Complete The IRB Proposal Worksheet In Relation To Your Group Proposal.

The University of Phoenix Institutional Review Board (IRB) exists to ensure university compliance with federal regulations regarding research involving human subjects.  This application is used to facilitate and document this compliance review.  Research projects which meet the federal definition for research and the federal definition of human subjects must be approved by the University of Phoenix IRB before any data collection begins.  If an IRB application is approved by the IRB and, later, the nature of the research design, requirements, or site locations change, a revised application describing these changes must be submitted for reconsideration and approval by the IRB.  This application is intended as a stand alone document, so reference to other documents or appendices of dissertation proposals or other research studies does not substitute for direct provision of that information as part of this application, either as a response within a section or as an addendum.  This application pertains to both pilot studies and full studies.  Please note that it is the researcher’s responsibility to give complete and accurate information about the nature of the proposed study, particularly in terms of the effects on, and expectations for, subject participants.  Please note that you must document currency in CITI certification as part of this application.  

Informed Consent:    Briefly explain and address the following questions.

      a)  How will subjects be informed of the study’s purpose, procedures, intent, duration of the study and any

           potential risks or discomforts to them?  Check all that apply:

() Informed Consent form  () Email  () Letter  () Meeting () Phone Call () Other _______

      b)  How will subjects be informed of withdrawal procedures? Check all that apply:

() Informed Consent form  () Email  () Letter  () Meeting () Phone Call () Other _______

     c)  How will the researcher contact information be provided to the subjects? Check all that apply:

() Informed Consent form  () Email  () Letter  () Meeting () Phone Call () Other _______

     d)  How will subjects withdraw from the study as participants after data collection is completed?

() Email the researcher    () Phone call to researcher    () Submit withdrawal form

() Other (please specify) ___________________________________________________________

     e)  Please explain what subjects must do to withdraw from the study after data is collected and how subject data

          will be retrieved and handled to ensure security and confidentiality.

    f)  If any subjects are under the age of 18 years, parental consent is required.  What provision is made to

        answer any questions the parents have about this study or to address any individual concerns?  (For example,

        will there be an informational meeting with the parents, etc.?) If this scenario does not apply to this study,

        please indicate “Not applicable” here.

       PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION

       OR EXPLANATION THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING ANY OF THE ABOVE

       QUESTIONS OR ABOUT THE INFORMED CONSENT FOR YOUR RESEARCH STUDY.

PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOXES BELOW:

          I attest that no primary data collection from human subjects will occur  without a prior signed Informed  

               Consent form completed for each subject and that Informed Consent documentation will be retained

               separately from study data.

          I attest that a process for subject withdrawal will be implemented whereby subjects may withdraw without

              penalty before, during and after data collection has been completed and submitted and that the

              information they provided will be identified, secured, withdrawn and kept confidential.

       a)  How will subject identity and data be protected?

            ()   Subject names will not be used or identified 

            ()   Pseudonyms or numbers will be used instead of subject names

            ()   Data will be coded alphanumerically

            ()   Other (please specify) ________________________________________________

       b) Will any audio and/or video tape or other recording of data be done in this study? 

            () Yes                               () No

       c) How long will the study data be kept after study completion?

            ()   Three years (please note this is the minimum required retention time)

            ()   More than three years

      d) Where will the data be stored:

            ()  In an office or other location at the researcher’s residence

            ()  At an office at the researcher’s place of employment

            ()  At a third party facility (please specify) ________________________________

            ()  Other (please specify) ______________________________________________

      e) How will data be destroyed at the appropriate time?

            ()  Shredding            ()  Burning or incineration        ()  Smashing          () File Deletion

            ()  Other (please specify) ______________________________________________

      f)  How will the results of this study be disseminated?

            () Publication            () Presentation             ()  Other _____________________________           

       PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR EXPLANATION CONCERNING THE ABOVE THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING CONFIDENTIALITY AND PRIVACY CONCERNS ASSOCIATED WITH YOUR RESEARCH STUDY.

PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOX BELOW:

          I attest that the data from this research will be kept in a secured location for at least three years following

              study completion, and then will be permanently destroyed.