Please provide a response to each item below.  Do not skip or leave anything blank.  This completed form must be submitted to the JSCC IRB along with Form A and Form C.  Subject recruitment and data collection may not be initiated prior to formal approval from the JSCC IRB.

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* 1. Anticipated Review Category:

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* 2. Statement of Purpose and Background:  In one or two paragraphs, state the purpose of the research and relevant background information to provide a rationale for the proposed research.  Provide a justification for the use of humans in the research if the project could conceivably use some other source of data.

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* 3. Research Design and Methods:  Discuss the data collection methods, the research activities and any devices, tests, questionnaires, interview guides, or other instruments that will be used.  If applicable, include information such as the number of groups, types of groups, number of participants in each group, and other relevant information.  Identify the location and setting where subjects will participate in this research and address any special considerations.

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* 4. Subjects:  Describe the characteristics of the subjects.  Discuss your recruiting methods.  How will you determine who is included or excluded?

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* 5. Project Management and Risks: 
  • Identify potential or known risks associated with the research.
  • Describe precautions, safeguards, or other steps incorporated into the research activity to reduce or limit the severity or likelihood of harm. 
  • If deception or incomplete disclosure methods are going to be used, please fully justify and describe.
  • Describe provisions made to maintain confidentiality of data.  Who will have access to the collected data, where will it be stored, and for how long?

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* 6. Costs, compensation, and incentives:  describe any costs that the subject may incur from participation.  If you are providing compensation or incentives, please describe.  Compensation/incentives should be appropriate but not excessive to a degree that would unduly influence a potential subject's decision to participate.

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* 7. Electronic signature:  typing  your name in this box represents your electronic signature.

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