All College of St. Scholastica students, faculty, and staff who conduct research involving human participants must follow the following steps.
- Go to the Purpose page and determine the level of review needed.
- Once you have determined the type review that is appropriate for your project, complete the online NIH training tutorial. If you have any doubts about the level of review that is appropriate for your study, please contact the IRB Chairperson, Steve Cope, at firstname.lastname@example.org.
- Once the NIH training tutorial is completed, save your certificate in pdf format as you will submit this along with your applicatino and related materials to email@example.com. A Proposal Help Page is available.
Review by the IRB
- Applications should be submitted well in advance of the proposed initiation of any study so that approval can be acquired prior to the intended start date. Projects requiring full-board review should be submitted no less than 10 days prior to the scheduled monthly IRB meeting. The meeting schedule can be found online.
- When your application is ready for submission, submit the application and any related files as attachments in an email to firstname.lastname@example.org. You should send the application form, NIH training certificate, and any related files such as questionnaires, informed consent forms, letters of affiliation, and/or advertising flyers.
- Files should be in MS Word or pdf format. Do not submit files in Google Doc format.
- Projects that require full-board review will be placed on the agenda for the next regularly scheduled monthly meetings if received 10 days prior to the meeting. All members of the IRB will review and discuss your proposal; you may or may not be invited to the IRB meeting. You will be notified by email of the IRB's decision on your research application. If changes must be made in the project (for example, obtaining a permission letter of affiliation from participating organization), the researcher must indicate compliance to these stipulations before the data collection can be initiated. The letter you receive will specify all necessary changes. Once these changes are satisfactorily provided, you will receive a letter from the IRB indicating you may begin your research study.
- Projects that do not require full-board review (those that meet either exempt or expedited review) will be reviewed outside the regularly scheduled monthly meetings by at least two members of the IRB committee. Applications being reviewed in this way can be submitted at any time using the same procedures as stated above. Once reviewed, you will receive a letter from the IRB indicating that your project has been approved or needs modifications before approval can be granted. If modifications to the application or related materials are necessary, details will be specified in your letter.
- If there are any substantial changes in the project following approval that would have impact on human participants (e.g., switching from non-vulnerable to vulnerable subjects), the revision must be resubmitted for approval before the research continues.
If you have questions or comments on these procedures, please contact:
Steve Cope, IRB Chairperson, HSC 321, 218-723-5915, email@example.com