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.
- An IRBManager New Protocol Submission Form
Additional items which may need to be included are:
- Informed consent forms
- Completed informed consent form checklists
- Evidence of approval by cooperative IRBs at other sites
- Data collection instruments
- Certification of translation for consents or instruments to be used with non-English speaking subjects
- Brochure/recruitment materials
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.
- If the protocol does not require Expedited or Full Review, the College Representative will indicate that the study is exempt from further review after all documents are in order. All College Level reviewed protocols that are unfunded are submitted to the IRB office via the NSU-IRB log system. The College Representative notifies the principal investigator in writing of the determination of exemption. If the study is funded, a copy of the memorandum sent to the principal investigator is forwarded to the Office of Sponsored Programs.
- If the protocol requires an Expedited Review, the College Representative will forward the complete submission to the IRB Office. The Expedited Review is conducted by the IRB Chair or his/her designee. Please note, studies from the Health Professions Division may require review and approval by the HPD Research Committee. Please visit the HPD Research Committee Web site for more information at http://www.nova.edu/hpdresearch/hpdresearch_committee/.
- If the protocol requires a Full Review, the College Representative will work with the principal investigator to assure that all documents are in order and will then ask that the principal investigator provide an original signed copy of the complete IRB submission.
- In addition, one copy of all research instruments to be used in the study (questionnaires, interviews, surveys, etc.) must be included. Upon receipt of all required paperwork, the IRB Office logs the IRB submission, assigns a protocol number, reviews it for completeness, forwards all copies to the IRB members, and places the protocol on the agenda for the next IRB meeting. Any revision requests by the IRB Office will be sent to the principal investigator via electronic mail. Once IRB approval is granted, the IRB Office notifies the principal investigator and in the case of funded research, the appropriate agency.
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.