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FAQ: About IRB Applications
1. How do I know if my study is exempt?The categories for exempt studies are set forth by the Office for Human Research Protections under 45CFR 46.101 (Exempt Criteria (PDF, 96K)). If the study falls into one of these categories, please complete the exempt application. If you have questions about whether a study is exempt please contact the main office at 882-3181. 2. How do I know if my study can be expedited?The criteria for expedited review are set forth by OHRP in 45CFR 46.110 (Expedited Review Categories (PDF, 32K)). Some items on the list may be bumped full-board depending on study. For example, surveys are often expedited but surveys containing questions about illicit drug use, potentially sensitive information or confidentiality concerns are bumped full board. If expedited is chosen on the application, the compliance specialist will review the study and let the primary contact know if the study does not meet the criteria. The IRB reviewer also has the option to send the study full-board after reviewing it. All expedited studies that are sent to the fully convened board are scheduled for the next available meeting. 3. Should I fill out the medical or the behavioral application?answer 4. I want to create a database, which application should I complete?answer 5. I would like to do a case review/report. What do I need to do?answer 6. How do I know what type of consent to use?answer 7. Do I need a protocol? What should I include?Other than exempt applications, all studies require a protocol or a grant application. Download a protocol template here: Protocol Outline (Word, 32K) 8. Do I need a HIPAA form?answer 9. How do I know which HIPAA to choose?answer 10. I submitted my application and want to make changes but it won't open.answer 11. When can I start enrolling subjects?answer 12. How do I know when I have approval?answer 13. How long is the approval good for?answer Amendments14. I have an approved study but would like to change something. Do I need to do anything?Yes, any change to a study requires IRB approval. To change the study, log into the e-IRB at https://irb.missouri.edu/eirb/gen4/User/Login/ and go to ‘IRB forms’. Click on Health Sciences IRB Forms and choose HS Amendment Request. You will then be asked if you would like to: Create a new HS Amendment Request or Open a previously started HS Amendment Request. Don’t forget to attach a highlighted copy of the changed documents (protocol, consent, etc.) so that the reviewer can see what is different. If the study is a sponsored study with many changes throughout the protocol/CIBD please provide a summary of the changes. When completing an amendment form with a long list of changes, please try to group the changes so that the reviewer has a clear picture of the overall changes. For example, a summary of changes may include a change to inclusion/exclusion to allow for increased enrollment and this change may be seen in several places throughout the protocol- do not list all of the sections in which the changes are made but describe the overall change. 15. I started an amendment but I can not find it.Log into the e-IRB at https://irb.missouri.edu/eirb/gen4/User/Login/ and go to ‘IRB forms’. OR Go to “My saved IRB projects” 16. My sponsor has sent an amendment. How long do I have before I need to submit it?answer 17. There is a new risk. Should I contact participants right away?answer 18. I want to increase the enrollment -- do I need to change any supporting documents?answer Continuing Review (CRR)19. How will I know when to complete a continuing review?answer 20. I want to create a CRR but the computer won't let me.answer 21. I want to change my study; can I do this on the CRR?answer |
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