Information for Students     

• The IRB is located at 16 Munson Road on the 2nd floor.  
• The primary contact person for students is Patricia Gneiting.  Her phone number is 860-679-4849 and her e-mail address is gneiting@exchange.uchc.edu  
• If Patty is unavailable students may also call Donna Horne (860-679-4851, horne@nso2.uchc.edu) or Pamela Colwell ( 860-679-1019, engelson@nso.uchc.edu ).
• The mail code for the office is 3926
• The office fax number is 860-679-1005

General Tips:

You should read the student brochure and student packet for some general introductory information and tips.

You should complete the CITI training as early as possible.  Training is good for three years and must be completed prior to IRB approval being granted.  Once at the CITI web site, click the button to register for the course and then create your own user name and password.  Select the student course module as your training requirement.  Also be sure to affiliate yourself with the University of Connecticut Health Center, not just the University of Connecticut which is for the Storrs campus. 

Students cannot be the PI on the IRB application.  A faculty mentor must be the Principal Investigator (PI) of the project.

Your project should be well thought out and 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. 

You should take time to read the IRB Application Instructions.   While they may seem daunting at first glance, several areas are not likely to apply to your project, e.g. the section on investigational drugs.  What the instructions will provide you with is a sense of what the IRB is looking for in terms of responses.   

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.

When conducting your project, do only and exactly what you described in the material submitted to the IRB.  Changes to your project (whether adding or deleting something) must be approved by the IRB, via a request for modification, before they are implemented.  

Research involving intervention or interaction with children may not be granted exempt status. Permission from parents will be required and assent of the children may be required in a separate assent statement.

Some project designs will require a few additional steps when preparing your submission, for example:

• if subjects will not be fluent in English, documents must be translated and the IRB must approve the translated documents
• if the study will be conducted off of UCHC premises at a site that does not have an IRB or the equivalent of an IRB, a letter of permission must be submitted and signed by someone with the authority to grant  permission for the project to be conducted at that site.
• if a non-exempt study includes a vulnerable population additional protections for these populations must be addressed within the application packet by completion of additional worksheets

You and your faculty mentor (PI) are encouraged to ask questions early on in the process.  You can call (679-4849) or e-mail Patty to schedule a time to meet and discuss the particulars of your project. 

General Summary of the Submission Process for Expedited and Exempt Applications:

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.  Applications are generally screened within 10 days of receipt.  Then, if needed, an e-mail is sent requesting additional information/clarification.  Once all necessary information and/or documentation has been received the application packet is forwarded to the IRB Chair for review.  The Chair may have additional questions resulting in another e-mail or  may approve the project.  

You should 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.  What you should do is submit all of the other documents and indicate on the IRB Application Checklist that you are in the process of obtaining the relevant document.  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. 

You cannot begin the project until you have IRB approval.

What Documents to Submit:

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 student 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.  Some projects may combine characteristics of more than one study type.  Items with an asterisk (*) indicate documents that are created by the student. 

 

Type of Study	Documents to Submit	Comments
1.  All Studies	IRB application checklist IRB application Protocol*	A student's Selective proposal generally serves as the protocol. You are encouraged to read the application instructions.
2.  Chart Reviews when identifiable information WILL be recorded	Documents in row 1 Data collection form*  Request to waive or alter informed consent  Request to waive the requirement for a HIPAA Authorization  Request for expedited review form	Based on the information that will be abstracted from the medical chart, create your own  data collection form.  The PI must sign the forms to request a waiver of consent, a waiver of HIPAA.  Refer to the student packet for sample responses.
3.  Chart Reviews when identifiable information WILL NOT be recorded	Documents in row 1 Data collection form*  Request for exempt review form Certification of creating a de-identified data set	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	Documents in row 1 Survey or surveys that will be administered* Survey cover letter or introductory paragraph* Recruitment material that will be used* Request for Exemption form (no children in the research) - OR Request for Expedited form (including children in the research)	Subjects of interview/survey studies must be informed of certain elements of consent via either a cover letter or introductory paragraph.  Refer to the student packet.    If the study is reviewed under an expedited category, informed consent must be addressed If the study involves PHI HIPAA must be addressed.
Special Situations - Vulnerable Populations
Inclusion of Children in non-exempt research	Relevant Documents from above Form to obtain permission from parents for inclusion of their child in interventional, survey or interview studies Form D404	If the IRB determines the study is above minimal risk a different form (D405 or D406) and full board review will be required The form to obtain permission from parents may be modeled after the consent form
Inclusion of UCHC students / employees in non-exempt research	Relevant Documents from above Form S
Inclusion of Pregnant Women, Neonates in non-exempt research	Relevant Documents from above Form B204 for pregnant women Form B205 for  neonates
Inclusion of Prisoners	Relevant Documents from above Form C	Full board review by panel 2 is required
Special Situations - Studies Conduct Off Site
Studies in Foreign locations or off of UCHC grounds (e.g. in an elementary school setting)	Translated documents Permission to conduct the study at that site from that site's IRB or equivalent of an IRB; or if there is no IRB or equivalent to an IRB a permission letter signed by someone with the authority