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Bystanders, risks, and consent.

¹Department of Philosophy, Stockholm University, Stockholm, Sweden.

|November 22, 2020

Summary

Medical research trials can impose risks on bystanders, but the acceptable risk level should consider potential trial benefits. Consent is not always required for bystanders, unlike research participants, as harm is a side effect.

Area of Science:

Medical Ethics
Research Ethics
Philosophy of Medicine

Background:

Current ethical frameworks for medical research trials often propose a low threshold for imposing risks on bystanders.
This approach is partly based on the general requirement for informed consent from research participants.
The moral status of bystanders, who are not direct participants but may be affected by research, requires careful ethical consideration.

Purpose of the Study:

To evaluate the ethical permissibility of risk imposition on bystanders in medical research.
To determine if the prospective benefits of a trial should influence the acceptable level of risk for bystanders.
To analyze the necessity of bystander consent for exposure to research-related risks.

Main Methods:

Philosophical argumentation and ethical analysis.

Keywords:

bystanders human subjects research informed consent research ethics research subjects risk

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Examination of existing ethical principles regarding research participation and bystander rights.

Distinction between direct harm to participants and indirect harm to bystanders.

Main Results:

The threshold for permissible risk to bystanders should be sensitive to the prospective benefits of the medical research trial.
Bystander consent is not always a prerequisite for exposing them to significant risks, even for the benefit of others.
Harm to bystanders as a side effect of research is ethically more justifiable than direct, intentional use of participants without consent.

Conclusions:

Ethical justification for risk imposition on bystanders in medical research is complex and should weigh trial benefits.
The ethical distinction between participants and bystanders impacts consent requirements and risk assessment.
Further consideration is needed regarding the influence of potential bystander benefit on acceptable risk levels.