Navigating the Challenges of Biosample Consent in Clinical Trials

Navigating the Challenges of Biosample Consent in Clinical Trials
Navigating the Challenges of Biosample Consent in Clinical Trials


Sonia Fischer, Customer Integrations Manager, IQVIA

In the age of biotechnologybiosample collection has become an essential part of medical research. Through this process, samples are taken from patients through a variety of sources, including blood, tissue, saliva, hair, and other bodily fluids. The samples are then analyzed for their genetic, biochemical, or physiological properties, and the findings are used to further the understanding of human wellh, disease and the environment.

Many times, during clinical trials, sponsors will want to save leftover samples in case they become useful for additional research in the future. Although this may be brilliant for research, the practice can lead to compliance complications without a clear plan on how patient biosamples will be used.

You may recall the famous story of Henrietta Lacks, an African American woman whose cancer cells became the first human cell line in medical research without her knowledge or consent. Though this use of samples wasn’t illegal at the time, patient sentiment for more privacy and control over how samples are used has changed drastically.

Ensuring Transparency

To accelerate research and innovate new drugs, sponsors need to obtain explicit consent from patients on how their biosamples will be used.  As you may imagine, this requires a detailed consent process. To ensure success, trial organizers should adopt the following process:

  1. Defining future uses: Having a clear consent policy regarding the use of biosamples prior to sample collection is essential for researchers, as it prevents unauthorized use. For example, some may only agree to participate in an immediate trial, others to participate only in subsequent trials for a specific treatment or disease, and others may consent to participate in research for ten years or in perpetuity.

Each option affects how, where and when individual samples can be used. Even if a study collects thousands of samples, tracking each of them back to the original donor and their signed consent is imperative. To ensure compliance, sponsors must acquire consent that provides guidance for the specific use in every possible scenario.

  1. Providing patients with increased autonomy: As mentioned, patients are more knowledgeable about their rights concerning clinical research than before. They want to be able to decide how their samples are used and to have the option of revoking that permission. To ensure patients are in control of their samples, sponsors must get permission for each use and be able to find and dispose of the samples if permission is no longer valid.
  1. Ensuring samples can be tracked: It is essential that sponsors have end-to-end tracking for every biosample collected to ensure that the usage of each sample is in accordance with the consent given by the donor. This requires a very precise traceability and permission system that is not achievable through conventional consent methods – here, advanced solutions, such as electronic consent (eConsent), can play a revolutionary role.

The Answer to Complex Biosample Tracking

The capability to monitor biosamples from the moment of collection through utilization and disposal is a non-negotiable in today’s clinical trial landscape. To attain this level of comprehensive lifetime tracking, sponsors must invest in an end-to-end tracking solution that offers distinct consent choices for every single occasion a sample is utilized.

Once a patient has given authorization, the program designates each sample with a unique identifier to correlate it with the research, site, participant and permissions. All details are logged in the laboratory’s data storage system, and if the sample is moved to a different study site the authorization documentation goes with it. Any changes made to the consent are also connected to the sample through the eConsent system.

Anticipating Consent Requirements in Advance

To establish a comprehensive consent process, sponsors should aim to anticipate every possible outcome that may arise. This may be difficult, but this practice will help them gather the appropriate consent and establish a level of trust with patients while maximizing the value of the samples. The extra effort may require a greater initial investment, but it could potentially prevent the need to recruit additional patients.

Ensuring Long Term Compliance and Patient Autonomy

Biosample collection is an integral part of medical research. As sponsors continue to advance medical research, they must be aware and equipped to handle the complexities associated with consent, traceability and sample tracking. Through the implementation of advanced technology, sponsors can future-proof research and protect patient privacy and sample integrity long term.


About Sonia Fischer

Sonia Fishcer is a health information technology leader with a focus on data interoperability. With over 20 years of experience in healthcare technology, Sonia is now focused on bringing her knowledge of clinical sites and software systems to the clinical trials industry as the Customer Integrations Manager for Patient Consent at IQVIA.  In this role, she collaborates with clients on interoperability initiatives focused on connecting systems in order to improve clinical workflow and the patient experience from the point of consent.



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