IRB is an important step in the research process. State the required components one should look for in a project to determine if IRB submission is needed. Discuss an example of a research study in one of your literature review articles that needed IRB approval, and describe why IRB approval was needed in this instance.
IRB Approval: Ensuring Ethical Research Practices
Institutional review boards (IRBs) play a vital role in protecting the rights and welfare of human subjects involved in research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). All research studies involving human participants conducted by investigators affiliated with educational institutions or non-profit organizations in the United States must obtain approval from an IRB before beginning any research activities (U.S. Department of Health and Human Services, 2009). This paper will discuss the key components an IRB examines to determine if a project requires review, provide an example of a study that necessitated IRB approval, and explain why approval was needed in that specific case.
Components of IRB Review
There are several factors an IRB considers when evaluating whether a project meets the regulatory definition of human subjects research and requires submission for review (U.S. Department of Health and Human Services, 2009). First, the project must involve living individuals about whom an investigator conducting research obtains data or identifiable private information (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). This includes obtaining information through intervention or interaction with individuals or by accessing private identifiable information.
Second, the individuals must be identifiable, either directly or through identifiers linked to the subjects. Research that involves only coded private information or specimens is not considered human subjects research if the investigators cannot readily ascertain the identity of the individuals (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Third, the project must be considered research, defined as “a systematic investigation designed to develop or contribute to generalizable knowledge” (U.S. Department of Health and Human Services, 2009, p. 2). Activities such as journalism, oral history, literature reviews, program evaluation, and quality assurance projects are generally not considered research.
If a project involves living individuals, obtains private identifiable information or specimens, and aims to contribute to generalizable knowledge, it meets the basic criteria for human subjects research and requires IRB review and approval (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979; U.S. Department of Health and Human Services, 2009). The IRB is responsible for ensuring adequate provisions are in place to protect participants’ privacy, maintain confidentiality of data, and minimize risks to subjects (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).
Example of IRB-Approved Research
To illustrate the IRB review process, consider a qualitative study examining the experiences of homeless youth (Dang, 2020). Researchers conducted in-depth interviews with 20 homeless individuals between the ages of 18-24 in a large metropolitan area. Participants were asked open-ended questions about their life histories, current living situations, health and social service needs, and perspectives on programs designed to assist homeless youth.
This study met the criteria for human subjects research as it involved living individuals, directly obtained private identifiable information through interviews, and aimed to develop knowledge that could generalize to the broader population of homeless youth (Dang, 2020; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Given the vulnerability of this population and sensitivity of the topic matter, the researchers’ institution required IRB approval to ensure adequate protections were established prior to initiating the study. The IRB reviewed the researchers’ plans for recruitment, consent, data security, risks and benefits to ensure all necessary safeguards were in place. This oversight helped guarantee the rights and welfare of the homeless youth participants were adequately protected throughout the research process (Dang, 2020).
In conclusion, IRB review provides an important ethical check for research involving human subjects. By outlining the key components reviewed and using a real-world example, this paper illustrates the types of studies that require IRB approval and the purpose this process serves in protecting vulnerable populations. With IRB oversight, researchers can feel confident their work complies with ethical standards and that participants’ interests remain the top priority.
References
Dang, M. T. (2020). Understanding the lived experiences of homeless young adults. Child & Youth Services, 41(2), 118-139. https://doi.org/10.1080/0145935X.2019.1660705
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
U.S. Department of Health and Human Services. (2009). Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
