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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
Legal and Ethical 2
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
Legal and Ethical 3
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 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
Legal and Ethical 5
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
Legal and Ethical 8
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
Legal and Ethical 9
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)
Legal and Ethical 10
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
Legal and Ethical 11
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
Legal and Ethical 12