Physicians as Consumers: Biorepository Specimen and Data Search for Research Studies

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Biorepository specimen, also regarded as biobanks are a collection of patient biological specimens that are kept for future research studies. Physicians use bio-banks for research studies in the US. The facilities acquire the specimens in several ways that are guided by federal guidelines. The samples are collected for clinical examination in pathology departments. However, there is concern regarding the appropriateness of using the stored specimens to be used for clinical research. As such, there have been policy recommendations that specialized physicians should research human specimens since they use human biological materials. Banking of high quality consented human samples are necessary for understanding disease pathogenesis and improvement of physicians’ knowledge of patient care. This paper seeks to identify biorepository specimen from an economic model citing the lower rate of demand for these specimens by the physicians in question.

Financial and economic sustainability are the two areas that have posed a challenge to the survival of biobanks. This has been attributed to the current management at healthcare institutions that have embraced a model, which has not considered an economic perspective. There is an urgent need to draft and roll out strategic and applicable business plan (Ciaburri, Napolitano & Bravo, 2017). It is the case because it also happens to be the reason behind the disconnection between the economists and biobanker scientists who have never considered the application of the economic model that has never been in existence. For demand to balance with supply for Biorepository specimen, the Business Plan of the Biobank should develop a mission statement on which to base its business and future sustainability. The business plan happens to be the mother of the biobank’s future mission since it indicates the financials and lends itself to the management’s projected targets in the long run. By so doing, all interests of the stakeholders will remain guarded regarding the activities in biobanking processes (Ciaburri, Napolitano & Bravo, 2017).

There are advances in genomics that have been used to frame the ethical considerations with regards to informed consent as well as protection of the identities of the contributors. However, several factors inhibit the activity of ascertaining quality from a non-commercial and commercial biobank service. The case for commercial biobanks happens to be the go-between the producer and the financial user of the product; hence, the issues on the credibility of the samples do arise. They are majorly concerned with the needs of their customers, and not much emphasis is placed on the feasibility studies required. The growth trends in biobanks indicate a 36% increase in the last decade alone hence the prediction that biobanking will hit the USD 24.4 billion mark soon (Mackenzie, 2014). Some of the reasons that were cited for underuse of biobanks specimens were: poor or low quality and unverifiable quality concerning the collection (Paradiso, Daidone, Canzonieri & Zito, 2018).

There exists a lot of controversy concerning how to offer protection to the contributors of the human samples as well as the environments in which such sample collections are done (Zain et al., 2013, p. 45). As such, the biospecimens should be collected and be used by specialized physicians from pathology departments as well as clinical laboratories, particularly in academic research facilities. Also, the specimens should be gathered by the bio-banks that have the most salient features to collect and store specimens from clinical sources (Zain et al., 2013, p. 48). As such, physicians use biobanks to keep clinical samples for future research purposes even though they are challenged to ensure that the studies utilize specimens that are based on government guidelines.

Overall, as the target market of the bio-banks, physicians are considered as consumers since they are the ones with specialized skills necessary to understand the issues regarding the acquisition of the specimens. However, under unified regulations meant to protect human subjects, which are also codified under the common rule, it is necessary to ensure that the acquisition, as well as release of the specimens, is overseen by several IRBs. These boards are mandated to set policies, especially in the context of national regulations and should align with local needs. As such, physicians should focus on the issue of consent, especially in challenging situations, for physicians who are responsible for maintaining and overseeing the banked human specimens.

References

Ciaburri, M., Napolitano, M., & Bravo, E. (2017). Business planning in biobanking: How to implement a tool for sustainability. Biopreservation and biobanking, 15(1), 46-56.

Mackenzie, F. (2014). Biobanking trends, challenges, and opportunities. Pathobiology, 81(5-6), 245-251.

Paradiso, A. V., Daidone, M. G., Canzonieri, V., & Zito, A. (2018). Biobanks and scientists: supply and demand. Journal of translational medicine, 16(1), 136.

Zain, R. B., Athirajan, V., Ghani, W. M. N., Razak, I. A., Latifah, R. J. R., Ismail, S. M., … & Talib, N. (2013). An oral cancer biobank initiative: a platform for multidisciplinary research in a developing country. Cell and tissue banking, 14(1), 45-52. Retrieved from https://link.springer.com/article/10.1007/s10561-012-9298-0.