I believe there are many potential benefits to this study. As we know, people of different ethnicities, gender and socioeconomic statuses, etc. can be at higher risk for different disease processes as well as have limited access to health care and risk modification prevention education. Studying the variables in the data might be helpful in determining where the education/intervention should be directed.
Some studies suggest that there is a culture in which HIV high risk behaviors occur within racial/ethnic groups as well as differences in the presence of risk factors associated with engaging in HIV risk behaviors. Additionally, these findings are consistent with calls to culturally adapt evidence based interventions and the need to maintain core elements of the intervention when adapting the intervention for increased relevance to the new targets. (Brooks 2013) Other studies like a study conducted in the Chinese Province of Sichuan, found that utilizing a mathematical model based approach on research data collected from the township from 2005-2010 were helpful when assessing the temporal dynamics of a HIV epidemic which may be helpful when assessing other characteristics the populations studied. Furthermore, when integrated with epidemiological and surveillance data, it can be an effective tool for assessing the impacts of HIV interventions. (Su, 2016)
Stark racial/ethnic disparities exist along the HIV prevention and care continuum, hence the need for further assessment. Some studies suggest that psychologists can contribute to the elimination of HIV disparities with decreasing the stigma surrounding prevention or for those who are HIV positive. Societal stigma contributed to racial and ethnic disparities can be directly related those who are unaware of their sero-status and receive treatment earlier. Such biomedical strategies will not be successful without changing behaviors associated with stigma. Interventions and clinical practice that increase resilience to societal stigma have the capacity to improve these behaviors and ultimately reduce disparities across the HIV continuum. (Valerie A. Earnshaw, 2013)
Therefore, I would support the practice of studying populations based on the variables discussed and would venture to say it’s our duty to ensure education efforts for prevention and disparity relief is focused where it should be.
An Expedited Level Review, because the study involves focus groups and it is a study of existing data that may include identifying information is needed in this case. The data collected during this study was anonymous data; the subjects cannot be identified directly and are an observation of public predispositions. However, even though a data set may have been stripped of direct identifiers, it may be reasonable to consider the possibility that an individual may be identified through a combination of other characteristics like age, gender, ethnicity and place of employment, therefore requiring a review. We may not also assume that a coding system was not used by the original investigators who obtained the specimens. Additionally, vulnerabilities such as medical, economic, social, etc. among other issues should have been measured when considering the level of review required in the initial study as well, we are also not to assume that the initial study was done ethically and done only after receiving permission to do so.
Audrey J. Brooks, Y. L.-P. (2013). Racial/Ethic Differences in the Rates and Correlates of HIV Risk Behaviors among Drug Abusers. The American Journal on Addictions, 136-147.
Depaul University. (2018). Office of Research Services. Retrieved from Levels of Review: https://offices.depaul.edu/research-services/research-protections/irb/Pages/levels-of-review.aspx
Su, Z. C. (2016). A Mathematical modeling study of the HIV epidemics at two rural townships in the Liangshan Prefecture of the Sichuan Province of China. Infectious Disease Modelling, 3-10.
Valerie A. Earnshaw, L. M. (2013). Stigma and Racial/Ethnic HIV Disparities: Moving Toward Resilience. The American Psychologist, 225-236.
As you mentioned, there are not any direct patient identifiers available through this study however I wonder if consent was obtained from these individuals prior to the study? If these individuals tested positive, I am hopeful there was some sort of protocol in order to notify them appropriately. According to the National Bioethics Advisory Commission, “Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 46.116.”
Possible harm these individuals could endure would include possible psychological harm caused by anxiety/embarrassment depending on how positive test results were communicated to them.
Christan, this is a hard topic and something that warrants a change in perspective and culture. A review of studies by, Mak, Ma, & Lam, showed minimal improvements in reduction of adverse attitudes toward HIV patients. They recommended increased quality stigma reduction programs with multi-dimensional stigma indicators and outcome measures are necessary. The programs these authors recommended maybe valuable to reduce the HIV stigma. I think it has to be on a case by case basis that individuals choose to let that stigma go. Of course, that is much easier said than done, but it can be done. And I believe it comes down to educating more people about HIV. That may be where these programs can focus on high quality programs, educating individuals one at a time.
Mak, Mo, Ma, & Lam. (2017). Meta-analysis and systematic review of studies on the effectiveness of HIV stigma reduction programs. Social Science & Medicine, 188, 30-40.
Christian,
Your information provides data as to why to conduct a study to analyze race, ethnicity, gender, socioeconomic status, age group, and education level for HIV. The data supports the information collected is necessary for society as a whole. The results allow researchers to analyze if treatment methods have improved, if the disease is or is not being controlled in specific group and if new treatment modalities need to be assessed.
Institutional Review Board (IRB) is essential to determine if the study is ethically acceptable and protects participants (National Academics of Sciences, 2018). Research may impact the participant, family or society as well as specific groups of society. “Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).
In this case the data is obtained through anonymous government funded clinics. The data did not have study participants consent as the researches collected past data which would not have patient identifiers on them. The risk for subject breach of confidentiality would be minimal needing an expedited IRB review (National Academics of Sciences, 2018).
References
National Academics of Sciences. (n.d.). (2018). Chapter 4: Assessing risks and potential benefits and evaluating vulnerability (research involving human participants V1). Retrieved on June 13, 2018 from: http://www.onlineethics.org/cms/8033.aspx
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979, April 9). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved on June 15, 2018 from: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Yes, I agree that the data proves that it is important to study these populations. I think some ethnicities are under studied and under appreciated as a potential productive group to society if assisted. And, its always important to review previous education implementation and or interventions for effectiveness as well. I will have to disagree that a low level of review is required here as we cannot assume all rules where followed in the first study and given the sensitive nature of the data collected as well as the social stigma attached and the potential for discrimination, the study as shouldn’t be dismissed as minimal or low risk. In an effort to not marginalize this group, every caution should be taken to do the right thing.A country’s discriminatory laws, rules and policies regarding HIV can alienate and exclude people living with HIV, reinforcing the stigma surrounding HIV and AIDS. (Avert, 2018)
Avert. (2018). HIV Stigma and Discrimination. Retrieved from https://www.avert.org/professionals/hiv-social-issues/stigma-discrimination
There is always room for differences in opinion and I respect your passion to protect this vulnerable group of individuals. I too respect the Health Information Privacy Act(HIPA)laws. I also respect the ethical principal of the Belmont Report of respect for others, beneficence and justice. The searches I conducted reveled the following for ADIS research guidance for IRB’s:
For regulatory purposes [HHS at 45 CFR 46.102(f)] a human subject means a living individual, about whom an investigator conducting research obtains (1) data through intervention or interaction with the investigator, or (2) identifiable private information. Some research designs may involve only the study of existing data, documents, and records, recorded by investigators in such a manner that subjects cannot be identified directly or through identifiers, HHS regulations are not applicable. When reviewing studies based on such existing data, or specimens, it is sufficient for the IRB to determine that there is not link between the item under study and any living human being (Office for Human Research Protections, 1984).
The key question for the case study is if identifiers are used, consent and full board review would be needed. If the identifiers were removed then consent would not be needed. The case study states anonymous to me that is no identifiers.
References
Office for Human Research Protections (OHRP). (n.d.) (1984, Dec 26). AIDS research, guidance for IRBs(1984):OPRR reports guidance for institutional review boards for AIDS studies. Retrieved on June 16, 2018 from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/aids-research-guidance-for-irbs/index.html
Catherine, I enjoyed reading your first paragraph just above. This topic definitely allows room for differences in opinion. And I see both sides of what you and Christan are saying.
Emmureithi has a good point about completely de- identified data, 18 data elements that need decoded- that would be hard to prove if they were concerned about their age.
The data collected from this study might provide insight as to whether there were key populations that were mostly affected when it comes to new HIV diagnosis. The data might be used to initiate public policies that could help with outreach to subset groups that might be identified.
According to the National institute of Health, ” De-identified health information as described in the Privacy Rule, is not PHI, and thus is not protected by the Privacy Rule”. If the data is de-identified, then researchers can use the data for analytical purposes.
There are 18 data elements that would need to be decoded as per the HIPPA rules (DHHS, 2010), one of them being dates that include a person’s birthday. Given that the researcher would like to analyze different age groups, the board would need to decide whether the exemption can be permitted.
References:
National Institute of Health. How Can Covered Entities Use and Disclose Protected Health Information for Research and Comply with the Privacy Rule? (2007).Retrieved from: https://privacyruleandresearch.nih.gov
US Department of Health and Human Services. Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. (2010). Retrieved from: https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html#standard
I totally agree, completely de- identified health information with 100% certainly would be hard to prove in this situation since the researchers are interested in their ages. Good point.
I think that it is a great idea to test different races, genders, age, education, etc., when studying the HIV disease. We know that there are different diseases that are more prevalent in some ethnic groups than others. For example, Diabetes is higher in African-American people than other races. How would we know whether HIV can be more attracted to one race, age, or gender if we do not test more than one. I think that as long as there is transparency in the study and the patients are aware of the details then there should be no question as to unethical behavior.
The only thing that does concern me is that some people may think that we are taking advantage of those less fortunate by providing income or gifts to those that participate. Some people would do anything for a little money and, sadly, it may be considered unethical to some to provide money for someone using their bodies for testing.
Yes, I agree, there needs to be transparency in the study for it to me ethical, good point. You would think that if the researchers wanted an accurate and useful study, they would not risk skewing the data by doing something unethical like offer money or gifts.
When studying a disease for risk, prevention education, treatment effectiveness, or other reasons which may be related to specific demographics, it’s important that vulnerable groups are protected. Ethical issues in epidemiology arise related to the benefit of reduction of communicable disease occurrence in society versus the need to protect the rights and privacy of the individuals involved or potentially involved.
This type of study would fall under the “surveillance” regulations and procedures, instead of the urgency related to an outbreak. When working an emergency response regarding outbreaks, data collection would be considered a “public health activity” instead, (Coughlin, 2006), and would have a very different focus– that of determining when action is needed, and determining if there is a public health risk, and if so, how widespread the expected impact would be.
Because this study focuses on various ethnic groups, socioeconomic groups, and education groups, I agree that it is not exempt, but that an expedited review would be appropriate as long a identifiers are removed from the data being collected. Otherwise, a full review should be performed to ensure that appropriate precautions are taken to protect individual privacy.
The study presented states that it is anonymous data and most identifiers would have to have been removed, but there is still the risk of specific populations being further stigmatized related to HIV/AIDS since age, race, ethnicity, socioeconomic status, and education level are variables being examined.
Coughlin, S. S. (2006). Ethical issues in epidemiologic research and public health practice. Emerging Themes in Epidemiology, 3, 16. http://doi.org/10.1186/1742-7622-3-16
Well said, I agree that there still a risk to be further stigmatized as you mentioned.
According to the CDC, HIV is a reportable disease (2018). Therefore, the information is already gathered and reported to local, state and federal health departments. Reporting HIV infections, and data collection are useful in directing specific prevention activities such as “patient counseling, partner notification, and referral for appropriate medical management (2018).” Early reporting can also allow earlier recognition of patients with or at risk for HIV infections and allow for earlier interventions to prevent the spread of HIV. The data collected in the study can help identify those at a greater risk for exposure and increase the educational options for awareness and prevention.
Your perspective on health disparities in racial and ethnical groups and how to eliminate the stigma of HIV is a great example of why studies like these need to be performed. In my current practice, patients sign a consent form prior to testing, to ensure they are aware of mandatory reporting and the value of the statistical information provided. While some research is performed with patient awareness and consent, this form of collection from government funded facilities, patients do not have to be informed, and it is based off deidentified data.
I also agree with your explanation of why an expedited IRB is necessary, due to the use of existing data, and the possibility of identifying a vulnerable population (2016).
References:
“HIV/AIDS.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 7 Mar. 2018, http://www.cdc.gov/hiv/guidelines/reporting.html.
hhs.gov. “OHRP Expedited Review Categories (1998).” HHS.gov, HHS.gov, 30 Mar. 2016, http://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html.
Yes, I agree, its our duty as nurses to be an advocate for the vulnerable populations. In fact the ANA recently published its new Code of Ethics for Nurses with Interpretive statements, within the document, certain provisions call on nurses to stand up for human rights and social justice and to address health disparities.
Disclosure is definitely a hot topic and has been for decades with HIV. It is sad that it still carries such negative connotations in society, as it is indeed one of the health disparities nurses deal with regularly. It is reportable, yes, in the spirit of public health, but there is still much to learn, especially for those infected. Many times, diagnosis and/or disclosure to partners or family is when a person’s HIV education starts as the move “from unawareness to knowledge “(Li, 2015).
Reporting this type of information is often times embarrassing and there can be many factors hindering disclosure such as consequences from family, partners, judgment or loss of friends and loss of social status. In some cases, it has raised the moral dilemma of whether or not an individual properly discloses their HIV status to potential sexual partners. In 2000, the UK had its first successful prosecution of an HIV-infected man, Stephen Kelly. He contracted HIV from IV drug use during prison. After his release, he engaged in a sexual relationship with a woman without disclosing his HIV status and told her condoms were not necessary. He was later sentenced to five years in prison for recklessly causing injury to another (Chalmers, 2001)
Li, X., De Wit, J., & Sherr, L. (2015). What’s in the telling? Understanding social, psychological and clinical aspects of HIV disclosure. AIDS Care, 27(S1), 1-5. http://dx.doi.org/10.1080/09540121.2015.1102687
Chalmers, J. (2001). The criminalisation of HIV transmission. British Medical
Journal, 28(3). http://dx.doi.org/10.1136/jme.28.3.160