The Reasonable Person Standard: A Critical Examination of a New Requirement for Informed Consent Open Access

Rhee, Shelby I. (Spring 2018)

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Background: The 2017 revisions to the Federal Policy for the Protection of Human Subjects, often referred to as the Common Rule, will, for the first time, require investigators and Institutional Review Board (IRB) to design informed consent disclosures based on what a reasonable person would want to know before making the decision to participate in the study. This requirement, called the Reasonable Person Standard (RPS), is worthy of greater exploration now that it will be supported strong arm of federal enforceability and implemented on the scale the Common Rule will require.

Discussion: In this paper, the author examines the underlying principles, requirements, and processes of the RPS, tracing its history from its origins in the legal profession to its use in research and describes the potential challenges of implementing it under the 2018 Common Rule. These challenges include understanding the conceptual underpinnings of the standard and ensuring its consistent use by groups with different regulatory responsibilities. Ideally, implementing the RPS should shift the processes of research toward power sharing, empathy, and deep respect; ultimately humanizing the research enterprise. However, questions remain if these ethical goals will be realized.

Summary: Recognizing the potential challenges and harms that may arise in applying the RPS provides an avenue for investigators, IRB members and institutions to remedy them before they arise. Ultimately, the paper advocates for an increased emphasis on training implementing parties on the potential harms and provides a value proposition for integrating community engagement strategies into early stages of the design of the informed consent process.

Table of Contents

Abstract 4


Chapter 1: Introduction and Background. 1

Introduction. 1

Problem Statement 3

Purpose Statement 3

Chapter 2: Review of Literature. 4

Informed Consent 4

Informed Consent Under the Common Rule. 4

Disclosure. 5

Comprehension and Voluntariness 6

The Reasonable Person Standard. 8

The Reasonable Person in Law, Medicine, and Research. 8

Gaps in Research. 10

Chapter 3: Methods. 12

Chapter 4: Conclusions and Implications for Global Health. 13

References. 18

Appendix 1: The Reasonable Person Standard: A Critical Examination of a New Requirement for Informed Consent Project Document 21


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