The IRB Proposal Worksheet

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.

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       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) ________________________________________________