University of St. Thomas	IRB USE Only
Institutional Review Board	IRB #: _____________________
Application for Approval to Conduct Research	Date Received: ______________
Requested category: Exempt From Further Review	Date Approved: ____________

 

1.        Project Title:

         Application Type: [  ] Initial Review     [  ] Resubmission/Revision

         If Resubmission/Revision, list original IRB # here: __________________________________

2 .     Mark the Exempt Status category that applies to this research (see Appendix for details):

[  ]     Instructional Strategies in Educational Settings

   [  ]     Surveys/Interviews; Standardized Educational Tests; Observation of Public Behavior

   [  ]     Public Officials -- Surveys/Interviews; Observation of Public Behavior

   [  ]     Existing Data; Records Review; Specimens

   [  ]     Public Service Programs; Demonstration Projects

         [  ]     Taste Testing and Food Quality Evaluation

3.      Will This Research last more than one year?  [  ] Yes     [  ] No

   Project Period (from data collection to project completion): _______ through         _____

4.      Name of Principal Investigator:     ___________________________________________                       

         University Department/School:     _____________________________________________              

         Primary Mailing Address:                 ____________________________________________              

         Telephone:                                          __________________________________________              

         E-mail:                                                  __________________________________________  

5.      Name of Research Advisor (if applicable):_____________________________________

         University Department/School:        ____________________________________________             

         Primary Mailing Address:                   ___________________________________________

         Telephone:                                           __________________________________________

         Email:                                                    _________________________________________

6.      Please list any Co-Investigators:      ___________________________________________

         University Department/School:        ____________________________________________             

         Primary Mailing Address:                  ___________________________________________

         Telephone:                                           __________________________________________

         Email:                                                    _________________________________________

7.      Mark the appropriate category:

         [  ]  Faculty or Staff Research (1)                                [  ]   Undergraduate Student Research (3)

         [  ]  Graduate Student Research (2)                            [  ]   Classroom Protocol (4)

         [  ]  Student/Faculty Collaboration (6)

         [  ]  Other (specify): _________________________________________________________

 

8.      Is this research subject to any other type of review?  [  ] Yes                     [  ] No

         If YES, specify:    

         [  ] Dissertation or Thesis committee         [  ] Grant agency               [  ] Project site           

         [  ] Other IRB (Specify Location/Source of Committee): ___________________________________

         [  ] Other: _______________________________________________________________________

 

9.      Lay Summary

Please complete each section in clear, easy to read language that can be understood by a person unfamiliar with your research and your field.  Done correctly, sections of this summary can be used in your consent form by changing the voice to first and second person and deleting information your participants do not need. 

a.      Purpose of the research:  Provide a concise statement of 2-3 sentences.

 

 

b.      Background: Provide 1 or 2 brief paragraphs to explain the importance of the research and how

      it fits with previous research.

 

 

c.       Research Methods and Questions: Specify your research questions, hypotheses, and present specific methods you will use to address these hypotheses.

 

 

d.      Target Population: Describe your target population (e.g. seniors, children ages 9-12).  If you plan to exclude women and/or minorities, provide reasons for doing so.

 

 

e.      Expectations of Participants: State precisely what you will have participants do.  Attach any surveys, tests, instruments, interview questions, etc. that you will use with participants.  Also state the location of data collection and the expected time commitment of participants.

 

 

 

f.        Analysis of Existing Data: If you are analyzing existing data, records, or specimens, explain the source and type, as well as your means of access to them.

 

 

10.    Anticipated Subject Population

         These are your best estimates based on the population you wish to study.

         a.   Number of Males: _______      Females: ________      Total Human Subjects: ________

         b.   Age Range:    Youngest Subject __________       Oldest Subject ___________

         c.   Location of Subjects (check all that apply):

[  ]   University of St. Thomas campus

[  ]   Elementary/Secondary school

[  ]   Hospital

[  ]   Clinic

[  ]   Long Term Care Facility

[  ]   Prison/Halfway house

[  ]   Other Special Institution (Specify): ______________________________________

[  ]   None of the above (Describe location of subjects): _________________________

______________________________________________________________________

NOTE: If subjects are recruited or research is conducted through an agency or institution other than UST, submit written documentation of approval and/or cooperation. This document should use the agency or institution’s letterhead and contain enough information to demonstrate the agency or institution’s understanding of their role in your research.

 

d.      Does your target population(s) fall in the following categories?

[  ]  Normal Adult Volunteers (see appendix for definitions)

[  ]  Children under federal exemption for educational settings (see appendix for details)

NOTE: If any part of your target population does not fall into these two categories, you will need to stop now and complete a expedited/full board application for your proposal.

 

 

11.    Recruitment of Participants

         a.   Describe how subjects will be identified or recruited.  Attach copies of recruitment materials to be used (e.g.  advertisements, bulletin board notices, letters, emails, phone scripts, etc.).

        

 

         b.   Specify who will make initial contact with subjects, and how that contact will be made.   Contact may be made through emails, phone calls, letters, etc.  It is important that potential subjects have a choice to be in your study.  Measures should be taken to eliminate potential coercion.

 

 

         c.   Will subjects be chosen from existing records?  [  ]  Yes            [  ] No

               If subjects are chosen from records, indicate who gave approval to use the records.  Approval must be given by an individual who has the authority

               to release the records.  Attach a signed  letter of approval from that individual, preferably on letterhead from their organization.

 

 

 

NOTE: If records are private medical or student records, provide a clear description of how you will be securing consent of the subjects of the records

and approval from the holder of the records.  Attach written documentation of consent of subjects and approval of record holders.

 

 

   d.   Will the subjects receive incentives before and/or rewards after the study?   [  ] Yes   [  ]  No

         If Yes, describe these incentives and/or rewards.  Include this information in your consent form.

 

 

e.      What is the nature of the relationship between the researcher and any cooperating agency or organization?

        

        

f.        What is the nature of the relationship between the researcher and the potential participant?

 

 

 

12.    Confidentiality of Data

Please completely answer each question in clear, easy to read language.  As with the lay summary, the information in this section should be used in your consent form.  It is extremely important that all information obtained from your participants be kept as confidential as possible.

a.      In what format(s) will the data be created? (e.g. written notes, surveys, audiotapes, video tapes/DVD’s, photographs, etc.) __________________________________________________

NOTE: IF you are making any electronic records (e.g. audio or video recordings, photographs), stop now and complete an expedited/full board application for this proposal.

 

Answer the following questions for each form of data you create.

         b.   Where will the data and records be kept?  Specify the setting where the data will be kept (e.g. home, work, school, etc.), and how the data will be made

               secure (e.g. kept in a locked file in a locked room, secured computer. etc.).

           

 

        c.    How long will the data and records be kept?   Specify the exact date when the data and records will be destroyed.  If the data and records are to be kept indefinitely, specify how they will be deidentified (see appendix for details).

     

 

 

      d.   Will information from the data be transcribed?  [  ]  Yes   [  ]  No  

             If Yes, please explain who will transcribe any information from this media and where it will be kept.   If the researcher is not the person transcribing the media, attach a statement of confidentiality from the transcriber.

 

 

e.      Who will have access to the data and records?  Will data identifying the subjects be available to anyone other than the principal investigator (e.g. school officials, research advisors, etc.)? List  these people in the Consent Form.

 

 

f.        Will the data be recorded in any permanent record, such as a medical chart or student file?

[  ]  Yes   [  ]  No           If Yes, Please explain below.

 

 

 

13.    Informed Consent

         Though informed consent is required of all participants in your research study, a signed consent form is often not necessary in exempt-level studies where

        the subject remains anonymous.   For example, a survey with no identifying information mailed to potential participants can include a consent letter with the

        phrase “Your consent to participate in this study is implied when you complete and return this survey”.  Please see appendix for more information.

a.      Prepare and attach a Consent Form for IRB review.  A consent form template may be found at www.stthomas.edu/irb.   Information from these sections

     will be needed to complete this form:

                                                  i.       The Lay Summary (question 9)

                                                ii.      Recruitment of Subjects (question 11 part d)

                                              iii.      Confidentiality of Data (question 12)

In addition, you must give information about direct benefits for the participant, as indicated in the consent form template.  If there are any potential risks to participants in your research, stop now and complete an expedited/full board application for your proposal.

b.      Describe what will be said to the subjects to explain the research.  Do not say “see consent form”.  Write the explanation in lay language.

 

c.       At what point in the research process will consent be obtained?  Be specific.

 

 

 

         d.   Will the investigator(s) personally secure informed consent for all subjects?  [  ]  Yes   [  ]  No

               If Yes, identify below the individuals who will obtain consent (include job title/credentials):

 

 

 

14.    Assurances

 

NOTE: Inked signatures are required on the original application, to be submitted with the appropriate number of copies (2 copies for an exempt level review).

 

This research, once approved, is subject to continuing review and approval by the IRB.  The principal investigator will maintain records of this research according to IRB guidelines.  If these conditions are not met, approval of this research could be suspended.

The signatures below certify that:

The signatory agrees that he or she is aware of the policies on research involving human subjects of the University of St. Thomas and will safeguard the rights, dignity, and privacy of all human subjects.

The information provided in this application form is correct.

·           The principal investigator will seek and obtain prior written approval from the IRB for any substantive modification in the proposal, including but not limited to changes in cooperating investigators/agencies as well as changes in procedures.

·           Unexpected or otherwise significant adverse events in the course of this study which may affect the risks and benefits to participation will be reported in writing to the IRB and to the subjects.

·           The research will not be initiated and subjects cannot be recruited until final written approval is granted.

 

 

Signature of Principal Investigator ___________________________________ Date _______________

 

Signature(s) of Co-Investigators _____________________________________ Date _______________

 

Signature of Research Advisor  ______________________________________ Date _______________

Student Research:  As Research Advisor to the student investigator, I assume responsibility for insuring

that the student complies with University and Federal regulations regarding the use of human subjects in research.

 

 

Signature of Department Chair, or Designee ____________________________ Date ______________

Faculty/Staff Research:  As Department Chair, or Designee, I acknowledge that this research is in keeping with the standards set by our department and assure that the principal investigator has met all departmental requirements for review and approval of this research.