Case Study 1
Overview of the study is to determine the race differences in HIV positive test results in the Midwest.
Risk and Benefits of the researcher
Risk for the researcher include a small sample size as they only collected data from the Midwest. The demographic data in the Midwest is going to be vastly different than other parts of the country. Utilizing data from government funded clinics narrows the subjects down. This population would generally be of a lower socioeconomic class, have a lower level of education, and a higher percent of minorities. Benefits would include that is testing is already done and the data is readily available. This eliminates cost and risk of testing or potential harm to participants. The data that is available is anonymous and this is beneficial as the study will not require review from IRB.
Risks and Benefits of the Participants
In this case, risks are associated with breaches in confidentiality, and the IRB should determine whether confidentiality protections are appropriate. Because none of the research procedures off the prospect of direct benefit, the risk/potential benefit analysis involves judging whether the risks are reasonable in relation to the potential gains in knowledge for society (National Bioethics Advisory Commission, 2020). Justice is also questionable in the case study. Has the group of individuals data been chosen out of convenience due to availability? It does not appear that the burden has been equally distributed by limiting data only from government funded clinics. There is no direct benefit for the participant.
Risks and Benefits of the Society
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. Limiting data collection to the Midwest will only give results based on that geographical area. Benefits for the society is that it may allow for grants or additional funding to assist with more education, prevention, testing, or treatment in regards to HIV. The importance of the knowledge to be gained mya 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).
The Need for IRB Approval
According to HHS.gov (2019), Chart 1 since the information is no individually identifiable it is considered research that is not research involving human subject, and 45 CFR part 46 does not apply. Chart 2 the research involves the collection or study of existing data, documents, records, or pathological or diagnostic specimens exemption 45 CFR 46.101(b)(2) or (b)(3) may apply. 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