#15 Practical RWE – Ethical and Moral Obligations: Informed Consent
#15 Practical RWE – Ethical and Moral Obligations: Informed Consent
Informed consent for non-interventional studies is a crucial ethical requirement, deeply rooted in the principles established by the Nuremberg Code (1947) and later reinforced and expanded by the Declaration of Helsinki (1964).
[1] Nuremberg Code Context: The Nuremberg Code, was one of the first documents to set the ethical principles for (permissible) human experimentation in response to the atrocities committed in Nazi concentration camps. Key among its principles is the requirement of voluntary informed consent. The Code stipulates that participants should be able to exercise free power of choice and should have sufficient knowledge and comprehension of the elements of the subject matter involved to enable them to make an understanding and enlightened decision.
[2] Declaration of Helsinki Context: The Declaration of Helsinki, first adopted in 1964 by the World Medical Association, is a set of ethical principles for the medical community regarding human experimentation. It sets the ethical principles for all human research. It emphasizes the importance of informed consent, stating that every person has the right to make informed decisions regarding their participation in research. The Declaration makes clear that this consent should be obtained freely and should be based on adequate information. It also adds that the welfare of research participants must always take precedence over the interests of science and society.
In the context of non-interventional studies:
– Informed Consent is Essential: Even though non-interventional studies do not involve active healthcare intervention, they often involve the collection and analysis of personal data or biological samples, which can have implications for privacy and autonomy. Informed consent ensures that participants are aware of what the study involves, including the purpose, procedures, risks, and benefits.
– Respecting Participant Autonomy: By obtaining informed consent, researchers respect and uphold the autonomy of participants, acknowledging their right to make decisions about their own bodies and personal information.
– Building Trust: Informed consent also helps in building trust between researchers and participants. When participants understand the study’s aims and methods, they are more likely to trust the researchers and cooperate fully.
– Ethical and Legal Compliance: Following these principles helps ensure compliance with ethical standards and legal (regulatory) requirements, which is essential for the validity and legitimacy of the research.
Informed consent in non-interventional studies is not only a moral obligation but also a practical necessity for ensuring respect for participant autonomy, building trust, and maintaining ethical and legal standards in research.
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Real World Evidence (RWE) 101 – eConsent
RWE 101 – eConsent
Electronic consent or eConsent refers to the process of using electronic systems and processes to convey information related to the study and to obtain and document participant consent. While eConsent brings numerous benefits to the table, such as improved participant comprehension, streamlined workflows, and easier tracking and managing of consent versions, it is not universally accepted in Real-World Evidence (RWE) studies due to several reasons:
[1] Regulatory Variations: Regulatory guidelines and requirements vary across different jurisdictions and countries. Some regions may not yet have clear guidance or regulations that specifically endorse eConsent, causing uncertainty about its legal validity.
[2] Digital Divide: While digital technologies are pervasive (increasingly accepted), access to and familiarity with these technologies is not universal. Some potential study participants may lack the technology needed for eConsent or may not be comfortable using it, which could potentially exclude certain populations from participation (introducing bias).
[3] Data Security and Privacy Concerns: As with any digital system, there are concerns related to data security and privacy. Participants may worry about their personal information being mishandled or leaked, especially given the sensitivity of health data.
[4] Implementation Costs: Setting up a secure, user-friendly eConsent system that can also meet all regulatory requirements is a significant investment. Small research entities or those in low-resource settings might find it challenging to bear these costs.
[5] Technical Hurdles: eConsent systems require a level of technical infrastructure and support to function effectively. This can include the need for reliable internet connectivity, ongoing technical support, regular software updates, and more.
Despite these challenges, the adoption of eConsent is increasing due to the evolution of technology, better regulatory support, and the COVID-19 pandemic necessitating remote study processes. As these challenges are addressed over time, it’s expected that eConsent will become a more universally accepted practice in RWE studies.
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Real World Evidence (RWE) 101 – Consent to Participate in Research vs Consent to Access and Process Sensitive Healthcare Data (GDPR)
RWE 101 – Consent to Participate in Research vs Consent to Access and Process Sensitive Healthcare Data (GDPR)
Consent to participate in research and consent to access and process sensitive healthcare data are two different but overlapping types of consent, each governed by distinct legal and ethical principles. In the context of Real-World Evidence (RWE) studies:
[1] Consent to Participate in Research: This is the informed consent given by individuals to participate in a research study. Informed consent is a process by which researchers provide potential and enrolled participants with information about the study (purpose, procedures, risks, benefits, alternatives), and the participants voluntarily agree to participate. This consent can be withdrawn at any time, at which point the individual’s participation in the study would end.
[2] Consent to Access and Process Sensitive Healthcare Data: This relates to the consent given by individuals to have their personal and sensitive health data accessed and used for specific purposes, such as research. This type of consent is governed in Europe by the General Data Protection Regulation (GDPR). Under the GDPR, the use of health data is considered a processing of special category data and requires explicit consent, which must be freely given, specific, informed, and unambiguous.
In a RWE study, both types of consent may be (are) needed. The first ensures that participants agree to be part of the study and understand what will happen during the study. The second ensures that participants agree to their data being used in the manner specified, and it provides protections around how their data can be stored, transferred, and otherwise processed.
One key difference between these two types of consent is that withdrawal of consent to participate in the research study generally means the individual will not be part of the study going forward, but it does not necessarily mean that the data collected up to that point cannot be used. In contrast, under the GDPR, if an individual withdraws their consent to data processing, not only does the data processing have to stop, but in many cases, the data collected up to that point cannot be used further and may need to be deleted.
Another difference is that, while there are legal and ethical requirements to obtain informed consent for research participation in most cases, there are certain circumstances under which health data can be processed for research purposes under the GDPR without obtaining explicit consent, such as if the processing is necessary for reasons of public interest in the area of public health, or if the data has been anonymized.
In both cases, the principles of transparency, respect for persons, and their autonomy are paramount. Proper management of both types of consent is crucial for ethical research and for maintaining trust with study participants.
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