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
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 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
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
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
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
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
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
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