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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 Mayra Cagganello (860-679-8802) with questions pertaining to iRIS training.

If additional guidance is needed regarding the IRB submission process (e.g. initial submission, continuing review, request for modification, problem report form), Mayra can also provide education related to preparing an IRB submission. The IRB Regulatory Specialists (Pamela Colwell x1019, Patricia Gneiting x4849, 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.

Review the applicable training tutorials (Your UConn Health username and password will be required):

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 call 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 to an IRB member 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.  If the study is a CICATS study it must be reviewed by the CICATS panel.  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 Checklist for Expedited Submissions as the official guide for what documents to provide. 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.   Review Module 1 – “Common Steps for all Studies” to learn the initials steps required for all IRB submissions.
2.  Chart Reviews when identifying information WILL be recorded Based on the information that will be abstracted from the medical chart, create your own data collection form.  Refer to the Protocol Template & Guidance for Chart Review Submissions.  Refer to the Chart Review Diagram.  Review Module 3 – “Chart Review Studies” to learn the steps specifics for chart review studies.
3. Chart Reviews when identifying information 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.  Refer to the Protocol Template & Guidance for Chart Review Submissions  Refer to the Chart Review Diagram.   Review Module 3 – “Chart Review Studies” to learn the steps specifics for chart review studies.
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 and if the study involves PHI HIPAA must be addressed.  Refer to Protocol Template.  Review Module 2 – “Survey Studies” to learn the steps specific for Surveys studies
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
  • Relevant Documents from above
  • Form S (Word)
 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
  • Relevant Documents from above
  • Form B204 (Word) for pregnant women
  • Form B205 (Word) for neonates
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 is only required to be submitted to the IRB if a study team members discloses that s/he does have a conflict of interest.