consent, privacy, confidentiality, social value, dengue diagnosis, rapid tests, reuse of blood samples, dengue patients with positive antibody
Blood samples containing antibodies can be used as a public health tool for validating antibody-based tests used in the diagnosis of infectious diseases, including during outbreaks and pandemics. The availability of inexpensive, accurate, and rapid tests to diagnose infections and monitor disease outbreaks is essential to improve patient outcomes and to minimize the overuse of interventions such as antibiotics.
A local company approached a research institute in Southeast Asia to develop and manufacture a reliable rapid antibody test kit for dengue fever. Since dengue fever is endemic in the region, the company asked to acquire blood samples with positive antibodies from a local hospital to validate the test kit. The hospital’s antibody-positive blood samples had been acquired for dengue diagnostic testing only; patients had not consented for use of their blood for research.
Both the company and the hospital agreed that given health concerns from dengue, seeking informed consent was too time-consuming and impractical. They also reasoned that availability of biological samples created important opportunities for researchers to advance medical science and contribute to collective good for humankind by potentially improving diagnosis of infections, especially during disease outbreaks. The company paid the research institute for blood samples, testing reagents, labor costs, and lab fees.
Questions
What are the ethical concerns raised in this case, and how might you address them as 1) a researcher from the research institute and 2) a clinician from the local hospital?
Do you think this type of activity should be reviewed by a research ethics committee? Why or why not?
What considerations or best practices should guide the reuse of biological samples, such as those described in this case?
Who owns the samples? Are there laws in your country that govern such commercial interests? Do you think that the financial compensation by the company is justifiable? Why or why not?
Would your ethical analysis or recommendations change if the test kits were for detection of COVID-19 antibodies during the height of the global pandemic? Why or why not?
