Initial Review
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.
The Center Representative works with the principal investigator to prepare the required IRB documents in accordance with NSU policies/procedures.
These documents include:
- An IRB submission form
- A research protocol (in accordance with the sections defined in the model within this guide).
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 must be reviewed and approved by the HPD Research Committee prior to submission to the IRB for Expedited Review.
- 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 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 United States postal mail (or campus-wide Interoffice Mail for university faculty/staff). Once IRB approval is granted, the Office of Grants and Contracts 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.
Continuing Review
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 asked to submit the continuation/renewal form (see Appendix E) and all appropriate documentation by no later than one month before the expiration of the protocol’s approval date. Investigators are asked to check with center representatives for the procedure to submit a request for continuation/renewal or revision. For studies requiring continuing review to occur at a convened meeting of the IRB (if the study was previously approved by the full board) then principal investigators must submit 23 copies (and 1 original) of the request for continuing review form and materials.
Revision/Amendment
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 Submission Form for Continuation or Amendment, 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 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 is minor or if the study was originally approved via an expedited procedure than only one copy of all documents are necessary.
Continuation/Renewal/Revision of approved studies is commenced by the principal investigator completing the NSU-IRB Submission Form for Continuation/Renewal/ Revision of Approved Studies (see Appendix E) and attaching all necessary documents.
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
As a part of the Expedited and Full Review procedures, the IRB has the authority to approve, tentatively approve pending receipt of additional information or revisions, request revision and resubmission, or disapprove (only via Full Review) the research protocol.
Approve
The protocol is approved as submitted.
Pending
A protocol is considered pending when problems are identified in the protocol. These problems frequently fall into two categories: 1) the investigator needs to clarify an aspect of the study, provide additional information, or discuss at great length the potential risks and benefits the study presents, or 2) minor changes need to be made to the informed consent document(s) or the research protocol. In these cases, approval may be given after the investigator rewrites the protocol and/or informed consent and/or submits to the Chair a written response to the IRB's questions and concerns. The Chair may then poll IRB members to receive final approval, as appropriate or can approve the changes as submitted.
In some instances, the Board may request that an investigator resubmit the revised protocol for review by the full Board.
Disapprove
The IRB will disapprove the proposed research if it places the subjects at risks that outweigh the benefit or value of the knowledge to be gained, or it raises such ethical questions as to be unacceptable. A research activity may be disapproved only after a full IRB review has been conducted.
In each of the above cases, the IRB shall notify the principal investigator of the results of its action in writing.
Suspension or Termination of Research
The IRB has the authority to suspend or terminate research that is not conducted in accordance with the IRB's requirements, other institutional and federal requirements, or has been associated with any serious harm to subjects. Concerns regarding the conduct of research must be reported immediately to the Chair of the IRB by any individual having such knowledge. Any suspension or termination of research must include a statement of the IRB's action and the Chair must report its decision promptly to the principal investigator, the Office of Grants and Contracts, and the funding agency, in the case of a sponsored project.