In the case study that I was assigned to, I had to analyze race differences in HIV positive test results from anonymous demographic data that was collected from an initial testing center. The labs test were preformed and collected at government funded clinics throughout the Med-west region of the United States. The case study began in January 2010 and ran till December 2011. Variables in the analysis included race, ethnicity, gender, socioeconomic status, age group and education level.
When it comes to analyzing the risk for the researcher, I would say that their risk is minimal. The researcher does not provide any personal information and only receives it. When it comes to the participant I feel like they encounter a huge risk as it is their personal information that is being shared. Now, the reason why I say that it is a huge risk for the participant, is because if they are HIV positive and somehow that information gets linked back to them on “accident” or a system gets hacked and someone outside the research intercepts the information, it could be traumatizing for that participant. As far as the risks go for society, I think the risk comes into play in the high clustered areas where people are unaware of the disease be prevalent in their location.
Assisting in research has it benefits to the community/location as well. Some of the benefits for the researcher and society in this particular case study, is that it shows where and if there are clusters spots where HIV might be prevalent. I think also as a researcher it would be interesting to see if there is any correlation between race, age, socioeconomic status and education level. When it comes to the participant there really is no benefit to them other then them knowing that possibly that they are not the only HIV positive people in their location.
When it comes the the level of IRB approval for this case study, it would be minimal risk. The reason why this particular case study would impose a minimal risk is because it simply is asking for anonymous demographic data that was collected through a testing center. It presents minimal risk for all involved and information is collected through private health information.
References
National Bioethics Advisory Commission. (2016). Reporting on Ethical and Policy Issues in Research Involving Human Participants; Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability. Retrieved from onlineethics.org/cms/8033.aspx
If the data collected is retrospective and anonymous, then how is personal information tied to the participant? Who actually is the “participant” in this case study? Don’t forget to support your standpoints with the evidence. How can you use the Belmont report or ANA code of ethics to define why the risks and benefits are supported? After further assessment of this information, should the study be IRB exempt, expedited, or full board review?
Mrs. Gabel,
Given that the data was collected anonymous, there should be no way that personal information should be leaked out at all. However upon researching I found an interesting article about how laptops were stolen with PHI in those lab tops. Now if the person giving their information had signed a release, that would put them in jeopardy considering their laptops were stolen. I just personally feel that having a life long disease would be enough to deal with let alone a company accidentally breaching my information. I know that scenario was not shared in the case study however that is where my thought process went.
This case study would be exempt as it entails minimal risk to the client. However, if the breach of HIPAA did occur it then would become a full board review.
By using the Belmont report is a great tool I think when it comes to ethics and research. It defines the statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research when it comes to the human population.
McGee, M. K., & Ross, R. (n.d.). Research Institute Breach Results in $3.9 Million Sanction. Retrieved June 17, 2020, from https://www.databreachtoday.com/research-institute-breach-results-in-39-million-sanction-a-8979
I was wondering about the anonymous part too. If it is anonymous how can the personal information get linked? Did the participant sign a consent? I am assuming a consent was signed because the researcher has to have the participants permission. Is that how you were thinking the information could be leaked? Just a thought!
I absolutely was thinking about a participant signing a consent. I am not sure why I didn’t mention that but my mind was there. Thanks for bringing that up!
-Nichole
Your welcome! I am sure a consent was signed but it wasn’t clearly stated in the case. That is why I was wondering. I figured you thought about that too!
You always wonder how well your personal health information is protected. The study does say its anonymous collected data, and with no identifiable data to link the information to a participant. When going to most hosptials and clinics they have to signs a consent to use your information for research but you never know what for or when the information will be used.
It is interesting. I always wondered how protected my PHI is. Being a nurse and working on an inpatient ward, there are a lot of different charts and programs that we have access too. Now, having a baseline code of ethics and not violating HIPAA is huge however some people are not so honest. It’s scary, if I had something to where there was no cure and it was like long, I would think long and hard about being a participant.
It is interesting. I always wondered how protected my PHI is. Being a nurse and working on an inpatient ward, there are a lot of different charts and programs that we have access too. Now, having a baseline code of ethics and not violating HIPAA is huge however some people are not so honest. It’s scary, if I had something to where there was no cure and it was like long, I would think long and hard about being a participant.
To me if we are saying the risk to the patient is huge because of the risk of their information being leaked then it is no longer considered minimal risk for IRB review. Personally, I feel as though if the information is anonymous then it is an exempt IRB review however if the risk to the patient is huge then it would need a full IRB review but I don’t not believe that to be the case in this instance.
Resources:
STEP ONE: Before You Begin. (n.d.). Retrieved June 19, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin