Case Study 1
In case study one, it is analyzing the race differences in HIV positive test results.
Risks & Benefits to Researcher
When reading the case, the biggest benefit to the researcher is that the data was already collected from government-funded clinics. This benefit then makes it easier for the researcher themselves to be able to compile and perform their job. Another benefit to the researcher is that these results are anonymous. This makes the testing to not be bias and to not know who the patients are personally. The risk that I found in this case study the region is Midwest. I found this to be a risk because in the Midwest it isn’t as occupied, and the diversity is not as widespread as some of the other places throughout the United States which could honestly impact the way of the study as it could be less anonymous for the researcher themselves.
Risk & Benefits to Participant
One of the benefits to the participant in this case study is that the case is anonymous. With this case being anonymous a patient is typically more likely to want to share more information than what they would if they were having to put down information that would help identify them. When being anonymous they aren’t discriminated against either based on their race, ethnicity, gender, etc. This would be a risk to a patient is that often they could be turned away from doing something based off of their demographics and ways of living. Another benefit is that they’re able to be more comprehensive as researchers if the patient remains anonymous.
Risk & Benefits to Society
Benefits to society with this case study include being able to find out more information about the people that have HIV positive results. With these results they’re able to find more information out how to help prevent the spread of HIV positive results. The main risk that I do see with this case study is that it is the Midwest region. Not only does this limit the amount of people you’re testing with only complying information with the Midwest region but also with doing this case study you do risk exposing the population and letting them know how many people really are infected with HIV. This could in turn expose the people that have tried to remain anonymous and help the case but in turn really could affect them.
Level of IRB Review Needed
There is three types of levels or IRB review. These levels include exempt, expedited, and full. The level that I feel this case study falls under is the expedited review. With the expedited review, according to the CFR, “minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (Lafyette, 2020.) This case study also does not involve any vulnerable populations. This case study does not fall under the full review since it should not include children under the age of 18, prisoners, individuals with impaired decision-making capacity, have procedure that may cause physical harm or significant psychological/emotional distress. (Lafyette, 2020.)
References
The Three Types of IRB Review. (2020). Retrieved from https://irb.lafayette.edu/the-three-types-of-irb-review/
While I understand the concern of how the population of the Midwest is smaller and possibly not as diverse as those on the coast, one must also consider that the Midwest is not immune to HIV/AIDS. Using this area to conduct the research can give a new level of information that could be compared to that of the more urban areas of the coats. The Belmont report (1979) looks at the ethical standards, and while this may be a stretch, we must consider the country as a whole and not just where the most densely populated areas are. Take Kansas, as an example, one might think that it is most important to do their research in the more Eastern part of the state where there is a higher population. However, by only looking at part of the state (Wichita and KC area) and not the state as a whole you only get part of the picture. Just because an area is not densely populated doesn’t mean that the same things don’t happen there as do in the big cities. I also think it is important to look at how those areas compare to the larger places as many times these more rural areas have less resources.
Department of Health, Education, and Welfare. (1979, April 18). The belmont report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
I do agree with the risk and benefits you have provided or this case study. I also agree with your level of review needed as expedited but one could debate that an exempt review maybe needed. Under the exempt category four (Secondary Research of Identifiable Private Information or Biospecimen) states when secondary research for which consent is not required it list four types. This case study could fall under (iii) and/or (iv). (iii) the research involves only information collection and analysis involving the investigator’s use of identifiable health information, (iv) the research is conducted by using government generated or government-collected information. Again, I believe you are correct with the case needing a expedited review but it could be debatable with some.
STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.). Retrieved April 3, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin