1. Legal & Ethical Issues

2. 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 Ethical2

3. 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 Ethical3

4. 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 Ethical4 The Foundation of Ethical Principles

5. 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 Ethical5

6. 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 Ethical6

7. 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 Ethical7

8. 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 Ethical8

9. 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 Ethical9

10. Legal Issues Related to Chemotherapy/Biotherapy Administration Strategies 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 Ethical10

11. 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 Ethical11

12. 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 Ethical12

13. Questions?