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Putting the ‘Informed’ in Informed Consent

Why is informed consent important?

In the era of General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPPA) regulations, we would be amiss to not revisit the beginning of it all. When Henrietta Lacks revolutionized medical research with her samples in 1951, she was completely unaware of it, and her family only learned of their existence some 20 years after her death. At the time, the researchers who succeeded in creating the most utilized cell line in the world had no idea how influential or widely used HeLa cells would be. Some argue that because the cells were obtained without Lacks’s knowledge or consent (even though this was legal at the time), any use of them is unethical and perpetuates an injustice.

There are four components of informed consent: 1) decision capacity 2) documentation of consent 3) disclosure and 4) competency.

In short, informed consent is a procedure through which a legally competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate.

Does the end really justify the means?
Ultimately it has been acknowledged both by legislative and standardization bodies that both data protection (HIPPA and GDPR) and informed consent (ICH-GCP) of the donor are not only important, but it is also the ethical thing to do. Especially given that today’s advancements in science allow us to achieve so much more than immortalization of cells.

A prime example being DNA sequencing, which has proven to be a pivotal point in the evolution of understanding disease and discovering new ways to treat them. However, DNA sequencing no longer enables us to irreversibly anonymize samples and rest assured that donor privacy is ensured, since the unique code of each individual human could lead to identification of the donor, which could lead to unknown consequences.

In the end, the ethical guidelines of human rights on voluntary donation ensure that informed consent will make the headlines every time it is questioned.

How much information is enough?

Here is some of information that potential donors should be privy to as part of any donation process:

  1. Procedural details
    • expected types and volumes of samples collected
    • potential risks
  2. Voluntary participation
    • refusing to participate should not affect medical treatment
  3. Withdrawal of consent
    • individual has the right to withdraw consent at any point
    • individual should be aware of any consequences of such withdrawal
    • individual should be made aware of the process for withdrawing consent
  4. Compensation
    • is it provided?
    • what amount?
    • is for time and effort only?
  5. Data and identity protections
    • type of data is collected
    • what the anonymization procedures are
    • whether or not there is a clear list of individuals or organizations with access to identifiable data
  6. Retention period for samples and for data
  7. Intended area of research and associated risks
    • Use by for-profit organizations – the samples might generate profit
    • Used to generate a commercial product – donor has no claim on the results
    • In vivo use – tested in/with animals
    • Genetic and genomic analysis – might lead to identification of individual
    • Gene Editing – modify the donor’s genetic code
    • Cell line derivation and immortalization – might be vastly used indefinitely
    • Potential future technology to be developed – that might affect stated provisions on retention period, identity protections and other unknown consequences.

Opt-In vs Opt-Out: Which is preferred?
Opt-in is always preferable to Opt-out, regardless of the local legislation. This ensures all the above information is provided to the donor, proactively, and minimizes misunderstandings and misinformation.

Why should we care?

Donors:
Medical research cannot progress without the valuable gift of donated tissue for research. However, as a donor, you should be aware of the use of that tissue and potential impacts it could lead to. Your gift is important, and you can help develop future treatments and cures. Feel free to always ask questions about how and where your samples will be used.

Researchers:
Because they are of human origin, both research users and research providers must take great care to ensure that samples are handled with care and sourced ethically. Any missteps in the sourcing process can lead to detrimental financial and reputational outcomes for organizations. In order to address these issues and many of the challenges mentioned above, Scientist.com launched an award-winning compliance solution called COMPLi® that reduces the inherent risk in sourcing human samples.

The COMPLi framework minimizes risk through a comprehensive and proprietary due diligence process conducted on all providers offering human biological samples as well as on users requesting samples for scientific research. By ensuring visibility, traceability and transparency of sample usage without sacrificing quality or ethics, Scientist.com will continue to support the acceleration of research to fight human disease.

To learn more about COMPLi, or Scientist.com can help you source human biospecimens ethically and legally, visit https://www.scientist.com/compli/