All research conducted by faculty, graduate students or staff, involving human subjects, must first be reviewed by the Columbia University Institutional Review Board.

The first step towards securing IRB approval is to complete a certification test on IRB rules. Both the test and study materials for certification are located on the Rascal web site. The IRB encourages consultation at all stages of the research process and can be reached Monday through Friday, 9 - 5, by calling 212-851-7040 or by email at .

Protocols

In order to gain IRB approval to conduct research, you must first submit a protocol. This is your IRB application. Protocols can be created or modified on the Rascal web site. Once on the Rascal home page, go to 'Compliance', click on 'Human Subjects', and then login. Once you're logged in, click on 'Create a Protocol'. Rascal can be reached by phone at 212 870-3840 or by email at

A protocol must be submitted for each study or set of related studies. The protocol follows a set format dictated by the IRB. It spells out all of the details of the study, from the subject population (including any risks as well as compensation for their participation) to confidentiality measures (i.e., how subjects' data will be kept confidential) to a study description that explains the theoretical rationale.

A modification is filed when there is a need to change the study. For example, if a procedure needs to be added or changed, a modification would need to be filed. Similarly, to extend a study beyond the expiration date of its IRB approval (usually a year), file a modification for a renewal.

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Processes

Once you have received IRB certification, you can begin the process of getting IRB approval for your research study. Your first step is to complete and submit a protocol. This is accomplished through the Rascal web site (as noted above). It will walk you through the necessary steps which include several pages of online forms to fill out. It is useful to have a lab member's approved protocol in hand as a guide.

Once all parties involved in the study, including the supervising faculty member, department chair, department administrator and all co-investigators (grad students and post-docs) have approved the study, it can be submitted to the IRB electronically.

The IRB meets at least once a month to review submitted studies. Check out the submission deadlines associated with each scheduled meeting (on the IRB web site) to ensure that your study will be reviewed close to your submission time.

Based on the review of your protocol in these meetings, it will either be approved or returned. If approved, you are ready to run your study. If the protocol is returned, the IRB will explain their concerns or problems with the study. You will need to amend and resubmit your protocol. This return-resubmit process can take over a term to get passed. Plan accordingly and be sure to check the IRB meeting schedule. Checking on your study by phone can often expedite matters.

The Rascal web site maintains a record of your IRB protocol for each study. This history of the protocol tracks the submit-return-resubmit process so that you can see where your study stands and what you have done. It also logs this information by date. The log is handy to refer to if you want to review what you've done or if you are talking with the IRB about a problem.

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