Learn eCORE is pleased to feature a second blog from our colleagues at Solutions IRB that provides guidance on another common issue for investigators: Determining when a study needs IRB certification.
Federal guidelines dictate specific requirements that must be followed when research involves human subjects. An Institutional Review Board or IRB is the body designated by Federal regulations to review study protocols to ensure the ethical rights of human subjects are protected. While clinical research studies typically require IRB certification, it might not be as clear for social- behavioral-educational research (SBER) studies. The following checklist of questions can assist a researcher in deciding whether or not an IRB review might be needed.
1. Does your institution require IRB certification for all human subjects research studies? You can consult your institutional compliance staff to determine institutional policies. The IRB will help you determine if your study is human subjects research.
2. Does the funding source require IRB certification? Many grants and sponsor-based sources will require as a condition of funding that the study be approved by an IRB. Researchers should check the funding agreement to determine whether or not this is a requirement.
3. Is the ultimate goal to publish the study findings? If the answer to this question is ‘Yes’, the researcher should consider obtaining IRB approval prior to beginning the study. Most peer-reviewed journals require that the study complies with ethical research guidelines. Obtaining IRB approval ensures this requirement is met.
4. Does the study involve a program evaluation? The answer to this question is dependent upon various factors. If the program evaluation is being conducted solely for internal quality assurance, it may not be considered human subjects research and an IRB review is not required. However, if the program evaluation is a requirement of the funding source or is needed to substantiate to external sources the on-going existence of the program, an IRB review is likely required.
5. Does research involving only secondary data analysis require IRB approval? Again, the answer is dependent upon various factors. In situations where the secondary data has been completely de-identified prior to receipt by the researchers, IRB certification may not be required. However, the researcher(s) might need to obtain an Exempt or Expedited category approval if the findings will be published or if the researcher(s) will be de-identifying the data after it is received from the original source. If any of the researchers will retain access to subjects identifiers during the secondary analysis, the study should be reviewed by an IRB.
About the Author: Dr. Ron Wallace is a criminal justice professional with almost 40 years of experience in both the public and private sectors. His background includes working both as a practitioner and consultant in the field of criminal justice. Ron earned a PhD in Public Safety with a specialization in Criminal Justice. Since earning his doctorate degree, much of his time has been spent teaching, mentoring, consulting, and working with Institutional Review Boards. Ron has been with Solutions IRB since 2019. In addition to serving as an IRB Reviewer, he is also the Prisoner Representative.
About Solutions IRB: Solutions IRB is a private, commercial, AAHRPP accredited Institutional Review Board. They are a team of experienced reviewers readily supporting researchers with IRB services, including the review of exempt, expedited, full board, minimal and greater than minimal risk studies. Solutions IRB is committed to protecting research participants, monitoring approved protocols, and providing outstanding customer service to our researchers. They provide quality and timely IRB review for many facets of studies, including social-behavioral, vulnerable populations, international, clinical trials, medical device, non-significant risk, and non-investigational new drug studies. Feel free to schedule a time here to discuss your research and what services they can provide for you!
