Cast Study 1 involves the analysis of existing data.
The investigators are analyzing race differences in HIV positive test results. The data was obtained retrospectively from anonymous demographic data collected with initial testing that also included race, ethnicity, gender, socioeconomic status, age and education level.
Retrospective chart reviews are considered to be human subjects and therefore the research must be approved, as well as meet both human subjects and HIPPA requirements. The meaning of a retrospective chart review means the study is evaluating already existing data at the time the protocol is submitted to the IRB for initial review. Case Study 1 tells us that the information was obtained retrospectively from January 2010 to December 2011.
Following the guidelines outlined by the Office for Human Research Protectors ( OHRPP) this research is eligible for the IRB Exemption under 45 CFR 46.101(b) (4) (for existing data). In order to meet “exempt” status the study must meet two criteria: 1) The project must involve the use of existing data within a given time frame, and 2) the information recorded by the researcher must not identify the subject nor have any individually identifiable data recorded nor linked in any way. Case Study 1 tells us the results were obtained anonymously between the dates of January 2010 to December 2011, therefore meeting these two requirements.
A retrospective chart review that involves the use of medical information for research without seeking written permission from the patient must abide by HIPPA Privacy requirements that must include plans to protect the identify, plans to destroy identifiers, PHI not to be re-used for another purpose and the research cannot be done without the waiver of privacy or the use of PHI. Due to the fact that this data was obtained from varies clinics throughout the Midwest and collected anonymously retrospectively, seeking consent would be impossible.
The Belmont Report gives a framework in which to assess risks and potential benefits of a research study to the researcher, the participant and to society at large. The principle of beneficence requires that researchers attempt to maximize possible benefits and minimize possible harms. As research gathers data to gain knowledge that is beneficial t society, it may expose individuals or groups of individuals that belong to a certain ethnic group or race to harm. Harms can be physical, psychological, social, or economic. IRB’s must determine whether the research is justifiable and that the benefits outweigh the risks.
The fact that all data was obtained/collected anonymously and retrospectively in this HIV positive research makes risks to the researcher and the participant minimal. A greater risk would be to society at large with the published results. Just because data has been de-identified from a research participant doesn’t mean it has been from a racial, ethnic, gender, age or socioeconomic point of view. HIV positive causes a stigmatization, especially to vulnerable groups in society, that can affect them psychologically, socially, and economically. Placing safeguards must be put into place in a study but balancing the harms to societal groups can be difficult. There are benefits to the participant, the researcher and society as a whole. Even though the participant is anonymous, the individual benefits from the results of the study in regards to testing, trends, results of current care/medication, and advances in care/medication results. The researcher benefits in that the studies are generally simple, quick and inexpensive to conduct. With the stigmatization that comes with HIV positive results, anonymity allows researchers to collect data they might not otherwise been able to. The ability to monitor trends in positive HIV cases depends on data collected. Society as a whole benefits with the research of HIV results data. HIV is a preventable disease. Certain groups of society are more at risk for HIV than others. Research helps society to understand the issues presented to certain vulnerable groups with positive HIV results, and programs can be designed to meet the needs of our society where best suited.
Sources:
Department of Health, Education and Welfare. ( 1979). The belmont report: Ethical principles and guidelines for the protection of human subjects of research ( DHEW Publications No. (OS_ 78-0013. https://www.hhs.gov/ohrp/regulations-
HIV and AIDS Social Issues. Avert. August 10, 2016.Global information and education on HIV and AIDS. avert/org/professionals/hiv-social-issues.
Human Subject Regulations Decision Charts. (February 16, 2016). HHS.gov. Office for Human Research Protections. U.S. Department of Health & Human Services. Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply? hhs.gov/ohrp/regulations-and-policy/decision/index.html
John Carroll University. (2019). STEP ONE: Before You Begin: Types of IRB Review. EXEMPT: (n.d.). Retrieved January 28, 2020, from https://jcu/research/irb/investigatiors-guide/step-one-you-begin
Summary of the HIPPA Privacy Rule. HHS.gov. Health Information Privacy. U.S. Department of Health & Human Services. July 26, 2013. hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html+++
Case study 1stated, the investigators are analyzing race differences on HIV positive test results from anonymous demographic data collected at the point of service for initial testing. I analyzed the case and totally agree with your decision in regard to the research that it is eligible base on the standard of the IRB. Your supporting document (Retrospective Medical Review) has proven that the information was base on fact which has been a reliable source. In addition other supporting information in the article had shown to be factual base on the information;“ The desired medical record data is recorded by the investigator in such a way that the patient cannot be identified.(i.e., by the investigator or others) either directly or indirectly via linkage codes assigned to data. This mean that the investigators cannot link names, social security numbers or any other patients identifiers to the data set. As a consequence , the resulting research data set is necessarily completely anonymous. For that reason, once the information has been extracted from the medical record, it will not be possible for the investigator to go back to the medical record and add other, patient-specific information to this research dataset”.
Also the minimal risk that you have addressed in your research of participants and investigators are unbiased. Case study 1 clearly reported that investigators are analyzing race differences in HIV positive test results from anonymous demographic data. It has been demonstrated that HIV individuals have been stigmatized by society, so placing safeguards must be put in place. The retrospective medical review record also confirmed that there is no link between investigators and patients. Other related evidence in Assessing Risks and Potential Benefits and Evaluating Vulnerability article have also showed ; “Risk to subject are minimized: (I) by using procedure which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purpose”.
As a result of case study 1, I believe the research was beneficial to society, researchers, and participants. According to report from chapter 4 in Assessing Risks and Potential Benefits and Evaluating Vulnerability article stated that, society will gain understanding about treatments and cure. Researcher will be able to identify potential risk and treatments needed for society to survive and participants would receive clinical information, standard treatments or intervention that will improve their health status.
Base on the information from the articles I am convince that your analysis is factual.
References
Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). (n.d.). Retrieved from https://www.onlineethics.org/cms/8033.aspx
University of Pittsburgh University Marketing Communications Webteam. (n.d.). Retrospective Medical Record Review. Retrieved from https://www.irb.pitt.edu/retr ospective-medical-record-review
Hi Igbergman. I did not found anything on minorities, but during further research I realized a few unethical behaviors. Properly controlled studies with human subjects are vital to identify conclusion and prevent unethical research. Apparently not all clinical research is ethical. Researchers
have the responsibility to protect the life of each participant and know when to draw the line. Researchers need to understand and practice the code of ethics so that participants feel safe. The IRB video discusses about an institution that falsifies and fabricates documents. This unethical behavior leads to questionable premature death of two subjects. This happens because researchers did not follow protocol. Unethical research can be preventable if investigators and clinical coordinators adhere to IRB protocol and other ethical review committees. According to Chapter 3: Methods for Ensuring Protection: Education, Certification, and Accreditation “ protecting the rights and welfare of research participants is the major ethical obligation of all parties in the oversight system, who, to meet this obligation, must demonstrate competence in research ethics by being able to conduct, review or oversee research involving human participants in an ethically sound manner”.
Technology also plays a great role to minimize harm to participants. Technology creates an easy guideline to both investigators and human subjects. Researchers have access through internet networks and other mobile devices that can deliver safe and effective communication. Technology reduces health disparities and protect health information of individuals.
Human subject research. (2020, January 18). Retrieved from https://en.wikipedia.org/wiki/Human_subject_research
Ly, S., & Magee, W. P. (2017, April 7). Annals of Global Health. Retrieved from https://doi.org/10.1016/j.aogh.2017.03.005
Hello Karlene,
Thanks for your reply to my post on HIV analysis. We both agree that the literature provided to us for this research subject: Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability, give’s support that the risks to the participant and researcher is minimal in that the data is retropectively obtained and that the greater risk is to venerable groups in society. This is what I would like to touch upon a bit more with this discussion blog.
While Chapter 4: Assessing Risks… tells us the Federal regulations include the principle of beneficense by requiring IRB’s to include safeguards that the risks are minimal as compared to the potential benefits offered. Chapter 4 also tells us that the current regulations of the IRB boards do not provide a detailed guidance on how risks and benefits are to be assessed. Chapter 4 also tells us that how the IRB’s and the groups being evaluated might see risks and benefits differently. The National Bioethics Advisory Commission (NBAC) voiced these concerns in two different reports: (NBAC 1998 and NBAC 1999b). They concluded that the IRBs must find ways to be sensitive to the groups that they are doing analysis on.
In my research I came across information on past research studies that involved minorities, that led to the distrust of research studies and how the information obtained was used or misused. While these studies involved more than analyzing data, I do not believe the public compartmentalizes this, they just see research. This being the Tuskegee Health Benefit Program ( THBP). The research involved treatment for Black Males with Syphilis. It turns out that this research study was deemed “ethically unjustified”-the knowledge knowledge gained was sparse when compared with the risks the study exposed its participants to, which involved some of the men not being treated for Sphylis, when the researchers knew they were positive. ( Environ Health Perspectives: Racial and Ethnic Disparities in Research Studies: The Challange of Creating More Diverse Cohorts, 2015.
One of the challanges to the IRBs will be to include members of color and members of the community to participate on their boards. Karlene, did you come across anything in your research about minorities and their distrust, and do you feel like adding persons of color or involving the community would help to lessen the distrust of minorities in research?
Thanks for your post and I look forward to your reply,
Gayle
I agree with you in that the exempt level of review is most appropriate based on the definitions from John Carroll University Institutional Review Board Exempt Research Categories. It appears the research falls under Exempt 4 because it uses identifiable private information about biospecimens that has bene de-identified.
I do disagree with some of the benefits to the participant you listed. Can you better explain how the individual benefits from the study results in regard to testing and trends? I’d like to better understand your perspective. I do agree with the benefits to the researcher and society as well as the risks. I believe you have a well thought out and thorough post. I look forward to your response.
Exempt research categories. (n.d.). John Carroll University. http://webmedia.jcu.edu/research/files/2019/01/Exempt-Research-Categories.pdf
Hi Tammy,
The participant in anonymous HIV testing allows the participant to get tested on his own terms. Anonymity provides an opportunity that this person may not have taken otherwise. Even though the researcher is not able to identify this person, and the data is obtained retrospectively, he/she, meaning the participant, will know the outcome of their test, further allowing the opportunity on a treatment plan. With a positive test the participant also will have opportunity to learn safe practices to prevent the spread of HIV to others. The results that would be obtained via the research provides data to estimate HIV prevalence rates and geographic infection rates, monitor trends in specific groups i.e. racial groups, and to identify groups at risk. The data collected leads to improved treatment and treatment plans that is beneficial to the participants of anonymous testing.
Thanks for sharing your thoughts,
Gayle
Gayle,
Thank you for explaining your thought processes on the benefits to the participant. While I can see where you are coming from, I respectfully disagree with one of the points. Because this is a retrospective review, the anonymity of the data does not factor into the patient’s decision to be tested. The participant does benefit by knowing the results of the test and from the education and treatment planning provided as you said. That is not a result of the study as they would have received the test results and education whether or not they were anonymous participants in the study. I do agree that the study participants would benefit if the data collected leads to improved treatment and treatment plans. Additionally, your points about prevalence rates and monitoring trends is excellent and I agree thoroughly. Thank you for the opportunity to have further discussion on this! It has really made me think and see different perspectives.
I am really enjoying the conversation you two are having concerning the benefit of the study. I completely understand where both of you are coming from. It does benefit the participant on a personal level when the participant gets HIV results (which I assume are low cost or free). They may not have decided to get the testing done otherwise. However, it is not really a benefit to the study. Perhaps if we were more involved in the study we could have a better understanding of how it is conducted. I do agree that if the data was collected retrospectively then the participant could benefit from future treatment plans. I feel that the benefits of this case study outweigh the risk, and that the review would fall under the exempt category. I just also think this study is redundant. Study after study have already targeted populations prone to HIV infections. After information about HIV became available to the population (in the United States), this country has had a decline in new HIV infections up until 2013. After 2013, it has plateaued for 7 years now (CDC, 2020). So I feel a downside to this study, but not a risk necessarily, is that we have numerous studies with this information and we need to focus on what interventions prevent, how to cure, and how to use resources properly.
Centers for Disease Control. (2020, January 16). U.S. statistics. Retrieved February 10, 2020, from https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics