This retrospective study is from the Netherlands. See the published research article in the reference section below. The article review uses data from 2000 to 2016 and identifies 2,037 children that were previous patients at a university hospital (Draijer, Bosch, Wiegman, Sjouke, Benninga, & Koot, 2018, p.174). The kids screened for liver disease with the goal of this study to use a higher-performing algorithm that improves the accuracy in detecting the condition. The Wolman disease is a lethal threat to children if left untreated, and early detection is critical. The algorithm did prove useful in helping to pre-determine which patients should have further screenings for the disease. The study indicated that the number of cases where kids had liver disease, and not diagnosed, was very low (Draijer et al., 2018, p.178). Draijer et al. (2018) suggested their algorithm use in prospective cases for early detection of liver disease in children (p.179).
Draijer et al. (2018) mention for ethical reasons they could not physically test the children that the new algorithm discovered for the liver disease (p.178). The ethics comment is the only written indicator that the researchers are aware of the ethical issues of using retrospective data. Under the obtaining informed consent rules of 45 CFR 46.116 (HHS.gov, March 18, 2016), the guidelines say, “explanation of the study’s purpose, duration, experimental procedures, alternatives, risk, and benefits” shall be explained in detail (p.1). The potential issue could be the original study didn’t know if this data would be used again in the future. Under HHS.gov (2016), the confidentiality section in (instructions for informed consent) states how the records shall be maintained and what happens to the results later (p.2). Retaining the retention and “informed” consent records for three years after the research and once the three years have passed the informed consent records must be destroyed (p.3); otherwise, the patients’ parents waived the requirements for the informed consent. The data used at a future date, and the patients do have a right to know; however, there may have been no way of obtaining approval, or the patients were no longer traceable. I can only guess these researches received the proper authorization to use this data and to publish the findings because Draijer et al. (2018) mention ethical reasons for not contacting the past subjects for further testing (p178). One thing I realized is this study would have fallen under the European ethics review, which I assume is a bit more stringent from my readings on the subject.
References
Bietz, M., Bloss, C., Godino, J., & Patrick, K. (2015). Exploring personal data for public good research. Interactions, 22(5), 62-65. https://doi.org/10.1145/2810221
Draijer, L., Bosch, A., Wiegman, A., Sjouke, B., Benninga, M., Koot, B. (2018). Screening for lysosomal acid lipase deficiency: A retrospective data mining study and evaluation of screening criteria. Atherosclerosis, 278, 174-179. https://doi:10.1016/j.atherosclerosis.2018.09.023
HHS.gov (March 18, 2016). Informed consent tips (1993). Retrieved from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent-tips/index.html