justice, risk-benefit, multinational industry-sponsored research, payment, researcher responsibilities, cell regeneration study, biosample collection, patients with liver damage
The World Health Organization (WHO) estimates that 10 million people in Southeast Asia live with hepatitis C.1 While the incidence of hepatitis C in Southeast Asia is about 2.7%,2 in one particular country in the region, the incidence is much higher, nearing 10% of the population. Due to the high level of disease and scarcity of organs, many patients spend more than 10 months waiting for a liver transplant. The transplant wait time is substantially higher than the regional average of 15 to 17 weeks.3 As a result, the mortality rate from liver failure in the country is very high: up to 30% of the population.
Through their Ministry of Health, the country set up a collaborative research project with a foreign private biotechnology company that recently developed a biological matrix that can induce cell regeneration that might advance treatment options for liver disease. With robust preclinical data from animal experiments but no clinical data from human participants, the company asked for help from a local hospital to conduct a small pilot study. The lead company researcher requested ethics approval from the hospital. Thereafter, doctors in the hospital recruited 20 patients with liver damage, informing them about the study and asking for their consent to participate. After completion of the pilot study, the research team expanded recruitment to 200 patients. An academic researcher from the country was designated a coinvestigator on the project.
Although health officials from the country considered the research project a useful effort toward lowering the mortality rate from liver failure, they did not have sufficient resources to provide financial support for the study. The Ministry of Health thus agreed to allow the company to charge study participants a “budget-friendly” sum of money. As part of a technology-transfer agreement, the country requested that the company help establish a modern liver disease clinic in exchange for long-term storage of patient biosamples to be used for future research. The amount of money charged to participants and the risks and benefits of the procedures were all clearly explained in the information sheet.
The study protocol involved surgically harvesting a small sample of a patient’s liver tissue and culturing it in the experimental biological matrix for 2 to 3 weeks to return the cells to a health state. The researchers then transplanted the “healed” cells back into the livers of patients, where the cells were to stimulate liver tissue regeneration.4, 5, 6 Although the researchers did not tout use of the matrix as a curative therapy, they considered it a way to improve liver function enough to survive the long wait for a liver transplant from a suitable donor. The protocol stated that patients recruited have poor prognoses and will die eventually without any treatment.
Questions
What arguments could be made toward justifying the study’s scientific and social value? Are there any counterarguments worth considering?
Although this study intervention is potentially life-extending, is it ethical to ask participants for payment because of the lack of government support? Why or why not?
Should internal review board approve this study, and, if so, what safeguards should be put in place to ensure the risks are appropriately managed?
What concerns, if any, do you have about the collection and storage of biosamples?
What are the ethics-related responsibilities of both the local academic researcher and foreign biotechnology company researchers? To what extent are you satisfied that they are likely to be able to fulfill those responsibilities given the study arrangements? What might help to increase your confidence that they will be able to meet those obligations?
