Transcript Slide 1
Tips for Completing an NSU IRB Protocol The IRB office has created this guide to facilitate completion of an NSU IRB Protocol (http://www.nova.edu/irb/manual/forms.html) Rev. 04/12/2007 Make sure your title here matches the title of the study on all your other forms. Include complete contact information for principal and co-investigator(s). If your research team also has assistants please attach a list of these individuals with the protocol. The IRB asks that you provide references to the literature to support your study and/or the proposed experiment; however, this should not be a literature review. This section should be succinct, clear, and in appropriate language for an “intelligent lay person.” If you use professional terminology, please explain it. The location of the study must match information provided on your other forms. If there is a site, the site information has to be specific and include physical addresses where the investigators or site can be immediately contacted if a subject has a question or there is an emergency. Your start and end dates of the study must be in agreement with the submission form. This is one of the most important sections in the research protocol. In this section, be sure to provide specifics! This is especially true if you propose to work with vulnerable populations. If the subjects have a particular diagnosis this should be included and if the site (e.g., a school system) has a particular classification system if you use that terminology it should be explained. In this section, be sure to provide specific/detailed information about selection of subjects. Why is someone eligible for your study? How are you going to ask someone to be in the study? Here be sure to provide detail as to how the informed consent procedures will occur. Who will lead the informed consent process? How much time will subjects be given to consider their participation? Remember, informed consent is an ongoing process that begins at recruitment and goes throughout the time of the study—it isn’t just a form. Details you should include: •Describe all procedures •Time Commitments (specifics) •If audio/video recording, how will tapes be secured •How you will collect data, if there will be identifiers on the data •How data will be maintained and when data are to be destroyed •How you will manage adverse reaction/unanticipated problems •Compensation for injury discussed if applicable If your study involves groups of people, be sure to discuss how these will be established and confidentiality safeguards. Also include a detailed account of what the groups will be doing (focus group, interviews, interventions, etc.). All tests (standardized, questionnaires, surveys, etc.) are described. Include one copy of instruments/forms included when appropriate. Risks are noted as minimal risk or greater than minimal risk. Each risk is listed separately, with the likelihood described as minimal, moderate, or high. The magnitude/duration and the steps proposed for minimization are discussed. This section does not include benefits to science. If no direct benefits this is stated. Payment information is not included in this section. The Risk/Benefit ratio should reflect a detailed discussion of the possible risks and benefits (to science and/or to subjects) presented by the study. This section notes whether or not consent forms/assent forms are going to be used. This section discusses the use or lack of use of protected health information (PHI). For more information about PHI, researchers should review the Health Insurance Portability and Accountability Act (HIPAA) within the IRB manual found at http://www.nova.edu/irb/manual/index.html. Exact PHI gathered is noted. If the data are to be de-identified, the specific procedures for de-identification are noted. If the study does not involve PHI please mark this section “Not Applicable.” A completed Credentials/Qualifications of Researcher(s) is provided for the principal investigator and all co-investigators. If you have human subjects in your study, now proceed to creating your Consent and/or Assent Forms using the templates and model forms as guides: http://www.nova.edu/irb/manual/forms.html Still need help? Ready to submit your forms? Contact your IRB center representative: (http://www.nova.edu/irb/membership.html)