Reuse of Human SpecimensCOLLAPSE
Research on biological specime
Reuse of Human SpecimensCOLLAPSE
Research on biological specimens is ever growing. With genetic and unspecified future research becoming more common, there is need for increased regulatory oversight for the use of biological specimens (and PHI). In the article, Ethical issues in the export, storage and reuse of human biological samples in biomedical research: Perspectives of key stakeholders in Ghana and Kenya, the authors outline five key issues researchers in Ghana and Kenya face when working with biological samples for research: cultural influences on blood sample collection; broad consent; export of samples; local ethics committees' concerns; and feasibility of monitoring such future use of specimens. The issues described in this article are applicable to almost any institution that collects and uses biological specimens for future research.Cultural implications and export of samples is underrated. I don't think this is usually considered by researchers using human specimens for secondary research. Future research may include testing a human blood sample in an animal, and what if that person's religion or cultural belief was against testing in animals?
How would they be able to redact that consent? They'd likely never be provided with this updated information. This touches on the idea of broad consent which usually has specific limitations (some information on the future research is usually provided). However, researchers may want to keep consent vague as to not limit their opportunities. Lastly, local ethics boards must create a proper reviewing mechanism to ensure original consents are being followed for secondary research. This is often very difficult as some committees are small and lack proper resources.
Additional Information on the Issues:
There exists several studies that resulted in poor outcomes due to the issues noted above. For instance, a patient sued his physician after discovering his physician created a cell line from his spleen cells and ultimately filed for a patent (Hakimian & Korn, 2004, p. 2502). However, the only research activities the patient agreed to in the consent form he signed was a splenectomy. There was no mention in the consent of future use of specimens/data for commercial profit. uch misuse led to a lawsuit. Interestingly, the California Supreme Court ruled against the patient's claimed ownership as it œcontradicted the notion that a cell line is the product of invention (Hakimian & Korn, 2004, p. 2502). This is very similar to Henrietta Lack's case where the HeLa cell line was created from her cervical cancer cells and are still used today. Today, consent forms are drafted intentionally vague. Researchers don't want to limit what they can do with specimens/data they've collected. This relates to broad and blanket consent. Blanket consent is essentially consent to future researcher with no specific limitations as to what the researcher can do with the specimens/data (Chandros Hall). It essentially gives the researcher free reign. Broad consent on the other hand is consent with outlined limitations (Chandros Hall). Broad consent is still vague, but it offers more information on what could possibly be done with specimens/data collected. These issues will continue to arise as future research consent is becoming more and more common.
Having reviewed many research studies, most research that involves future use is medical. And many of those are industry-sponsored projects. The majority of those consent forms reflect a contract”it's somewhat chilling to imagine an individual with an 8th grade reading level presented with that type of consent form. It's hard to believe they fully understand the research at hand, but to ask them for permission to keep and use their specimens for future research is even more unimaginable. How do they know what œfuture research is? And how do they know their specimens/data will be used in accordance with applicable regulations? The problem is that there really is no way for a subject to truly understand œfuture research because even the researchers don't know what that future research will entail. So how can they agree to it? That's somewhat like someone asking you for money, but they want your approval to do whatever they want with”buy drugs, invest to make more money, etc.”and they may not tell you right now what they're going to use it for. Would you be OK with this?
Hakimian, R., & Korn, D. (2004). Ownership and use of tissue specimens in research. JAMA, 292(20), 2500-2505.
Chandros Hall, S. The ethics of genetic research with stored samples and data [PowerPoint slides]. Retrieved fromhttps://www.bioethics.nih.gov/courses/pdf/2015/session4_hull.pdf.
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