IRBNet Assignment

  1. Submit a summary (one page or less) within IRBNet describing the project goals. The abstract must:

1) describe the reasons for conducting the proposed project,

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2) provide a brief description of the project including objectives, and

3) describe the proposed activities for the project.

Proposal Preparation:

 

  • Clear description of the problem to be studied.
  • Level of review requested (QI, Exempt, Expedited, Full Board)
  • Projected project timeline (Note: Proposals are approved for one year, so give yourself adequate anticipated time to complete the project).
  • Succinct background and rationale addressing the problem and the need to conduct the project including references.
  • Statement of the purpose of the project.
  • Detailed project methodology: This is often a problem area in student submissions.  Be sure to identify your specific design (e.g. quasi-experimental, cohort model) and describe your intervention in detail (step-by-step).  If, for example, conducting an educational intervention be sure to include a detailed content outline and any handouts as a supplementary submission file. 
  • Identify your target population for the project. Be sure to include who is eligible to participate (inclusion criteria) and who is not eligible (exclusion criteria).  Describe how subjects will be recruited, what the “subject burden” of participation will be and include any recruitment flyers or announcements that will be used.
  • Include any and all instruments, surveys, or forms that subjects will be asked to complete. If the instruments are in the public domain and free to use and/or modify, provide documentation of this.  If approval to use or modify is required from the author, you must obtain this in writing and include the approval.  Finally, if instruments are published, include any validity and reliability information available on the instrument(s).

IRBNet Assignment

  • Describe the risks and benefits of the study. All research has “some risk”, though it may be minimal.  For very benign projects, subject burden and possible mild psychological distress from completing instruments should be noted.  If it is possible that more serious distress can occur, you must describe in detail how this will be handled (e.g. debriefing, counseling) and by whom.
  • Confidentiality must be clearly addressed in the application: Where will subject data be stored?  Who will have access to the data?  Typically, data should be securely stored for 3 years.  If de-identification of subjects is needed, this should be described in detail.  De-identification rosters must also be securely stored but must be kept separate from the data.

Discussion Process Summary(One Page)
As you complete your IRB submissions, tell us about the process. Is it more difficult than you expected? What went more smoothly than you expected? What will you do in the planning stages of future projects to move through the IRB process more effectively?

 

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