The purpose of this study is to analyze HIV positive participants and race differences from anonymous demographic data. The risks for the researcher is minimal to none. The investigators are collecting retrospective data from January 2010-December 2011. There is also minimal risk for the participants because the data is collected anonymously through a clinic, there is always a risk of a breach of private information. With this study using only government funded clinics and only one region may skew the results because the midwest region population may be a majority of a certain race, no much of a variety of data. There is a little risk after the conclusion of this study with the society believing that a certain races being more likely to being HIV positive and stereotyping.
Some benefits for the researcher would be finding a correlation between certain races, genders, socioeconomic status, age group and positive HIV test results. This may give society and the public health system a better understanding of HIV impact on certain demographics and risk factors to better assist with prevention and education. There is not much benefits for the participant in this study due to the data being retrospectively collected.
The level of IRB for this study falls under “Exempt 2 : Minimal-Risk Test, Surveys, Interviews, or Observations” (Types of IRB Review, n.d.). It also could fall under Exempt 4: Secondary Research of Identifiable Private Information or Biospecimens, still under the DE-IDENTIFIED (iii) section (Types of IRB Review, n.d.). This is because the participants are anonymous and it presents minimal risk for all involved and information is collected through private health information.
Types IRB Review. (n.d). Retrieved June 13, 2020 from http://sites.jcu.edu/research/pages/irb/review-types/
National Bioethics Advisory Commission. (2016). Reporting on Ethical and Policy Issues in Research Involving Human Participants; Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability. Retrieved from onlineethics.org/cms/8033.aspx
In any research, there is always the risk of breach of confidentiality whether minimal or high. Even though, the case study used demographic data anonymously and the breach of confidentiality might be minimal. Nevertheless, a breach of confidentiality might still occur whether accidental or intentional. That is why researchers need to use appropriate security measures to protect the privacy of the participants. In any research where private information of human subjects are being used, the researcher should be able to justify the benefit of the research study to the participant and the society (Putney, 2008). In this case, there is hardly any benefit to the participants, but the result of the research might create awareness in the society about the prevalence of HIV.
References
Putney, S. (2008, March 29). Privacy and confidentiality in human subjects research. Retrieved June 14, 2020, from http://www.irb.emory.edu/documents/CertConfid.pdf
I agree there is always a risk with breach of confidentiality with any research study. I also agree that there is not any benefit to the participants in this study, they are just a number and retrospective data.
Consider that anonymous data does not have any patient identifiers provided at the time of service. Their demographics may simply be tied to a collection number rather than name, DOB, ssn, etc. How are your risks and benefits supported by ethical guidelines?
The charter of the National Bioethics Advisory Commission (NBAC), a presidential commission created in 1995, makes clear the Commission’s focus: “As a first priority, NBAC shall direct its attention to consideration of protection of the rights and welfare of human research subjects.(National Bioethics Advisory Commission, 2016)In research, however, the process of gathering data to gain knowledge of benefit to society may expose some individuals to harm, and IRBs must determine when it is ethically justifiable to seek certain benefits despite the risks involved, and when the potential benefits should be foregone because of the risks’ (National Bioethics Advisory Commission, 2016). For research to work the benefits have to outweigh the risks and in this case I believe they do.
National Bioethics Advisory Commission (2016). Report on Policy and Ethical Issues Involving Human Participants Volume 1: Protecting Research Participants-A Time for change. Retrieved from https://www.onlineethics.org/cms/8033.aspx
National Bioethics Advisory Commission (2016). Report on Policy and Ethical Issues Involving Human Participants Volume 1: Chapter 4. Retrieved from https://www.onlineethics.org/cms/8033.aspx
I agree that the location chosen to gather information for this study would provide skewed results. However, in the description of the case study it said that the subjects information was anonymous. I also wondered if that meant it was completely de-identified so that it would fall under the exempt IRB classification. I found this article that showed that many clinics can de-identify information and have two sets of information so that it can be used for studies like these.
Kayaalp M. (2018). Modes of De-identification. AMIA … Annual Symposium proceedings. AMIA Symposium, 2017, 1044–1050.
I agree with your benefits to society—that it could give better information to be used in public health settings. I do however disagree in that there is an indirect benefit for the participant. If public health systems improve, the participant will hopefully indirectly see improvements in their very own community and more resources available to them through possible education and funding.
Reference
Duke Center for AIDS Research. (n.d.). NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding. https://cfar.duke.edu/funding/nihfunding