In case study 1, the investigators are analyzing the differences in race and HIV positive test results. The test results are from anonymous demographic data collected at the point of service for initial testing. The lab tests were performed, and demographics data was collected at government-funded clinic throughout the Midwest region of the United States from January 2010-December 2011. Analysis variables included race, ethnicity, gender, socioeconomic status, age group, and education level. This is a retrospective data previously collected.
Risk-Being this a retrospective study, the risk is minimal. The participants are anonymous, so they are not identified in this study. However, there is a risk of breaches in confidentiality that can occur. The risk to the researcher is also minimal being the data has already been collected and no more continued data will be done. The risk for society would be that if confidentiality is broke it can possibly cause a stigmatization or discrimination against the participants.
Benefit-There was no risk of physical harm or psychological harm to the participants. The participants benefit from the anonymity removing judgment and bias to a disease that already has a stigma. The benefits for the researcher are that the data is already collected. This saves lots of time, money and other resources. The goal of research is to develop knowledge that is beneficial to society. (National Bioethics Advisory Commission. (2006, June 13) For the society the existing data can be analyzed to generate new hypothesis or answer critical research questions. New prevention and treatment can be targeted towards certain groups to decrease incidences of HIV which can benefit the society.
Level of IRB Review-Since this study does involve research with human subjects an IRB review is required. The three levels of IRB are exempt, expedited, and full board. This case study would be classified as exempt since the research is minimal risk and falls under one of the eight exempt categories There are eight categories of Exempt studies. This study would be Category Four Exempt. According to the John Carroll University Institutional Review Board’s (IRB) if “The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.” The participants are anonymous, so they are not easily linked to the study since there are no patient identifiers. The data is recorded in a way that maintains anonymity from the researchers themselves. The data samples already exist, and no more data will be collected.
References
John Carroll University Institutional Review Board. (2018, November). Exempt research categories. Retrieved January 23, 2020, from http://webmedia.jcu.edu/research/files/2019/01/Exempt-Research-Categories.pdf
Online Ethics Center for Engineering. (2006, June). Chapter 4: assessing risks and potential benefits and evaluating vulnerability (research involving human participants v1). Retrieved January 23, 2020, from https://www.onlineethics.org/cms/8033.aspx#risks
I would agree with your analysis that this is a low risk research project. The subjects and the researcher are both at minimal risk, and the benefits of this project could potentially help many people. Case studies that identify at risk population, can lead interventionists to populations they should focus on to prevent and treat disease. An IRB would still be required as it is focusing on human case studies, but like you stated it would require minimal intervention. The researchers should follow the ethical principles and guidelines put forth by the Belmont Report. The privacy of the individuals from which the data was collected should be protected, and their identities should remain anonymous. This is an excellent way to gather data. Inserting a question on the patient’s H and P that can lead researchers to new revelations is an excellent way to gather data. Overall, this case study seems as though it could lead to some positive outcomes.
The Belmont Report (Rep.). (1979, April 9). Retrieved https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
Yes I agree! Researchers should follow the ethical principles and guidelines put forth by the Belmont Report. Human beings should be treated as persons. Doing this means that we do not use human beings as mere resources, respecting their autonomy, respecting their rights, and respecting their choices. Researchers must respect that individuals should make their own informed decisions about whether to participate in research or not. Some people in society such as children and those with mental disabilities may not have the capacity to make a fully informed decision about what they do or what happens to them. These are the people who should especially be protected. I love what Immanuel Kant said: “Act so that you treat humanity, whether in your own person or that of another, always as an end and never as a means only” (Kristinsson, 2009)
Principles of Research Ethics. (2019, April 25). Retrieved February 8, 2020, from https://www.avac.org/principles-research-ethics
Kristinsson, S. (2009, August 1). The Belmont Report’s Misleading Conception of Autonomy. Retrieved February 8, 2020, from https://journalofethics.ama-assn.org/article/belmont-reports-misleading-conception-autonomy/2009-08
After reading the case study, I agree with the risks and benefits you listed. I did not think about the benefits of cost with retrospective studies, not only with money but time as well. An article I found discussed that retrospective studies do not require near as much time to complete since the information is there, it’s just the act of reviewing the data, which has the potential to address rare diseases (Formplus , 2020). A big cost of most investigations is the data collection, which makes prospective studies more costly than retrospective studies (Formplus , 2020). I wasn’t able to find an exact cost comparison unfortunately. Being able to use previously collected information allows researchers to gain knowledge on that research group, in this case being HIV, to be able to look at trends and create educational and preventative measures for higher effected groups.
Reference:
Formplus . (2020, January 27). 11 Retrospective vs Prospective Cohort Study Differences. Retrieved from Formplus: https://www.formpl.us/blog/retrospective-prospective-cohort-study
Sadie, I wasn’t able to find out an exact cost either on how much it would save a retrospective study either. I would think it would save quite a bit since the researcher is just looking back in time and using questionnaires, medical records and other methods to compare studies. Another benefit of a retrospective study is that the studies take less time, because the data is readily available and just has to be collected analyzed.
Stephanie. (2018, August 14). Retrospective Study: Case-Control and Case-Series. Retrieved February 9, 2020, from https://www.statisticshowto.datasciencecentral.com/retrospective-study/
As Camorris6 and Sadie have rightly pointed out, the study is retrospective; hence, the risk to participants is minimal. An IRB review is still required since research involves human subjects, and the board has to determine potential harm or benefits that will come to participants, the researcher, and the society at large. As corroborated by the Online Ethics Center (2006), the review of risks may prove difficult because of the complexity of determining nonphysical harm. My concern, however, is that the result may not be valid since the sample is not an accurate representation of the population in the study. Data retrieved was from a specific region (Midwest), which may represent more or less of a particular race.
Reference
Online Ethics Center. (2006). Report on Ethical and Policy Issues in Research Involving Human Participants (Chapter 4, Vol. 1). Retrieved from https://www.onlineethics.org/cms/8033.aspx
Post Continued. This type of validity is referred to as external validity and is the extent to which you can generalize your findings to a larger group or other contexts. If your research lacks external validity, the results cannot be applied to settings other than the one in which you carried out your research. For example, if the subjects are all males from one ethnic group, your findings might not apply to females or other ethnic groups (Henrichsen et al, 1997).
Reference
Henrichsen, L., Smith, M. T., & Baker, D. S. (1997). Validity. Retrieved from http://linguistics.byu.edu/faculty/henrichsenl/ResearchMethods/RM_2_18.html
I see your point on this data, is it a true representation of the demographics in the Midwest?It’s unfortunate that we do not know how accurate the race, ethnicity, gender, socioeconomic status, and education level are. With this being a retrospective study it is hard to be able to rely on this data alone. People are constantly moving around the United States, therefore, each year the population with HIV is changing. The CDC states that “HIV diagnoses are not evenly distributed across the states and region” and found that southern states accounted for more than half of the new HIV diagnoses in 2017 (Centers for Disease Control and Prevention, 2019). Your point on the type of validity is is interesting. I didn’t think about that.
Centers for Disease Control and Prevention. (2019, October 30). HIV. Retrieved from CDC: https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html