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FOUNDATIONS OF NURSING RESEARCH Sixth Edition CHAPTER 2 Ethical Issues in Nursing Research Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objectives 1. Discuss Some Of The Unethical Studies That Have Been Documented In The Literature 2. Trace The Development Of Ethical Codes And Guidelines 3. Appreciate The Role Of Institutional Review Boards 4. Identify The Elements Of Informed Consent Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objectives 5. Recognize Unethical Research 6. Act As A Patient Advocate During Research Investigations 7. Critique The Ethical Aspects Of A Study Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective One Discuss Some Of The Unethical Studies That Have Been Documented In The Literature Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Unethical Research Studies at Concentration Camps • Victims not “real” • Drug effectiveness on wounds • The prediction of skeletal size Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Unethical Studies in the United States • Exposure to disease – Children and cowpox – Mentally retarded children and hepatitis – Elderly patients and cancer Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Unethical Studies in the United States (cont’d) • Experimental vaccines – American Indian children with hepatitis A – Foster children with AIDS – Minority children with measles Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Unethical Studies in the United States (cont’d) • Leaving diseases untreated – African Americans with syphilis Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective Two Trace The Development Of Ethical Codes And Guidelines Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. The Nuremberg Code, 1947 • A result of prisoner research • Criteria for research identified – Researcher must inform subjects. – Research for the good of society – Research based on animal experiments – Researcher must avoid injury to subjects. – Researcher must be qualified to do research. – Subjects or researcher can stop study if problems occur. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Other Ethical Codes • Universal Declaration of Human Rights, 1948 • The Declaration of Helsinki, 1964 • The Belmont Report, 1979 – Respect for persons – Beneficence – Justice • The Department of Health and Human Services (DHHS) Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Research Guidelines for Nurses • Human Rights Guidelines for Nurses in Clinical and Other Research (1975, 1985) – Protects subjects from harm – Ensures privacy – Preserves subject’s dignity – Keep nurses fully informed Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Research Guidelines for Nurses • Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995) – Research integrity – Reporting scientific misconduct Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective Three Appreciate The Role Of Institutional Review Boards Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Institutional Review Boards (irbs) • 1981: DHHS published guidelines. • Guidelines led to IRBs. • Overseen by Office of Protection from Research Risk (OPRR) • Human research needs IRB approval. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Nursing Research and Guidelines • Nursing research committees • Policies vary agency to agency. • Be informed about institution’s specific requirements • Permission to conduct research can take time. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective Four Identify The Elements Of Informed Consent Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Informed Consent • • • • Protects rights of research subjects Receives full explanation of the study Allows time for clarification Submits permission by signed name Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Major Elements of Informed Consent • • • • • • • • Researcher and credentials Subject selection process Study purpose Study procedures Potential risks Potential benefits Compensation, if any Alternative procedures, if any Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Major Elements of Informed Consent (cont’d) • • • • Anonymity or confidentiality Right to refuse or withdraw Questions addressed Means of getting study feedback Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Researcher Identification • Research name and qualifications • Sponsor or sponsoring agency • Confusion if nurse caregiver is also researcher Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Subject Selection Process • • • • Other names for “subject” Selection goal—unbiased sample Subjects told how they are selected Women, men, ethnic, and cultural groups Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Study Purpose • Presented clearly • Open, honest explanation • Enough information for informed consent Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Study Procedures • • • • Place Time commitments Procedure format Debriefing if necessary Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Potential Risks • Risks that might influence decision to participate – Physical and psychological discomforts – Invasion of privacy – Consult with experts Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Compensation • • • • Monetary incentives Other incentives Risk of bias “Potential benefits” as “compensation” Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Alternative Procedures • Treatment • Control group • Hawthorne effect Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Anonymity or Confidentiality • Anonymity: no link between subjects and data • Confidentiality: protects subjects’ identities – Deletion of identification information – Data reported in aggregate. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Right to Refuse or Withdraw • Voluntary • No penalty for withdrawal • Able to withdraw at any time Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Answer Questions • At time of informed consent • Available by phone or e-mail • Always there to answer questions Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Means of Obtaining Results • • • • Publication plans must be given. Subjects may receive study results. How to obtain these results Date when results are available Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective Five Recognize Unethical Research Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective Six Act As A Patient Advocate During Research Investigations Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Patient Advocate Role • Protect privacy and dignity of subjects • Clinical trial questions – Purpose – Work setting – Available brochures Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Do No Harm • Physical harm • Psychological harm • Assume responsibility for study conditions Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Vulnerable Populations • • • • • • • • Children Geriatric clients Prisoners Homeless AIDS patients Unconscious Sedated Assent (express agreement or refusal) considerations (comm. Limitations) Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Learning Objective Seven Critique The Ethical Aspects Of A Study Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Critiquing Ethical Aspects of a Study • Little mention in report Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved. Critiquing Ethical Aspects of a Study (cont’d) • Guidelines for critiquing – Approved by IRB? – Informed consent obtained? – Provisions for anonymity and confidentiality? – Vulnerable subjects? – Coercion? – Benefits outweigh risks? – Subjects given opportunity to ask questions? – Results made available to subjects? Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Copyright ©2012 by Pearson Education, Inc. All rights reserved.