Conclusion

Abstract

In this book I have covered a broad array of issues pertaining to the ethics and regulation of research involving human subjects, ranging from theoretical and historical matters to practical and policy dilemmas. In the first chapter, I observed that moral predicaments involving research with human subjects often boil down to a conflict between protecting individual rights and welfare and promoting scientific research that benefits the public. I argued that while most people agree that both values are important, ethical disagreements can arise with respect priority-setting. I suggested that a philosophical framework that emphasizes promoting trust can help us set priorities when values conflict. I set the stage for my trust-based approach by reviewing the history of research with human subjects in Chap. 2 and examining influential moral theories in Chap. 3. In Chap. 4, I reflected on the nature and importance of trust and discussed some strategies for promoting trust among the various stakeholders in involved in research, i.e. subjects, investigators, institutions, communities, sponsors, IRBs, and the general public. I argued that we can apply four widely recognized moral principles, respect for dignity and autonomy, non-maleficence, beneficence, and justice to practical and policy questions involving research with human subjects and that we can appeal to the goal of promoting trust to adjudicate conflicts among the four principles. The trust principle compliments the other four principles but it is not a meta-rule that can resolve all conflicts. Difficult questions may still arise when trust conflicts with other principles, such as respect for dignity and autonomy or justice. Even so, the principle can play augment and fortify ethical decision-making in research with human subjects. In Chaps. 5, 6, 7, 8, 9, 10 and 11, I applied my decision-making framework to various topics in research with human subjects, including informed consent, privacy and confidentiality, risks, benefits, vulnerable subjects, research integrity, and regulatory reform.