Please Note:The IRB Office is no longer accepting Initial Submission Form via the paper format. All new submissions must be submitted using the new IRBManager electronic submission system. Please see the IRBManager Electronic Submission System page to find further information regarding this new submission process.
All research studies involving human subjects are reviewed in one of three ways, Center Level Review (previously labeled Exempt Research), Expedited Review, and Full Review. Every new research protocol begins with a completing an IRBManager New Protocol Submission Form, which is forwarded to the principal investigator's respective College Representative. The College Representative, not the principal investigator, is charged with reviewing the submission to determine the appropriate level of review for the study as well as assuring that all necessary documents are included. Examples of studies falling into the different types of reviews may be found on the web site here: www.nova.edu/irb/process/review.html. Investigators are also reminded that the IRB's policies and procedures are available at: http://www.nova.edu/irb/manual/policies.html
The College Representative works with the principal investigator to prepare the required IRB documents in accordance with NSU policies/procedures.
Additional items which may need to be included are:
Once a submission is determined as complete, it is submitted, via IRBManager, to the College Representative who is the starting point for the IRB process. For students, a faculty advisor or dissertation chair must sign off on their protocol prior to submission to the appropriate College Representative.
Please note studies from the Health Professions Division as of December 1, 2006 will no longer need to be submitted to the HPD Research Committee before they are submitted to the NSU-IRB. Both processes will now run separately. The principal investigator will still require both HPD and IRB Office approvals to conduct a research project. NSU’s IRB will notify the Chair of the HPD Research Committee once the protocol is approved. Individuals within HPD should check with their respective college representative.
For all funded research involving human subjects, the IRB Staff will coordinate the distribution of required documentation to the IRB Board for review at its next scheduled meeting. The IRB Chair or the Chair's designee, in consultation with the IRB Office Staff, determines if the research can be reviewed through expedited review.
The IRB must conduct a continuing review of all research, funded or unfunded, approved via the Expedited or Full Review procedures in accordance with the policies and procedures outlined in this manual at intervals appropriate to the degree of risk, but not less than once per year for the life of the project. Federal regulation requires that IRB approved research be reviewed by the IRB by no later than one year from the date of approval—or sooner if the IRB determines that the nature of the research warrants shorter review intervals. No study may continue beyond the one-year approval until the IRB has reviewed the continuation request (see Appendix E). Researchers are also reminded that the IRB may conduct audits at intervals sooner than continuing review periods.
Per federal regulations, research can be approved by the IRB for no more than one year. A protocol may be reviewed more frequently if the degree of risk warrants. Research cannot continue beyond the one-year period without IRB approval. It is the researcher's responsibility to secure this approval allowing adequate time for the process. Any correspondence from the IRB Office regarding continuation/renewal will be to the email address provided in the original submission. Principal investigators are encouraged to notify the IRB if their contact information changes during the study’s implementation.
In order to allow for review and approval of a continuation request, investigators are advised to submit the IRB Submission Form for Continuing Review of IRB Approved Studies and all appropriate documentation by no later than two months before the expiration of the protocol’s approval date. Investigators are asked to check with College Representatives for the procedure to submit a request for continuation/renewal. For studies requiring continuing review to occur at a convened meeting of the IRB (if the study was previously approved by the full board) the principal investigators must submit an original copy of the request for Continuing Review Form and materials.
Currently the Continuing Review Form for submissions originally submitted via the electronic submission system is live in IRBManager. If you completed your Initial Submission Form via the old paper format, the Continuing Review Form will need to be completed via the paper submission form.
If the investigator, during the course of conducting the research, revises the research protocol (e.g., makes changes to the informed consent form, survey instruments used, or number and nature of subjects), the principal investigator will notify the IRB Chair immediately, and in the case of funded research, the Office of Sponsored Programs. The Chair will determine the need for additional review, the type of review-full or expedited-and notify the IRB members.
It is important to note that: 1) the principal investigator must submit in writing any changes he/or she intends to make to the study to the IRB office via the IRB Submission Form for Amendment of IRB Approved Studies, 2) no changes can be implemented until the Chair and/or the IRB Committee approves the changes, and 3) failure to do so may result in the protocol’s suspension and/or termination. Requests for review of amendments typically an original of all documents noted in the form for protocols originally approved by the IRB Office or Board. Amendments submitted as "minor" for full reviewed studies may be determined as requiring full review.
Currently the Amendment Form for submissions originally submitted via the electronic submission system is live in IRBManager. If you completed your Initial Submission Form via the old paper format, the Amendment Form will need to be completed via the paper submission form.
Investigators are encouraged to review some examples of studies that qualify for Center Level Review, Expedited Review, or Full Review. Please note that this is not an exhaustive list, and is intended to give investigators examples of what qualifies for each type of review. Investigators are encouraged to speak to their College Representatives who can assist in determining which type of review a protocol may qualify for.
For information about the different IRB actions, please see the IRB Levels of Review and Decisions policy.