As researchers, we are familiar with why we have the need for biobanking regulations due to the story of Henrietta Lacks. HeLa cells survived in vitro more than 60 years ago and are still contributing to medical science advancements.1 Scientists across the globe have monetarily capitalized off therapeutic discoveries derived from the use of HeLa cells.1 The human subject should be aware of the drug discovery and development process that may involve their biological specimen (also referred to as biospecimen).
The National Cancer Institute (NCI) defines “biospecimen” as “A quantity of tissue, blood, urine, or other human-derived material. A single biopsy may generate several biospecimens, including multiple paraffin blocks or frozen biospecimens. A biospecimen can comprise subcellular structures, cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, and kidney), blood, gametes (sperm and ovum), embryos, fetal tissue, and waste (urine, feces, sweat, hair and nail clippings, shed epithelial cells, and placenta). Portions or aliquots of a biospecimen are referred to as samples”.2
What is the Biobanking Informed Consent Missing?
In addition to Federal, State and the institution’s Institutional Review Board (IRB) requirements, the biobanking consent should also include the following information:
- Commercialization
The informed consent must provide language that informs the human subject that their specimen(s) may develop new commercial products and other discoveries. The human subject must be aware if you or your institution will possibly collaborate or distribute specimens with outside pharmaceutical and biotechnology companies to develop new commercial, therapeutic options derived from the use of human specimens.
- Laboratory mouse models
If the research being conducted involves laboratory mouse models, the human subject should be informed. Reason being, some human subjects may not want their specimen utilized with laboratory mouse models due to their personal views on animals being used in research protocols.
- Genetic testing
If DNA or RNA is extracted for genetic testing, this must be included in the informed consent. Many of the human subjects do not understand how their specimen may be used to create immortalized cell lines and if this should possibly occur, it must be stated in the informed consent.
How Do We Ensure Human Subjects Are Aware?
Human subjects should be able to sign off on what they will and will not consent to for research purposes. The graphic below should be located near the signature line of the informed consent document. The completed document should be stored electronically in the biobanking database.
The written context of the informed consent matters and human subjects need to know if their specimens will be stored indefinitely. Remember, human subjects are doing researchers a huge favor by participating in various research projects.Researchers must at all times respect human subjects by conducting research that is ethical and compliant.
Concerns About Clinical “Leftover” Specimens
There is a major concern about the appropriateness of using residual or “leftover” specimens in ways not intended for what they were initially collected.3 The Federal Policy for the Protection of Human Subjects (2015) informs researchers that informed consent is generally required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is”.4 “Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a “broad” consent form in which a person would give consent to future unspecified research uses”.4 For samples collected on or after the effective date of the National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy (January 25, 2015), the NIH expects that research participants have given consent for their genomic and phenotypic data to be used for future research purposes and shared broadly, in order for the data to be submitted to an NIH-designated repository.5 NIH requires consent even for cell lines or clinical samples which are de-identified.5
In summary, it is important for all researchers and those operating biorepositories to be aware of current regulations associated with biobanking. There needs to be a central website that researchers and regulatory administrators can easily go to that outlines the most current Federal and State regulations associated with biobanking instead of searching through multiple websites. For example, it would be great to be able to click on your State and view any State administered updates associated with biobanking. I recently attended a conference and attendees even mentioned that consented human subjects should be provided a website that outlines medical advancements achieved by the institution, who administered consent and is storing the consented biospecimens since in many cases human subjects are not provided updates about their specimen per the informed consent document.
Remember, informed consent is an important process and not just a document.
References:
- Skloot, Rebecca. The Immortal Life Of Henrietta Lacks. New York: Crown Publishers, 2010. Print.
- National Cancer Institute Division of Cancer Treatment & Diagnosis. Glossary of Terms. https://biospecimens.cancer.gov/bestpractices/got/#B
- Edwards, T., Cadigan, R. J., Evans, J. P., & Henderson, G. (2014). Biobanks containing clinical specimens: defining characteristics, policies, and practices. Clinical Biochemistry, 47(0), 245–251. http://doi.org/10.1016/j.clinbiochem.2013.11.023
- Federal Policy for the Protection of Human Subjects. 2015. https://www.federalregister.gov/documents/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
- National Cancer Institute Division of Cancer Treatment & Diagnosis. 2016. Federal Regulations and Guidelines Pertaining to Informed Consent. C.2.1.4. https://biospecimens.cancer.gov/bestpractices/elp/ic.asp
About the Author
Dr. Dina Avery is an Assistant Professor and Regulatory Affairs Specialist for the University of Alabama at Birmingham, Biotechnology Regulatory Affairs Program. Dr. Avery has professional experience with tissue banking, clinical research, health disparities research, community based participatory research, regulatory/compliance and program management. She has worked in the areas of cardiovascular surgery, ophthalmology, neurology, preventive medicine, oncology and biotechnology.
