I have been assigned to case study 1. Case study 1 is a study put together by retrospective data collected from government funded clinics between January 2010- December 2011. The investigators are analyzing differences in HIV positive results for the anonymous demographic data collected prior to HIV testing such as race, ethnicity gender, socioeconomic status, age group, and education level.
No ties are linked back to the variables and the patient gave consent for the reportable disease at time of testing. Information used for this research was coexisting and placed on a chart to see trends in race, ethnicity, gender, and socioeconomic status, age group, and education level. All participants were just variables and remained anonymous.
Institutional review board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in studies. Levels of IRB include full board, expedited, and exempt. Full board reviews are studies that include greater than minimal risk. Studies are reviewed by IRB committee.
Examples are interventions involving physical or emotional discomfort or sensitive data such as domestic violence or drug study. Expedited level provides minimal risk to humans and is reviewed by IRB chair. Examples are collections of biospecimen by noninvasive means, research with existing documents/records collected for non-research purposes in which subjects are identifiable such as alcoholism studies or blood draws. Exempt level is not less than minimal risk. It’s reviewed by IRB chair. Examples include research with de-idenitifed records and anonymous surveys such as educational studies.
My case study was anonymous and used retrospect information to gather the findings. All information has been stripped from the owner and it would be merely impossible to link back. Under the criteria for exemption by IRB the study must involve existing data in a given time frame and the information recorded by the researcher must not identify the subject or have any identifiable information present. The case used information from January 2010 – December 2011. The information was coexisting and de-identified from the person. I would mark my case study as exempt.
Benefits to the research are that unbiased accurate data on the current percentage of those living in the mid-west region with HIV + status of those in the area with HIV and direction of HIV epidemic were collected. The study also was able to give specific populations, genders, education status, and race to pinpoint vulnerable populations. It allows us to recognize high risk areas and jump in to provide education for those with HIV, support groups, IV drug use education and prevention, STD and protection education, and prevention of HIV. The participants are free from being named or embarrassed. It gives the society the realization that HIV is still out there, prevention education groups for civilians, and allowing public health to provide more resources to areas known with HIV patients or populations that are high risk.
It is no secret that HIV holds a high stigma. People fear those with it. Society has a lot of negative attitudes and can insult, reject, and gossip about HIV carriers. HIV carriers experience discrimination. The research breaks down education status, race, socioeconomic status, age groups, gender, and ethnicity putting weight on certain factor may bring discrimination to those who fall into those categories. Also, we must rely on several different people to report accurate information regarding their race, ethnicity, gender, and socioeconomic status, age group, and education level. From my experience working in the ER, people are very unique. Some individuals have difficulties answering questions without explanation. I remember asking a female if she was sexually active and she respond “No, I don’t think so at this time.” The population is made of unique individuals whom may identify differently than what they were born as such as gender, race, and etc which could slew results.
Sources:
Human Subject Regulations Decision Charts. (February 16, 2016). HHS.gov. Office for Human Research Protections. U.S. Department of Health & Human Services. Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply? hhs.gov/ohrp/regulations-and-policy/decision/index.html
Case study 1 stated the investigators are analyzing race differences on HIV positive test results from anonymous demographic data collected at the point of service for initial testing. I analyzed the case and I agree with your analysis on a negative stigma being placed on people that are HIV +. This has always made it more difficult for people to come forth and participate in any research due to the fear of being exposed. According to NCBI article, stigma and discrimination are among the greatest challenges that people living with human immunodeficiency virus (HIV) face and both are known to negatively affect quality of live as well as treatment outcome”. ( Tran, B. X., Phan, H. T., Latkin, C. A., Nguyen, H. L. T., Hoang, C. L., Ho, C. S. H., & Ho, R. C. M. (2019, May 29). Understanding Global HIV Stigma and Discrimination: Are Contextual Factors Sufficiently Studied? (GAPRESEARCH). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6603743/ ). The article goes on to to say “since its identification nearly 40 years ago one of the toughest challenges faced by people living with HIV is social stigma and discrimination.” Having an exempt IRB in place will allow for research without the fear of being exposed and discriminated against.
Case study 1stated the investigators are analyzing race differences on HIV positive test results from anonymous demographic data collected at the point of service for initial testing. I analyzed the case and I agree with your analysis on a negative stigma being placed on people that are HIV +. This has always made it more difficult for people to come forth and participate in any research due to the fear of being exposed. According to NCBI article, Understanding Global HIV Stigma and Discrimination: Are Contextual Factors Sufficiently Studied?, “stigma and discrimination are among the greatest challenges that people living with human immunodeficiency virus (HIV) face and both are known to negatively affect quality of live as well as treatment outcome”. The article goes on to to say “since its identification nearly 40 years ago one of the toughest challenges faced by people living with HIV is social stigma and discrimination.” Having an exempt IRB in place will allow for research without the fear of being exposed and discriminated against.
References
Tran, B. X., Phan, H. T., Latkin, C. A., Nguyen, H. L. T., Hoang, C. L., Ho, C. S. H., & Ho, R. C. M. (2019, May 29). Understanding Global HIV Stigma and Discrimination: Are Contextual Factors Sufficiently Studied? (GAPRESEARCH). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6603743/
Stigma against a particle race or gender was my biggest fear. It’s great that the case is anonymous and gathered from a previous study. It’s unfortunate that we do not know how accurate the race, ethnicity, gender, socioeconomic status, and education level are. HIV is perceived as a death sentence. It would be nice to put forth more education regarding prevention in communities were incidents are high.
Limited IRB review is a process that is required for projects qualifying for exempt status. In limited IRB review, the IRB must determine that there are acceptable requirements to protect the privacy of subjects and to maintain the discretion of study. Limited IRB review may be completed by a single IRB member via the expedited review mechanism. It’s usually completed by IRB chairman.
Hopkins Medicine. (2019, January 23). Exempt Research Studies Involving Human Subjects. Retrieved from https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/exempt_research.html
Good job. I like how you really simplified this case study, which made your points easy to follow. I agree this case study falls under Exempt. After reading up on different types of research, I really like the fact that this case used retrospective data. “Retrospective studies are designed to analyse pre-existing data, and are subject to numerous biases as a result. Retrospective studies are quicker, cheaper, and easier than prospective cohort studies. They can address rare diseases and identify potential risk factors (e.g. case-control studies). They are also not pron to loss of follow-up and may be used as the initial study generating hypotheses to be studied further by larger, more expensive prospective studies.” (Retrospective Studies and Chart Review, 2019). I also agree with the high stigma you stated with HIV. People with HIV are discriminated. Society definitely does have a fear when it comes to HIV. What is good is we know how it is spread and the precautions to take to prevent contracting HIV. Hopefully with advances in research on HIV, there will eventually be a cure, and the stigma society has against HIV will lessen.
Nickson, C., M.D. (2019). Retrospective Studies and Chart Reviews. Life in the Fastlane. Retrieved from http://www.litfl.com.