Informed consent is a legal and ethical requirement of all clinical research.
While specific patient consent guidelines differ around the world1, all conform to the Declaration of Helsinki’s principles of protecting patients involved in clinical research2. Using broad, generic or tiered consent will allow researchers to reuse patient samples in future studies. Many funding agencies, such as the Medical Research Council in the U.K., support the reuse of patient samples in ethically-approved research wherever possible3.
The Informed Consent Process
Patient consent is not a simple matter of having patients fill in an informed consent form on paper or electronically. Researchers are first required by law to give each patient ample information, so they can make an independent decision about whether or not to participate in clinical research studies³. Patients must understand:
- How their sample will be collected, including any risks
- How their sample will be used, including current and future clinical research
- How their sample will be identified
- How their privacy will be protected
- Who will be in charge of the custody of the sample
- Whether the sample will be shared with other researchers
- Who has rights to any IP resulting from sample use
- Whether the patient will receive updates on clinical research results
It’s important to give each patient the opportunity to ask questions about the clinical trial process, clinical research and sample use. It’s just as important to be sensitive to language and cultural differences between populations when designing informed consent processes.
Paper or Electronic Informed Consent?
Electronic informed consent or eConsent can streamline the patient consent process. It can be more convenient for patients as they may be able to start the process at home and stop and start again at their own leisure. eConsent can also save time for researchers as data can be automatically uploaded into a data management system. However, researchers handling electronic patient data must abide by international guidelines such as the U.S. Health Insurance Portability and Accountability Act (HIPAA) and the EU General Data Protection Regulation4,5.
Patient Consent for Future Use
Informed consent for future use has various names in different jurisdictions and may be called broad consent, generic consent or consent to future use.
Government agencies such as the Medical Research Council and Human Tissue Authority in the U.K. recommend researchers obtain broad consent for clinical research whenever possible3. Re-purposing existing patient samples can save time and money by decreasing the need to collect samples in the future. Obtaining broad consent at the time of sample collection also means that researchers don’t have to recontact participants for informed consent to reuse their samples.
Different countries have different regulations on broad consent. The U.S. Office for Human Research Protections has published an overview of where to find more information on country-specific laws and guidelines. This overview is called the International Compilation of Human Research Standards1.
When asking for broad consent, researchers should ensure that patients understand:
- How long their samples will be stored
- Whether their samples will be shared
- How their samples will be shared
Researchers can use two-part or tiered consent where patients consent to different stages of clinical research such as current research, storage, and future research for one or more indications3.
Ethical Oversight of Informed Consent
Most countries require that an Ethics Committee or Institutional Review Board (IRB) approve the patient consent process before a clinical trial can commence. Any deviations from the approved process can be a protocol violation. All violations must be reported to the IRB.
Your Global Partner in Patient Consent
Azenta Life Sciences’ experts can help clients ensure your patient consent process respects patients, complies with regulatory guidelines and allows for future sample use in clinical research. We can manage the entire sample collection, consent, and storage workflow to increase the value of every sample collected, reduce your patient recruitment burden, and accelerate clinical study timelines.
Azenta Life Sciences works with clients on projects ranging from a single clinical trial to entire drug programs with over 70 studies in 30 countries and 20 different languages.
Download our whitepaper on Informed Consent to learn more about how Azenta Life Sciences can help you lower sample management costs, shorten research timelines, and maximize the use of your research samples.
References
1. International Compilation of Human Research Standards: 2018 Edition. Compiled by Office for Human Research Protections. U.S. Department of Health and Human Services.
2. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. World Medical Association. 2018.
3. Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines. 2014. Medical Research Council.
4. HIPAA for Professionals. Health Information Privacy. HHS.gov
5. EU GDPR.org