Frequently Asked Questions
Yes, exempt studies must be submitted through the electronic management system, myResearch, for approval prior to study commencement. Exempt studies are exempt from the requirements of the federal regulations. However, they are still subject to local policies as specified in the Stony Brook Human Subjects Standard Operating Procedures.
Research involving a living individual about whom data or biospecimens are obtained, used, studied or analyzed through interaction/intervention, or where identifiable, private information is used, studied, analyzed, or generated is considered to involve human subjects (45 CFR 46),
Studies that are considered “greater than minimal risk”. The definition of minimal risk is that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life of the general population or during the performance of routine physical or psychological examinations or tests.
The new Common Rule (federal regulations governing the protection of human subjects in research) went into effect on January 21, 2019. All minimal risk studies approved under an expedited category before this date are subject to the old Common Rule requirements. These requirements include an approval period of no more than one year and continuing review in order to extend the approval period. Studies approved under an expedited category on or after January 21, 2019 are subject to the new Common Rule. This revised Common Rule allows the IRB to determine if an approval period of one year or two years is appropriate. The IRB determination is included in the initial approval letter.
Generally, Stony Brook University researchers must receive Stony Brook University Institutional Review Board approval for investigator-initiated research studies. Industry Initiated/Sponsored studies and some collaborative research activities may qualify for review by an external IRB. For more information, please visit: https://www.stonybrook.edu/commcms/research-compliance/External-IRBs/index.php
No, quality assessment or quality improvement (QA/QI) activities do not require review by the IRB. A QA/QI activity falls under the jurisdiction of SBUMC’s Division of Medical and Regulatory Affairs and/or a hospital-recognized departmental quality assurance committee (collectively referred as ‘Hospital QA’).
QA/QI initiatives are a mandated function of the University Hospital. These activities are focused on a local practice and consequently limit their scope specifically to SBU. It is designed to continuously evaluate and improve performance in a clinical area or department. These activities primarily include changes to clinical systems or processes, the development of implementation guidelines, or training and education programs for SBU faculty and staff. The fundamental goal of QA/QI activities is continuous monitoring of hospital operations and improved care of our patients at Stony Brook University Medical Center.
QA/QI initiatives can often seem like the type of human subjects research that the IRB needs to review. Common activities include surveys, reviewing identifiable data, drawing conclusions about problems, and suggesting methods for improvement. However, QA/QI activities do not meet the federal definition of research, and do not require review by the IRB.
Below are some criteria that tend to representative of either QA/QI or research; this list is to be used as a guide and not a definitive determination:
The focus is local and specific, aiming to improve a particular institutional practice
Aims to explore a hypothesis or theory in order to draw general conclusions beyond the scope of the institution
Does not use participants as a representative sample of a broader population
Results or data from participants may be generalized as being representative of the population at large
Conclusions are intended to only be directly applicable to the particular institution; no claim that the results apply outside the institution
Conclusions are meant to be disseminated and applicable to people and institutions beyond the site where the project took place
Any publication or presentation on the project would still focus on the specific practice and improvement at the particular institution; it is only relevant to external institutions to the extent that they can draw their own conclusions about applicability at their institution
Publications and presentations aim to be applicable to the field more broadly. For example, if a particular intervention in the research study led to better outcomes, a publication would generalize those findings and suggest that they are applicable to other institutions as well.
Approval Process for QA/QI Activities:
The “Application for Designation of Activity as Quality Assurance/Quality Improvement or Research" is available in the IRBNet Forms and Documents Library. The completed application must be uploaded to IRBNet along with supporting documentation. Once the Principal Investigator signs the package, share it with the Chief Medical Officer, Dr. Mark Sands. Activity may commence upon Medical Officer approval documented by e-signature in IRBNet. All questions regarding QA/QI activities should be directed to the Division of Medical and Regulatory Affairs office.