Case Study 1
The investigators are analyzing race differences in HIV positive test results from anonymous demographic data collected at the point of service for initial testing. The lab tests were performed, and demographic data were collected at government-funded clinics throughout the Midwest region of the United States from January 2010 – December 2011 (retrospective data previously collected). Variables in the analysis include race, ethnicity, gender, socioeconomic status, age group, and education level.
Risk and Benefits related to the Research
Risk related to research that includes human subjects requires a greater level of confidentiality of identifiable information. In this case, the information used for the research study is gathered form anonymous demographic data. The risk of bridging confidentiality is minimum in this case since test results are from anonymous participants from the Midwest region. The data should be carefully collected about these individuals, should be coded and securely stored so that only the investigator and authorized staff may assess it. All the regulations must be followed for the research to be approved by the IRB. The downside is that the research can be applied only to the Midwest region of the United States.
Risk and Benefits related to the Participants
The benefit of the anonymous participants includes a study design to offer intervention or procedure based on race, age, ethnicity, gender, socioeconomic status, age group, and education level. The study will show which group of people are willing to getting medical treatment and continue treatments in that region. With this research, the researcher will also identify what will prevent others from getting treatment.
According to the National Bioethics Advisory Commission, “Individuals may directly benefit from participation in certain types of research, such as studies designed to offer interventions or procedures that offer a prospect of benefit. For example, potential benefits include receiving clinically important information that could be used to influence the care provided, receiving standard treatments or interventions as part of the research, such as counseling and testing, or gaining access to experimental therapies that may improve the participant’s health status.” The other benefit of this research is that the participants are not known, so their identity is secured. The risk is minimum in this research study since the participants are not known. But in a case where the participants are known, they are to be treated ethically by respecting them and securing their well-being.
Risk and Benefits related to Society
Potential benefits for this research will be the knowledge of new findings gained about a patient with HIV from different backgrounds and ages, which will result in new products, treatments, or cures. According to the National Bioethics Advisory Commission, “The goal of the research is to develop knowledge that is beneficial to society. In considering whether to approve a proposed research study, IRBs must make judgments about the importance of the knowledge that is likely to result from research studies.” The importance of the knowledge to be gained may increase when significant new findings are expected; when it may result in new products, treatments, or cures; or when it applies to many different social groups. Another benefit of this study is that it will allow the researcher to work closely with the government and health agency on ways to help people that fall into their research category in the Midwest region of the country.
In research, the process of gathering data to gain knowledge that will be of benefit to the society can pose harm to the participants, so the IBRs determine when it is justifiable for the researcher to carry out their research despite the risk.
The Need for IRB Approval
The institutional review boards (IRBs) are instituted to protect human research participants through an independent review of the ethical acceptability of proposals for human research studies (Grady, 2015). IRBs serve an objective, oversight committee, regulated by federal regulations with the sole intention of protecting and managing ethical compromise and minimize risk to human participants of a research study. IRB is an essential component of a research study because the committee promotes the safety and well-being of all human participants. Further, IRB ensures that the principal investigators adhere to the ethical values related to research. More so, IRB ensures that a research study that does not meet the federal guidelines for ethical and scientific valid research is discouraged.
Lastly, IRB, as a committee, alleviates the fear and concerns the general public may have about the moral responsibility of the principal investigators. That said, the approval from the IRB should not be difficult to get for this research study because the participants are anonymous. This research will not affect the participants from the Midwest region. In a case that the participants are aware of the study, then they must be told what the research is about. The participants will need to know what questions will be asked and how long. The benefits and risks will be explained. You have to figure out a way to protect the participants, and it must be clear that the document is voluntary. If all these are followed, then the IRB will approve it.
Grady, C. (2015). Institutional review boards: Purpose and challenges. Chest, 248(5), 1148-1155
National Bioethics Advisory Commission. (2020). Exhibit 4.2: using the framework to assess risks and potential benefits. Report of Ethical and Policy Issues in Research Involving Human Participants Volume 1 – Report and Recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
Weiserb, K. F., Lyutic, C., & Weinberg, J. (2009). Should Quality Improvement Projects Require IRB Approvals. Volume 84 – Issue 2 – p 153 https://journals.lww.com/academicmedicine/fulltext/2009/02000/should_quality_improvement_projects_require_irb.7.aspx
UC Davis Office of Research. (2020). Risk and Benefits of Research. https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html