University of St. Thomas	IRB USE Only
Institutional Review Board	IRB #: ___________________
Application for Approval to Conduct Research	Date Received: _____________
Requested review category: [  ] Expedited  [  ] Full Board	Date Approved: ___________

 

1.        Project Title:

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

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

2.      If Expedited, Indicate Research Category (see appendix for descriptions): ______________

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).  Provide reasons for targeting any special populations (see question 10d) or for excluding women or minorities (as appropriate).

 

 

 

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.      Special Populations

NOTE: These groups require special consideration by federal regulatory agencies and by the

IRB.   In the Lay Summary (question 9d) you should have provided a rationale for focusing on special populations.  If women and minorities are to be excluded from the study, a clear rationale for their exclusion should also be provided in the Lay Summary (question 9d).

 

[  ] Minors (under age 18) - volunteers    [  ] HIV/AIDS patients

[  ] Minors -- patients                               [  ] Economically disadvantaged

[  ] UST Employees                                    [  ] Educationally disadvantaged

[  ] Students                                              [  ] Hospital patients or outpatients

[  ] Pregnant women                                 [  ] Prisoners

[  ] Elderly/aged persons                          [  ] Cognitively impaired persons

[  ] Minority group(s) and non-English speakers (please specify in question 9s)

[  ] Other Special Characteristics and Special Populations (specify and provide rationale in

      question 9d)

 

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.) __________________________________________________

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.    Risks and Benefits

         a.   Does the research involve any of these possible risks or harms to subjects?  Check all that apply:

[  ]     Use of private records (medical or educational)

[  ]     Possible invasion of privacy of subject or family

[  ]     Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stresses

[  ]     Any probing for personal or sensitive information in surveys or interviews

[  ]     Use of deception as part of experimental method

[  ]     Social or economic risk

[  ]     Other risks (please specify):_____________________________________________________

b.   Describe the precautions used to minimize risks.  This information must be listed here and on the consent form.

 

 

c.   Use of Deception: If this research involves the use of deception as part of the experimental method, the method must include a “debriefing procedure” which will be followed upon completion of the study or subject’s withdrawal from the study.  Specify this method here.

 

 

d.   Benefits to participation:  List any anticipated direct benefits for subjects that participate in this research project.  This does not include statements like "add to the existing knowledge" or "assisting your school/agency/company, etc."  If there are no benefits, state “None”.  List this information here and in the consent form. 

 

14.    Informed Consent

         NOTE: Simply giving a consent form to a subject does not constitute informed consent.  Consent itself is a process of communication.

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)

                                               iv.      Risks and Benefits (question 13, parts a, b, d)

                                                 v.      Special Concerns for Research in School Settings (question 16, part b, if applicable)

 

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.       What questions will be asked to assess the subject’s understanding of the risk and benefits of participation?  Questions should be open-ended – not “yes/no” questions.

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

 

 

 

         e.   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):

 

 

 

 

15.    Determination of Full Board Review (check all that apply)

         Checking either of the categories below qualifies this study for full board review under federal regulations.

         [  ]     Research involving more than minimal risk to the subject (see appendix for definition of minimal risk)

         [  ]     Research involving children or vulnerable populations (see appendix for definitions)

 

16.    Special Concerns for Research in School Settings

         If you are conducting research on school children during class time, please answer the following questions.

a.      Describe in detail the activity planned for children not participating in your research.

 

 

 

b.   Who will supervise non-participants?  Include this information in the consent form.

                       

 

 

17.    Assurances

 

NOTE: Inked signatures are required on the original application, to be submitted with the appropriate number of copies (4 copies for an expedited review, 12 copies for a full board 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.