The IRB Approval process is the same across all IRBs unless otherwise noted.
Possible Review Actions
|Approved as Submitted||No Changes have been requested by the IRB and a Notice of Approval will be processed. Commencement of research related activities may only start upon e-mail receipt of a Rutgers IRB Approval Letter.|
|Modifications / Revisions Required (Minor)||The committee requires minor, administrative, or change(s) requiring simple concurrence from the PI prior to final IRB approval and study activation. The committee's requested changes need to be explicitly communicated to the investigator, in writing, with appropriate rationale. An investigator's response to these committee specified changes may be reviewed only by the chair or his/her designee. If the chair or designated IRB member conducting the review of the investigator's response is satisfied that all committee specified changes were incorporated, the IRB office may then route all final approval documents to the investigator and the study may be initiated. The IRB meeting minutes should note that the committee agreed with this approach and did not require re-submission for full board review, provided the investigator agreed and implemented the changes specified by the committee.|
|Modifications/Revisions Required (Major)||Requested modifications or clarifications are more substantive, or require explanation by the PI, including request for additional information that would affect the IRB's determinations with regards to the criteria for approval (for example, risk/benefit determination, confidentiality/privacy, appropriate informed consent process, etc). These types of responses from the investigator must be brought back to the full committee for final approval determination.|
|Approved with Conditions/Stipulations||
For ArtSci IRB:
Approved with Conditions: This actions means that your study has been approved but contains an Additional Condition(s) which is an unmet requirement that may prevent all or some of your research from being conducted until the condition is fulfilled.
Approved with Stipulations: This determination is not currently used at the ArtSci IRB.
For HealthSci IRBs:
Approved with Conditions: At the time the IRB reviews and approves a research study, the IRB requires that before research can be, approved, the investigator must make changes specified in the action letter/debriefing memo they recieved from the IRB.
Approved with Stipulations: The IRB has approved the proposed research or changes as submitted with stipulations. Stipulations mandated by the IRB may prohibit the investigator(s) from conducting or initiating certain aspects of the study. Stipulations may only be removed by submitting required documents for review by the IRB.
Deferred or Tabled:
This action can be taken by a fully-convened board of the IRB if a) the application is incomplete and the level of risk cannot be determined; OR b) There are substantial clarifications required or major modifications required that the principal investigator must address before a determination can be made. Any tabled protocol must be re-reviewed at the next fully convened IRB meeting
Returned Without Review
This action means that the committee has not reviewed the submission due to it being incomplete and/or that vital information missing. A brief description about what’s missing or incomplete will be conveyed. A new submission is expected.
Suspend or Terminate Approval (For Existing Research Only)
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, co-investigators, and the department chair or Dean. If applicable, a report will also be circulated to, the Rutgers Department of Grants and Contracts, University Officials, the Office of Human Research Protections (OHRP), and/or the investigator’s funding agency (in the case of a sponsored project).
Disapproval of New Studies
The study is disapproved. Disapproval may occur because the IRB determines that the study is not scientifically sound, the risks are not reasonable given potential benefit, or any of the factors that would make it impossible for a required approval criterion to be met.The committee is required to notify the investigator, in writing, the decision to disapprove the research application as well as the justification for reaching the decision. The investigator is permitted a chance to respond to the committee's action and concerns either in person or in writing.
Under current Federal Regulations, the maximum approval period for expedited and full board projects is 12 months. Most studies are typically approved for a 12 month period as noted on your written Notice of Approval. The approval date is created according to when the study was reviewed and approved by the IRB Committee, and not according to the dates the study will be conducted. All FB/Expedited studies require at least annual (yearly) renewal via a Continuing Review request.
- Approved with no expiration date.
- Any changes require submission of an amendment request.
- Study should be closed when completed.
Full-Board / Expedited:
- Approved for 12 month period.
- If your study will take place over several years, you will need to renew your study annually by submitting a continuing review every 12 months until your study is fully complete (including data analysis).
Approved studies which encounter delays will still have their original review date. If the study is deferred to another review cycle or reviewer comments are not resolved in a timely manner, any delayed will reduce the study’s approval period.
Elements of Review
The IRB must review your protocol by the following criteria:
- The Risks to the subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- The risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 46.116.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
- When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Contact, financial and personal relationships with the sponsor must be disclosed, as the IRB is required to assess whether there may be a conflict of interest.