I was assigned Case Study #1. In the case study that was assigned to me. Investigators are analyzing race difference in HIV positive test results from anonymous demographic data. The Demographic data was collected at government-funded clinic throughout the Midwest region of the United States from January 2010- December 2011 which retrospective data previously collected. Variables in the analysis include race, ethnicity, gender, socioeconomic status, age group, and education level.
With every study there come risks. The risk to the participants is very low, because the information is collected anonymously and retrospectively. There is always a chance of technology breach but again information is collected anonymously. When someone is HIV positive it has to be reported the health department with the state according to (hiv.gov). This being said this information of a positive test result without personal information attached to it places a low risk for breach of confidentiality to participants. The research is just taking the positive result and analyzing the race, ethnicity, gender, socioeconomic status, age group, and education level for the person who was positive. I am unaware if participants know they are apart or the research and how they are notified. With this information collected form this can help target communities that need more resources and funding, therefore improving the care for these participants who are HIV positive. This study also has minimal risk for researchers also because all information has been obtained anonymously, and they have no in person contact with participants.
Though the risk for participants and researchers are low I do believe the risk for the society is high because this information can form bias and stereotyping in the communities who have a high number of positive HIV participants. The data being collected is from government-funded agencies, which provides primary care to the undeserved areas, and can skew the data collected. The results can lay heavily on the poverty side of society. This can lead to social stereotypes and discrimination, but this data collected and used for this research can be beneficial in the future for these communities that suffer for negative stigma. With these results they can provide resources such as medication, education, and treatment to these communities to help treat HIV and prevent future spread of HIV
The case study falls under the Exempt level of IRB review. Exemption category #4- Existing (Secondary) Data. The data already exist because the research is pulling data from the past years. The labs were performed for other reasons that were not to benefit the research, the lab was drawn diagnostically for the patient from the primary care provider. There data obtained for the study was anonymous.
Content Source: HIV.govDate last updated: May 15, 2017. (2017, August 31). Limits on Confidentiality.
Retrieved from https://www.hiv.gov/hiv-basics/living-well-with-hiv/your-legal-right/limits-on-
confidentiality.
Funding at Work. (2020, May 11). Retrieved from https://www.cdc.gov/hiv/policies/funding/index.html
Types of IRB Review. (n.d.). Retrieved June 14, 2020, from
http://sites.jcu.edu/research/pages/irb.review-types/
I agree with you post you make some excellent points. I would hope to try to minimize the stereotyping and bias the results would be generalized to the “midwest” rather than to the specific communities served. I think the study is doing a disservice to the HIV community by only evaluating the midwest. According to CDC.gov, “many people think of HIV as a disease that only certain groups get. This leads to negative value judgments about people who are living with HIV”. a narrow research scope can only help perpetuate this thought process.
Facts about HIV Stigma. (2019, September 27). Retrieved June 16, 2020, from https://www.cdc.gov/hiv/basics/hiv-stigma/index.html
I’ve found an article that details how the personal information of thousands of HIV patients was spread by employee error. Information that should only be shared with 3 people involved with the study was accessible to the entire staff of 500 people.The information included name, address, date of birth, social security number, and more. The patients whose data was spread have not been notified. What level of IRB review would have been required for this study?
Accidentally hit post before adding my reference.
Health Information of Thousands of HIV Patients Exposed by Employee Error. (2018, July 12). Retrieved June 17, 2020, from https://www.hipaajournal.com/health-information-of-thousands-of-hiv-patients-exposed-by-employee-error/
I believe this study would require a Full Board review because it involves patients social security numbers and all personal information. This is very interesting article and gives great information that reminds others that one clinical error can affect many lives. When looking at this article it makes me change my mind of how low of a risk this is for the participants. I still have a question of how they are going to notify patients who were participants in this study.
When reading the article I couldn’t help but think to myself who is responsible for the breach? Who should report the breach? Should the clinic who sent over to much information inform the patients that there information has been breached? Or should the facility who was performing the research inform the patients of the breach?
I am trying to research how people are notified when their information is being used for research or if they have to be notified about there labs being used for research.
Secretary, H., & (OCR), O. (2013, July 26). Breach Notification Rule. Retrieved June 20, 2020, from https://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html
STEP ONE: Before You Begin. (n.d.). Retrieved June 20, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
I agree with your statement. I think that it is important to know how prevalent HIV is around the areas where you live. I have read where simple research cases have been breached when information was submitted anonymously. This involved a person filling out a release of information. Silly things can happen which can cause major breaches. How could you justify a breach of information. What would be the first thing you would do in that scenario?
https://www.hipaajournal.com/category/hipaa-breach-news/
I do not believe there is a justification for breach of information. The first thing I would do is report the information and notify the patient or guardian of patient about what happened and if it has been taken care of. The most important part about breach of information is to inform the person whose information was breached as soon as possible and according to HHS.Gov reporting as soon as you are aware of the breach is most important. At my current facility even is a piece of paper with patients information is found on the ground it has to be reported to our safety team and they send out letters to information parents of patients that there information has been seen and the scenario within 60 days.
Secretary, H., & (OCR), O. (2013, July 26). Breach Notification Rule. Retrieved June 20, 2020, from https://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html
While its not being laid out in the case study, most anonymous studies still collect data that could link back to participants in some way, maybe through a record number that links to their name in another system or record keeping or the area they are located with a low population of HIV positives. Through the Belmont report, its the job of the researcher to protect the participants how would you help to protect the participates from a breach in technology?
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
The best way to prevent breach of information with technology is make sure when requesting information from the government funded clinics that you specify what information is needed such as the positive test result, the race of the patient, ethnicity, gender, socioeconomic status, age group, and education level. When receiving the research information it needs to be looked at by only the people involved in the research in great detail to make sure that information received has no greater information than what was ask for by the clinic.
According to Belmont report ” One circumstance involves the use of existing identifiable data. As noted in an earlier NBAC report on research involving the use of human biological materials, when the study offers the potential to gain important knowledge, poses little or no risk to participants, and consent would be difficult or impossible to obtain, it is appropriate to waive the informed consent requirement.” (2018).
If the researchers notice that they have personal information that was not needed it needs to be reported to the clinic and the facilities HIPPA team or report the potential breach of information. that sent the information but the information also needs to be exposed of permanently. I know that the facility I work for if patient information is found left unattended such as a nurses report sheet that has the patients name and date of birth. It is sent to the safety team and the family is notified of the potential breach of information.
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
WhitneyB, I think you and I are interpreting this survey/research in a very similar manor. I also wrote about the study and how the collected data may fall into exemption categories. As you stated, Exemption #4 has cause for some question to be raised both about how protected the test subjects are and how their demographic information may be obtained as well. In a matter as sensitive as HIV/AIDS diseases, patient anonymity is and should be of the utmost concern. Another exemption that should be considered is Exemption #5. If the information is from a federally funded programs with the intention of benefiting the public, the research can also be exempt.
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