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Viterbo University Institutional Review Board 

 Application for Approval of Research Involving Human Subjects

 

Type of Review

                                                                                                       

Project Information

 Title of Project:


Anticipated Project Start Date:       Anticipated Project End Date:

List all of the investigators involved in this project.  Student researchers should list their faculty advisor(s) as an investigator. 

Principal Investigator:     

Department or Organization:

Email address:   Phone:

Responsibilities in the research project:

 
Name:   

Department or Organization:

Email address:   Phone:  

Responsibilities in the research project:

 
Name:  

Department or Organization:

Email address:   Phone:

Responsibilities in the research project:
   
 
Name:  

Department or Organization:

Email address:    Phone: 

Responsibilities in the research project:

 

Name:

Department or Organization:

Email address:    Phone:

Responsibilities in the research project:


If needed, send information for additional investigators to: IRB@viterbo.edu.
 

Provide an abstract (maximum 250 words) that describes the purpose of the project, including the research questions and/or hypotheses to be examined.


Describe the participant population.


If your participants will include a vulnerable population (such as fetuses, minors, pregnant women, prisoners, or mentally disabled persons), identify the population and provide a rationale for their inclusion.


Describe the process that will be used to recruit and select participants.


Provide a step-by-step description of the research procedures that participants will undergo. Include the time commitment required by participants.

 

Risks

Describe the possible risks to participants, such as physical injury, psychological stress, emotional discomfort, or disclosure of sensitive information.


Describe the precautions that will be taken to minimize the risks to participants.


Describe how you will respond if adverse effects occur.


If your participants will include a vulnerable population, describe any additional safeguards that will be used to protect them from harm.

 

Voluntary Participation

Describe how informed consent will be obtained from participants and/or their legally authorized representatives.


If your participants will include a vulnerable population, describe any additional safeguards that will be used to ensure their voluntary participation.


If the study involves deception of any kind, describe the deception, the rationale for its use, and the procedure for debriefing participants.


If participants will receive inducements, describe the inducements and the rationale for their use.

 

Confidentiality

Describe the methods that will be used to protect the confidentiality of participants' information. Examples might include using pseudonyms or reporting data in aggregate form.


Identify who will have access to the data.


Describe how the data (including data files, completed surveys, transcripts, audio/video recordings, etc.) will be stored.


Describe how the data will ultimately be disposed of.

 

Supporting Materials

Each application must be accompanied by the following documents. Check each box to indicate that the item has been submitted to IRB@viterbo.edu.
   
 
 s (such as recruiting flyers or emails inviting individuals to participate)
 , or date certificate was issued 
 

Researcher's Assurance

  • I certify that the information provided in this application is accurate and complete.
  • I understand that, as principal investigator, I have the ultimate responsibility for the ethical performance of this project and the protection of the rights and welfare of human subjects.
  • I agree to comply with all Viterbo University policies and procedures, the terms of its Federal Wide Assurance, and all applicable federal, state, and local laws regarding the protection of human subjects. 
  • I certify that all individuals involved with this project are qualified to carry out their specified responsibilities and are knowledgeable about the regulations and policies governing this research. 
  • I certify that the proposed project will not begin until IRB approval is obtained. 
  • I certify that the project will be conducted according to the protocol and no changes will be implemented without prior approval from the IRB.   
  • I agree to promptly report to the IRB any significant adverse events involving participants.
  • I agree to submit a renewal request if the project continues beyond the one year approval period.
  • I agree to submit a final report upon completion of the project.
Principal investigator's name:
 
Principal investigator's ID number (found on Viterbo University ID card):

Date: