IRB – Module 2, Case Study #1

Case Study 1

The case study that I was assigned to focuses on analyzing race differences in HIV testing. In studying the data collected over a 2-year time period, it is important to acknowledge that this information is anonymous.  All of the data was collected at the point of service where the initial testing occurred.  The clinics included in this study were from government-funded clinics across the Midwest region of the United States.  The lab work was performed at these clinics.

There are challenges with this study as presented. No information was provided to determine whether the test subjects were aware of the study or if they gave permission for to be included in the study.  Additionally, only looking at one region may skew the data as the race and ethnic make-up is not as diverse in the Midwest as in other regions. (census.gov)  Risks of this study are minimal for all individuals. This is important because HIV status can be detrimental to more than just the health of a patient.  This diagnosis carries a stigma so it is essential that the information remains anonymous.  No interventions or changes in care are implemented for the patients in this study.  A potential challenge could also be the type of clinic that obtained the data.

This study has the potential to benefit unlimited people.  In looking at the data, it may identify clusters of high-risk populations based on multiple variables including race, education, age and socioeconomic status.  In working at a government funded clinic these results are essential in planning the resources needed for the clinic to reach the patients that need the most assistance.

The level of IRB would be exempt. (usc.edu) This study did not include any experiments or intervention and maintained anonymity. All data used was from secondary research and treatment would not be a part of this study.

 

https://www.census.gov/quickfacts/fact/map/US/RHI125218

https://oprs.usc.edu/irb-review/types-of-irb-review/exempt/

10 Responses

  1. jjcorbett at |

    I agree with your post. I had a hard time determining if this study would actually be exempt because as far as I could tell, people that are HIV positive are considered vulnerable so wondered if the study would require a full review because of that. I settled on exempt because, assuming full anonymity was maintained and confidentiality was not breached, since only secondary, retrospective data was collected that the study would be exempt.

  2. ajrountree at |

    My concern with this study is that by using only government funded clinics, the information may be more skewed to certain health disparities. I think that using a larger range of data may have provided better results. I also wonder why they used data from 2010-2011? I would think researchers would want more recent data as so many things have changed in our world and with healthcare since this the time frame of this study.

    https://www.cdc.gov/nchhstp/healthdisparities/docs/nchhstphealthdisparitiesreport1107.pdf

  3. jaacheson at |

    While I agree that the risk would be fairly low for a breach in privacy, do you feel this would need a full review with it being a vulnerable population if there was a security breach in the data? Making sure the participants are protected is the job of the researcher according to the Belmont report and having a full review could help find weaknesses in the study to protect them.

    Office for Human Research Protections. (2018, January 15). Read the Belmont report. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

  4. armcdaris at |

    Hello, I enjoyed reading your blog post about this case study. You brought up a very valid point about the results possibly being skewed since the only area that is included in the research is the Midwest.
    One thing that I considered while reading this case study is the question of “will this research cause harm”. Since it is anonymous, the individuals whose data is included in the research may not be harmed, but what about society as a whole? With the volatile climate of American society recently, will the results of this study be more helpful than harmful? I believe that understanding and learning more about who is at greater risk for disease transmission is important, but this might not be an appropriate time to be researching topics that might further drive a wedge between individuals of different race, gender, age or ethnicity. I’m not saying that the research isn’t important, but just that maybe the timing isn’t the most ideal? This is a question the IRB may have to carefully consider before allowing the research to begin (Fleischman et al., 2011). This would be a difficult decision to make! Thanks for sharing!
    References
    Fleischman, A., Levine, C., Eckenwiler, L., Grady, C., Hammerschmidt, D. E., & Sugarman, J. (2011, May). Dealing with the long-term social implications of research. Retrieved June 20, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4814211/

  5. afheimann at |

    jlgaines,

    I agree that there is a problem with how the data was collected. When looking at a study, there is a possibility that this research could fall into some categorical exemptions form IRB review. For example, the patients themselves may or may not be aware of the information being used and how it could be traced back to them. This could be damaging to their reputation as well as that of the researcher. Also, if the data is collected from a federally funded institution, this places the study into another exemption category of Federally Funded research for public benefit programs.

    Exempt Research Categories. (n.d.) John Carroll University, Retrieved June 21,2020 from http://webmedia.jcu.edu/research/files/2019/01/Exempt-Research-Categories.pdf

  6. mmoney at |

    HI, I agree with you ajrountree. I think that the use of only government clinics limits the data collected to only those that use those clinics. I do have questions on how truly anonymous this study can be since HIV is reportable in some states by name. I might be understanding this part of the study. For this reason, I think this study would require a full board review.

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