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 research protocol begins with a complete submission to the principal investigator's respective Center Representative. The Center 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/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 Center Representative works with the principal investigator to prepare the required IRB documents in accordance with NSU policies/procedures.
- An IRB New Protocol Submission
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 to the Center Representative who is the starting point for the IRB process.
- If the protocol does not require Expedited or Full Review, the Center Representative will indicate that the study is exempt from further review after all documents are in order. All Center Level reviewed protocols that are unfunded are submitted to the IRB office via the NSU-IRB log system. The Center 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 Grants and Contracts.
- If the protocol requires an Expedited Review, the Center Representative will forward the complete submission to the Office of Grants and Contract (OGC). 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 prior to initiating the research. Please visit the HPD Research Committee Web site for more information at http://hpd.nova.edu/hpdresearch/hpdresearch_committee/index.html
- If the protocol requires a Full Review, the Center Representative
will work with the principal investigator to assure that
all documents are in order and will then ask that the principal
investigator provide 23 copies (and one original) 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. The 23 copies (and one set of the instruments) will then be forwarded to the Office of Grants and Contracts. Upon receipt of all required paperwork, the Office of Grants and Contracts 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 will be sent to the principal investigator via electronic mail, postal mail, or campus-wide Interoffice Mail for university faculty/staff. Once IRB approval is granted, the Office of Grants and Contracts/IRB 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 PI will still require both HPD and IRB 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 center representative.
For all funded research involving human subjects, the IRB staff will coordinate the distribution of required documentation to the IRB for review at its next scheduled meeting. The IRB Chair or the Chair's designee, in consultation with the Office of Grants and Contracts, determines if the research can be reviewed through expedited review.
The IRB must conducts 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.
On the next page a flow chart summarizes the IRB process from the moment of initial protocol submission until an IRB decision is made.
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 can not 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 regarding continuation/renewal will be to the email, post office address, or intercampus mail 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 protocolís approval date. Investigators are asked to check with center 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 23 copies (and 1 original) of the request for continuing review form and materials.
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 Grants and Contracts. 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 PI 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 protocolís suspension and/or termination. Requests for review of amendments typically must include 23 copies and one original of all documents noted in the form for protocols originally approved by the full board. If the amendments are minor or if the study was originally approved via an expedited procedure than only one copy of all documents are necessary. Amendments submitted as "minor" for full reviewed studies may be determined as requiring full review.
Types of Review
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 Center Representatives who can assist in determining which type of review a protocol may qualify for.
Different IRB Actions
For information about the different IRB actions, please see the IRB Levels of Review and Decisions policy.