Item Details

title

THROUGH THE LENS OF THE STAKEHOLDER: INFORMED CONSENT AND THE “REASONABLE PERSON” IN GENETIC RESEARCH

author

Ontjes, Noah J

abstract

ABSTRACTThe quest to better understand the intricacies of the human body inspired investigators to embark on different research projects to uncover the relationship between genes and health. Due to advancements in technology, new and innovative methods for analyzing genomic information have led to massive research projects such as whole- exome sequencing, whole-genome sequencing, and genome-wide association studies. However, this field of human subject research has been met by scholarly debate regarding the ethical treatment of participants. In this thesis, I explore the challenges that genetic research poses to the ethical and legal obligation to obtain informed consent. I specifically examine the “reasonable person” standard of disclosure for both the general requirements of informed consent and elements of broad consent recently added to the Common Rule in 2018. This thesis argues that guidance for researchers and IRBs on how to properly interpret and apply the “reasonable person” standard of disclosure is necessary within genetic research. I introduce and defend a “stakeholder” interpretation of the “reasonable person” standard that calls upon investigators to take an evidence- based approach to determine the information a “reasonable person” would need to provide valid informed consent. I also demonstrate that the practice of broad consent is incompatible with my interpretation of the “reasonable person” standard and argue that a dynamic consent model is better suited to disclose the information a “reasonable person” would want to know.

subject

Genetic Research

Informed Consent

Reasonable Person Standard

Stakeholder Interpretation

contributor

Iltis, Ana S. (committee chair)

Colgrove, Nicholas M. (committee member)

King, Nancy M.P. (committee member)

date

2022-05-24T08:36:04Z (accessioned)

2022-05-24T08:36:04Z (available)

2022 (issued)

degree

Bioethics (discipline)

identifier

http://hdl.handle.net/10339/100745 (uri)

language

en (iso)

publisher

Wake Forest University

type

Thesis