Title of Presentation

Session C: Respect for all subjects of science: Toward a unified system of research oversight

Sub-theme

Research and Theory

Keywords

animal research, bioethics, research oversight, moral status

Start Date

12-10-2018 1:30 PM

End Date

12-10-2018 2:45 PM

Abstract

Human and nonhuman animal research are guided by different ethics and policy frameworks, with an assumption of little overlap between these research programs. However, we argue that two ‘outlier’ cases—companion animal research and Phase I trials—illustrate the ethical danger of separately regulating human and nonhuman animal research. On one hand, companion animal research utilizes privately ‘owned’ animals for example to test new veterinary products. Unlike in conventional laboratory research, these animals are subjects at large in the community whose guardians bring them in for any study-related procedures. Hence, the structure of these research studies is similar to human trials, perhaps pediatric trials in particular where one person consents on behalf of someone in their care. On the other hand, Phase I human trials test safety and tolerability of investigational drugs in paid healthy volunteers. Phase I clinical trials typically take place in confinement facilities where subjects are monitored for compliance with requirements from what food to eat and when, to limitations on exercise, and are readily available for drug dosing, blood draws, and other interventions. As a result, these trials can be said to mirror the structure of nonhuman animal research. These cases suggest that the human subject oversight norm becomes critical for ethical animal research and vice versa. Companion animal research cannot be successful without the meaningful consent and cooperation of animal guardians. Further, companion animals may be viewed more as vulnerable subjects than as research animals whose interests the needs of science may override. Similarly, because healthy humans in confinement facilities are tightly controlled in their environment and activities, welfare is a crucial ethical norm to guide this type of research.

In this paper, we problematize the different formal systems of oversight to which human and nonhuman animal studies are subjected, including separate laws, policies, and oversight bodies for the ‘care and use’ of animals and for the ‘protection’ of human subjects. These regulatory systems are also guided by divergent ethical frameworks. Animal researchers are required to attend to animal welfare through implementing the three Rs (reduce, refine, replace), while those working with human subjects must adhere to the principles of respect for persons, beneficence, and justice. Less explicit, but crucial to their functioning, these ethical frameworks trade on an assumed hierarchy of moral status between humans and other animals. While the harmful use of animals should be avoided where possible, human benefit is presumed to justify such uses. Some uses of human subjects, however, are deemed unethical regardless of potential benefit to others. While the relative moral status of human and nonhuman animals is the subject of much bioethical debate, less attention has been given to how structural features of human and nonhuman animal research relate to the regulatory differences in oversight of each group. By focusing on companion animal research and Phase I healthy volunteer trials, we make a case for a unified regulatory structure and ethical framework that respects all subjects and attends to the structural features of the science in determining relevant protections.

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Oct 12th, 1:30 PM Oct 12th, 2:45 PM

Session C: Respect for all subjects of science: Toward a unified system of research oversight

Human and nonhuman animal research are guided by different ethics and policy frameworks, with an assumption of little overlap between these research programs. However, we argue that two ‘outlier’ cases—companion animal research and Phase I trials—illustrate the ethical danger of separately regulating human and nonhuman animal research. On one hand, companion animal research utilizes privately ‘owned’ animals for example to test new veterinary products. Unlike in conventional laboratory research, these animals are subjects at large in the community whose guardians bring them in for any study-related procedures. Hence, the structure of these research studies is similar to human trials, perhaps pediatric trials in particular where one person consents on behalf of someone in their care. On the other hand, Phase I human trials test safety and tolerability of investigational drugs in paid healthy volunteers. Phase I clinical trials typically take place in confinement facilities where subjects are monitored for compliance with requirements from what food to eat and when, to limitations on exercise, and are readily available for drug dosing, blood draws, and other interventions. As a result, these trials can be said to mirror the structure of nonhuman animal research. These cases suggest that the human subject oversight norm becomes critical for ethical animal research and vice versa. Companion animal research cannot be successful without the meaningful consent and cooperation of animal guardians. Further, companion animals may be viewed more as vulnerable subjects than as research animals whose interests the needs of science may override. Similarly, because healthy humans in confinement facilities are tightly controlled in their environment and activities, welfare is a crucial ethical norm to guide this type of research.

In this paper, we problematize the different formal systems of oversight to which human and nonhuman animal studies are subjected, including separate laws, policies, and oversight bodies for the ‘care and use’ of animals and for the ‘protection’ of human subjects. These regulatory systems are also guided by divergent ethical frameworks. Animal researchers are required to attend to animal welfare through implementing the three Rs (reduce, refine, replace), while those working with human subjects must adhere to the principles of respect for persons, beneficence, and justice. Less explicit, but crucial to their functioning, these ethical frameworks trade on an assumed hierarchy of moral status between humans and other animals. While the harmful use of animals should be avoided where possible, human benefit is presumed to justify such uses. Some uses of human subjects, however, are deemed unethical regardless of potential benefit to others. While the relative moral status of human and nonhuman animals is the subject of much bioethical debate, less attention has been given to how structural features of human and nonhuman animal research relate to the regulatory differences in oversight of each group. By focusing on companion animal research and Phase I healthy volunteer trials, we make a case for a unified regulatory structure and ethical framework that respects all subjects and attends to the structural features of the science in determining relevant protections.