Case Study 1
The investigators are analyzing race differences in HIV positive test results from anonymous demographic data collected at the point of service for initial testing. The lab tests were performed and demographic data was collected at government- funded clinics throughout the Midwest region of the United States from January 2010 – December 2011 (retrospective data previously collected). Variables in the analysis include race, ethnicity, gender, socioeconomic status, age group, and education level.
-Risks and Benefits of the study to researcher
People may not want to participate in study due to being afraid of not remaining anonymous and have certain stigma. Participants from urban areas may not provide an accurate representation of that area due to people always moving in and out. There can be a risk of participants not being completely honest about any of the variables so this can sway results.
Data is already collected so researchers don’t have to use time or funds to collect it. Several variables collected so this will be beneficial in following trends.
-Risks and Benefits of the study to participant
There is a risk of breach of confidentiality. Participant may not know that their information is being used for study.
Participant remains anonymous during study. This is not a continuous study that the participant will have to keep checking in and provide further lab results. Participant has the satisfaction that this information can help decrease HIV infections and help make a difference in the community.
-Risks and Benefits of the study to society
There is a risk of discrimination of different groups with HIV. If participants aren’t honest about certain variables this can show inaccurate representation in certain areas/groups.
This study can possibly show trends in different groups. This research can help educate groups that are at a higher risk of contracting HIV. This can help bring funding to certain areas to bring HIV awareness, prevention, and provide medical resources.
Level of IRB approval needed and delineates the rationale
IRB approval is needed due to having human subjects. “All human subjects research projects will be classified into one of three types of review categories: Exempt, Expedited, or Full Board.” I believe this study would need an expedited approval. This study does provide minimal risk to the participant but a collection of blood sample was needed in order to get lab result.
Reference:
STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.). Retrieved April 4, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
I agree with a lot of your risks and benefits of this study. There is one point that I would like to make sure and point out. When you discuss the risk of confidentiality of the patients themselves. Yes, there is always that risk. But, according to Office of Research (2019), there are certain protocols, protocols should be designed to minimize the need to collect and maintain identifiable information about research subjects. If possible, data should be collected anonymously or the identifiers should be removed and destroyed as soon as possible and access to research data should be based on a “need to know” and “minimum necessary” standard. Also, when it is necessary to collect and maintain identifiable data, the IRB will ensure that the protocol includes the necessary safeguards to maintain confidentiality of identifiable data and data security appropriate to the degree of risk from disclosure (Office of Research, 2019.) With these practices I do feel as if the risk of a possible breech of patient information getting out would be minimial.
Privacy and Confidentiality. (2019). Retrieved from https://www.research.uci.edu/compliance/human-research-protections/researchers/privacy-and-confidentiality.html
I definitely agree that there are protocols in place that help help protect confidentiality but I think especially now with technology there are more chances of information being compromised.
Research involving human subjects should be carried out in an ethical manner. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being (Department of Health, Education, and Welfare, 1979). It is imperative that when lab tests were performed that patients gave informed consent.
There may be risk of legal harm to the researcher if it is determined that the research was improperly designed. A benefit for the researcher is receiving resources to improve a program as a result of a research study (National Bioethics Advisory Commission, 2016). The goal of research is to develop knowledge that is beneficial to society (National Bioethics Advisory Commission, 2016). The benefit to society is the knowledge to be gained from the research. Communities can benefit through improved access to programs or through the emergence of programs targeted to specific groups within the community (National Bioethics Advisory Commission, 2016).
In this research, it may be discovered that certain races have a higher incidence of HIV positive test results for which education and programs could be geared toward that population. A potential benefit to participants is to receive clinically significant information that could be used to influence the care provided, receiving standard treatments or interventions as part of the research, or gaining access to experimental therapies that may improve the participant’s health status (National Bioethics Advisory Commission, 2016).
The expedited review procedure may not be used where identification of the subjects would reasonably be stigmatizing unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal (Fort Hays State University, 2016). This research may require a full board review because it contains very sensitive data (HIV positive results) that can be stigmatizing to participants if their identity were to be discovered.
Department of Health, Education, and Welfare. (1979, April 18). The belmont report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Fort Hays State University. (2016, March 10). Institutional review board for human research policies and procedures. https://www.fhsu.edu/academic/gradschl/ossp/documents/ossp-docs/irb-docs/IRB-Policy-for-Human-Research/index
National Bioethics Advisory Commission. (2016, February 1). Chapter 4: assessing risks and potential benefits and evaluating vulnerability (research involving human participants v1). https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
I also believe that participants should be treated in an ethical manner. I’m not sure if consent was obtained to use information or how they went about this in this study.
I do agree that this study can be beneficial if the results showed that there was a higher incidence in a certain group. This would help bring in supportive programs in that community.
The researcher gained knowledge about the participants through the clinic medical records. It did not say whether the participants were aware their demographics were going to be used for research purposes. In a poll administered to members of the general public by Kass et al. (2003), only 18% of the public were alright with their records being used for research purposes without their knowledge. The cast study does not specify if there was a blanket consent signed to release medical records for research purposes. The level of IRB review I believe this case would need would be exempt. This is because they are using existing data and do not need to contact the subjects and the subjects can not be identified (Human Research Protection Program & IRB, 2016).
Human Research Protection Program & IRB, & University of California San Francisco. (2016, October 3). Medical Record Review. Retrieved from https://irb.ucsf.edu/medical-record-review
Kass, N. E., Natowicz, M. R., Hull, S. C., Faden, R. R., Plantinga, L., Gostin, L. O., & Slutsman, J. (2003). The use of medical records in research: what do patients want?. The Journal of law, medicine & ethics: a journal of the American Society of Law, Medicine & Ethics, 31(3), 429–433. https://doi.org/10.1111/j.1748-720x.2003.tb00105.x
Kristen,
I do have to change my mind about the IRB approval. I do also believe that this study would be considered exempt due to using pre existing data.
I am wondering if the patients signed a consent for the clinics to possibly use their information in a study prior to receiving treatment, anonymously of course. Is being part of a government funding clinic something that allows this type of study to collect information from the patients that are treated there? Those are some of my thoughts when I think about participants at risk for their data being breached and not remaining anonymous. I have tried to find studies where that has actually happened to use them as scholarly support here but I have not had that much luck. I am sure that has happened. Benefits for the participants may be further down the road after the study has completed and brings forth change, treatment, or resources the study finds necessary. I have to respectfully disagree with you on the IRB approval for this study. I find this study is exempt from IRB approval by using the algorithms and charts provided by Hhs. gov on February 16, 2016, Human Subject Regulations Decision Charts. Yes, they are human subjects and they are not part of the prohibited exemption of the human subject research such as prisoners or children. The research involved is a collection of existing data meeting exemption 45 CFR 46.101, go to chart 5. The research involves only the collection or study of existing data and the information will be recorded by the investigator in such a manner that the subjects cannot be identified. Which happens to be the case. Therefore research is eligible for exemption under 45 CFR 46.101(b)(4) from 45 CFR part 46 requirements. Meaning the study is exempt from IRB approval all together. Initially I thought because it involved human subjects, even at minimal risk, would require IRB approval. After trying to follow the charts mentioned above several times I concluded the study was exempt from IRB approval (Hhs.gov, 2019) This is how I interpreted it and I could be totally wrong.
Reference
Hhs.gov. (2019, June 18). Human Subject Regulations Decision Charts. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html
National Bioethics Advisory Commission (2020). Chapter 4: Assessing risks and potential benefits and evaluating vulnerability (research involving human participants V1) Retrieved from https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
I wasn’t sure either if the patients had provided consent for their information to be used in this study.
After following the flow chart on Hhs.gov and was also able to see that this type of study is exempt for IRB approval. I had a hard time figuring this out but this chart definitely makes it a lot easier. Thanks for your input.