I was assigned Case Study #1. In this case study 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.
This research study has minimal possible risks for the researcher because the information is anonymous, and the researcher does not have direct contact with the participants. The researcher is then unable to put a face to the information, therefore decreasing the possible risks. The researchers are also only dealing with data, not performing the actual test so the researcher is not at risk of contracting the disease. It does have benefits for the researcher because it can allow them to better promote HIV prevention in the needed areas.
This research study does have risks for the participant. One risk is psychological. “Psychological harms include the research participant’s negative perception of self, emotional suffering (e.g., anxiety or shame), or aberrations in thought or behavior. Psychological harms also include distress, anger, or guilt related to the disclosure of sensitive or embarrassing information and distress and fear upon learning of one’s likelihood of developing a disease for which there is no treatment or cure,” (Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability, 2006). This could be particularly true for a study on HIV positive patients. Another risk to the participant could be social harms. “Social harms involve the negative effects on one’s interactions or relationships with others. For example, research findings or even study participation itself may expose participants to insurance or employment discrimination or other forms of social stigmatization,” (Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability, 2006). If for whatever reason the information were to be hacked or if the clinic sends more than the required information to the researchers, the participant is at risk of their information not being confidential. This case study does say that the information is anonymous. I do question if the researchers have patient participation through the actual patient agreeing and consenting or if the information is given without the patient knowing since it is de-identified before it is given to the researcher. If that is the case, then the patient would have minimal risks because they would not even know about the study. The participants could benefit from the study results if it were to lead to broader access to HIV care and increase funding.
The risk to society is how the study is focused only on government-funded clinics in the Midwest. This can greatly skew the results because many patients who use government-funded clinics are of a low socioeconomic status and there is a larger percentage of minorities served. The results would show that the lower socioeconomic status and minorities as the highest risk for being HIV positive. This could lead to social stigmas and discrimination. On the flip side it could have benefits such as increased awareness of those who are at highest risk and then more health promotion on HIV prevention. It could also lead to more HIV funding and care in the communities that need it most.
This case study would fit under the Exempt level of IRB review. Under the Exempt level, this case study would meet the Exempt Category 4 requirements of using only existing secondary data that is de-identifiable. This is because the data is unidentifiable, it was from patients who had already been tested prior to the study, the researcher has no contact with the participants and the collected data will not be re-identified.
References
“Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1)” Online Ethics Center for Engineering 6/14/2006 OEC Accessed: Sunday, June 14, 2020 www.onlineethics.org/8033/hchapter4
I was assigned case 2 so I did not read case 1. It seems to me that they would get more reliable results if they tested people from other clinics too, not just government funded. Maybe the testing should also be done in higher income towns. I know it said it was done throughout the Midwest region of the US but it was only in government funded clinics. Good analysis though!!
I thought the same thing. I feel like they needed to expand their study to more than just federally funded clinics. It seems to me that the study would be skewed.
Nice job on your analysis. I am wondering how the participants would have a risk for psychological harm if they don’t know that they are research participants. I didn’t read the case study however if the research information was gathered anonymously then the information would be de-identified before it is provided to the researcher. Even if they saw the study and read the information, it is still conceivable that they weren’t part of it based on the inclusion criteria.
I felt that if the patient had to agree before their information was shared that it could cause psychological harm. If they did not have to agree and the information was shared without their knowledge then of course there would be no psychological harm.
Hello, I enjoyed reading your blog post about Case study #1. I like that you mentioned that the research discussed in this case study could have potential social consequences. Might these social harms extend beyond just the participant and include society in general? I also agree that by utilizing on government run clinics, the research is in jeopardy of being skewed.
One thing that wasn’t mentioned that would be of interest to the IRB is if the investigators conducting the study had patient care responsibilities at the facility where data was collected. If the answer is yes, this could interfere with any anonymity the research might have had.
References
Retrospective Medical Record Review. (n.d.). Retrieved June 20, 2020, from https://www.irb.pitt.edu/retrospective-medical-record-review
Yes, I agree that the social harms do extend beyond the participants and include society in general. Depending on the results of the study it has the potential for causing harm to society. I like that you brought up the part about if any of the investigators took care of patients at the facility. That wold definitely interfere with anonymity and I would consider it a conflict of interest as well.
I also has case study #1 and while analyzing the information about how this can affect the participants I was stuck on how it could psychologically affect them and how they would be notified about being in a study. I remember working in a clinic setting as a float nurse that certain positive STD’s and other diseases have to be reported the health department. This is done without consent. Meaning that this information that the research is looking for can be obtained by the health departments.
I did some research on confidentiality and reporting. This is what I found. You can get anonymous testing and this test links no information the person being tested. You get a unique identifier and than you are able to obtain your results this is the only way that you and only you know the results. Than there is according the to CDC “Confidential testing means that your name and other identifying information will be attached to your test results. The results will go in your medical record and may be shared with your health care providers and your health insurance company (2020).”
After finding this research I understand know that this study is exempt category 4 for IRB. Because HIV is a reportable disease to the health department and the CDC. The health department receives all information about the patient with patient identifiers but the CDC only gets the positive result without personal information. There is always a risk of breach of information with electronics. But I found this to be great information to clarify how they can use these positive test results without consent.
Sharing Your Test Result. (2020, June 04). Retrieved June 20, 2020, from https://www.cdc.gov/hiv/basics/hiv-testing/sharing-test-results.html
Content Source: HIV.govDate last updated: May 15, 2. (2017, August 31). Limits on Confidentiality. Retrieved June 20, 2020, from https://www.hiv.gov/hiv-basics/living-well-with-hiv/your-legal-rights/limits-on-confidentiality
I work for a health department and you are correct about HIV and STDs being reportable diseases, however they do not have to be reported to the local health departments. They are reportable to KDHE, who has HIV or STD specific departments that follow up. We only follow up if we do the actual testing and then we report to KDHE and offer treatment for the STDs. Even in those instances the patient is told that it is a reportable disease to KDHE. I am curious though if this is not a study by the CDC if they had the patient’s permission.