In the first case study it talks about conducting a study that analyzes race differences in HIV positive test results. All of the data collected is anonymous that was collected from different government funded clinics. The benefits a researcher can get from this study is they can see what positive cases of HIV have in common as they are also separating the variables to include the persons race, ethnicity, gender, socioeconomic status. age and education level. This helps the researcher see if there are areas where there are more positive cases and groups more vulnerable to getting HIV. The risks for the researcher for this study is they are getting anonymous information. There is no for sure way all of the information is accurate as they are not obtaining the information themselves but getting it from the clinics. There is a risk the information is inaccurate which could make the results they get from the study false. The benefits for the participant are that they are anonymous. Their HIV status is not made public nor the people who are conducting the study know who the information came from. The risks although include that the participant does not know that they may be involved in a study. They were not made aware that their results were part of a study. Even if they may never know there is still a risk in the study as the participant in the study. The benefits for society are there could be more information regarding the statistics of HIV and who is at an increased risk for getting HIV. There is no risk for society as they are not involved in the study or they are not directly affected as the study is in progress. After reading through all the information and looking over the case study I have come to the conclusion that the level of IRB approval needed is exempt. I believe this study falls under the exempt level as this study is getting their information from random government funded clinics. Also the ones conducting this study never met or spoke to any of the subjects and they were anonymous. They only received some information about them but never enough to where they could figure out who someone was. With this case being exempt it is considered a minimal risk research. After this determination the IRB office will then evaluate the protocol for general confidentiality and data security issues, informed consent format, experimental methodology and ethical considerations before giving their approval. Usually after their approval there is not reviews of the research.
Referances
Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). (n.d.). Retrieved from https://www.onlineethics.org/cms/8033.aspx
STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.). Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
Although I do agree with most of your risk and benefits of your research study. I do not feel as if this case study is an exempt IRB review. I felt as if this case study is an expedited case study. Because of the information that we received on this case study it is a minimal invasive case study that does meet the criteria I felt for expedited. If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review. (Lafayette, 2020.)
The Three Types of IRB Review. (2020). Retrieved from https://irb.lafayette.edu/the-three-types-of-irb-review/
The risks and benefits to researcher, participant, society should be looked at from the view of research and not from a medical view. Benefits to the researcher are that the testing is done and data is readily available. This allows the researcher to eliminate the cost of testing in the research. This also eliminates the potential of researcher inflicting harm on the participants. Another benefit is since the data is anonymous it will not require IRB approval. Risks for the researcher are narrow sample size that is only collected from the Midwest. Another risk is that the data is only collected from government funded clinics which narrows participants down to a population of lower socioeconomic class, lower education, and higher minorities. This limits the credibility of the research.
There are several benefits to the society. The importance of the knowledge to be gained may increase when significant new findings are expected; when it may result in new products, treatment, or cures; or when it is applicable to many different social groups. Institutions benefit, for example, from enhanced capacity to conduct research or by receiving resources to improve a program as a result of a research study. Communities can benefit through improved access to programs or through the emergence of programs targeted to specific groups within the community (National Bioethics Advisory Commission, 2020). There are also risks for the society as well. Risks for the society is getting skewed data due to the limited diversity of the sample size. Only collecting data from government funded clinics is not a true representation of the rest of the community.
I agree that this study does not require IRB approval. According to HHS.gov (2019), chart 5 since the information will be recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers liked to the subject it is eligible for exemption under 45 CFR 46.101(b)(4) from 45 CFR part 46 requirements. Through following the chart it an be determined that this study does not require IRB approval.
References:
HHS.gov, (2019). Human Subject Regulations Decision Charts. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html#c1
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
Benefits for the participants may lead to exactly what the Bioethics Advisory Commission states in Chapter 4 under “Potential Benefits to Participants” that “could be used to influence the care provided, receiving standard treatments or interventions as part of research, such as counseling and testing, or gaining access to experimental therapies that may improve the participants health status.” Although the information is gathered from government funded clinics after these “anonymous” patients have been seen, the information and study may lead to the benefits listed, such as clinics geographically located where needed the most, additional resources, etc. The patients may not have a direct effect as one would if they were apart of a live study but may benefit from the results later on down the road. It was difficult for me to identify a risk for society, like you mentioned in your post that you did not notice or find a risk for society in this case study. I went out on a limb and reached for the opposite end of optimism and beneficial health care and tried to think about the part of society that may view the results of the study in their society as something negative. For instance, although nobody will be made aware of the actual persons in the study, the results may lead to changes in a society or section of a city, or even a new wing or section of a clinic that people will notice and draw their attention to. Some people may be offended, scared, biased, or opinionated about the resources they notice popping up in their society and draw them further away from supporting the need of the individuals with HIV. I know that is a stretch but it’s all I could come up with. It is good to see that other people are going for the IRB not needing to approve this study. I questioned myself a few times as well on this question but after following the algorithms and charts from Hhs.gov I settled on Chart 5.
References
Hhs.gov. (2019, June 18). Human Subject Regulations Decision Charts. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html
National Bioethics Advisory Commission (2020). Chapter 4: Assessing risks and potential benefits and evaluating vulnerability (research involving human participants V1) Retrieved from https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
I would say that I agree with most of the benefits. I would say that I disagree with there not being risks for society. I think back to the argument made in the late 1970s and early 80s when it was thought that only homosexuals could have HIV/AIDS. This would be no different. If there were a study that said one race is more likely to have HIV than another, then society would definitely have attitudes towards the results, which could in turn be applied to the race as a whole. There is already so much racism in today’s world, and adding to the fire with the ability to add fuel that is backed up with research would definitely affect society.
I struggled between whether or not this case would be exempt from an IRB or if it would fall under expedited IRB. I ended up deciding that this case study would fall under the category of exempt from IRB because of several reasons. For one, the clinics are government funded, which makes them fall under category five of the exempt IRB. Another reason, is that this study poses minimal risk for the subjects as the information comes from several government funded clinics and not just one specific place. This would help in protecting the privacy of the subjects. Also the study is for essentially for the benefit of the public (University of Southern California, n.d.).
University of Southern California. (n.d.). Levels of IRB Review. Retrieved from https://oprs.usc.edu/irb-review/types-of-irb-review/