Submitting an Application
When should you apply?
You should apply to the IRB as soon as you can, i.e. as soon as you have a clear picture of a project that might involve human subjects. You are not allowed to conduct human subjects research until you receive IRB approval.
Note that the full IRB committee does not meet over the summer. It may be possible to approve some less risky projects during that time, but you should definitely plan to avoid a summer application, and you should contact the board as soon as you can if this is absolutely unavoidable.
Students applying for Summer Research Opportunites, in need of IRB review and approval, are required to submit a completed application and supporting materials no later than April 1.The IRB will need to recieve 1 copy to IRB@swarthmore.edu and 2 signed hard copies to Parrish 12 before IRB review may begin.
How long will it take?
The length of the application process will depend on how risky the board decides your project to be. For projects deemed to be exempt or expedited, approval may take a minimum of 2 weeks. For projects involving more serious dangers to the people involved, a full committee meeting is required, and this may take from four to eight weeks to complete. If a project needs to be reviewed at a full committee meetings, all materials must be submitted no later than 6 business days piror to a scheduled meeting. Full committee meetings are scheduled on the following dates for the 2013 Spring semester:
February 8 & 22
April 12 & 26
May 3 & 17
How do you apply?
You apply by emailing a completed application, plus the supporting materials it describes, to firstname.lastname@example.org and handing in two signed hard copies to the Institutional Review Board Office, Parrish 12.
If you are a student you will have to get your advisor's signature on the hard copies of the form. You should cc: your advisor when you initially email your form to the IRB, and whenever you have follow-up discussions with board members.
The form is designed to be as self-explanatory as possible, breaking your project description down into precisely the elements most relevant to protecting human subjects, and providing examples of the kinds of things the IRB wants to know.
The most important additional document will be the written form (or verbal 'script') that you use to ensure that participants are freely consenting to participate, on the basis of adequate information. The content of this ‘informed consent' form/script has to conform to a set of Federal guidelines (see part E5 at the end of the application form), but it should be in a style and language appropriate to the project and the people involved.
• Tips on writing a form or script from the Department of Health and Human Services Office for Protection from Research Risks.
• Checklist of what to include in an application from the Department of Health and Human Services Office for Protection from Research Risks.
If you have any questions about the form and supporting materials, please contact the IRB office via email at IRB@swarthmore.edu.
What happens after handing in the form?
The board will review your application and get back to you with any comments, questions, or requests for additional information. You should respond to these as soon as you can. In difficult cases the board may request that you meet with one or more members to sort things out. Once the board informs you that your project is approved, you can start your research. A written copy of the approval will also be sent.
How long does approval last?
Approval typically lasts for one year, or until the research is complete—whichever is shorter. If your project lasts longer than a year you must hand in a renewal application along with a cover letter that includes:
• An indication of the number of subjects involved so far.
• A summary of any unanticipated problems and adverse events. In many cases, such a summary could be a simple brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and any investigator brochure.
• A summary of any withdrawal of subjects from the research since the last IRB review.
• A summary of any complaints about the research since the last IRB review.
• A summary of any recent literature that may be relevant to how the research is done, and any amendments or modifications to the research since the last IRB review.
• Any relevant multi-center trial reports.
• Any other relevant information, especially information about risks associated with the research.
• A copy of the current informed consent document and any newly proposed consent document(s).