Legal & Ethical Issues
Objectives
 At
the completion of this session the
participant will be able to:
◦ Describe the ethical principles associated with
clinical trials
◦ Identify the nurse’s role in informed consent
◦ Discuss legal issues related to
chemotherapy/Biotherapy administration
Legal and Ethical
2
The Foundation of Ethical
Principles
 The Nuremberg Code
◦ Drafted in 1946
◦ The first document written to address ethics
associated with human subject participation in
scientific studies
◦ Based upon 10 principles, the first of which
addresses the voluntary consent of human
subjects
Legal and Ethical
3
The Foundation of
Ethical Principles
 The Helsinki Declaration
◦ Issued by the World Medical Association
◦ States that the mission of healthcare
providers is to safeguard the health of the
research participants (World Medical
Association, 1997)
Legal and Ethical
4
The Foundation of Ethical
Principles
 The Belmont Report
◦ Written by the United States National
Commission for the Protection of Human
Subject of Biomedical and Behavioral
Research
◦ Addresses three basic ethical principles:
 Respect for persons
 Beneficence
 Justice
Legal and Ethical
5
The Foundation of Ethical
Principles
 The Code of Federal Regulations
◦ Regulates aspects of human subject
protections in the United States
◦ Definitions in the code:
 A “human subject” is a living individual
 “Minimal risk”
 “Children” are persons who have not
attained the legal age for consent
Legal and Ethical
6
Regulatory Groups
 Food
and Drug Administration (FDA)
 Office of Human Research
Protections (OHRP)
 Institutional Review Board (IRB)
 National Cancer Institute, Data
Safety Monitoring Boards (DSMB)
 Hospital Ethics Boards
Legal and Ethical
7
Informed Consent


The process of explaining
key elements of the
treatment plan including
risks, benefits, possible
treatment alternatives,
and agreement with
treatment plan
Documentation of
discussion in MD
progress notes
Legal and Ethical
8
Nursing Role in
Informed Consent
 Educating
patients and families about
the diagnosis, prognosis, and
treatment plan
 Encourage patients and families to
maintain a journal containing the
questions and the responses to those
questions
Legal and Ethical
9
Legal Issues Related to
Chemotherapy/Biotherapy
Administration
 Strategies
errors:
◦
◦
◦
◦
◦
◦
to reduce medication
Medication error reporting
Computer system
Infusion pump improvements
Dose verification
Information access
Health care provider education
(Committee on Drugs and Committee on Hospital Care, 2003; Fernandez & Gillis-Ring, 2003;
King et al., 2003; National Initiative for Children’s Health Care Quality Project Advisory
Committee, 2001)
Legal and Ethical
10
Legal Issues Related to
Chemotherapy/Biotherapy
Administration
 Strategies
to reduce
chemotherapy/biotherapy errors:
◦ Standardizing chemotherapy/biotherapy order
forms
◦ Nurse check before administration
 Ensure that the chemotherapy /biotherapy has been written
and signed by healthcare providers familiar
with chemotherapy/biotherapy and the treatment plan
 Verify that the appropriate laboratory work is within the
parameters specified
 Verify the chemotherapy /biotherapy orders against the
treatment plan
Legal and Ethical
11
Legal Issues Related to
Chemotherapy/Biotherapy
Administration
 Strategies
to reduce
chemotherapy/biotherapy errors:
◦ Nurse check before administration (cont.)
 Re-calculate all pre-medication doses,
chemotherapy/biotherapy doses, and hydration
rates
 Check the orders and treatment plan against
the chemotherapy/biotherapy itself
 Verify positive patient identification
Legal and Ethical
12
Questions?