Research Oversight Committee - Application for Study Consideration

  • Research Oversight Committee - Application for Study Consideration

  • Please type information and identify all abbreviations used. All questions must be answered. Incomplete forms will not be accepted. Please type 'N/A' if a question does not apply.

  • Submitter Information

  • Format: (000) 000-0000.

  • Project & Site Information

  • Has cost of IRB review been budgeted?
  • Which health system locations will be involved?*
  • Proposed start date?*
     - -
  • Proposed end date?*
     - -
  • Does this initiative involve patients?*
  • How will the patients be selected?
  • Has anyone from DCH been involved or provided support for this initiative?*
  • Will this initiative involve any of the following populations? Select all that apply*
  • Will this initiative involve any procedures conducted at DCH?*
  • What type of procedure will be conducted?
  • Will this initiative require DCH staff training?*
  • Who will provide the training?
  • Do you intend to publish or present study findings (e.g., conference, journal, poster, or another public forum)?*

  • Data Collection & Management

  • Does this initiative involve collecting or using data?*
  • Will data come from DCH electronic data storage systems (EMRs)?*
  • If Yes, what type of data?*
  • Who will collect the data?*
  • How will the data be collected?*
  • Where will the data be stored?*
  • Is the storage location HIPAA compliant?*
  • Who will have access to the stored data?*
  • How will confidentiality be maintained?*
  • What will happen to the data after the project?*

  • IRB & Compliance

  • Has this material been submitted for review by an external IRB?*
  • For DCH requests, has the cost of IRB review been budgeted?*

  • Recruitment, Distribution, & Consent

  • Will recruitment materials (e.g., flyers, posters, brochures) be used?*
  • Will any materials be provided directly to patients?*
  • Who will be responsible for participant recruitment?
  • How will recruitment materials be distributed?*
  • How will recruitment materials be removed?
  • Do you confirm that recruitment materials will include the institution's logo, undergo marketing review, and not be used until approved?*
  • Is informed consent required for this initiative?*
  • What type of consent will be obtained?*

  • Costs & Funding

  • Will this initiative require funding or resources from the health system?*
  • Which staff groups will be involved?*
  • How will it be funded?*
  • What type of costs will be incurred?*
  • Will participants be compensated financially (gift cards)?*

  • Submission Awareness & Review

  • Please upload the required documents listed below: Accepted formats [PDF, DOCX,  XLSX, etc.]

    • Research Protocol
    • Good Clinical Practice CITI Training Certificate
    • CV
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  • Please upload any other documents listed below: Accepted formats [PDF, DOCX,  XLSX, etc.]

    • IRB Application or Approval Letter
    • Informed Consent Form (ICF)
    • HIPAA Authorization (if applicable)
    • Data Collection Tools (Survey’s, guides, questionnaires)
    • Recruitment Materials
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  • Contact Information for questions related to completion of this form:

    ROC Email: research@dchsystem.com

    Ashley McFerrin
    Research Oversight Committee Coordinator
    (205) 343-8331

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