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      19 December 2024

      Human biospecimens play a critical role in medical research and diagnostics, and their importance continues to grow.1,2 This means it’s becoming increasingly important to address the ethical, legal and social implications (ELSI) of biospecimen collection and research activities. Ethical practices are essential at every step of the journey when working with biological specimens.3

      The role of biospecimens in research and diagnostics

      Biospecimens are biological materials such as blood, plasma, serum, urine, saliva, cerebrospinal fluid and others that can be collected from donors and used for diagnosis and/or research. For example, if a patient with cancer undergoes a biopsy, it’s often possible to save and store a small amount of residual specimen for use in later research. These specimens are stored in ‘libraries’ known as biorepositories or biobanks. Many patients allow their biospecimens to be used in research, in the hope that this could help other patients in the future.4

      “Biorepositories are critical to enabling modern molecular-based research (including genomics, proteomics, molecular imaging, etc.) that will drive the development of a new generation of targeted diagnostics and therapies (i.e., personalized medicine) to improve clinical outcomes for patients.”
                                                                                                                                                                                                                        -  National Cancer Institute4

      When a donor provides a specimen to be stored in a biorepository, it’s essential to consider their autonomy and privacy.3 This begins with informed consent.

       

      Informed consent and HIPAA

      What is informed consent?

      Informed consent means that the healthcare provider must ensure that the patient understands the benefits, risks and alternatives of a medical procedure or intervention. The patient must also be competent to make a voluntary decision about whether they will undergo the procedure.5

      Click here for more information on the different types of consent (e.g. broad, specific or dynamic)6

      When a patient or participant is donating a biospecimen to a biobank, there are some potential uses that could be considered ethically or legally challenging, such as:6

      • The transfer of samples or data across national borders
      • Using samples in experiments involving animals
      • The creation of cell lines, including stem cell lines, from the samples
      • The use of samples and data by commercial researchers
      • Research linked to reproduction, including the use of embryos

      Any potentially ethically or legally challenging uses should be outlined in the consent form.6

      There are a few important aspects to consider during the consent process.6

      • If possible, the necessary document/s should be given to the participant ahead of time.
      • The participant should be given adequate time to read and consider the information.
      • The person conducting the consent process must be convinced that the participant has the capacity to give consent.
      • The participant should not be coerced in any way.
      • The participant should have the opportunity to ask questions and be given acceptable answers before consenting.

       

      What is HIPAA?

      The Health Insurance Portability and Accountability Act (HIPAA) of 1996 is a US federal document designed to protect sensitive health information from being disclosed without a patient's consent.7 In terms of biospecimen collection, this protects the donor’s identity.

      Read more about the HIPAA Privacy Rule and the HIPAA Security Rule7

      HIPAA includes requirements for the collection and transmission of the clinical annotations that typically accompany biological specimens collected for research. These annotations include demographic and clinical data about the person the sample was collected from.4

       

      The role of institutional review boards in ethical biospecimen use

      What is an IRB?

      An institutional review board (IRB) is a committee that provides ethical and regulatory oversight of research involving human subjects.8 IRB board oversight is crucial for aligning practices with ethical standards, protecting donor anonymity and preventing coercion.9 

      In the modern biological and biospecimen diagnostic landscape, having IRB-approved suppliers and specimens is key to ensuring research success and ultimately securing approval by the relevant governing bodies, such as the US Food and Drug Administration (FDA).9

      The functions of an institutional review board include:10

      • Safeguarding the rights and welfare of participants, and minimizing the potential risks to participants
      • Conducting comprehensive reviews of research protocols, to ensure scientific validity and ethical integrity
      • Ensuring regulatory compliance (with federal, state and institutional policies)
      • Providing a comprehensive review and approval process 
      • Reviewing consent procedures and applying additional safeguards for vulnerable populations
      • Addressing potential conflicts of interest
      • Reviewing data collection, storage and sharing practices to ensure data safety and privacy protection

      An IRB must be made up of at least five members from a variety of backgrounds (scientific and non-scientific), and must include a member who is not affiliated with the institution. In the USA, the Common Rule outlines the requirements for IRB membership.10

      Read more about the Common Rule (45 CFR 46)11

      Regulation in the biospecimens industry ensures ethical practices in the collection, processing and usage of specimens, maintaining integrity and quality standards.9

       

      The risks of non-compliance with IRB regulations

      These are a few common examples of non-compliance errors:12

      Category Description
      Protocol non-adherence  Failure to follow protocol or notify the IRB about changes and/or violations
      Clinical records poorly documented Incomplete, inaccurate, out of date or data trail cannot be followed
      Informed consent issues  Missing, incomplete or backdated
      Investigational product supply chain problems Failure to account for all products
      Adverse event collection and reporting Errors in determining severity or lack of timely reporting

      The risks of non-compliance include:

      • Effects on participants: The rights and/or welfare of the donors may be impacted.

      • Regulatory sanctions: Non-compliance with IRB regulations can lead to significant penalties from bodies such as the FDA. These bodies may suspend research, reject product submissions and/or enforce costly audits.13,14 

      • Legal and financial penalties: In some serious cases (e.g. where participant safety is affected) non-compliance can lead to lawsuits, fines and/or withdrawal of federal funding.14

      • Damage to reputation: Companies that violate IRB regulations may suffer serious reputational damage, leading to loss of customer trust.

      • Product liability: Failure to comply with IRB regulations increases the risk of adverse events going unreported,15 exposing companies to potential liability from unsafe products reaching the market.

      With the above risks in mind, the importance of proper regulatory compliance and ethical practices when working with biological specimens cannot be overstated.

      Medix Biochemica provides IRB-approved human biospecimen and bulk human biological material collections and processing.16 By partnering with us, you can rest assured you’re getting high-quality materials that are ethically sourced.

      Contact our team of experts to discuss your specialty reagent requirements

      Get in Touch!

      References: 

      1. Betsou F. Clinical biospecimens: Reference materials, certified for nominal properties? Biopreserv Biobank. 2014;12(2):113-120. doi:10.1089/bio.2013.0086.
      2. Elger BS, Caplan AL. Consent and anonymization in research involving biobanks: Differing terms and norms present serious barriers to an international framework. EMBO Reports. 2006;7(7):661. doi:10.1038/sj.embor.7400740.
      3. Ethics in biobanking. National Cancer Institute Biorepositories and Biospecimen Research Branch. Accessed October 22, 2024. https://biospecimens.cancer.gov/programs/ethics/.
      4. Frequently asked questions. Patient corner -  National Cancer Institute Biorepositories and Biospecimen Research Branch. Accessed October 22, 2024. https://biospecimens.cancer.gov/patientcorner/faq.asp.
      5. Shah P, Thornton I, Turrin D, et al. Informed consent. StatPearls Publishing; 2023. Accessed October 22, 2024. https://www.ncbi.nlm.nih.gov/books/NBK430827/.
      6. Mendy M, Caboux E, Lawlor RT, et al. Recommendations for biobanks. In: Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research. International Agency for Research on Cancer; 2017. Accessed October 22, 2024. https://www.ncbi.nlm.nih.gov/books/NBK567244/.
      7. Health Insurance Portability and Accountability Act of 1996 (HIPAA). Public Health Law. Centers for Disease Control. Accessed October 22, 2024. https://www.cdc.gov/phlp/php/resources/health-insurance-portability-and-accountability-act-of-1996-hipaa.html.
      8. Institutional review board. National Institutes of Health. Accessed October 22, 2024. https://orwh.od.nih.gov/toolkit/human-subjects-protections/institutional-review-board.
      9. Expert opinion. Anthony Austin. Global Marketing Manager, Medix Biochemica. October 2024.
      10. What best describes the purpose of IRB: 5 key functions in 2024. Infonetica. Accessed October 22, 2024. https://www.infonetica.net/articles/what-best-describes-the-purpose-of-the-irb.
      11. 45 CFR 46. US Department of Health and Human Services. Accessed October 22, 2024. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
      12. Neely JG, Paniello RC, Graboyes EM, et al. Practical guide to understanding clinical research compliance. Otolaryngol-Head Neck Surg. 2014;150(5):716-721. doi:10.1177/0194599814524895.
      13. Snider SH, Flume PA, Gentilin SL, et al. Overcoming non-compliance with clinical trial registration and results reporting: One institution’s approach. Contemp Clin Trials Commun. 2020;18:100557. doi:10.1016/j.conctc.2020.100557.
      14. Russell BJ. Research compliance: entering Phase II. Proceedings (Baylor University Medical Center). 2001;14(4):349. doi:10.1080/08998280.2001.11927787.
      15. Liu MB, Davis K. Adverse events and unanticipated problems involving risks to subjects or others. Published online 2010:123-139. doi:10.1002/9781444315219.CH6.
      16. Medix Biochemica USA (MO). Medix Biochemica. Accessed October 24, 2024. https://career.medixbiochemica.com/departments/medix-biochemica-usa-mo.