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USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent

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USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent2024-03-10T15:31:54+00:00

#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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#15 Practical RWE – Ethical and Moral Obligations: Informed Consent2024-02-01T18:12:15+00:00
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