Human Biological Sample Ethics

Upon review of “Ethical issues in the export, storage and reuse of human biological samples in biomedical research: perspectives of key stakeholders in Ghana and Kenya,” there are several key issues identified in the trial in regards to bio-specimens (Tindana, P., Molyneux C., Bull, S., & Parker, M., 2014). The first being the ability to understanding the collection process and the purpose for the collected samples. There were many misconceptions to how blood samples were transported and if it was safe to be collected. The second issue identified was the determination of consenting to biological samples being used for future use and what the potential impact of the future studies have on a the research subjects and/or community. The third issue was the ownership of samples once collected and is the work of collecting the samples acknowledged in future research and publications. The cultural negative associations with blood complicated these issues and the consenting process. Although suggestions to aid in the protection of subjects and their biological samples were provided, like the IRB deciding future use acceptability, the intertwining of all of the issues was clearly depicted indicating the complexity of a solution (Tinda et al., 2014). 

The study, “The debate over research on stored biological samples: what do the sources think” supports the complexity of bio-specimen collection and processing, even with the subject population being in the United States of America (Wendler & Emanuel, 2002). The debate included samples that were personably identifiable versus “anoymized” and the difference in future research for the disease the sample was originally collected for versus new indications. The idea to consent subjects at the start of the trial for future research, so re-consenting difficulties to “lost” subjects can be minimalized, adds the issue of how subjects can consent to future research when they do not know the future risks and benefits. The data collected indicated five suggestions to the current process, like “requiring consent the first time the samples are used for research purposes.” (Wendler & Emmanuel, 2002).

The complexity of research biological samples is apparent, but I do not believe it always gets the attention it deserves. As someone who has worked in a clinical research laboratory processing research samples, I can attest to the high level of care and detail put forth to process and handle samples correctly, so the proper analysis could be completed. The samples are irreplaceable, which supports the concern for ownership of the samples once collected that the first article described with publications (Tinda et al., 2014). I have also consented patients to clinical trials and had to explain the different bio-specimen collection parameters outlined in the consent form. From my experience, most patients do not truly understand what will happen to their biological samples, but they understand it could potentially help make new discoveries in science and medicine, so they are more inclined to participate. The idea if subjects consent to future research for their disease then they are open to future research for other diseases (Wendler & Emmanuel, 2002), also holds true when I have personally spoke to patients. It is interesting to me to learn about the perceptions of biological samples collection for different diseases, as almost all of my research experience is in oncology and there is definitely an altruistic component to consenting to research when it is a matter of life and death.  

References:

Tindana, P., Molyneux C., Bull, S., & Parker, M. (2014). Ethical issues in the export, storage and reuse of human biological samples in biomedical research: Perspectives of key stakeholders in Ghana and Kenya. . BMC Medical Ethics. 15(1). Retrieved From https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4210627/

Wendler D., & Emanuel E. (2002). The debate over research on stored biological samples: what do the sources think? Arch Intern Med, 162. (pp. 1457–1462). Retrieved From http://www.lcg.unam.mx/frontiers/files/frontiers/Wendler%20D.pdf