Case Study 1
Overview of the study is to determine the race differences in HIV positive test results in the Midwest.
Risk and Benefits of the researcher
Risk for the researcher include a small sample size as they only collected data from the Midwest. The demographic data in the Midwest is going to be vastly different than other parts of the country. Utilizing data from government funded clinics narrows the subjects down. This population would generally be of a lower socioeconomic class, have a lower level of education, and a higher percent of minorities. Benefits would include that is testing is already done and the data is readily available. This eliminates cost and risk of testing or potential harm to participants. The data that is available is anonymous and this is beneficial as the study will not require review from IRB.
Risks and Benefits of the Participants
In this case, risks are associated with breaches in confidentiality, and the IRB should determine whether confidentiality protections are appropriate. Because none of the research procedures off the prospect of direct benefit, the risk/potential benefit analysis involves judging whether the risks are reasonable in relation to the potential gains in knowledge for society (National Bioethics Advisory Commission, 2020). Justice is also questionable in the case study. Has the group of individuals data been chosen out of convenience due to availability? It does not appear that the burden has been equally distributed by limiting data only from government funded clinics. There is no direct benefit for the participant.
Risks and Benefits of the Society
Risks for the society is getting skewed data due to the limited diversity of the sample size. Only collecting data from government funded clinics is not a true representation of the rest of the community. Limiting data collection to the Midwest will only give results based on that geographical area. Benefits for the society is that it may allow for grants or additional funding to assist with more education, prevention, testing, or treatment in regards to HIV. The importance of the knowledge to be gained mya increase when significant new findings are expected; when it may result in new products, treatment, or cures; or when it is applicable to many different social groups. Institutions benefit, for example, from enhanced capacity to conduct research or by receiving resources to improve a program as a result of a research study. Communities can benefit through improved access to programs or through the emergence of programs targeted to specific groups within the community (National Bioethics Advisory Commission, 2020).
The Need for IRB Approval
According to HHS.gov (2019), Chart 1 since the information is no individually identifiable it is considered research that is not research involving human subject, and 45 CFR part 46 does not apply. Chart 2 the research involves the collection or study of existing data, documents, records, or pathological or diagnostic specimens exemption 45 CFR 46.101(b)(2) or (b)(3) may apply. Chart 5 since the information will be recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers liked to the subject it is eligible for exemption under 45 CFR 46.101(b)(4) from 45 CFR part 46 requirements. Through following the chart it an be determined that this study does not require IRB approval.
References:
HHS.gov, (2019). Human Subject Regulations Decision Charts. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html#c1
National Bioethics Advisory Commission, (2020). Exhibit 4.2: using the framework to assess risks and potential benefits. Report of Ethical and Policy Issues in Research Involving Human Participants Volume 1 – Report and Recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx#exhibit4-2
6 Responses
Leave a Reply
You must be logged in to post a comment.
I agree that this information obtained in this study will be skewed because of the location in the Midwest. I also agree with your observations that the information from subjects will also be a risk because if it is a government funded clinic, then subjects are more likely of lower socioeconomic status (and lower education). The data obtained may be good as long as the researcher is identifying that the research came from this specific region and does not try to pass it off as worldwide, or USA wide.
The IRB level I was determining looks like exempt because the information was already available, the subjects were anonymous, and the subjects did not have to be contacted.
Human Research Protection Program & IRB, & University of California San Francisco. (2016, October 3). Medical Record Review. Retrieved from https://irb.ucsf.edu/medical-record-review
You make a good point. If the researched makes it know and publishes this study as a study of the Midwest then yes it could supply good data. However, I do still think that it will be limited in the data was only obtained from government funded clinics. That only gives a picture of one group of patients.
I agree with the risks and benefits you have listed for the case study. After reading through case study one, I am torn between exempt and expedited. I think arguments could be made for either side. Since the information used for the case study was based on government-collected information and health information already gathered the case would qualify for exempt. Expedited review could also be used due to the minimal risk. A full review would not be necessary because there wasn’t a vulnerable population being used. Consent also would not be necessary leading one believe it is exempt. I find it interesting that it is debatable on which review is needed and not necessarily black or white.
STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.). Retrieved April 3, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
I agree the distinction between exempt and expedited seems to be muddy at times from my novice eyes. I had originally believed this research to be considered exempt. However, reading this Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected
solely for non-research purposes (such as medical treatment or diagnosis)(John Carroll University) makes me believe it may be considered expedited. Thanks for bringing this to my attention.
Reference:
John Carroll University, (n.d), Categories of Expedited Review. Retrieved from http://webmedia.jcu.edu/research/files/2019/01/Expedited-Review-Categories.pdf
I do agree that this sample is a limited sample size to a region, certain socioeconomic class and minorities. Results will not be the same for other areas. Government funded clinics do provide many services and often times at no cost to the patient depending on a sliding-scale. Patients with no insurance are also more likely to use these types of facilities. These types of facilities tend to medically underserved and uninsured population. However, anyone can be seen.
I do think that an IRB review is needed. I think an expedited review would be best because this research involves specimens that have been collected. This type of research is considered “minimal risk.”
References
McNamara, Jon. “Federal Government Health Centers and Clinics.” Federal Government Health Centers and Clinics, http://www.needhelppayingbills.com/html/federal_government_health_cent.html.
“The Three Types of IRB Review.” Institutional Review Board for Human Subjects The Three Types of IRB Review Comments, irb.lafayette.edu/the-three-types-of-irb-review/.
You make great arguments for the risks and benefits for the subject, researcher, and society.
I am glad to see so much discussion regarding whether this research proposal would be exempt v. expedited. A great point is made in the comments about how muddy all of this can be for a novice. I could not agree more. I ended up going with the argument that this particular case study would be exempt of IRB on my first discussion post comment, but I really feel that a strong argument was made by you for expedited. I believe that this particular study would be exempt because it poses minimal risk for the subjects, benefits the public, and is federally supported (University of Southern California, n.d.). Government clinics are the entities being used to gather research,so this makes me believe that there is federal support for the study. This would fall under category five of the exemption categories (John Carroll University, n.d.).
John Carroll University. (n.d.). STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin
University of Southern California. (n.d.). Levels of IRB Review. Retrieved from https://oprs.usc.edu/irb-review/types-of-irb-review/