I have been assigned Case Study 1. Case Study 1 is a case where investigators are analyzing retrospective data that was collected from government-funded clinics in the Midwest Region of the United States from January 2010 to December 2011. The investigators are analyzing race differences in HIV positive test results from anonymous demographic data collected at the point of service for initial testing. Variables in this analysis include race, ethnicity, gender, socioeconomic status, age group, and education level. I’m going to analyze and discuss the risks and benefits for the researcher, participant, and society of this research study and lastly, I will discuss the level of IRB review that will be needed.
When it comes to HIV research there is a special sensitivity where IRBs are cautioned to exercise particular care in overseeing all regulatory provisions. Consent was obtained from patients for HIV testing at the initial point of service. The risk for the researcher and participant is minimal in this study with society being more at risk. The researcher has followed the appropriate guidelines all while maintaining confidentiality for all the participants. IRBs have the responsibility to see that the risks to the subjects are minimized with sound research design. Whenever appropriate, procedures already being performed on subjects for diagnostic or treatment purposes should be used, such as the lab results as stated above. IRBs should determine that the risks are reasonable in relation to the benefits and the importance of the knowledge that can be gained from the results (U.S Department of Health and Human Services). The benefits from this study much outweigh the risks as will be explained further. All information used was coexisting and the participants remained anonymous. It would be very difficult to link the results with an individual with the precautions in place prior to even collecting the data. With the information already being gathered and the specimens collected puts the researchers and participants at low risk. Once the results are gathered, it could affect how society acts towards the variables (race, socioeconomic group, education level, gender, and age group). Society has been known to treat certain races, genders, etc. differently. Society has come a long way with this issue but still has room for improvement. Society does have a stigma when it comes to HIV and with statistics proving that certain races, genders, etc are more prone to HIV, this in turn could cause these individuals to be treated differently whether they have HIV or not. This is a risk that will be outweighed by the benefits. The IRB will review all the data, then decide what research will be published.
With the results from this research it will hopefully put society at a decreased risk for HIV. This research will be used to inform the public about statistics that put a person at high risk for contracting HIV. This is where evidence-based research can come into play on educating society. According to the Health and Human Services Department, with the wide publicity and special sensitivity associated with HIV, the information gathered is only shared with the professionals that have the “responsibility for conducting the research in a fashion that is both scientifically rigorous and consistent with the rights and welfare of the subjects involved in the research.” There are three ethical considerations when it comes to HIV/AIDs research according to the U.S. Department of Health and Human Services. These three ethical considerations are, there must be fairness in the distribution of both the risks and benefits of the research, the possible benefits of the research must be maximized and possible harms minimized, and the rights of research subjects to make choices based on informed judgements must be respected. This study abides by all three ethical considerations. With the information gathered from this study, resources can be more readily available in the areas where needed. More education can be done in the areas that were found to be more at risk. Overall the society will benefit as with more resources and education, society will take more precautions when it comes to HIV. This study could lead to more treatments for HIV based on the information they gain from the variables. This is both beneficial for the researcher and participant.
Since this matter involves a human subject an IRB review will be needed. There are three levels of IRB reviews by federal regulation. These levels are exempt, expedited, and full board. The criteria for IRB review are applied to both the expedited and full board reviews but not all criteria are applied to the exempt. For exempt the research must be minimal risk and the research must fall under one of the eight exempt categories. This case study would be classified as exempt and fall under the category exempt 4. Exempt 4 is “secondary research of identifiable private information or biospecimens.” This case study falls under 2 of the 4 criteria in exempt 4. The case study specifies it is anonymous and is not linked to any specific individuals. There are no patient identifiers. The data has also already been collected and will not continue to be collected. The data was also collected at a government-funded clinic. Case Study 1 is also minimal risk which qualifies the research as exempt. Expedited review requires fewer reviewers for approval. This is also minimal risk research and is reviewed by the IRB according to The Criteria for IRB Review. Full Board is research that poses greater than minimal risk to research participants and will be viewed at a convened meeting of the IRB. (John Carroll University).
References
Bryan, C., Divya, A., & Smith S. (2009). HIV/AIDS Ethics Education. AMA Journal of Ethics.
Retrieved from https://journalofethics.ama-assn.org/article/hivaids-ethics-education/2009-12.
John Carroll University. (2018). STEP ONE: Before You Begin. Retrieved from
https://jcu.edu/research/irb/investigators-guide/step-one-you-begin.
U.S. Department of Health & Human Services. (1984) AIDS Research, Guidance for IRBs (1984).
Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/aids-research-guidance-for- irbs/index.html.
Great post. I agree that the level of IRB approval is Exempt 4. Only minimal risk research may be classified as exempt (John Carroll University, 2019). Here, the investigators are analyzing data collected of identifiable private biospecimens retrospectively.
The level of risk that the research poses to the researcher is minimal. There is no physical, psychological, social, economic, legal, or dignitary harm to the researcher. One may argue that the researcher could possibly suffer from psychological distress related to the knowledge gained by this sensitive information and may limit their interactions with certain races for fear of contracting HIV. However, still the risk is minimal. There is a risk to participants. Participants may endure psychological distress, anger, or guilt related to the distress and fear upon learning of one’s likelihood of developing HIV for which there is no cure. I agree with your analysis that with the knowledge gained from this study, that certain races in society may face discrimination from being labeled HIV positive. Therefore, there clearly is a risk to society as a whole from this study.
I agree with your analysis that there are benefits to society, participants, and researcher. IRBs must make judgments about the importance of the knowledge that is likely to result from research studies (National Bioethics Advisory Commission, 2016). The importance of the knowledge to be gained may increase when significant new findings are expected; when it may result in new products, treatments, or cures; pr when it is applicable to many different social groups (National Bioethics Advisory Commission, 2016). This study is beneficial for society as a whole because the knowledge gained may result in new treatments or cures for HIV positive patients. There are benefits to participants including receiving standard treatments or interventions, counseling and further testing, and gaining access to experimental therapies that may improve the participant’s health status. The benefit to researchers may include personal satisfaction from participating in the research.
References:
John Carroll University. (2019). Things to do and know before preparing your IRB application. Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin?_ga=2.39043363.1009771939.1580600399-681300779.1580179266
National Bioethics Advising Commission. (2016). Report on ethical and policy issues in research involving human participants volume I report and recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx
The investigators in this study used anonymous demographic data collected at the point of service for initial testing. There are no potential risks to the individuals. Therefore, I agree that the data used in this study will fall under exempt review. According to the National Bioethics Advisory Commission, if the data sets are unidentifiable, the research should not be covered under the oversight system because no human participants are involved.
This study has potential to provide substantial gains in knowledge for the society. The government that funded the study could use this knowledge for planning and distributing resources efficiently as well as implementing preventative education programs.
National Bioethics Advising Commission. (2016). Report on ethical and policy issues in research involving human participants volume I report and recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx
Thank you both for your input! “Like privacy, health research has a high value to society.” It can provide important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs and use. Health research has led to significant discoveries, the development of new therapies, and a remarkable improvement in health care and public health. “If the research enterprise is impeded, or if it is less robust, important societal interests are affected.
The Value, Importance, and Oversight of Health Research. (2009). Retrieved from http://www.ncbi.nim.nih.gov.