I need IRB approval, now what?
See decision tree
Do I need IRB approval before or after I collect/analyze assessment data?
Before collecting assessment data from students (e.g., survey, focus group), classroom data (e.g., coursework, projects), or student academic data, ask yourself whether you intend to disseminate findings or would disseminate if the findings are interesting or valuable. If the answer to either of these questions is "Yes", IRB approval is required prior to the collection of data.
If, during the initial collection of assessment data, there is no intention to disseminate findings (even if the findings are interesting/valuable); however, interest for disseminating results or analyzing data for research or dissemination purposes develops at a later date, IRB approval for the analysis and/or use of existing data is required as soon as there is intent to analyze the existing data for research and/or dissemination purposes.
To emphasize, if you have ANY intention of using future classroom data for presentations, publications, or any other dissemination purposes, you are required to obtain IRB approval prior to the collection of such data, including the conduct of related classroom activities.
NOTE: students should be provided advanced notice of the classroom-related research project within the class syllabus. In addition, IRB approval is required PRIOR TO the analysis of previously collected (e.g., past semesters) data (e.g., coursework, grades, attendance rates, etc.) for research / dissemination purposes. failure to obtain proper IRB approval at the appropriate time (i.e., at the time of intent to use, collect, or analyze data for dissemination purposes) will be documented under all involved research investigators IRB records as an incident of noncompliance, which may result in sanctions to include destruction of research records; termination of research activities; notification of noncompliance to appropriate department heads, deans, study sponsor, and/or DHHS; loss of the privilege to conduct research at Salisbury University; and (for graduate students) postponement of graduation.
What happens at each level of review?
Exempt: for all exempt applications, one committee member is assigned to review the application. After this review, if the committee member has no questions, the application is approved and research can begin. If the committee member does have questions, these will be sent back to the Principal Investigator (PI) listed on the application. The PI needs to submit a response for review prior to approval being granted.
Expedited: for all expedited applications, two committee members are assigned to review the application. After this review, if the committee members have no questions, the application is approved and research can begin. If the committee members do have questions, these will be sent back to the PI(s) listed on the application. The PI(s) needs to submit a response for review prior to approval being granted. Both committee members must agree and sign off on the application before approval can be granted and the research can begin.
Full: for all full review applications, the entire committee is sent the application to review prior to the stated meeting date. At the meeting, the researcher(s)involved in the project must be present and will be asked to give a summary of the application and respond to questions by the committee. After the committee has asked all of the questions they have, the researchers are asked to leave the room while the committee deliberates. If all questions have been answered satisfactorily, approval will be given. If there are unanswered questions, the researchers will be given a list of points to clarify and re-submit. These will be discussed with the researchers prior to the ending of the meeting. The submitted responses are sent out to the committee as a whole for review. If all points have been answered satisfactorily, approval will be given. If they have not, the question and response process continues until all issues are resolved.
What key things are looked for in an IRB review? (this does not guarantee there won't still be questions from the committee)
Here are a few things at which the committee looks closely: checklist
What are the IRB deadlines?
The Committee requires two weeks to review and respond to Exempt or Expedited protocols. As such, these protocols need to be submitted at least three weeks prior to the planned start of the research in order to leave time for comments and revisions, if necessary.
Full Committee reviews require submission at least three weeks prior to the scheduled IRB meeting date. All listed researchers are required to attend the IRB meeting for full reviews. Researchers who need to follow a modified timeline should contact the IRB Committee Chair to discuss this.
A note about reviews over breaks (Thanksgiving, Winter Break, Spring Break, and Summer): the IRB committee is made up of faculty and therefore we cannot guarantee that applications will be reviewed following the stated timelines above. Once contracts end in June, no IRB applications will be reviewed again until contracts begin in August. There are no full committee reviews scheduled during these times. Please plan accordingly.
What do I need to do to continue my research past my original IRB approval date?
If you intend to continue your research past the original expiration date, you must re-submit an IRB application with the updated dates for the research. Submit the application through the official IRB email and it will be sent out to the appropriate committee member(s). Deadlines as outlined above still apply.
What do I need to do to amend a previously approved protocol?
All amendments to the previously approved protocol must be sent through the official IRB email and approved by the IRB committee prior to any changes being implemented. When submitting an amendment, please include 1) a document with the original plan and the amended plan, and 2) a statement on why the amendment is needed to strengthen the research and/or protect the interests of your human subjects. Deadlines as outlined above still apply.
To whom do I send my IRB application?
All IRB applications (regardless of level of review, continuations, or amendments) are to be sent electronically through the official IRB email. This will ensure that your application is sent to the appropriate committee member(s).
Application for Research with Human Subjects (PDF document)
IRB Committee email: firstname.lastname@example.org
IRB Committee Meeting Dates for Fall 2017:
**If you have a full committee review, 1) your proposal must be submitted at minimum 14 days before the scheduled meeting, 2) you must attend the scheduled meeting. Failure to comply with either condition will delay review of your proposal**