Informed consent for low-risk thyroid cancer

Author:

Rosenthal M Sara1,Angelos Peter2,Bible Keith3,Fassler Cheryl Ann4,Finder Stuart5,Greene Loren Wissner6,Tulchinsky Mark7

Affiliation:

1. Departments of Internal Medicine, Pediatrics & Behavioral Science, Program for Bioethics, University of Kentucky, Lexington, KY, USA

2. Department of Surgery, University of Chicago, MacLean Center for Clinical Medical Ethics, Chicago, IL, USA

3. Mayo Clinic, Rochester, MN, USA

4. Heritage Medical Associates, P.C., Nashville, TN, USA

5. Center for Healthcare Ethics, Cedars-Sinai Medical Center, Los Angeles, CA, USA

6. Division of Endocrinology & ObGyn, and Associate Faculty, Department of Population Health, Division of Medical Ethics, New York University School of Medicine, New York, NY, USA

7. Division of Nuclear Medicine, Department of Radiology, Penn State University, Milton S. Hershey Medical Center, Hershey, PA, USA

Abstract

Significant barriers to informed consent surround the clinical management of adult patients with well-differentiated thyroid cancer. The literature reveals lack of disclosure surrounding clinical equipoise; confusing and conflicting terminology; and an insufficient number of prospective trials with proper ethical oversight. We provide guidance for valid consent to treatment in this population, and propose stipulative definitions for a variety of terms used in this context. Three critical areas are addressed: surgical management, radioactive iodine management and nonvalidated practice. Sound ethical frameworks for valid consent in patients with low-risk thyroid cancer include consent to observational (or ‘active surveillance’) research protocols, consent to nonvalidated practice and consent when there are opposing standards of care due to insufficient data and disagreement among the community of experts.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Endocrinology,Oncology,Endocrinology, Diabetes and Metabolism

Reference70 articles.

1. Equipoise and the Ethics of Clinical Research

2. US Department of Health and Human Services. “Code of Federal Regulations – Title 45 Public Welfare CFR 46” – Title 45 Public Welfare CFR 46.116(a). www.hhs.gov/ohrp/humansubjects/commonrule/.

3. Office of Human Subject Protection. Proposed Rules 53933. Federal Register 80(173) (2015).

4. Office of Human Subject Protections. Draft Guidance on Disclosing Foreseeable Risks in Research Evaluating the Standards of Care. www.hhs.gov/ohrp/newsroom/rfc/comstdofcare.html.

5. Radioiodine-remnant ablation in low-risk differentiated thyroid cancer: pros

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