SRB vs. IRB

The goal of the RBHS scientific review board is to determine the scientific validity of non-oncology research protocols. The board looks at whether the design of the study is appropriate in answering the overarching scientific questions of the study. Analysis includes whether the research methodology is feasible and how it can be best implemented to ensure that the project goes to completion. The SRB looks for elements of successful research design including clearly stated objectives, appropriateness of scientific background, data collection methods, randomization, minimization of bias, proper patient communication and safety monitoring, eligibility criteria, and defined endpoints of the study. Even after the project is done, the SRB looks at how the scientific information can be looked at from a statistical standpoint. For example, the SRB may evaluate the sample size, distribution, and determination of factors to be sure conclusions from the data are valid.

The SRB makes sure that these components are present not only to ensure the success of a project but also in hopes of helping the investigator improve his or her prospects of funding and publication. It is also hoped that SRB review will result in higher quality and better written protocol, which will ultimately have a smoother path to IRB approval. The SRB is not limited to only the scientific elements of a research project. They may also comment on other aspects including human subject risk and ethical issues that the IRB may look into deeper.

Once submitted, the SRB reviewer will provide feedback to the primary investigator of the study prior to the scheduled SRB meeting. SRB is a requirement for all RBHS-PI initiated studies that have a consent process. Upon SRB approval, the project must then be sent to the IRB for a full, detailed review of the entire research protocol.

The Institutional Review Board (IRB) is a group that protects the rights of human subjects involved in research by looking at potential ethical concerns of the project. The IRB has the responsibility to approve, require modifications for approval, or disapprove human subject research. They review not only the protocol but also materials disseminated to research participants including informed consent forms and recruitment brochures. One of the areas of focus is ensuring that risks are minimized and that they are properly communicated to the subjects prior to starting the study. Aspects of a research protocol that the IRB will focus on include risk level, research methodology, sensitivity of the research design, participation of vulnerable populations, and biometric based identification of subjects.

The IRB assures that the investigator has a plan to properly protect the participant’s confidential private health information.

Unless a change to the research is required immediately to protect the health of study participants, the investigator must submit any proposed changes in the research to the IRB prior to implementing these changes.

The IRB conducts two types of review: Full Board Review and Expedited Review. A Full Board Review is reserved for applications that are defined as having greater than minimal risk to human subjects. For example, it may involve vulnerable populations or involve the study of sensitive topic matter such as drug abuse. An expedited review is reserved for applications that pose no more than minimal risk. The expedited reviewer can either approve the research protocol or refer it for a full board review.

Both IRB and SRB are integral to the advancement of research from its stage of development to execution. While the RBHS SRB focuses on the scientific validity of the non-oncology research protocol, the IRB reviews the study to assure that it is conducted in compliance with applicable ethical and legal regulations in place to protect human subjects. Submission to the SRB occurs prior to IRB review. This allows the investigator to incorporate the results of the review into the protocol document. Essentially, SRB review facilitates the process of final IRB review.

Differences between SRB and IRB lies in what they analyze and look for in a research protocol. The SRB looks at the feasibility of the research design and whether it has the potential to yield results that align with the end goals of the study. For example, they will evaluate the sample size, control and experimental variables, the level of rigor, and even at the background of the team overseeing the research. They may also look into the potential ways that the project will be statistically presented at the end and whether it will answer the overall research question. The IRB, however, focuses on whether the research design protects human subjects ethically, medically, and legally. They remediate high risk protocol as well as ensuring that participants are well informed of the project prior to giving legal, written consent. While the IRB may also comment on the research design and scientific validity, they do so by looking into the scope of overall protection of human subjects.

An RBHS Faculty Investigator outside of CINJ is required to submit to the SRB. The study must also be investigator initiated (i.e. not initiated by industry or by an NIH research consortium) and entail obtaining consent from subjects.

Or the investigator can email the protocol to njacts.srbregulatory@rbhs.rutgers.edu for SRB review.

The link to submit to the Rutgers IRB is: https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-irbs/electronic-irb.

The email address for the Rutgers IRB is: IRBOffice@research.rutgers.edu

For any further questions please email njacts.srbregulatory@rbhs.rutgers.edu