heart disease, research misconduct, data use, genetics/genomics, liability
Many birth defects are inherited, and several affect the proper function of the heart. An atrial septal defect is a birth defect of the heart in which there is a hole in the wall (septum) that divides the upper chambers (atria) of the heart. The hole increases the amount of blood that flows through the lungs and can cause damage to blood vessels in the lungs that sometimes appears as high blood pressure, heart failure, or risk of stroke later in life. The hole may get better on its own or require surgery to fix it.
A researcher wanted to study the genetic contributions to atrial septal defect (ASD). The researcher planned to recruit patients with ASD at a clinic where they received care. The researcher approached the patients and withdrew 8 milliliters of peripheral blood from each individual, thinking patients would consider the blood draw as a part of their standard treatment procedure. Half of the blood was subjected to DNA extraction followed by gene sequencing to detect mutations in certain genes. The researcher intended to use the other 4 milliliters of blood to obtain plasma and serum (storing it at −80°C for future analyses). There was no informed consent obtained for either the current study or the intended future use of the samples. The researcher also did not seek approval from an ethics committee to conduct the research.
Questions
It is clear that the researcher not only violated ethics requirements but also the legal rights of patients in the clinic.
What should be done with the data and results of the genetic sequencing?
What should be done with the remaining stored plasma and serum?
What consequences should the researcher face? What about the institution where the study was conducted?
