Ch 10 research ethics


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Ch 10 research ethics

  1. 1. Ethics in the Life Sciences Chapter 10 Research Ethics 1
  2. 2. Learning Objectives • Describe the tenets of the Nuremberg Code and other applicable codes covering human subject research • Identify the ethical themes of advocacy, confidentiality, truth-telling, and allocation of resources in the conduct of research • Identify the ethical issues in conducting research with human subjects • Describe the elements of informed consent for participation in research • Determine the adequacy of protection of human subjects in proposed research studies. 2
  3. 3. Ethical Themes Advocacy • Principal investigator has a responsibility to fully inform a potential research subject about possible risk and benefits and to answer questions that enable the subject to decide to participate or not. • Advocacy ensures that patient understands the information provided and knows who to call for more information. • Advocating for the patient ensures that patients are protected and patient safety is maintained throughout the research study. 3
  4. 4. Ethical Themes Truth-Telling • Patients must understand that the research is not intended to benefit them, but it is meant to benefit future patients. • Patients also need to know that they may be part of a control group and may not receive the benefit of the actual therapy being studied. 4
  5. 5. Ethical Themes Confidentiality • Data collected in the research study must be kept confidential. • All measures should be taken to blind patient information when possible. This can be accomplished by using codes instead of patient names in the actual research. • Data and information should be locked and computer access should be controlled with password protected files. 5
  6. 6. History Of Research Ethics Past Abuses in Research • The need for regulatory bodies to oversee human subject research is founded in past research indiscretions. • In 1891, a physician in Stockholm, Sweden started to test the small pox vaccine on children due to the cost of calves being to expensive. • Repeated abuses have paved the way for regulation and oversight to establish standards for ethical standards in research. 6
  7. 7. History Of Research Ethics Vulnerable populations • Vulnerable populations were not isolated to children. Research on Prisoners raised skeptics as well. • The involvement of prisoners in research did not come to light until the early 1970’s. • As a result, special regulations exist for research involving prisoners. 7
  8. 8. History Of Research Ethics Evolution of U.S. Regulations and Human Research Subjects • In 1974, the United States enacted regulations protecting human subjects. • The National Commission for the Protection of Human Subjects of Biomedical and Behavior Research was established through the National Research Act. • The Belmont Report contributed to changes to the FDA’s regulations and led to the development of specific guidelines for Research. 8
  9. 9. Institutional Review Boards • The Belmont Report from 1979 described ethical conduct of human research subjects and led to the creation and implementation of Institutional Review Boards (IRB’s). • IRB’s are guided by the guiding principles of respect for persons, beneficence and justice. • One foundational concept was the use of informed consent. 9
  10. 10. Informed Consent • Informed Consent is the cornerstone of human subject research. • Informed consent ensures • The subject understands purpose, duration, procedures of research. • All risk and discomforts are explained. • All alternatives to participation are disclosed. • Confidentiality is maintained. • Compensation is provided for injury is described up front. • Contact information for principal investigator and IRB is given to subject. • Consent clearly indicates the research is voluntary. 10
  11. 11. Summary • Nurses need to be aware of research ethics no matter what their roles. • Studies should follow the Nuremberg Code and should be approved by oversight bodies (IRB’s) and should protect vulnerable groups. • Research team members should keep the ethical obligation in the forefront in their mind. 11