consent, conflict of interest, cord blood, regenerative medicine, biobanking, pregnancy
Regenerative medicine is a promising field with potential for developing new therapeutics using stem cells for a range of medical conditions that are presently incurable by conventional medical interventions. Currently, only a few stems cell-based therapies, including those using cord blood stem cells, have been proven to be safe and effective. Umbilical cord blood stem cells, which can be frozen and stored in cell banks for future use, can be used to treat blood-related diseases such as leukemia. Cord blood also contains stem cells that can be harvested to produce other types of specialized cells in the human body.
A first-time expectant mother was a patient of a renowned obstetrician at a private hospital. During the patient’s clinic visit at 37 weeks, she was informed about the potential benefit of storing her baby’s cord blood, which contain stem cells that can be harvested to treat her newborn or siblings should they develop blood-related diseases or cancer in the future. The doctor briefly explained the benefits of storing cord blood cells in a commercial cell bank. A brochure for the cell bank touted storage as modern medical “insurance” but did not disclose the cost of harvesting the stem cells and storing them long-term.
Given the trust this patient has with her doctor and the perceived future benefit not only for her first-born child but for all her future children, she agreed and signed a consent form in the presence of a representative of the cell bank. At 39 weeks of pregnancy, the patient went into spontaneous labor, and the delivery of her child was conducted by both the patient’s doctor and the midwife on duty. The baby’s cord blood was successfully collected and given to the representative from the cell bank who was waiting at the hospital. Per standing hospital policy, the cell bank provided a financial incentive to the delivery team upon each successful collection of cord blood. Therefore, the obstetrician and midwife each received payment.
Apart from providing storage facilities for cord blood stem cells, the cell bank is also involved in a stem cell research collaboration with an international research team to create cell lines using the stored cord blood stem cells. Potential use of these cells for research and commercialization was mentioned in the fine print of the brochure presented to this patient before she agreed to have her cord blood cells harvested. However, that same information was not mentioned in the consent form she read and signed. Unknown to the patient, her doctor is a strong advocate for stem cell research and is one of the collaborators for stem cell research facilitated by the cell biobank.
Questions
International ethics guidelines stipulate that consent is a fundamental principle in medicine as well as in research. Does the case above raise any concerns about consent? Do you think the patient’s informed consent was appropriately obtained in accordance with international ethics guidelines? Why or why not?
In your opinion, was the approach to procure stem cells for research adopted by the cell bank appropriate? Why or why not?
What are your thoughts about doctors or health care providers receiving remuneration from a private entity for helping to obtain biological materials?
What do you think of the dual roles of the obstetrician as an advocate for stem cell research and therapy and a researcher in the cell bank? Is there a conflict of interest?
