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Using the forms: Identify the appropriate form, open it with a left click, and then save it on your machine, using your last name and the date as the document name. Answer every question. Incomplete protocols will not be reviewed. Form fields appear shaded on the computer screen. Use the tab key to move from one form field down to the next (or shift + tab to move up to the previous field). “Page down” and “page up” commands will have the same effect. Clicking the left mouse button will insert an x in a check box. Clicking it a second time will delete the x. Text form fields will expand as one begins typing. If necessary, text from other sources can be pasted into text fields (use ‘control + c’ or ‘copy’ with the original material; ‘control + v’ or ‘paste’ to insert in the field). Note that ordinarily, text formatting is fixed by the program and cannot be modified by the investigator. Using ‘tab’ in a form field will immediately move to the next form field. Unfortunately, spell-check programs are not enabled in these form fields, and bibliographic programs (like EndNote) canot be used. Submission Process:
All protocols must be submitted to the IRB using OSIRIS, the online submission system for IRB applications. Click here for access to the main OSIRIS page which includes links to a brief instructional video, as well as some general instructions on how to access and complete the smart forms that make up the OSIRIS submission system. The system will ask a series of questions, and ultimately, will request that you upload your exempt application, as well as other ancillary forms (e.g., an introductory script – if applicable; letters of support – if applicable). All exempt applications are, by definition, ‘minimal risk’ and in response to the question to justify why this is a minimal risk study, it is sufficient to indicate that ‘this is an exempt application’. As stated above, all supporting material (e.g., letters from a research site) must be uploaded into the OSIRIS system. If you do not have access to a scanner that can convert those letter(s) into an electronic file, you may fax it to the IRB, the IRB staff will scan it an produce an electronic file, and will e-mail the file back to you. It is the investigator’s responsibility to provide the IRB with an e-mail address and to upload the electronic file into OSIRIS. OSIRIS may ask you to indicate the number of subjects you plan to evaluate as part of this research. This is most applicable for studies in which surveys, interviews, or questionnaires are completed by subjects. When specimens or records are being reviewed, it makes no sense to indicate numbers; if the system requires a number, please type ‘999’ and indicate in the text box that this study involves specimens or records. Approval Letters : Official letters will be issued automatically by Osiris, following IRB approval. Letters will be sent as pdf files and as e-mail attachments. Unless otherwise indicated on the cover sheet, letters will be e-mailed to the investigator
Queries : You may track the status of your application through the OSIRIS system |
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