Case study one revolves around the collection of the data of HIV test results varying in race, ethnicity, sex, social status, age division, and education level. Examiners analyze race differences in HIV positive findings from January 2010 to December 2011. Government-funded clinics in the Midwest region of the United States were the basis of where the lab tests took place. The Institutional Review Board (IRB) has to review all research concerning human subjects. The main concern is to protect and minimize the potential risks or harm the research might cause. The research proposal must follow all regulations requirements before approval (National Bioethics Advisory Commission, 2006). IRB ensures that all divisions of society receive the same opportunity to contribute, as fit. Though this is true, inclosing factors that can render some individuals susceptible are the essential characteristics being mental health or terminal illness and situational factors being living status and employment, which depicts fully advised and conscious participation more vulnerable to compulsion. These situations can be most difficult for IRBs (National Bioethics Advisory Commission, 2006). There are underlying risks and benefits of researching in order to distribute proper precautions and course of treatment.
One of the risks of investigating is that the data collected by researchers from a particular neighborhood may or not represent the entire community because people are moving in and out of the location. According to the Infectious Disease Advisor (2019), the data collected in areas such as urban cities is drastically different from people in rural areas who live there permanently. The people living in urban areas are more prone to moving from one place to another after completing school degrees, political engagements, business employments, and other activities. The data collected may or not represent or provide the actual data outcome of the research of that particular demographic. Misguided or misrepresented data interpreted by researchers can be cognitive to the reputation of the specific urban or rural areas. If a participant who is from a metropolitan city contracted HIV without knowledge of doing so and moved to a new remote rural location where this research initially took place, this data would likely hinder the outcome of objective data. A social risk for research is discrimination amongst communities and or genders being affected with HIV. Test results could show a valid drift between individual races and genders contracting HIV, further causing a change in one’s interactions or relationships with another.
The data can potentially provide essential information for HIV awareness, prevention, and resources such as medical facilities, drugs, treatments, and where to relocate convention measures. Using the case study’s research convention measures can take government officials initiative to provide proper laws for medical insurance and healthcare. Another benefit from the outcome of the research is that it allows for data that can be used to allocate medical resources efficiently to HIV affected communities. The data can also be used by health officials to decide if they should pass a quarantine notice to the affected communities. National Bioethics Advisory Commission (2006) explains that research intends to be helpful to society. IRB takes responsibility in considering what importance the research contributes to further studies. The level of interest for new knowledge of the research may gain in significance for new results.
There are three types of IRB review levels, which include exempt, expedited, and full board. To be considered as an exempt level, there must be a marginal risk. For an investigation to be expedited, there are fewer reviewers who process and approve certain types of minimal risks from the research objective. Then there is a full board, where research with higher risk is up for discussion in a full meeting of the IRB. The level of risk depends upon how seclusive or extensive the sample occurs to be. With this in mind, the level of IRB that applies most directly to the given case study of HIV results in an anonymous demographic is exempt. In the exempt level, there are eight categories in which two of those are evident in the case study: educational research and federally supported research for public benefit or service programs (John Carroll University, 2019). Concluding that case study one has several defining risks, the variance of the sample is undetermined considering the demographics are unidentified, which lessens the risk of exploitation and security. Although the data may be misguided by people who move in and out of a location during data collection, having more extensive or expansive research will recover the odd outliners.
References
Infectious Disease Advisor. (2019 July 31). HIV Testing Rates Suboptimal in Rural vs Urban Regions in the United States. https://www.infectiousdiseaseadvisor.com/home/topics/hiv-aids/screening-for-hiv-varies-between-rural-and-urban-region-though-is-uniformly-suboptimal/
John Carroll University. (2019). Things to do and know before preparing your IRB application. https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
National Bioethics Advisory Commission. (2006, June 13). Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). https://www.onlineethics.org/cms/8033.aspx
Annlice,
I agree that if the researchers were taking their data from only one clinic that the results might not represent an entire community, but the data was taken from multiple clinics throughout the Midwest, so it should be broadly representative. A potential problem I noticed is that the data is only taken from government funded clinics, so that may limit the data to patients from from a group with low income, so results may only be applicable to the same group.
Identifying a race as higher risk for HIV infection could lead to additional targeting of people of that race for increased negative bias but the potential benefit to members of that group and to society in general appear to outweigh that risk. Results of this research can identify specific groups for targeted services to potentially decrease the risk for HIV infection, benefiting that group and all society. Since the data used in the study is already anonymous there is no risk to the individuals’ privacy. Because the data has already been collected there is no additional risk to the individual associated with this study but significant potential benefit to society by additional and specific information.
Since the research involves using existing data and will be recorded in a way that maintains anonymity from the researchers themselves as well as the general public this research is eligible for exemption from the requirements of 45 CFR part 46 through an exemption under 45 CFR 46.101(b)(4)(U.S. Department of Health and Human Resources, 2016).
U.S. Department of Health and Human Resources. (2016). Human Subjects Regulations Decision Charts. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html#c5
Still, the data collected from communities, for example, urban areas or cities whereby people tend to move from one place to another, may or not be a good sample to be used to investigate the spread of HIV throughout the Midwest region. The investigators may have had also missed collecting relevant data from some communities that are religiously base conservative, and due to their faith and beliefs, they chose not to participate in the program and thus missing essential data for HIV research or investigation. According to National Bioethics Advisory Commission (2006), “Risks may accrue not only to research participants but also to persons not directly involved in research, such as to the participants’ family, loved ones, other contacts, social groups, and to society in general.” Although the study data is from anonymous individuals, still the outcome of the research will provide data that reflects the same community including participants and non-participants. The investigation outcome may also lead to discrimination among social groups and hence society in general.
Reference
National Bioethics Advisory Commission. (2006, June 13). Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). https://www.onlineethics.org/cms/8033.aspx
This scenario does seem to fall into the exempt category as you stated. There is a need for the IRB, as the situation is dealing with human subjects, but the risk is marginal. The data was already previously collected, and there is no need for any future involvement for data collection from the subjects. The researchers would need to take great care in ensuring the privacy and anonymity of the subjects of this case study. With an illness such as HIV, which is already looked upon so negatively, it is important that individuals are not stigmatized even further related to research evaluations and breach of privacy. As the Belmont report reminds us, it is important to adhere to ethical principles to protect the subjects in any research activity performed. Even though this seems to be a very benign scenario, it is still a sensitive subject, and ethical principles should always be followed throughout any health care activity.
Types of IRB Review. (n.d.). Retrieved November 14, 2017, from http://sites.jcu.edu/research/pages/irb/review/review-types/
Laws may well protect the anonymity and consent of participants, but the subject is not how to preserve the anonymity of participants but the data collected from the participants who tend to move from one place to another, may not represent the targeted communities and, therefore, providing inaccurate results that could negatively impact the community under HIV research. According to National Bioethics Advisory Commission (2006), not only the individual participant may experience risks associated with the study but also the family members, social groups, or society as a whole may be affected as well by judgment made from inaccurate data.
Reference
National Bioethics Advisory Commission. (2006, June 13). Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). https://www.onlineethics.org/cms/8033.aspx
That is a very good point you brought up about the risk for the individual/s conducting the research project. The IRB is a great way to prevent risk for both parties, and ensure the studies are performed ethically. This case study is a great example of the exempt category of the IRB. There is minimal risk to both parties involved as the data was previously collected. It seems as though it would be a great way to provide results that could positively impact the community which is targeted through this study.
Types of IRB Review. (n.d.). Retrieved November 14, 2017, from http://sites.jcu.edu/research/pages/irb/review/review-types/
In this case study, the patient’s names are not exposed, the data had previously been collected, and it was governmentally funded, therefore, puts the research into the exempt category of the IRB. I also agree with there being a social risk of discrimination on HIV. There is a great stigma and discrimination on HIV, causing fewer people to come forward and discuss their disease.
People are constantly moving around the United States, therefore, each year the population with HIV is changing. I think that you have a great point when you discuss people moving from one area to another. 20.8% of the total US population lives in the Midwest vs. the 38.3% that live in the South (United States Census Bureau, 2019). “Southern states bear the highest burden of HIV, accounting for 52% of new HIV diagnoses” (Center for Disease Control, 2019).
Reference
HIV in the Southern United States. (2019, September). Retrieved from https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-in-the-south-issue-brief.pdf
(2019). Retrieved February 6, 2020, from https://www.census.gov/popclock/data_tables.php?component=growth
cdgabel,
Thank you!