Week 4.ppt

Chapter 5 Ethics in Research (Most Important Chapter in Book) Historical Background 1930s and 1940s: Nazi medical experiments – Subjects exposed to harm and forced to participate 1932–1972: Tuskegee Syphilis Study – Withheld medical treatment 1940s: U.S. radiation experiments...

Chapter 5 Ethics in Research (Most Important Chapter in Book) Historical Background 1930s and 1940s: Nazi medical experiments – Subjects exposed to harm and forced to participate 1932–1972: Tuskegee Syphilis Study – Withheld medical treatment 1940s: U.S. radiation experiments Copyright © 2019 Wolters Kluwer · All Rights Reserved Historical Background 1930s and 1940s: Nazi and Imperial Japanese medical experiments – Subjects exposed to harm and forced to participate Freezing Experiments High Altitude Experiments Sea Water Experiments Sulfanilamide Experiments TB Experiments Wound Experiments Poison Experiments Sterilization and Artifical Insemination Experiments Twin Experiments Copyright © 2019 Wolters Kluwer · All Rights Reserved Historical Background 1932–1972: Tuskegee Syphilis Study – Withheld medical treatment conducted by the United States Public Health Service (USPHS) – An objective to see the natural progression of syphilis in people – Testing included blood tests, x-rays, spinal taps and autopsies of the subjects – People were told they were receiving treatment but did not get any real medicine, even after the invention of penicillin they were not treated – Study finally ended when a whistleblower exposed things in 1972. At that time 74 participants were alive, 128 had died of syphilis or complications , 40 wives had been infected, and 19 children acquired congenital syphilis infections. Copyright © 2019 Wolters Kluwer · All Rights Reserved Historical Background 1940s: U.S. radiation experiments – US federal agencies had sponsored radiation experiments since the 1940s on hundreds of people, many of them prisoners or elderly hospital patients (a lot was also done to the soilders) – Also examples of military testing Copyright © 2019 Wolters Kluwer · All Rights Reserved Codes of Ethics 1949: Nuremberg Code: response to Nazi atrocities 1964: Declaration of Helsinki: World Medical Assn. 1978: Belmont Report 1995: ANA Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research 2002: CNA- Ethical Research Guidelines for RNs 2015: ANA declares Year of Ethics- Revised Code of Ethics for Nurses with Interpretive Statements Copyright © 2019 Wolters Kluwer · All Rights Reserved Ethical Dilemmas in Conducting Research Ethical dilemma in research: a situation in which the rights of study participants are in direct conflict with requirements of a study Examples of dilemmas – Does a new medication prolong life in patients with AIDS? (Why would this be an ethical issue- you would have to have a control group that doesn’t get treatment) – Are nurses equally empathic in their treatment of male and female patients in the ICU? Copyright © 2019 Wolters Kluwer · All Rights Reserved Ethical Principles: The Belmont Report Beneficence – Imposes a duty on researchers to minimize harm and maximize benefits (some research can have risks in relation to pt) Respect for human dignity – Includes the right to self-determination and the right to full disclosure Justice – Includes participants’ right to fair treatment and their right to privacy Research tool not able to be used know- deception (as it takes self-determination and full disclosure) Copyright © 2019 Wolters Kluwer · All Rights Reserved Beneficence Principle of beneficence: Above all, do no harm. Right to freedom from harm and discomfort – Beneficence—minimize harm; maximize benefits Right to protection from exploitation – Participants should not be placed at a disadvantage. – This special relationship should not be exploited. Copyright © 2019 Wolters Kluwer · All Rights Reserved Question Tell whether the following statement is True or False. The Nuremberg Code was one of the first established sets of ethical standards. a.True b.False Copyright © 2019 Wolters Kluwer · All Rights Reserved Answer a. True Rationale: One of the first international efforts to establish ethical standards was the Nuremberg Code. These ethical standards were developed in 1949 in response to the Nazi atrocities. Copyright © 2019 Wolters Kluwer · All Rights Reserved Principle of Respect for Human Dignity Right to self-determination (absence of coercion) – Deciding voluntarily whether to participate in a study, without risking prejudicial treatment – Having the right to ask questions, refuse answering questions, and drop out of the study Right to full disclosure (absence of deception or concealment) – Receiving a description of the study, the person’s right to refuse participation, and potential risks and benefits Copyright © 2019 Wolters Kluwer · All Rights Reserved Principle of Justice Right to fair treatment – Concerns the equitable distribution of benefits and burdens of research Right to privacy (confidentiality, anonymity) – Ensures that the research is not more intrusive than it needs to be and that privacy is maintained Copyright © 2019 Wolters Kluwer · All Rights Reserved Procedures for Protecting Study Participants Risk–benefit assessments Informed consent Confidentiality procedures Debriefings and referrals Treatment of vulnerable groups (power dynamic) External reviews and the protection of human rights Ethical issues in using animals in research Copyright © 2019 Wolters Kluwer · All Rights Reserved Potential Benefits and Risks to Study Participants Copyright © 2019 Wolters Kluwer · All Rights Reserved Question The principle of justice ensures a research subject’s right to: a. Self-determination b. Full disclosure c. Protection from harm d. Privacy Copyright © 2019 Wolters Kluwer · All Rights Reserved Answer d. Privacy Rationale: The principle of justice ensures a research subject’s right to privacy and fair treatment. The right to self-determination and the right to full disclosure are ensured by the principle of respect for human dignity. The right to protection from harm is ensured by the principle of beneficence. Copyright © 2019 Wolters Kluwer · All Rights Reserved Informed Consent Participants have adequate information about the research. Participants can comprehend that information. Participants have free choice in deciding whether to participate in or withdraw from the study. Researchers usually document informed consent by having participants sign a consent form. Copyright © 2019 Wolters Kluwer · All Rights Reserved Consent Form Informed consent means that participants have adequate information about the study, comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily. – Implied consent (e.g., for self-administered questionnaires) – Process consent (renegotiated over time, qualitative studies) Copyright © 2019 Wolters Kluwer · All Rights Reserved Confidentiality Procedures Anonymity—researchers cannot link participants to their data. Confidentiality in the absence of anonymity—other confidentiality procedures need to be implemented. – Taking steps to ensure breach of confidentiality does not occur Certificate of Confidentiality (NIH)—a certificate obtained to prevent forced disclosure of confidential information to authorities Copyright © 2019 Wolters Kluwer · All Rights Reserved Debriefings and Referrals It is sometimes advisable to offer debriefing sessions following data collection so that participants can ask questions or share concerns. Researchers can also demonstrate their interest in participants by offering to share study findings with them after the data have been analyzed. Finally, researchers may need to assist participants by making referrals to appropriate health, social, or psychological services. Copyright © 2019 Wolters Kluwer · All Rights Reserved Treatment of Vulnerable Groups Vulnerable subjects are study participants who require special protections. – May be incapable of giving fully informed consent (e.g., cognitively impaired people) or may be at high risk for unintended side effects (e.g., pregnant women) – Some (e.g., children) cannot make a truly informed decision about voluntary participation. Copyright © 2019 Wolters Kluwer · All Rights Reserved Groups Considered Vulnerable Children Mentally or emotionally disabled people Severely ill or physically disabled people Terminally ill people Institutionalized people Pregnant women Copyright © 2019 Wolters Kluwer · All Rights Reserved External Review and Protection of Human Rights Ethical aspects of a study are increasingly likely to be reviewed before permission is granted to conduct a study. – Human subjects committees – Institutional Review Boards (IRBs) – Research Ethics Boards (REBs—in Canada) Copyright © 2019 Wolters Kluwer · All Rights Reserved Question Tell whether the following statement is True or False. Children require special protection when they are involved in a research study. a.True b.False Copyright © 2019 Wolters Kluwer · All Rights Reserved Answer a. True Rationale: Children, because of their inability to make a truly informed decision about voluntary participation in a research study, are considered vulnerable and thus require special protection. Copyright © 2019 Wolters Kluwer · All Rights Reserved Guidelines for Critiquing the Ethical Aspects of a Study Copyright © 2019 Wolters Kluwer · All Rights Reserved End of Presentation Copyright © 2019 Wolters Kluwer · All Rights Reserved