Abstract

Many studies show that research participants frequently do not fully comprehend information regarding risks and benefits (R&B) associated with clinical trials even though this is a fundamental component of the research informed consent (IC) process, required by ethical and regulatory guidelines. Research nurses often take an active role in obtaining IC while explaining study details and verifying potential participants' understanding. Although there are published recommended strategies to enhance the IC communication process, particularly for R&B communication, there is a paucity of research focused on research nurses' perspectives about the process. This study addresses this gap in the literature and provides comprehensive empirical data on research nurses' attitudes and practices related to R&B communication in the informed consent process. Using a two-phase exploratory mixed methodology design, an online survey tool was developed and administered to a national sample of 107 research nurses having experience in obtaining IC for clinical trials. Variations in the research nurses' attitudes, preparedness, and practices related to R&B communication were identified. Recommendations directed at strengthening the IC process are suggested.

Description

This dissertation has also been disseminated through the ProQuest Dissertations and Theses database. Dissertation/thesis number: 10269670; ProQuest document ID: 1896117548. The author still retains copyright.

Author Details

Lidia Lika Nusbaum, PhD, CEN

Sigma Membership

Non-member

Type

Dissertation

Format Type

Text-based Document

Study Design/Type

N/A

Research Approach

Mixed/Multi Method Research

Keywords:

Clinical Trials, Risks and Benefits, Informed Consent, Communication

Advisor

Brenda Douglas

Second Advisor

Karla Damus

Third Advisor

Neenah Estrella-Luna

Fourth Advisor

Michael Paasche-Orlow

Degree

PhD

Degree Grantor

Northeastern University

Degree Year

2017

Rights Holder

All rights reserved by the author(s) and/or publisher(s) listed in this item record unless relinquished in whole or part by a rights notation or a Creative Commons License present in this item record.

All permission requests should be directed accordingly and not to the Sigma Repository.

All submitting authors or publishers have affirmed that when using material in their work where they do not own copyright, they have obtained permission of the copyright holder prior to submission and the rights holder has been acknowledged as necessary.

Review Type

None: Degree-based Submission

Acquisition

Proxy-submission

Date of Issue

2022-03-30

Full Text of Presentation

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