What is the Institutional Review Board (IRB) and what is its role?
The IRB is designated to protect the rights and welfare of human subjects participating in research conducted at or sponsored by an institution.
The Syracuse University (SU) IRB is comprised of 10 members from relevant and diverse academic backgrounds including two non-affiliated community members, one IRB chair and two IRB co-chairs.
SU receives federal funds and therefore is obligated to have a Federal Wide Agreement (FWA) with the government. As part of the FWA, SU pledges to follow the ethical principles outlined in the Belmont Report and the Federal Regulations 45 CFR 46-Part A (also known as the Common Rule) when reviewing research that involves human subjects.
The IRB at SU reviews all research studies involving human subjects for compliance with federal, state, and local laws as well as institutional policy whether they are funded and is responsible for reviewing, approving, requiring modifications, or withholding approval of research involving human subjects.
What requires IRB review? Do I need to submit?
The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definition of human research.
How do we define Human Research?
In accordance with federal regulations, any research activity that meets the Department of Health and Human Services (DHHS) definition of both “research” and “human subjects” be reviewed by the IRB prior to initiation.
The definitions of research and human subject as defined by DHHS regulations:
Research means a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)].
To be considered a systematic investigation, the concept of a research project must:
- Attempt to answer research questions (in some research this would be a hypothesis).
- Be methodically driver, that is, it collects data or information in an organized and consistent manner.
- Analyze or data or information in some way-whether quantitative or qualitative data.
- Draw conclusions from the results.
Generalizable knowledge includes the following:
- The knowledge will contribute to a theoretical framework of an established body of knowledge.
- The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study.
- There will be publication, presentation, or other distribution of the results intended to inform the field of study.
- The results are expected to be generalized to a larger population beyond the site of data collection.
- The results are intended to be replicated in other settings.
- The results will be presented in web based publication for professional purposes.
A human subject is defined as: “a living individual about whom an investigator conducting research obtains data through interaction and/or intervention with the individual or collects identifiable private information.” [45 CFR 46.102(f)].
- Intervention or Interaction includes physical procedures performed on an individual, manipulation, communication or interpersonal contact with an individual, or manipulation of an individual’s environment.
- Private information includes information that an individual can reasonably expect will not be made public, and information about behavior that an individual can reasonably expect will not be observed or recorded.
- Identifiable means that the identity of the individual is or may be readily ascertained by the investigator or associated with the information.
What do I do if I am unsure whether my proposed research constitutes ‘human research’ requiring IRB review?
Contact the Office of Research Integrity and Protections for guidance.
Training Requirements (Collaborative Institutional Training Initiative, CITI)
Learn more here.