Per institutional policy 2006-07, staff in OCTR complete a Budget Workbook for any clinical trial performed at UConn Health which accrues John Dempsey Hospital (JDH) and/or UConn Medical Group (UMG) charges. A Budget Workbook must be completed prior to a study being submitted to the Institutional Review Board (IRB) for initial review, though a study may be submitted if the Budget Workbook is complete and budget negotiations are ongoing with the sponsor.
uconn health
Contact the Human Subjects Protection Program
Human Subjects Protection Program (HSPP)
UConn Health
263 Farmington Avenue
Farmington, CT 06030-1511
Fax: 860-679-1005
Send questions, comments, concerns, or suggestions to: irb@uchc.edu
Institutional Review Board (IRB)
L Building, 5th floor
UConn Health
263 Farmington Avenue
Farmington, CT 06030-1511
Questions regarding new study submissions & active approved research:
- Stephen MacKinnon – 860-679-8729
- Galina Prpich – 860-679-4849
Questions regarding IRB Reliance:
- Kate Hayden Ames – 860-679-8802
Request IRB Submission Education / Training or General iRIS Support:
Questions regarding policy, regulations, post-approval monitoring Function:
- Rebecca Burke – 860-679-3054
Administrative Manager
- Julia Blair – 860-679-7555
Office Fax: 860-679-1005
Contact the IRB
Mailing Address:
Human Subjects Protection Program / Institutional Review Board
UConn Health
263 Farmington Avenue
Farmington, CT 06030-1511
Contact an IRB Regulatory Specialist:
- Galina Prpich, 860-679-4849
- Stephen MacKinnon, 860-679-8729
Questions regarding IRB Reliance:
- Kate Hayden Ames, 860-679-8802
Request IRB Submission Education / Training or General IRIS Support:
Monitoring Function:
- Rebecca Burke – 860-679-3054
IRB Frequently Asked Questions
Questions Related to the Need for IRB Review
Q: Does a case study / case series require IRB review?
A: Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Consistent with many other institutions, UConn Health does not consider a write up of a single case, or two or three cases, as constituting research. The retrospective summary of such a few number of cases is not considered to meet the definition of research. A review of four or more cases is considered to meet the definition of research and prospective IRB review is required.
Q: When should I submit a Human Subject Research Determination Form?
A: The Human Subject Research Determination Form can be submitted when an individual is considering a project that s/he does not think constitutes human subject research, but would like an official determination made by the IRB prior to initiating the project. A representative of the IRB will review the form and make the final determination as to whether the proposed activity meets the definition of human subject research. If the reviewer determines the project does not constitute human subject research the IRB will have no further involvement. If the reviewer determines that the project does constitute human subject research a complete IRB application will be required. Determination are usually made within two weeks of the date the IRB received the request for determination.
Q: Does a student project involving humans require IRB review?
A: If the project meets both the definition of research and human subject IRB review is required. The definition of research is often key in determining if a student project needs IRB review. Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. If a student project is not designed to develop or contribute to generalizable knowledge (e.g. it will be used only to satisfy a curricular requirement), it would not meet the definition of research. Master’s or Doctoral proposals are typically designed to develop or contribute to generalizable knowledge so IRB review for such is typically required if the project also involves human subjects. IRB approval cannot be granted retrospectively. Students are therefore encouraged to complete a Human Subject Research Determination Form prior to starting any activity for which a question exists as to whether it constitutes human subject research. That form can be used to self-determine whether IRB review is required; or it can be thoroughly completed and submitted to the IRB for a formal determination.
When students at UConn Health are involved in the conduct of human subjects research at an external institution, please consult this engagement guidance document to ensure any IRB requirements at UConn Health are addressed.
Q: What type of IRB review is required for a research project using existing specimens?
A: It depends on whether the existing specimens are identifiable. If not, and if the investigator will make no effort to re-identify the specimens, the specimens do not meet the definition of human subject and IRB review would not be required. If the specimens are identifiable, or efforts will be made to re-identify the samples, IRB review is required. Research that only involves the use of existing identifiable samples may qualify for exemption if one of the following is true:
- the specimens are publicly available
- information is recorded in such a manner that the identity of the human subject cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subject and the investigator will not re-identify subjects.
Q: Does a pilot study have to be reviewed by the IRB?
A: Yes. Any study involving human subjects, regardless of the number of subjects to be involved, must be reviewed and approved by the IRB prior to initiation. Because the purpose of a pilot study is to test the feasibility of a design that is intended to be used on a larger scale a pilot study is considered be “designed to develop or contribute to generalizable knowledge”.
Q: If I am going to do research on excess specimen samples (i.e., urine, blood, skin, etc.) that are being collected for a clinical purpose and that are otherwise going to be thrown away, do I have to get IRB review?
A: If the samples are to be used for a research purpose, and if at any point in time the investigator can link a sample (directly or through codes) to the individual from whom it came, IRB review is required. If information is record in such a way that individuals from whom the sample came cannot be identified the research may qualify for exempt status.
Q: If I am doing research on cadavers or on samples obtained from cadavers, do I have to get IRB review?
A: IRB review is not needed as the definition of human subject pertains to living individuals. However, if personal identifying information is linked to the materials, then HIPAA must be appropriately addressed. The Assurance of Using Decedent Information form must be submitted to the IRB, which also acts as the HIPAA privacy board for research purposes.
Q: If I want to make a change to my study after I’ve received approval, do I need IRB approval again?
A: Yes. Any change to a previously approved non-exempt study must be reviewed and approved by the IRB prior to implementation. This includes changes to any document related to the study (e.g. informed consent form, surveys, advertisements, recruitment letters, etc.) You will need to submit the form to request a modification / addendum to a previously approved study. The only exception to this is that a change can be implemented if it is needed to eliminate immediate harm to subjects or others. Such changes must be reported to the IRB within 5 business day. Investigators are encouraged to seek approval for any modification to an exempt study to ensure that the change does not invalidate the exempt status of the study.
Q: How does the mandate for single IRB review for multi-site federally supported research apply?
A: The NIH has published a list of frequently asked questions pertaining to the requirement for single IRB review. Please review this list. If your question is not addressed by this list, you may contact the IRB. Investigators should reach out to irb@uchc.edu early when the research will be subject to the single IRB requirement to discuss reliance. UConn Health can establish reliance with other institutions through the SMART IRB initiative, and has reliance agreements in place with commercial IRBs that are willing to act as the single IRB. Additionally, study specific IRB reliance agreements can be executed when needed. For more information visit our page on Reliance.
Questions Related to IRB Submissions:
Q: Once I submit my application, how long does the IRB review process take?
A: Review of exempt and expedited applications occurs on an on-going basis. Screening of the application will generally occur within 7 to 10 business days of receipt. Any concerns will be communicated to the investigator through iRIS. Once all concerns have been addressed the application will be forwarded for official review. Studies requiring full board review must be submitted by the published deadline. This allows sufficient time for the committee to review the application prior to the meeting. After the meeting the minutes must be prepared and approved by the committee before letters are sent to the investigators. Therefore, investigators should not expect an official letter until 7 to 10 business days after the meeting. Note that you may not begin your research until you have received final, unconditional approval from the IRB.
Q: Can I e-mail my IRB materials to the IRB office?
A: IRB forms (applications, requests for continuation, requests for modifications, problem reports) and supporting documents should be submitted through the iRIS system. For UConn Health employees and students, your UConn Health username and password can be used to access iRIS.
Q: What is my IRB number?
A: After you have submitted your application to the IRB for review, the IRB will assign an IRB number to your study. The IRB number can be used to search for the study within iRIS. The first two digits represent the latter part of fiscal year that the study was submitted, the next three digits represent the sequential order of receipt, and the last digit represents the panel to which the study was assigned. If there is an X after the first two digits it indicates the research was determined to qualify for exemption. If there is a letter appended after the three sequential numbers the letter indicates that UConn Health is acting as the IRB for another institution. For example an IRB number of 19-001C-2 reflects receipt of the study in fiscal year 2018/2019, that it was the first study received within the fiscal year and that Connecticut Children’s Medical Center is relying on the UConn Health IRB for oversight of the research, and that the submission was reviewed by Panel 2.
Note that any e-mail written or phone inquiry should make reference to the IRB number of the study. This will enable the IRB to quickly locate any required information.
Q: Why should I have a version number on my protocol and consent form?
A: It should always be possible to quickly determine which version of the protocol was current when the ICF was signed. Investigators are encouraged to maintain a link between the consent document and current protocol. For example, if you submit a modification that affects the informed consent form, but not version 1.0 of the protocol, the informed consent version reference should be revised, by adding a number after the version reference, e.g., Version 1.1. This indicates that the informed consent form is still linked to version 1 of the protocol.
Revising the version number also helps investigators to differentiate between copies of the protocol that have been modified. For example, if a modification was made to procedures in the protocol but both versions were labeled as version 1 (as opposed to 1 and 2 or 1 and 1.1) it would be easier for the investigator to follow the incorrect version of the protocol.
Q: I am not sure how to answer some questions in the application; can I leave them blank?
A: The IRB expects the investigator to respond to relevant items on the IRB application. Providing complete responses will make it less likely that the application will be returned for corrections. If you have a question as to how to respond you are encouraged to contact a Regulatory Specialist within the IRB for guidance.
Q: Can I submit my application without the signature of the Principal Investigator?
A: No, the application must be signed by the Principal Investigator. With the implementation of the iRIS system, the PI can access the system from any place with internet access in order to sign the submission.
Q: What documents do I need to submit to the IRB for review of my study?
A: Because every study is unique it is not possible to provide directions that will address every situation. The relevant IRB application checklist should be used as guide in determining the submission requirements. You may also want to review the table “What Documents to Submit” at https://ovpr.uchc.edu//rcs/hspp/resources/expedited-exempt/ . The documents common to all new expedited and exempt submissions are noted in the first row and additional documents that are often associated with specific study designs follow. Some projects may combine characteristics of more than one study type.
Q: Are there any protocol templates in the IRB/HSPP web-site that can guide me in preparing my study protocol?
A: A protocol template is available on the IRB forms page.
Q: My study was deferred at the IRB meeting held on Monday night. Can I have an extension to the submission deadline so that my study can be reviewed at the next regularly scheduled meeting of that panel?
A: Yes, you can have a one week extension on the submission deadline. This is allowed for two reason. First because the IRB recognizes that the turn-around-time without the extension is quite difficult to meet. Second, because the reviewers have already seen the initial version of the protocol and discussed it at the board, allowing the reviewer one week to re-review is sufficient. Note that if you study was deferred it must be reviewed by the same IRB panel that conducted the initial review.
Q: Do I have to submit every single protocol deviation (e.g. instance of non-compliance with the protocol) to the IRB?
A: Yes, however the timing of when you report the non-compliance may differ. If the non-compliance was within the control of the research team (e.g. a follow-up appointment was scheduled by the research team outside of the study window) it should be reported within 5 business days of becoming aware of it using the problem report form available in iRIS. All reports should contain a description of the deviation, why and when it occurred, and corrective action implemented, if any, to prevent future occurrence. If the non-compliance was not within the control of the research team it and it does not place a subject at risk (e.g. the subject canceled a scheduled appointment and had to be rescheduled outside of the study window) the event can be reported at the time of continuation. However, if the event was not within the control of the research team but has in impact on subject safety or data integrity it should still be reported within 5 business days of becoming aware of it. If possible, investigators should allow for “windows” within the protocol design to reduce the instances of non-compliance. For example, rather than stating that a second visit will occur in 2 weeks state that second visits will occur within 10 to 18 days.
Q: How do I know which HIPAA form to submit?
A: You must address HIPAA within your application if your study will involve the use of protected health information. Protected health information means individually identifiable health information transmitted or maintained in any form (electronic means, on paper, or through oral communication) that relates to the past, present or future physical or mental health or conditions of an individual. In general,
- if you are obtaining informed consent you will also need to obtain a HIPAA Authorization, or
- if you are seeing, but not recording any identifiable information you will submit a request for Waiver of HIPAA authorization and a Certification of Deidentification form, or
- if you need to keep some identifiable information, and you cannot obtain an Authorization, you will apply for a Waiver of HIPAA Authorization.
Q: If the sponsor requires that a safety report be submitted to the IRB, but the adverse event reporting policy requires that it be reported only at the time of continuation (e.g., it is a non-serious event), should I still submit it to the IRB?
A: You should inform the sponsor that our reporting policy is that non-serious events will be submitted in summary format at the time of continuation. The IRB will not review individual non-serious reports.
Q: If my project will most likely qualify for exempt status do I still have to submit the entire IRB application, write a protocol, and make sure everyone has completed training in the protection of human subjects?
A: Yes. The IRB is the only office that can determine if a research project qualifies for exemption and must have sufficient information in order to make that determination; and training requirements pertain regardless of the type of review conducted.
Q: I submitted an application for expedited review three days ago. Why haven’t I heard from the IRB yet?
A: Expedited review does not mean a quicker review. It simply means that only the Chair or an IRB member designated by the Chair has to review the project. All of the same criteria for approval still apply and applications are reviewed with the same level of scrutiny as a full board review.
Q: I will be doing research that will involve individuals who speak a foreign language. If the IRB approved the English version of the consent form do I have to submit a translated version for approval?
A: Yes. The IRB must approve all translated documents that will be presented to subject, e.g. the informed consent form and surveys. Investigators may either use a professional translation service or the back translation process. The full details are available in the Human Subjects Protection Office/IRB operating policies. Information on companies that provide translation services is available on the Information for Investigators page.
Questions Related to Continuing Review:
Q: How do I know when my study is due for continuing review?
A: When the IRB grants you final approval the approval letter will include the date by which your request for continuation is due. The iRIS system should send 30, 60 and 90 day reminders to you to request continuing review. However, the investigator retains the responsibility for seeking continuation of an approved study and the IRB encourages you to add reminder notices to your outlook calendar.
Q: What happens if I miss the submission deadline for my continuation that requires full board review?
A: A lapse in IRB approval for the study will occur if continuing approval is not granted by the end of day on the expiration date of approval. For example if the expiration date of a study is May 1st, research activity could occur on May 1st, but could not occur on May 2nd unless continuing approval had been obtained. If a lapse in approval occurs, all research related activity must cease until approval for continuation is obtained. If a subject is on active treatment and will be exposed to harm if treatment is withheld during the lapse in approval, you must request in writing approval from the IRB Chair to continue to treat the subject. You must also confirm that you are seeking continuation and will meet the next submission deadline.
Q: Why must I request continuation in less than one year when my colleagues’ studies where given approval for a full year?
A: When continuing review is a requirement, regulations require that continuing review occur at least annually. However, the IRB has the authority to require that review occur more frequently. Example scenarios of when the IRB may exercise this option include studies that pose a high risk to subjects or studies for which the investigator does not have extensive experience in the field.
Q: Why do I have to submit the complete protocol again at the time of continuing review if I haven’t changed it since the initial approval?
A: Federal guidance states that in order for continuing review to be meaningful and substantive the IRB must review the complete protocol. Attaching the protocol at the time of continuing review includes it in a master pdf file that the iRIS system creates for the assigned IRB reviewer. This facilitates the review process for them.
Questions Related to Informed Consent:
Q: What is informed consent?
A: Informed consent reflects an individuals voluntary agreement to participate in a research study. In order to make this agreement the individual must have adequate knowledge and understanding of the relevant information (purpose of the study, risks and benefits of the study, methods to be used, etc.). the process of informing a subject about a study is documented using the informed consent form.
Q: Who can provide informed consent?
A: Individuals who have reached the age of majority and who are competent can provide informed consent to participate in a research study. If the subject is either a minor or lacks the capacity to provide informed consent, a surrogate person (i.e. a legally authorized representative) must provide consent and the subject will generally be asked to provide assent. The policy to provide surrogate consent for research studies follows the same standards as providing surrogate consent for clinical care.
Q: What does a research subject need to be informed of during the consent process?
A: The informed consent checklist outlines the regulatory requirements of the informed consent form and these requirements are incorporated into the IRB sample consent form. If these documents are used as a guideline, you should address all required elements within your consent document. However, consent is more than a document. Consent must be a process in which the research subject has the right to read and discuss the form and to ask any questions regarding the study and have them answered in a satisfactory manner.
Q: Is informed consent always required?
A: In the majority of non-exempt studies informed consent is required. However, there are situations in which the requirement to obtain informed consent may be waived or altered. A retrospective chart review study is an example of when the requirement to obtain consent may be waived. The form to request a waiver or alteration of informed consent must be completed and submitted to the IRB for review and approval. The form describes the criteria that must be satisfied in order for the IRB to grant approval to the request.
Questions Related to Closure of Human Subject Research Studies:
Q: When should I close my study?
A: A research study should be closed by the Principal Investigator (PI) once all human research activities are completed regardless of whether a study is subject to the continuing review requirement. To do so, a closure form should be submitted to the IRB through the iRIS submission system for each non-exempt human research study (e.g., studies approved under Expedited review or Full Board review). The closure form should be submitted before the expiration of IRB approval, however, the PI can also submit a closure form after they have received a notice of lapse of approval.
If the study is an exempt study, the PI may allow the IRB approval to expire. When approval of an exempt study expires, the IRB will administratively close the study, but this does not invalidate the exemption. The research, as proposed to the IRB, may continue; it is not necessary to keep the exemption actively registered with the IRB.
A closure form allows the IRB to have a summary of the following information:
-
- the findings of the study
- the final enrollment data
- whether the study met the recruitment goals, and
- whether any of the following events occurred since the last approval (initial or continuing review):
- subject complaints
- unanticipated problems involving risk to subjects or others,
- unexpected profile of adverse events in terms of frequency and/or severity,
- non-compliance with or deviation from the approved protocol or procedures,
- audits, inspections or monitoring visits by internal or external personnel.
- any publications, presentations, trademarks, patents, etc. related to the study.
The Guidance on Closure of Human Subject Research Studies.docx explains the circumstances in which a non-exempt human research study may be closed from IRB oversight, as well as ongoing researcher responsibilities that apply to closed studies.
CITI Instructions for Human Subjects Training at UConn Health
Introduction
All personnel involved with the conduct of human subject research (inclusive of those key personnel listed on an IRB application or request for modification) must complete training in the protection of human subjects. Courses offered through the Collaborative IRB Training Initiative (CITI) are the primary mechanism used to satisfy this requirement. Once passed, the training is valid for a three year period. Training is required to be current at the time of initial approval or at the time the individual is added to a study.
Completion of CITI courses is strongly encouraged for anyone providing support to a study who is not designated as key personnel on the IRB application or modification form.
Instructions for registering for CITI courses are provided below. When registering for Human Subjects Training do not register to take the animal modules.
Individuals may check their training completion date in IRIS or in their CITI account. TIP: Make sure the email address you use for your CITI account is included in your IRIS profile, if different. so that the two accounts are linked for any automated training data updates. (See instructions to add an email address to your IRIS account.)
CITI Registration
Go to https://www.citiprogram.org.
- If you are a new user click Register in the upper right corner, or from within the Create an account box on the right side of the screen.
- If you are a returning user, Click Log In in the upper right corner, or type in your user name and password on the right side of the screen and click Log In
Please note that steps 1 – 6 area applicable to new registration. Returning users should skip to Step 7 regarding course enrollment
Step 1: Select Your Organization Affiliation:
- In the box to “Search for organization” type University of Connecticut Health Center, selecting this option when it becomes available. (Note: Be sure to include Health Center in your selection)
**NOTE: You must affiliate your CITI account with UConn Health to ensure training meets UConn Health requirements. Completed training reports will be sent to the UConn Health IRB only for those who affiliate with UConn Health. - Click Continue to Step 2
Step 2: Personal Information:
- Provide responses to the required fields denoted with an *
- Provide secondary email if you choose.
- Click Continue to Step 3
Step 3: Create your own User Name and Password
- Create your username in accordance with noted requirements
- Create your password in accordance with noted requirements
- Select a security question
- Provide a security answer
- Click Continue to Step 4
Step 4: Gender, Race, Ethnicity
- Provide responses to required fields (with an *)
- Click Continue to Step 5
Step 5: Continuing Education Credits
- Provide responses to required fields (with an *)
- Click Continue to step 6
Please note that it is not necessary to say YES to CEs to obtain a certificate of completion
Step 6: Additional Details (Note: per CITI this step cannot be skipped, but responses are not required. )
- Provide responses (optional)
- Click Continue to step 7
Step 7: Course Enrollment Procedure:
- Read the instructions below for details.
- For returning users, once logged into CITI, click University of Connecticut Health Center to see any assigned courses. Click on the course to begin it, responding to the integrity assurance statement if required. If necessary (i.e. you are up for renewal, but a course had not yet been assigned), click Add a Course under University of Connecticut Health Center and then follow the instructions below.
Course Enrollment Questions:
On the CITI site, scroll down to the section with questions.
User can skip questions in this process unless the question is denoted with an * which indicates a response is required. New users should first select the user group most applicable to the type of research with which the user will be involved. If a user only wants to take a Good Clinical Practice (GCP) training module, skip to question 3 to register for a GCP course for the first time, or to question 4 to renew GCP training.
The questions you will see on the CITI course enrollment page are provided below for reference, along with instructions for responding.
Question 1 – Human Subject Research Instructions:
Select the ONE option that best reflects your status. Only select the last option if you have previously completed CITI training at UConn Health and are now renewing your training because the three year expiration date is approaching. (Note: IRB chairs should select Group 4 initially. Group 5 can be added after the initial registration and course is completed. IRB members and HSPP staff must initially select Group 4)
Question 1: Please choose one learner group below based on your role and the type of human subjects activities you will conduct. You will be enrolled in the Basic Course for that group.
- Group 1: Biomedical Investigators and Study Personnel
- Group 2: Social and Behavioral Investigators and Study Personnel
- Group 3: Students
- Group 4: IRB Members or HSPP / IRB Staff
- Group 5: IRB Chair
- I have completed the Basic Course.
Question 2 – Refresher Courses Instructions:
For users who are renewing training, select the one option that best reflects your status.
- If in question 1 you indicated that you have completed the Basic Course, then select option 1, 2, 3 or 4 in question 2.
- If in question 1 you selected a Group designation, then respond to question 2 by selecting “I have not completed the Basic Course.”
Question 2: If you have completed the Basic Course portion, please choose one learner group below based on your role and the type of human subjects activities you will conduct. You will be enrolled in the Refresher Course for that group.
- Group 1: Biomedical Investigators and Study Personnel
- Group 2: Social and Behavioral Investigators and Study Personnel
- Group 3: Students
- Group 4: IRB Members or HSPP / IRB Staff
- I have not completed the Basic Course.
Question 3 – Good Clinical Practice Instructions:
Individuals involved with NIH funded clinical trials must also complete GCP training, in addition to human subjects training. UConn Health strongly encourages all other individuals who are involved with clinical research trials to take the GCP course. Individuals involved with FDA-regulated research should take this training. Individuals can opt to select the GCP course in addition to any other course selection in items 1 and 2, or to skip the GCP course (unless otherwise mandated by the NIH or IRB).
Question 3: If you are required to take: Good Clinical Practice (GCP) then please make your selection below.
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) – For clinical trials in the US
- GCP for Clinical Investigations of Devices
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) – For international clinical trials
- GCP – Social and Behavioral Research Best Practices for Clinical Research
- Not at this time.
Question 4 – Good Clinical Practice Refresher Instructions:
If you are renewing GCP training select from the applicable course
Question 4: Please make your selection below if you have previously completed the GCP Basic Course.
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) – Refresher – For international trials
- GCP for Clinical Investigations of Devices – Refresher
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) – Refresher – For clinical trial in US
- I have not completed the Basic Course
Question 5 – Question 7 may be skipped when registering for only human subjects training courses. If a user is required to take the course by another area of UConn Health, the course may be selected here.
After completing the course enrollment questions click Submit
To access the course for which you have registered
- Click University of Connecticut Health Center Courses
- Click on the assigned course to begin the work
- Click to complete the Integrity Assurance Statement before beginning the course
- Click on Required Modules to complete them in order.
To Successfully Complete the Course
A running tally is compiled in the Grade Book to ensure that the minimum passing score has been met. If you want to improve a score on a quiz, you may repeat any quiz in which you didn’t score 100% correct.
Print or download a Course Completion Report as evidence that you have met your institutional requirements. A copy will be sent to your institutional administrator. Certificates may also be downloaded at a later date by following these instructions.
Questions
- Questions regarding your requirements for human subjects training should be sent to irb@uchc.edu
- Technical issues should be addressed to citisupport@med.miami.edu or to 305 243-7970.
Education and Resources
If you have specific educational needs, please contact the HSPP for assistance at irb@uchc.edu.
Educational Resources for Research Personnel
- First time Principal investigator Orientation Session: this session is strongly recommended, and often required by the IRB. New faculty members who are planning to be the Principal Investigator of human research studies should schedule a one hour WebEx orientation session PRIOR to submitting their first research proposal to the IRB. To schedule this session please e-mail irb@uchc.edu
- Informed Consent- Process and Documentation – Educational Session: This session is offered via WebEx to individuals who will be obtaining informed consent from study participants. This one (1) hour session provides an overview of the informed consent process and documentation of consent.
- The HSPP Brown Bag Sessions: The brown bag lunch sessions take place every last Tuesday of the month at noon time (12 pm) via WebEX . These sessions are not provided during the months of November and December. These sessions provide an opportunity to expand your knowledge about conducting human subject’s research.
- IRB Guidance for New Investigators: The HSPP offers a one hour general educational session for study coordinators and investigators who plan to conduct Human Subjects Research at UConn Health. The training provides an overview of the research proposal submission and maintenance process. Registration is required. Interested staff should e-mail the HSPP at irb@uchc.edu to inquire about upcoming sessions.
- IRB Process Guidance: Individuals who need study specific guidance on preparing IRB submissions are encouraged to request assistance from the HSPP by contacting irb@uchc.edu to schedule a session.
- The Help section within iRIS contains training manuals.
- Training Classes on iRIS are offered. Register with the HSPP as noted above
- Study Start Up Educational Sessions, contact irb@uchc.edu to schedule
- Tutorial Privacy vs. Confidentiality (PowerPoint, developed by Joan Seiber)
- Tutorial #1 – Common Steps in the IRB Submission Process
- Tutorial #2 – Survey Research Under Exemption Category 2
- Tutorial #3 – Chart Reviews Under Exemption Category 4
- Tutorial #4 – Overview of HIPAA in Research
- Tutorial #5 – Considerations for International Research
Educational Sessions for IRB Members:
- Contact the HSPP to request training in iRIS or to request training on the IRB review process.
On line Educational Resources:
Institutional Review Board Members
IRB members are appointed by the Director of the Human Subjects Protection Program and are selected for their experience and expertise, as well as for their diverse backgrounds. Panel 01 generally meets on the first Monday of the month and Panel 02 generally meets on the the third Monday of the month.
Meeting dates and submission deadlines may be adjusted due to holidays therefore investigators should always refer to the published schedules. The submission deadlines only apply to studies that require full board review (either initially or at the time of continuation). Studies that qualify for expedited review or exempt status are reviewed on an on-going cycle as they are received.
Each member who is assigned as a primary review is provided with an electronic reviewer sheet within iRIS. The help buttons associated to the form address the points the IRB should consider as related to the criteria for approval. The forms provided by the PI address the special concerns of involving vulnerable populations in research and the IRB must consider those forms.
Members may find the following documents helpful:
- A general process for conducting a review (Word), as provided in the IRB Member Handbook by Robert Amdur
- The combined IRB Policy Manual
- Listing of individual HSPP/IRB Policies,
- Contact irb@uchc.edu for a guide for using the IRIS system to do reviews
- Template for Initial Review Presentation
- Template for Continuing Review Presentation
- Template for Addendum/Modification Presentation
- Guidelines for Assessing Risk
- Guidelines for Approved Contingent vs. Deferral of Approval
- Individual Financial Conflict of Interest in Research Policy 2006-01
- Significant vs. Non-Significant Risk Device Determination (pptx by Brian Seabolt IRBMED)
- Paper Reviewer Form for Initial and Continuing Review (for historical reference)
- Community Based Participatory Research (pptx )
- Regulatory Guidance for Academic Research of Drug and Devices
- Is my Device Study Exempt from Investigational Device Exemption (IDE) Regulations?
IRB Panel 01 Membership:
- I-Ping Chen, DDS, PhD, Professor, Endodontics
- Linda Choquette, MSHC, CCRP, Sr. Manager Clinical Research, JAX
- Terese Donovan, MS, RN, Clinical Nurse Education Specialist (retired)
- Julian Ford, PhD, Professor Psychiatry, Chair
- Agnes Kim, MD, PhD, Associate Professor of Medicine in Calhoun Cardiology Center, Internal Medicine
- Stephen MacKinnon MA, Regulatory Specialist
- M. Melinda Sanders, MD, Professor, Pathology and Lab Medicine, UConn Health
- Mitchell Sauerhoff, PhD, DABT, Volunteers at UConn Health in Medical Toxicology /Emergency Medicine and School of Pharmacy
- Ruchir Trivedi, MD, Associate Professor, Nephrology; Vice-Chair
- Rev. Daniel Warriner, DMin, BCC, Chaplain, UConn Health
- Jeffrey Wasser, MD, Assistant Professor, Neag Comprehensive Cancer Center (retired)
- Andrew Winokur, MD, PhD, Professor, Psychiatry
IRB Panel 02 Membership:
- Francesco Celi, MD, Professor, Department of Medicine
- Timothy Everett, JD, MA, Clinical Professor of Law, UConn School of Law, (Prisoner Advocate)
- Julian Ford, PhD, Professor Psychiatry, Co-Chair
- Martin Freilich, DDS, Professor, Department of Reconstructive Sciences
- Upendra Hegde, MD, Professor, Hematology/Oncology, UConn Health, Co-Chair
- Ronald Kadden, PhD, MA, Professor, Psychiatry (retired)
- Dayne Laskey, PharmD, Assistant Professor Pharmacy Practice, University of St. Joseph School of Pharmacy
- Janice Loomis, MA, Administrator, IRB William W. Backus Hospital
- Jun Lu, MD, Professor, Dermatology
- Edmund Mikolwosky, JD, Community Member
- Warren Osterndorf, MA, Assistant Professor of Communications, Eastern CT State University
- Amy Zipf, RN, PhD, Clinical Nurse Specialist, UConn Health
+Stephen MacKinnon MA may act as alternate
Institutional Review Board Meeting Dates and Submission Deadlines
There are two IRB Panels, each scheduled to meet once per month. With the following exception*, studies which are complete and ready for review are assigned to a panel based on submission deadlines. Once a study is assigned to an IRB panel, the study remains under that panel’s oversight for the life of the study.
*Any study proposing to include prisoners as subjects must be submitted for review by Panel 02. Panel 02 reviews all other types of studies as well as prisoner studies.
| Panel | Meeting Date | Submission Deadline Date |
|---|---|---|
| 01 | October 7, 2024 | September 24, 2024 |
| 02 | October 21, 2024 | October 8, 2024 |
| 01 | November 4, 2024 | October 22, 2024 |
| 02 | November 18, 2024 | November 5, 2024 |
| 01 | December 2, 2024 | November 19, 2024 |
| 02 | December 16, 2024 | December 3, 2024 |
| 01 | January 6, 2025 | December 24, 2024 |
| 02 | January 27, 2025 | January 14, 2025 |
| 01 | February 3, 2025 | January 21, 2025 |
| 02 | February 24, 2025 | February 11, 2025 |
| 01 | March 3, 2025 | February 18, 2025 |
| 02 | March 17, 2025 | March 4, 2025 |
| 01 | April 7, 2025 | March 25, 2025 |
| 02 | April 21, 2025 | April 8, 2025 |
| 01 | May 5, 2025 | April 22, 2025 |
| 02 | May 19, 2025 | May 6, 2025 |
| 01 | June 2, 2025 | May 20, 2025 |
| 02 | June 16, 2025 | June 3, 2025 |
| 01 | July 7, 2025 | June 24, 2025 |
| 02 | July 21, 2025 | July 8, 2025 |
| 01 | August 4, 2025 | July 22, 2025 |
| 02 | August 18, 2025 | August 5, 2025 |
| 01 | September 8, 2025 | August 26, 2025 |
| 02 | September 15, 2025 | September 2, 2025 |
| 01 | October 6, 2025 | September 23, 2025 |
| 02 | October 20, 2025 | October 7, 2025 |
| 01 | November 3, 2025 | October 21, 2025 |
| 02 | November 17, 2025 | November 4, 2025 |
| 01 | December 1, 2025 | November 18, 2025 |
| 02 | December 15, 2025 | December 2, 2025 |
| 01 | January 5, 2026 | December 23, 2025 |
| 02 | January 26, 2026 | January 13, 2026 |
| 01 | February 2, 2026 | January 20, 2026 |
| 02 | February 23, 2026 | February 10, 2026 |
| 01 | March 2, 2026 | February 17, 2026 |
| 02 | March 16, 2026 | March 3, 2026 |
| 01 | April 6, 2026 | March 24, 2026 |
| 02 | April 20, 2026 | April 7, 2026 |
| 01 | May 4, 2026 | April 21, 2026 |
| 02 | May 18, 2026 | May 5, 2026 |
| 01 | June 1, 2026 | May 19, 2026 |
| 02 | June 15, 2026 | June 2, 2026 |
| 01 | July 6, 2026 | June 23, 2026 |
| 02 | July 20, 2026 | July 7, 2026 |
| 01 | August 3, 2026 | July 21, 2026 |
| 02 | August 17, 2026 | August 4, 2026 |
| 01 | September 14, 2026 | September 1, 2026 |
| 02 | September 21, 2026 | September 8, 2026 |
| 01 | October 5, 2026 | September 22, 2026 |
| 02 | October 19, 2026 | October 6, 2026 |
| 01 | November 2, 2026 | October 20, 2026 |
| 02 | November 16, 2026 | November 3, 2026 |
| 01 | December 7, 2026 | November 24, 2026 |
| 02 | December 21, 2026 | December 8, 2026 |
Scientific Review Committee
The Scientific Review Committee (SRC) ensures that the scientific question being asked within a protocol is relevant and that the design of the protocol is appropriate to answer that question. A guide for using iRIS to access the material to be reviewed is available by clicking the Help button within iRIS.
The SRC review will primarily focus on the elements of good scientific study design. Proposals will be evaluated for the following criteria:
- clarity of the research question,
- appropriateness and efficiency of design,
- rigor and feasibility of methods,
- qualifications and expertise of the research team,
- scholarship and pertinence of background material and rationale,
- adequacy of sample size and relevance of controls,
- and the validity of the statistical analysis plan.
In addition, the Committee may desire to comment on the proposal’s scientific relevance or compelling ethical or patient safety issues. The SRC will submit a summary of their evaluation to the IRB and report their final recommendation as (1) recommend approval without revision, (2) recommend approval pending acceptable revision, or (3) recommend rejection. Recommendations will be based on consensus. The Scientific Review Committee may call upon a consultant if additional expertise is needed to conduct a review. The opinion of the consultant will be taken into consideration when developing the final report. The fact that a consultant was utilized will be noted in the letter to the IRB.
The IRB requires scientific review for all studies reviewed by the convened board that have not already undergone review by another body. The IRB also reserves the right to send any study to the Scientific Review Committee for evaluation. The Scientific Review Committee will generally meet the week before the scheduled IRB meeting to discuss the research protocol.
A member will not review any protocol in which s/he has an interest in the study. If needed, the IRB may call upon the Scientific Advisory Committee of the General Clinical Research Center for assistance.
Scientific Review Committee Membership:
- Dr. Julie Wagner, Chair, Professor, Oral Health and Diagnostic Sciences
- Dr. Sheila Alessi, Associate Professor, Calhoun Cardiology Center
- Dr. Biree Andemariam, Professor, Neag Comprehensive Cancer Center
- Dr. Molly Brewer, Professor, Obstetrics & Gynecology
- Dr. Kevin Claffey, Professor, Cell Biology
- Dr. Jonathan Covault, Professor, Psychiatry
- Dr. Richard Fortinsky, Professor, Center on Aging
- Dr. Ivo Kalajzic, Professor, Center for Regenerative Medicine and Skeletal Development
- Dr. Carla Rash, Associate Professor, Calhoun Cardiology
- Dr. Tannin Schmidt, Associate Professor, Biomedical Engineering
Guidance on the IRB Submission Process
GET HELP: iRIS is the system used to submit materials to the IRB for review. Individual who need to use iRIS are strongly encouraged to review the iRIS User Guides available within the Help section of iRIS, and/or attend an iRIS training sessions before using the system for the first time. Contact the HSPP at irb@uchc.edu with questions pertaining to iRIS training or if additional guidance is needed regarding the IRB submission process (e.g. initial submission, continuing review, request for modification, problem report form).
The IRB Regulatory Specialists (Steve MacKinnon x8729) are also available to provide assistance.
General Tips:
Allow yourself a sufficient amount of time for the IRB approval process to occur. The terms expedited and exempt do not mean a quicker response time from the IRB.
Review the categories of research that may be exempt or that may be reviewed through the expedited process to determine whether your study qualifies for exemption or expedited review. The PI/study team make the initial assessment, but the IRB will make the final determination.
Select a faculty member to be the Principal Investigator (PI) of the project. Students, residents and fellows cannot be the PI on an IRB application requesting exemption, expedited review or full board review.
If your study does not qualify for expedited review or exempt status, it will be reviewed by a convened panel of the IRB. Each panel is scheduled to meet once per month.
Use the applicable submission checklist (full board, expedited or exempt) to make sure you have all required documents for your submission.
If documents will require translation, obtain approval of the English version first, and then submit the translated documents for approval as a request for addendum/modification.
Ensure all study personnel have completed the CITI training as early as possible. Training is good for three years and must be completed prior to IRB approval being granted.
The project should be defined before you begin the process of completing the IRB paperwork. You should have the research question well formulated and know exactly what data you will be collecting and how they will be analyzed.
When possible build flexibility into the protocol to avoid protocol deviations.
- For example, in a survey study state in the protocol that minor adjustments to surveys may be made in the field to improve clarity or address cultural sensitivities. Also note that if done the revised survey will be provided to the IRB for reference at the first possible opportunity. This would allow you, for example, to reorder questions, or break one question into multiple parts, without having to first obtain IRB approval. (Note substantive content change would require IRB approval first, e.g. inclusion of new questions).
- For example, in a treatment study, if possible, rather than saying subjects will be seen 30 days after the first appointment, allow for flexibility in the scheduling by say subjects will be seen 30 days (+/- 5 days) after the first appointment.
Make sure there is consistency between the IRB documents. For example the IRB application, HIPAA Authorization, Informed Consent Form and your protocol should all be consistent regarding what procedures will be done, what data will be collected etc.
Do not delay the submission of your project when you are waiting for “static” documents, such as a permission letter to conduct the study off-site or proof of completion of human subjects protection training, because this type of document will not affect the content of your project. Submit all of the other documents and indicate on the electronic IRB submission by comment that you are in the process of obtaining the relevant document(s). In this manner the content of your project can be evaluated concurrently and will help reduce the amount of time required to obtain approval. Note that final approval will not be granted until all required documents have been provided to the IRB.
Ask questions early on in the process. You can contact the individuals noted above for assistance.
General Review Process:
Expedited and exempt applications are generally screened within 10 days of receipt. If needed, a communication is sent requesting additional information/clarification before the submission is assigned for official review. Once all necessary information and/or documentation has been received the application packet is forwarded for official review. The official review may result in additional questions.
If a new study requires review by a convened panel, it will be assigned to the next panel meeting for which the submission deadline has not passed. If the study includes prisoners as subjects it must be reviewed by Panel 2. After the meeting the Regulatory Specialist will prepare the minutes and give members 48 hours to comment on such. Within approximately 10 days after the meeting the IRB will issue a letter noting the outcome from the meeting.
You cannot begin the project until you have IRB approval.
General Documents to Submit for Expedited or Exempt Research:
The following information is intended to serve as a general guideline for what documents must be submitted with various study designs that are common to expedited and exempt projects. Because every study is unique it is not possible to provide directions that will address every situation. The documents common to all new submissions are noted in the first row and additional documents that are often associated with specific study designs follow. Investigators should use the Exempt Submission Checklist or the Checklist for Expedited Submissions as the official guide for what documents to provide. In addition the Request for Exemption or Request for Expedited Review Form should completed as noted on the applicable checklist. Some projects may combine characteristics of more than one study type. Items with an asterisk (*) indicate documents that are created by the investigator.
| Type of Study | Documents to Submit | Comments |
| 1. All Studies | The protocol may be provided by a sponsor, but for most expedited/exempt submission the protocol is developed by the study team. Use of a Protocol template is strongly encouraged. If another protocol format is used the IRB reserves the right to still require completion of this form. Protocol templates are available on the forms page. | |
| 2. Chart Reviews with Identifiers retained |
|
Based on the information that will be abstracted from the medical chart, create your own data collection form. |
| 3. Chart Reviews when identifying information is seen but WILL NOT be recorded |
|
The PI must sign the form to create a de-identified data set, most often under option 2. The person(s) abstracting the data from the medical record must also sign the certification of de-identification form. |
| 4. Survey / Interview Studies |
|
Subjects of interview/survey studies must be informed of certain elements of consent via either a cover letter or introductory paragraph. Refer to the Sample Cover Letter. Most survey studies will qualify for exemption. If not, and the study is reviewed under an expedited category, informed consent must be addressed
If the study involves PHI HIPAA must also be addressed. |
| Vulnerable Subjects | ||
| Inclusion of Children in non-exempt research |
|
If the IRB determines the study is above minimal full board review will be required.
The form to obtain permission from parents may be modeled after the Informed Consent Template |
| UConn Health students/employees as subject population in non-exempt research |
|
Applicable only when there is a relationship that may create undue influence and the research seeks to specifically enroll students or employees (e.g. teacher/student or supervisor/employee). Employees or students who respond to general recruitment material aimed at a broader audience are not considered vulnerable. |
| Inclusion of Pregnant Women, Neonates in non-exempt research | ||
| Special Situations: | ||
| Studies in Foreign locations or off of UConn Health grounds (e.g., in an elementary school setting) |
|
Note: If that site has its own Institutional Review Board you may need to obtain IRB approval from that site in addition to UConn Health. |
| Conflicts of Interest | For all studies, the PI (or designee) is responsible for soliciting information as to whether any study personnel have a significant financial interest related to the research. Proof that this informant was solicited from study personnel should be maintained in the regulatory binder for the study. The disclosure form, and if applicable corresponding management plane, is only required to be submitted to the IRB if a study team members discloses that s/he does have a significant financial interest. |