The idea that a study like this has any validity whatsoever is an interesting question. The inclusive parameters are far reaching so the study itself is susceptible to bias, fabrication of results and other flaws. That being said, do the results of a survey of HIV positive members of the population reflect that some areas may have a particular problem with the disease more so than others? And finally, are there demographic differences/disparities that contribute to this problem and do they have anything to do with a certain portion or group of the population in that region? These are all questions that the Institutional Review Board may be asking along with the manner in which the results of the study are taken and presented.
According to the criteria for IRB Approval of research, “using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk” (n.d., 2020). The CDC reports that 28 of the 50 states in the United States consider that HIV is a reportable and all 50 states consider AIDS to be reportable as well (HIV Infection Reporting-United States, n.d.). So this collection method has the potential to be both valid and credible if the information was collected from reputable institutions. The fact that it is a retroactive study does not change how applicable the results were as the disease is incurable. In addition to this, the collection method was one that was completed voluntarily by patients themselves so consent of data collection is covered. At first glance this seems to be looking like a reputable study and meeting criteria for IRB.
Where this study falls short is the fact that it is included in the Exempt categories of IBR. Exempt 2 states that “Minimal-Risk Tests, Surveys, Interviews, or Observations” (Types of IRB Review, n.d.). It also falls under Exempt 4, 5,7 and 8 of this same review process. These exemptions are: “Secondary Research of Identifiable Private Information or Biospecimens, Federally Supported Research for Public Benefit or Service Programs, Creation of Data/Biospecimens Repositories for which Broad Consent is Required, Secondary Research using Data Repositories for which Broad Consent is Required” (Types of IRB Review, n.d.) respectively.
Finally, the usefulness of a study like this one is a difficult one to implement any change after evaluating results. Collection of parameters such as education level will be a difficult challenge to collect. In place of this, would the implementation of collecting patient’s sexual orientation contribute to validating this study as the transmission rate from women to men is much lower than other combinations? Narrowing the scope of this study after compiling results will help to appropriately target populations that are found to be affected.
References
Criteria for IRB Approval of Research. (n.d.). Retrieved June 11,2020 from http://webmedia.jcu.edu/research/files/2019/01/45CFR46.111-Criteria.pdf
HIV Infection Reporting-United States. (n.d.). Retrieved June 11, 2020, from https://www.cdc.gov/mmwr/preview/mmwrhtml/00001425.htm#:~:text=All%2050%20states%20and%20the,HIV)%20(Figure%201).
Types of IRB Review. (n.d.). Retrieved June 11, 2020, from http://sites.jcu.edu/research/pages/irb/review/review-types/
I agree with you that the research study is susceptible to bias. Retrospective studies use existing data from chart reviews and convenience sampling to gather data. Gathering data using this method will generate bias in data collection and this might pose a risk in terms of the knowledge to be gained from the research. The case study only used data collected from government-funded clinics from the Midwest region of the United states and this does not represent the entire population thereby creating bias in the data collection method (Nickson, 2019). Using retrospective data for this kind of research study can cause an overestimation or underestimation of the data used in the data collection(Kim, 2017). This is because the sample used was restricted and did not represent the entire population. Demographic variables expected to be analyzed from the study including race, ethnicity, gender, socioeconomic status, age group and education level may not be well represented when the sample is limited only to government-funded clinics from the Midwest region of the United States.
References
Kim, K., Ph.D. (2017, March 8). Challenges of observational and retrospective studies. Retrieved June 13, 2020, from https://health.ucdavis.edu/ctsc/area/Resource_Library/documents/Challenges%20of%20Retrospective%20Observational%20Studies_8March2017_Kim.pdf
Nickson, C. (2019, April 9). Retrospective studies and chart reviews. Retrieved June 13, 2020, from https://litfl.com/retrospective-studies-and-chart-reviews/
Excellent points made oofakolujo. A retrospective study is incredibly susceptible to bias, particularly in the form of a Type 1 Error (Kim, 2017). It is extremely easy to favor the information and results that support a stated hypothesis. In a study like this one, or any for that matter, it is important to remember that revising your hypotheses if it is found to be null is part of the research and discovery process itself. Refusing to acknowledge that a study is not susceptible to an author’s personal and often times unconscious bias is dangerous when releasing the results to scrutiny.
Kim, K., Ph.D. (2017, March 8). Challenges of observational and retrospective studies. Retrieved June 13, 2020, from https://health.ucdavis.edu/ctsc/area/Resource_Library/documents/Challenges%20of%20Retrospective%20Observation
How can you use ethical guidelines to support risk/benefit analysis? I’m not quite sure what you are referring to when you state the study falls short for being IRB exempt. Can you explain further?
Ms. Gabel, My interpretation of where these exemptions came from can be found on the provided link below. John Carroll University published a list of IRB exemptions on the school website. In this publication, a list of 8 exemptions is provided and the criteria for each is defined. For example, in exemption 4, “a study that The identifiable private information/biospecimens are publicly available” (Exempt Research Categories, n.d.) is said to be exempt. Since HIV/AIDS is a recorded and reported disease in many states, that information is susceptible to being traced back to a community and the person themselves. This in turn could far reaching consequences as the stigma does exist in the public about persons with this disease.
Criteria for IRB Approval of Research. (n.d.). Retrieved June 11,2020 from http://webmedia.jcu.edu/research/files/2019/01/45CFR46.111-Criteria.pdf
Exempt Research Categories. (n.d.). Retrieved June 21,2020 from http://webmedia.jcu.edu/research/files/2019/01/Exempt-Research-Categories.pdf
Expanding on the demographics and the region would make for a better testing group with a wider population with different demographics data.
I agree with your comments and previous posters about using data from a retrospective data. Using data previously selected opens the door for these samples to not represent the entire population but instead one area and only those that use government funded clinics. I am not sure that replacing eduction and replacing sexual orientation would add to the validity. I think it would instead add to the potential bias for the study. Knowing transmission rates from men to women and so one would be helpful but in addition to the rest of the information in order to paint a full picture.