Chapter 5 Ethics and Responsible Conduct in Research and Clinical Practice

1. Chapter 5Ethics and Responsible Conduct in Research and Clinical Practice

2. Chapter Overview • Reinforcement of evidence-based practice’s (EBP) interconnectedness with ethical codes of conduct in research and clinical practice. • Role of culture in the advancement of medical care. • Belmont Report support of client/patient right to know the procedures that they will be exposed to or the extent to which they will be involved as participants. • Ethical procedures transcend the boundaries of the United States via international agreements on health, medicine, and medical research. • The federal government can intercede to make ethical guidelines clear and to aid in the advancement of medical practices.

3. Two Basic Tenets of Ethical Research • The majority of ethical and moral considerations in research and clinical practice have evolved from two basic tenets: • The first obligation is to protect the participant from physical and psychological injury (Hippocratic Oath). • The benefit (to the participant) of participation in the research must outweigh any potential risk (to the participant) associated with participation.

4. General Background: Review • Research results can offer evidence to support and validate clinical decisions as well as provide a stimulus for federal regulatory requirements and institutional policies made in attempt to provide ethical guidelines for patient care. • Ethical codes in the health care profession are developed and established to protect the patient and provide a procedural conduct approach for the practitioner. • Many ethical standards are legislated into federal or state law; but the origin, practice, and interpretation of them are left to those in the specified profession. • The only way the standard or paradigm of clinical practice is changed is through the advances of legitimized research.

5. Model of Interpretative Practice • EBP perspective: consideration of experience of the clinician, the most current research/literature available, and the patient to determine best clinical practice available • Clinician • There is a parity of knowledge that exists within the diagnosis and treatment of injuries in the medical community. • Research/Literature of the Field • Clinicians must (1) keep up with the current literature and advances in procedures/techniques and (2) be able to interpret the literature presented in the journals. • The Patient • Should be viewed as an individual with a variety of emotions, skills, education, religious beliefs, and personal history/background. • Should be educated on the various types of treatments available and be involved in his or her treatment process.

6. Ethical Principles and Human Participation Protections Informed Consent: • The researcher needs to lay out the protocol of the experiment to the participant; inform them on the benefits, obligations, and any potential risks • Consent forms have to be extremely explicit in their language, and must clearly state the roles in the study. • Participants must to be informed of confidentiality issues. • The informed consent form is in fact a contract between the participant and the researcher.

7. National and International Practices The Belmont Report • Originated from the Department of Health, Education, and Welfare [HEW]; lays down the guidelines for the protection of human subjects used in research • Covers three areas of ethical principles and conduct of behavior in research: • Boundaries between practice and research • Basic ethical principles • Application of these principles in doing research

8. Boundaries Between Practice and Research • Boundaries between practice and research: • The Belmont Report necessitates the separation and differentiation of the definitions of practice and research. • Practice—Refers to a practitioner adjusting or slightly deviating from the standard protocol of treatment to help an individual client or patient. • Research—Refers to a rigidly designed protocol that needs to be tested or is being tested. The goal is to develop a hypothesis and to contribute to the body of knowledge in the field.

9. Basic Ethical Principlesand Application to Research • Basic ethical principles: • Outlines the justifications for applying codes of conduct while proceeding forward with research on human subjects. • Application of these principles in doing research: • Respect for persons • Recognizes that individuals should not be pressured into doing something that they feel uncomfortable doing or that violates their own personal belief system.

10. Application of These Principles to Do Research Beneficence: • Refers to the ability of the practitioner to secure and stabilize the well-being of the client while that client is receiving treatments or involved in a research project. • The client should receive the maximum benefit from participation in the study while simultaneously minimizing his or her exposure to threat or harm. Justice: • Who should benefit from the findings of the research produced. • If benefactors of medical research are coming from a better social class; ideal health, age, or weight; and financial standing, then an injustice has occurred.

11. Applications and Informed Consent Under the Belmont Report • The client has the choice to accept or reject participation. • Under the Belmont Report guidelines of informed consent, researchers must disclose to the client what the research entails and possibly the results. • The client needs to be fully aware of what is being asked of him or her. A simulation or practice may be run prior to experiment.

12. World Medical Association (WMA) • The World Medical Association (WMA) is an institutional body that has set procedures, policies, and codes of conduct for doctors and medical researchers to follow on a global level. • WMA aids in furthering medical knowledge in developed nations. • This helps maintain a high standard of ethical treatment of research subjects while not impeding the progress of research in the field of medicine on a global level.

13. Purpose of the World Medical Association • “The health of my patient will be my first consideration.” • “A physician shall act only in the patient’s interest when providing medical care that might have the effect of weakening the physical and mental condition of the patient.” (World Medical Association, 2008)

14. Principles for All Medical Research • WMA extends beyond the Belmont Report: • The WMA requires that any medical research involving human subjects be research based • In agreement with the Belmont Report, the WMA: • Is clear on any inherent risks to human subjects, providing the subjects are healthy. • States that conducting medical research should proceed only if the importance of the medical objectives outweighs the risks and hazards to the subject.

15. Medical Research Combined with Medical Care • In cases where research studies and medical care share the same environment and relate to the health status of the individual under the care of a doctor, the two must be warranted by the value of the research to aid in the physical well-being of the client. • When a patient/client refuses to take part in a study, even if their participation may help them and improve their health, there should be no retribution to the patient or change in the professional relationship between doctor and patient.

16. Military and Other Special Interest Research • The funding of research at the university level can come from a number of different sources: • Universities in the form of internal grants • The private sector • The state government • The federal government (military) • The ethical issue with military funding tends to center around the concept of “intention,” or how will what is produced by the research be used? Will the research findings be used towards peaceful means (versus as a tool for destruction)? • The question becomes: How will the researcher’s work be used once is out of his or her control?

17. The Bayh-Dole Act • The Bayh-Dole Actput in place a series of ethical checks and balances for proper disbursement of inventions, along with a greater attention to the details to monitor that proper protocols and procedures are being followed by agencies receiving grants.

18. Chapter Summary and Key Points • The role of ethical treatment of clients is a product of protection for the client. • Ethical guidelines for client treatment go through a series of checks and balances to insure proper treatment of the client. • Institutions, medical or otherwise, must establish and uphold guidelines of ethical practice for uniform treatment of clients. • Ethical treatment includes, but is not limited to, the methods of selection of clients for research or aiding them in regaining their health status. • Legislation has helped reduce the problems of who has the rights to medical developments and other products that would benefit clients.