Legal & Ethical Legal & Ethical IssuesIssues

ObjectivesObjectivesAt 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

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The Foundation of The Foundation of Ethical PrinciplesEthical 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

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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)

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The Foundation of Ethical Principles

The Foundation of The Foundation of Ethical PrinciplesEthical 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

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The Foundation of The Foundation of Ethical PrinciplesEthical 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 consentLegal and Ethical 6

Regulatory GroupsRegulatory GroupsFood and Drug Administration (FDA)

Office of Human Research Protections (OHRP)

Institutional Review Board (IRB)National Cancer Institute, Data Safety Monitoring Boards (DSMB)

Hospital Ethics BoardsLegal and Ethical 7

Informed ConsentInformed ConsentThe 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

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Nursing Role in Nursing Role in Informed ConsentInformed ConsentEducating 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

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Legal Issues Related to Legal Issues Related to Chemotherapy/Biotherapy Chemotherapy/Biotherapy AdministrationAdministrationStrategies to reduce medication errors:◦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)

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Legal Issues Related to Legal Issues Related to Chemotherapy/BiotherapChemotherapy/Biotherapy Administrationy AdministrationStrategies 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

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Legal Issues Related to Legal Issues Related to Chemotherapy/BiotherapChemotherapy/Biotherapy Administrationy 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

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Questions?Questions?