Case Study 1
A study analyzing racial differences in positive HIV tests from a government funded clinic over the course of one year in a certain geographical area offers both pros and cons to the researcher or institution and the participants themselves. A year’s worth of data would likely yield enough samples, however gathering data from a cluster of patients in only one geographical area and only from government funded clinics could risk skewing the sample population to the researcher. This could be skewed as no less than 75% of the population claims their race as Caucasian in the Midwest according to the census(census.gov). Although private, identifying personal information being disclosed would be a deviation from privacy protocols, the participant does inherently assume some risk of confidentiality breaches. Although a study like this would pose minimal risk to society, the perception of one race having more positive rates in comparison to others could lead to stigmas.
The study has the potential to benefit a researcher and society, possibly yielding information that might show disparities between races that are HIV positive and open opportunities for further investigation or intervention if the study finds an incidence of much higher positive results in one demographic. As the risks are minimal for the participant, the benefits are also minimal as the participant has little to gain since the study collects secondary data(hhs.gov). As the participant is also a member of society, any benefit would be the same as the societal benefit.
This study does not pose more than a minimal risk to any group and because the specimens were anonymous this study would be considered exempt as it examines secondary, non-identifiable data(usc.edu). Although medical information and HIV results are sensitive in nature that carry a social stigmatization, the study states the samples were anonymous. The research is not intervening in any human treatment, nor is it experimental. Overall this is a very low risk study with minimal risks to all parties involved and there seems to be more benefit than risk.
References:
https://www.census.gov/quickfacts/fact/map/US/RHI125218
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/aids-research-guidance-for-irbs/index.html
https://oprs.usc.edu/irb-review/types-of-irb-review/exempt/
I agree with you that this study is an exempt form of IRB, as the patient’s are anonymous and at minimal risk.
I also agree with you that the results would more than likely be skewed with a lot of the population marking “caucasion” for multiple races when they may actually be another race.
I would be interested to know what they planned to do with the data they collect…why is it so important to know the ratio of HIV positive to race? And why is the data collected from so many years ago? What is it going to be able to do to help now?
Qiao, H. (3/2018). A Brief Introduction to Institutional Review Boards in the United States. Pediatric Investigation; 2(1):46-51.
Consider how initiatives to support education are driven for at-risk populations. You might find your answer there.
As long as the results of the study are balanced by the overall demographics of the area, it shouldn’t skew the results too much based on race. Hopefully the study wouldn’t be generalized to an area with different demographics as that would lead to ineffective allocation of resources.
I agree that this study poses minimal risk to the subjects because the information was gathered anonymously. However, I wonder if there would in fact be some risk to society if this research was published? Government-funded facilities tend to be in certain lower-income, socioeconomic areas. I do believe there could be potential social stigma if the results were publicized that certain races had more HIV-infected members than others within the community (Earnshaw, Bogart, Dovidio, & Williams, 2013). It depends on how this information is going to used. Perhaps the research data can be used to offer more treatment options for HIV-prevention and/or management education for individuals within the areas those clinics serve. In that case, the research would be beneficial to the society/ community and would outweigh the risk of social stigma. The study by Earnshaw, Bogart, Dovidio and Williams offers some suggestions of helping educate health care professionals and clinical practice as well to help decrease social stigma (2013).
Reference:
Earnshaw, V. A., Bogart, L. M., Dovidio, J. F., & Williams, D. R. (2013). Stigma and racial/ethnic HIV disparities: moving toward resilience. The American psychologist, 68(4), 225–236. https://doi.org/10.1037/a0032705