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Tips for Completing the New Protocol Submission Form

Tips for Completing the New Protocol Submission Form. The IRB office has created this guide to facilitate completion of the New Protocol Submission Form ( http://www.nova.edu/irb/manual/forms.html ) . Rev. 04/11/2007.

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Tips for Completing the New Protocol Submission Form

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  1. Tips for Completing the New Protocol Submission Form The IRB office has created this guide to facilitate completion of the New Protocol Submission Form (http://www.nova.edu/irb/manual/forms.html) Rev. 04/11/2007

  2. The top portion of the new protocol submission form is to be completed by your college/center representative. This person must sign-off on your protocol (and actually sign this form—do not word-process or fill in the name for them). For those protocols needing expedited or full review your center representative completes this portion before your protocol is forwarded to the IRB office for review. Remember, if your protocol needs full review, 23 copies of the submission form (plus the research protocol, consent forms, consent form checklist, and other supporting documents) must be sent to the IRB office.

  3. The proposed start date must allow for IRB review. The IRB recommends putting “Upon IRB Approval”unless you have a definite start date, such as the beginning of a school term. Please remember that while you may state that the research will last longer than one year, IRB approval cannot exceed one year (and may even be shorter depending on the nature of the study). Regardless of how long the IRB gives you for conducting your research, you must submit for continuing review prior to the continuing review date (expiration date of IRB approval). Duration of the study must include the time for data analysis, as this is considered research with human subjects. Please be sure to put your NSU email address.

  4. You must provide the complete contact information for all co-investigators in your study. If you’re a student, typically your dissertation/thesis adviser is Co-I 1. If you have research assistants, these need to be provided to the IRB on an attached list. These folks also need CITI training. Remember, everyone you list here must be CITI trained. For more information about CITI training please visit the http://www.nova.edu/irb/training.html.

  5. All funding information must be provided. You must provide the IRB with information related to any significant financial interest any of the researchers on the team may have. Please visit the link on the form that directs you to the NSU policy related to significant financial interest in funded research.

  6. If the research is being conducted at another site (non-NSU facility), the IRB of that organization must approve your research prior to submitting to the NSU-IRB. If there is no IRB, then the applicable governing body/authorizing individual must approve your research. This may be a research committee, a superintendent of schools, the owner of a private practice, etc.

  7. You must provide a breakdown by age/population type of all human subjects involved in your research. Written assent is required for children ages 7-12, verbal assent for the younger children. If your research requires the translation of consent forms, please do not submit translated consent forms with your initial submission. The IRB will notify you when the English versions of your forms are acceptable and at that time will ask you to provide translated documents. For studies requiring full review and studies reviewed at the expedited level where the IRB is unable to secure an individual who can read the translated documents, please provide translations done by a certified translator.

  8. The total number of subjects must match the breakdown provided in Section IV(A) of the formand all the information in this section must agree with what you state in the protocol. The time commitment for each subject is the cumulated time needed to complete all the subject tasks. The total compensation provided to each subject for completing all tasks must be disclosed.

  9. Please answer the questions related to protected health information (PHI). For more information on HIPAA and what constitutes PHI, see http://www.hhs.gov/ocr/hipaa/ The checklist here is intended to assist you in the completion of your IRB packet.

  10. Please review the assurance and obligations section carefully. A few items to note: 1. Please note that you must submit a final/closing report to the IRB 30 days from when research has ended (when data analysis has concluded). 2. Research records, including signed consent forms, must be retained for a minimum of 3 years (36 months) from the conclusion of the study. If you are a student, your dissertation/thesis adviser must sign on the last line. If you do not have an adviser your department chair must sign

  11. Now proceed to yourResearch Protocolusing the template:http://www.nova.edu/irb/manual/forms.html

  12. Still need help?Ready to submit your forms? Contact your IRB center representative: (http://www.nova.edu/irb/membership.html)

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