Protocol Deviations, Adverse Events or Unexpected Outcomes

BP-28-2022: Evaluating Scientific Rigor During Protocol Review

SI-01-2011: Use of Invertebrate Animals in Research and Teaching

SI-02-2012: Animal Transfer Between Protocols for Traditional Laboratory Species

SI-03-2010: Individuals Listed on Animal Protocols

SI-04-2010: Students Registered in Classes or Programs described in Protocols

SI-05-2011: Principal Investigator Responsibilities

SI-06-2011: Guidelines for Assigning Animals Into USDA Pain and Distress Categories

SI-07-2012: Activities Requiring IACUC Oversight

SI-08-2012: Animal Tracking for Animal Science General Husbandry Protocols

SI-09-2013: Regulation of Food or Fluid Intake

SI-10-2013: Determining Expiration Dates

SI-11-2012: Requirements for Personnel Listed on Protocols

SI-12-2020: Photography and Other Media Capture of Research Animals

SI-13-2021: Procurement of Animals for Research and Teaching

SI-14-2024: Protocol Oversight During Principal Investigator Absence

 

 

IACUC Deadlines & Meetings

Institutional Animal Care and Use Committee (IACUC) protocols are reviewed once per month; the typical turnaround time from submission to approval is 6-8 weeks. Please allow sufficient time to secure approval when approvals are required to meet funding deadlines.

Protocols must be submitted electronically in Microsoft Word format to iacuc@uconn.edu

Submission Deadline Date IACUC Meeting Date
Wednesday, November 27, 2024 Wednesday, December 18, 2024
Wednesday, December 24, 2024 Tuesday, January 14, 2025
Tuesday, January 7, 2025 Tuesday, January 28, 2025
Tuesday, January 21, 2025 Tuesday, February 11, 2025
Tuesday, February 4, 2025 Tuesday, February 25, 2025
Tuesday, February 18, 2025 Tuesday, March 11, 2025
Tuesday, March 4, 2025 Tuesday, March 25, 2025
Tuesday, March 18, 2025 Tuesday, April 8, 2025
Tuesday, April 1, 2025 Tuesday, April 22, 2025

Reporting Animal Concerns

Concern for the welfare of animals used in research and teaching is the responsibility of all members of the University community. The University of Connecticut is committed to complying with all animal welfare regulations governing animals used in research and teaching. If you have concerns about animal welfare or non-compliance, please communicate them to the Attending Veterinarian, the Institutional Animal Care and Use Committee (IACUC) or Research Compliance Services (RCS). Non-compliant incidents of a serious nature (those which harm animals or threaten their health) should be reported immediately. Your anonymity will be protected; however, providing your contact information will allow us to contact you if we need additional information. The Animal Welfare Act protects the rights of individuals reporting animal welfare concerns and prohibits discrimination or reprisal for reporting violations of regulations or standards.

You may contact the Attending Veterinarian at: Phone: 860-486-8882, e-mail: vet@uconn.edu

The IACUC Chairperson at: Phone: 860-486-9031

RCS at: Phone: 860-486-2459, e-mail: iacuc@uconn.edu

Concerns can also be reported anonymously through the REPORTLINE by calling a toll-free number at (888) 685-2637 or via the REPORTLINE website. The REPORTLINE is available 24 hours a day, 365 days a year operated by a private (non-UConn) company. You may contact the hotline to report a concern without giving your name. You will be able to re-contact the REPORTLINE to track your report to provide further information at a later date or to obtain general updates about the status of your concern.

The University welcomes and encourages good-faith reporting. As such, individuals who submit a report or participate in a compliance investigation in good faith are provided protection from retaliation per the University’s Non-Retaliation Policy.

Additional information on reporting concerns can be found at the Office of University Compliance website.

 

Approved by the Institutional Animal Care and Use Committee on October 24, 2018.

Institutional Animal Care and Use Committee (IACUC)

The Institutional Animal Care and Use Committee (IACUC) is responsible for reviewing the University of Connecticut’s program for the humane care and use of animals in research and teaching as described in its Assurance and University Policy.

The IACUC is created by and subject to federal law: the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS 1986), the USDA Animal Welfare Act/Regulations (CFR 1985) and related Guides. Members include scientists and nonscientists, veterinarians and nonaffiliated individuals from the community. Members are appointed by the Institutional Official.

For information, visit IACUC Contacts page.

 

Initial IRB 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:

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.

UConn HRPP Policies & Standard Operating Procedures

 

Human Research Protection Program (HRPP) Policy describes this Institution’s commitment to the protection of human participants at UConn-Storrs.

 

IRB Policies and Procedures describes how UConn-Storrs puts the various federal and local regulatory HRPP requirements into practice; refer to the following documents for updates:

 

 

 

Researcher’s Guide

This Researcher’s Guide provides investigators and students with information that will be helpful for meeting the standards set by the UConn IRB policies and by the Federal Regulations for the protection of human subjects in research.

Or go to each section in the guide:

IRB Meeting Dates and Membership

Beginning in January 2025, UConn will have two IRB committees, IRB 1 and IRB 2, which will allow us to hold two IRB meetings per month. With this change, there will no longer be submission deadlines for studies that require convened board review.  Submissions will be assigned to the next available agenda after undergoing pre-review.

 

2025 IRB 1 Meeting Dates

2025 IRB 2 Meeting Dates

Thursday, January 23rd Thursday, January 9th
Thursday, February 20th Thursday, February 6th
Thursday, March 27th Thursday, March 13th
Thursday, April 17th Thursday, April 3rd
Thursday May 15th Thursday, May 1st
Thursday June 26th Thursday, June 5th
Thursday July 25th Thursday, July 10th
Thursday, August 21st Thursday, August 7th
Thursday, September 18th Thursday, September 4th
Thursday, October 16th Thursday, October 2nd
Thursday, November 20th Thursday, November 6th
Thursday, December 18th Thursday, December 4th

 

IRB Members

The IRB is composed of members of the University and local communities. The individual members contribute the professional competency necessary to review specific research activities representing a broad range of disciplines through experience and expertise in their fields. In addition, the IRB seeks diversity in race, gender and cultural backgrounds to promote sensitivity to community attitudes and respect for the rights and welfare of human subjects. If you are interested in serving on the IRB, contact the IRB Office.

Each IRB meets virtually once per month and is made up of the following members:

 

IRB 1 Members & Alternates IRB 2 Members & Alternates
Rachel Tambling, PhD, IRB Chair, Human Development and Family Sciences Jeffrey Burke, PhD, Chair, Psychological Sciences
Jennie Albert, PhD, Community/Prisoner Representative Kristen Bissell, MD, Student Health and Wellness
Douglas Bradway, MA, CIP, Research Integrity & Compliance Gabrielle Brewer, PhD, CISSN, Kinesiology
Augusto Buchweitz, PhD, Psychological Sciences Valerie Duffy, PhD, Allied Health Sciences
Elaine Lee, PhD, Kinesiology David Embrick, PhD, Sociology and Africana Studies
Wesley Leong, MS, Psychological Sciences Thomas Hogan, Community/Prisoner Representative
Anita Morzillo, PhD, Natural Resources Management & Engineering Catherine Little, PhD, Educational Psychology
Meg Paceley, PhD, School of Social Work Mohamadmahdi Samandari, PhD, Biomedical Engineering
Louise Reagan, PhD, APRN, ANP-BC, FAANP, FAAN, School of Nursing Vida Samuel, PhD, Human Development and Family Sciences
Jeffrey Burke, PhD, Alternate Chair, Psychological Sciences Rachel Tambling, PhD, Alternate Chair, Human Development and Family Sciences
Gabrielle Brewer, PhD, CISSN, Alternate IRB Member, Kinesiology Tamika Blackburn, MD, Alternate IRB Member, Student Health and Wellness
Ruth Lucas , PhD, RNC, CLS, FAAN, Alternate IRB Member, School of Nursing Douglas Bradway, MA, CIP, Research Integrity & Compliance
Nicole Landi, PhD, Alternate IRB Member, Psychological Sciences Nicole Landi, PhD, Alternate IRB Member, Psychological Sciences
Wesley Leong, MS, Alternate IRB Member, Psychological Sciences
Lisa Sanetti, PhD, Alternate IRB Member, Educational Psychology

Experienced IRB staff serve as alternate members on both committees.

 

Human Subjects Research

InfoEd IRB Module updates were implemented on December 16th!

See the InfoEd Updates page for more information.

UConn-Storrs Human Research Protection Program (HRPP)


UConn-Storrs is dedicated to the protection of human subjects in research activities conducted under its auspices. The HRPP also covers research involving human participants conducted under the auspices of the Hartford, Waterbury, Avery Point, and Stamford campuses of the University of Connecticut.

The UConn-Storrs Institutional Review Board (IRB) within the HRPP reviews human subjects research to ensure that the studies it approves have appropriate safeguards for the ethical, compliant, and safe conduct of research, as well as the protection of the rights and welfare of the human subjects who will volunteer for participation. UConn-Storrs investigators must appreciate and understand their ultimate responsibility and obligation to protect the subjects participating in their studies. This includes conducting the study as approved by the IRB and reporting any unanticipated problems or noncompliance to the IRB for review and appropriate action.

The IRB is guided by the ethical principles of Autonomy, Beneficence and Justice, as outlined in the Belmont Report. The subject’s autonomy must be respected, study harms must be minimized and potential study benefits must be maximized, and the selection of who is versus who is not asked to serve as research subjects must be fair and directly related to the problem being studied (and not because of a group’s easy availability or compromised position).

If an investigator is part of an institution that already has its own IRB, either the UConn or the other institution’s IRB may serve as the IRB of record. The arrangement would be documented by a reliance or authorization agreement, which outlines each institution’s role in the research.

Frequently Asked Questions

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.

Note:

                (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 (irb@uconn.edu) 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 era-support@uconn.edu 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 irb@uconn.edu  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 11.5.6.1 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 irb-reliance@uconn.edu 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.

        For Faculty

        The mission of TCS is to expedite and facilitate the transformation of UConn discoveries into products and services that benefit patients, industry and society.

        TCS and its network collaborate to support technology transfer and venture development based on student and faculty innovation.  We provide services for entrepreneurial training, intellectual property protection, technology licensing, mentorship, business startup, and connections to the investment community.  UConn’s Technology Incubation Program, the University’s business incubator, is part of TCS.

        Working throughout UConn’s 14 schools and colleges, and participating in the state’s ecosystem, TCS is a focal point for the University’s innovation-based activities, particularly for faculty and external entrepreneurs and companies seeking technology partnerships at UConn.  TCS can provide access to university-wide programs supporting innovation and entrepreneurship.

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