IV. Instructions for submitting a protocol to IRB, Full Review (all projects that do not fall under the categories explained above should be submitted for full IRB review)
  1. Complete the attached human protocol Form-1. This form must be typed.
  2. Prepare a description of the research protocol by answering the questions which are listed in the attached protocol summary.
  3. Submit the consent form that you propose to use.
  4. If subjects from other organizations external to the School are to be recruited for the study, written approval should be obtained from an authorized official of that institution.
  5. If the research includes survey or interview procedures, the questionnaire, interview questions or assessment scales must be included in the application. (Note: If standardized scales and/or questionnaire are to be used, submit eight copies to the IRB.)
  6. If the research project is to be submitted to either an external or internal funding source, copy of the grant, contract proposal, or device protocol must be submitted to the IRB.
  7. Obtain the appropriate signature as specified on the form which is attached.
  8. Before submitting the research protocol to the IRB, the requested information must be collated in the following order:
    1. Cover letter
    2. IRB Form-1
    3. IRB Form-2 (Summary of Protocol)
    4. IRB forms 3,4,5,6,7; if applicable
    5. Full protocol
    6. Informed Consent Form (English and Spanish)
    7. Assent Form for minors if applicable (English and Spanish)
    8. Instrument to be used for data collection, if applicable (e.g., questionnaire, interview question or assessment scales) - English and Spanish
    9. Recruitment material (flyers, posters, advertisements). English and Spanish
    10. Certificate of human subject training.
    11. HIPPA authorization if applicable
    12. Biohazards approval letter if applicable
    13. IRB authorization agreement if applicable.

Please submit your protocol as early as possible. Note that incomplete IRB application will not be
scheduled for review and will be returned to the P.I.