Ethical Issues in Research PDF

Ethical issues in Research Dr Odette Griscti PhD, RN 1 Chapter 2 UNDERSTANDING THE RESEARCH PROCESS AND ETHICAL ISSUES IN NURSING RESEARCH 2 3  Ethical Issues in Nursing Research  Nursing has developed guidelines to ensure protection of human partic...

Ethical issues in Research Dr Odette Griscti PhD, RN 1 Chapter 2 UNDERSTANDING THE RESEARCH PROCESS AND ETHICAL ISSUES IN NURSING RESEARCH 2 3  Ethical Issues in Nursing Research  Nursing has developed guidelines to ensure protection of human participants in research Articles of the Nuremberg Code (1947) Declaration of Helsinki (1964)  Very few guidelines existed before World War II that protected human research subjects, causing many human subjects to die during research 4 The Nazi Program of Research used prisoners of war. 5  Nuremberg Code  Judges who presided over Nuremberg Trials instrumental in development of Nuremberg Code  Protection of human participants Informed consent Protection from risk or harm Right to withdraw from experimentation Adequate qualifications of those conducting research  Basic principles of ethical behavior 6  Other Unethical Studies  Tuskegee Syphilis Study 1932-1972  Sponsored by the US Public Health Service  Studied the effects of syphilis on 400 men from a poor black community  Medical Rx was deliberately withheld to study the course of the untreated disease (even when penicillin was known to be an effective Rx) 7 Tuskegee Syphilis Study 1932-1972 8 Tuskegee Syphilis Study 1932-1972 9  What Is the Declaration of Helsinki?  Therapeutic research Results must benefit participants  Nontherapeutic research Results are not of benefit to participants but might be in the future 10 10 Copyright © 2018, Elsevier Inc. All Rights Reserved.  Declaration of Helsinki (continued)  Subjects need to be informed of risks prior to enrollment  Allows legal guardians to grant permission to enroll subjects 11 Little Albert and Pavlov experiment 12 Stanford county prisoners 13  Clicker Quiz (continued_1) What should always be a priority in research involving humans? A. Obtaining verbal and written consent. B. Articulating risks and potential long-term effects of research. C. Maintaining safety and human rights. D. Preserving accuracy and integrity of data. 14  Answer (continued_1) C. Maintaining safety and human rights. Maintaining the safety and human rights of human participants must be the priority at all times. 15  Clicker Quiz (continued_2) The principle of self-determination is central to the process of: A. Data collection. B. Selecting research design. C. Using research findings. D. Informed consent. 16  Answer (continued_2) D. Informed consent The idea that individuals have the right to decide for themselves is referred to as the principle of self-determination, which is central to the process of informed consent. 17  Belmont Report (1979)  Identify the basic ethical principles that underlie the conduct of research involving human subject 1. Respect for persons – recognition of individual autonomy the freedom to participate or not participate in research 2. Beneficence – do not harm & maximize benefits 3. Justice – everyone is treated fairly 18  Belmont report: 5 important Risk Consideration  Brutal or inhumane treatment of human subjects is never morally justified  Risks should be reduced to minimal possible to reach the research objectives  When the study involves a significant risk of serious impairment, the REB should be extraordinary insistent on the justification of the risk  When vulnerable populations are involved in research, the appropriateness of involving them should be demonstrated  All risks and benefits should be made explicit in the informed consent 19 20 How can respect be applied to human participants? 21  Respect for persons recognition of individual autonomy the freedom to participate or not participate in research Also to protect those whose autonomy is limited such as children and cognitively impaired 22 23  Consent is a fundamental process for respecting individual autonomy. It must be voluntary, informed, and ongoing. Consent must precede the collection of, or access to, research data or biological materials. 24 1. Knowledge 2. Comprehension 3. Voluntariness 25 Informed consent emphasizes 3 elements Researchers have a duty to inform participants 1. Knowledge -what the research is about, 2. Comprehension - in a language that they can understand, 3. Voluntariness -their right to refuse to participate 26 Knowledge Elements of Informed Consent Form  Study involves research Purpose of research Expected duration for subject Description of procedures Identification of experimental procedures  Written consent usually signed. Implied consent is assumed with self- administered questionnaires (return of questionnaires reflects voluntary consent) 27  Informed Consent Form (cont’d)  Reasonably foreseeable risks or discomforts How can risks be minimized?  Reasonably foreseeable benefits for subjects or others How can benefits be maximized?  Alternative procedures or treatments Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 28  Informed Consent Form (cont’d)  Confidentiality  Compensation for research-related injury  Who can answer questions About study and research-related injuries About subject’s rights  Voluntary participation Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 29  Deception  Sometimes revealing the purpose of the study may cause participants to react differently and some form of deception may be necessary  If deception is necessary, it must outweigh the risks  Researchers need to offer debriefing after the study 30  Types of deception  Deception by omission: vague terms used to describe research  False feedback: participants are given a intelligence test, and told they scored low to see the effect on self esteem  Perseverance effect: the participants are still affected by deception even after they have been debriefed and deception is revealed and explained to them ( they may think the researcher is still lying to them) 31  Audience Response Question A researcher who does not disclose that a portion of the data from the original study sample was not used in the final data analysis could be accused of a. infidelity. b. lack of scientific objectivity. c. plagiarism. d. scientific misconduct. 32 32 Copyright © 2018, Elsevier Inc. All Rights Reserved.  Audience Response Question A nurse researcher is conducting an outcomes research study and would like to focus on patient care. Which outcome would be most valuable to examine? a. Assessment b. Care planning c. Interventions d. Evaluation 33 33 Copyright © 2018, Elsevier Inc. All Rights Reserved. Informed Consent Process Does NOT Equal Informed Consent Form! 34  Special Considerations  Vulnerable subjects Children Prisoners Mentally disabled persons Economically disadvantaged Educationally disadvantaged Subtle vulnerability: language, culture, pregnancy, students, employees, substance abuse, health status Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 35 36 Beneficence and Non-Maleficence 37 Risk- benefit ration is hard to estimate And requires serious deliberations by researchers and REB board 38  Risk/benefit Assessment Potential Benefits Potential Risks  Access to intervention not  Physical harm avail to them  Physical discomfort, fatigue  Comfort – able to discuss  Emot distress issue with objective person  Social risks  Knowledge about their  Loss of privacy situation  Loss of time  Excitement of being part of study  Monetary costs – transportation, child care  Satisfaction – that may help others  Monetary or material gain 39  Approval Criteria  Risks minimized  Procedures for consent  Risks balance benefits documentation  Subject selection  Data monitoring equitable provisions  Procedures for obtaining  Privacy & confidentiality informed consent measures  Safeguards for vulnerable subjects Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 40 Critical Thinking Decision Path: Evaluating the Risk– Benefit Ratio of a Research Study Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 41 Justice 42  Justice Social justice Power differences is acknowledged 43  Justice need to be demonstrated at two levels Individual Researchers obligations to avoid any particular biases in the selections of individuals for the study Society Is similar but involves broader factors such as economics, sex or culture 44  Appropriate inclusion  Expediency or convenience, on their own, are not valid reasons to choose a particular participant population. For example, where research is intended to explore some aspect of an ethnic community, participants should be recruited to reflect the full range of members of that community (i.e., considering criteria such as age, sex, gender, socio- economic circumstances). 45  Inappropriate exclusion  it is unethical to exclude individuals or group(s) from participating in a study, on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, sex, gender or age – unless there is a valid reason for the exclusion  Unjustified exclusion may delay or even undermine the advancement of knowledge.  Moreover, it deprives the excluded individuals or group(s) from contributing to research, and puts them at risk when the research results are inappropriately generalized to their group. 46  Special Considerations  Vulnerable subjects Children Prisoners Mentally disabled persons Economically disadvantaged Educationally disadvantaged Subtle vulnerability: language, culture, pregnancy, students, employees, substance abuse, health status Researchers and REBs must ensure the necessary additional measures are in place both to protect these individuals and to facilitate their equitable participation in research. 47 Research Involving First Nations, Inuit and Métis Peoples of Canada  The framework for the ethical conduct of research involving First Nations, Inuit and Métis Peoples of Canada.  It is inspired by the three core principles of the TCPS 2 (Respect for Persons, Concern for Welfare, and Justice)  was developed in keeping with the diverse worldviews of Indigenous communities. It is offered in a spirit of respect and is not intended to override or replace ethical guidance developed by Indigenous Peoples themselves. 48 Research Involving First Nations, Inuit and Métis Peoples of Canada  Historically, most research involving Indigenous Peoples in Canada has been defined and carried out primarily by researchers who are not Indigenous.  Researchers generally did not meaningfully engage Indigenous communities and much of this research neither benefited Indigenous Peoples nor reflected Indigenous perspectives and priorities.  Emphasis on first nations involvement in design, respect for cultural ways, making the research worthwhile to the people, working with people as partners 49 Community engagement Community engagement is “an interaction between a researcher (or a research team) and the Indigenous community relevant to the research project” It requires an investment of time on the part of the researcher(s), to understand the perspectives and priorities of the community, and whether those may be compatible with the objectives of the research.. 50 Engagement with communities may take many forms, including: Meeting formally or informally with community members; Consulting with Elders and/or knowledge keepers; Negotiating a research agreement with the formal leadership; and Working with a community advisory group or review body. 51 Levels of involvement A community’s level of involvement in a research project may vary. Some communities may want to collaborate in all stages of a research project a shared or sole leadership role Others may want to strengthen the research capacity of their members through local training that enhances skills in research methods and project management receive public recognition for their contributions. Other communities may choose not to engage actively in a research project. They may simply indicate that they have no objection to it, monitor the research (i.e., ensure that it follows the conditions set out at the start), and request to be informed of the results. 52 What are possible benefits of research for a community ? Knowledge gained from the research. Skills training opportunities for community members. Addressing a community priority related to research. 53  National Regulations and Policy  Canadian Nurses Association code of ethics— 1983, updated 1994, 2002, 2008  Health Canada—Good Clinical Practice: Consolidated Guidelines, 1997  CIHR, NSERC, and SSHRC—Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2003 & TCPS 2 (2010) Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 54  Research Ethics Boards (REBs)  Review research projects and assess that ethical standards are met in relation to the protection of the rights of human subjects 1. At least five members of various backgrounds to promote complete and adequate project review 2. Members qualified by virtue of expertise, experience, and reflect professional, gender, racial, and cultural diversity 3. Membership must include one member whose concerns are primarily non-scientific (lawyer, member of clergy, ethicist) Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 55  Research Ethics Boards (cont’d) 4. At least one member from outside the institution (community member) 5. REB members have mandatory training in scientific integrity & prevention of scientific misconduct, as do principal investigators of a research study & research team members 6. REB is responsible for protecting subjects from undue risk and loss of personal rights and dignity Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 56  REB Role  Assessing recruitment: Is it fair?  Evaluating inclusion and exclusion criteria  Investigator–subject relationship  Role of REB in study?  Consent: Maximize autonomy  Additional protections  Assessing risk and benefit  Assessing consent forms and process Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 57  Approval Categories  Exempt: Low risk, nonvulnerable, nonsensitive, short duration (6 categories; e.g., educational)  Expedited review: Minimal risk (no substantive increase beyond risks of ordinary life), nonvulnerable, nonsensitive topic (9 categories; e.g., chart review, questionnaires)  Full board review Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 58  CNA’s Code of Ethics, 2008  Promoting safe, compassionate, competent, and ethical care  Promoting health and well-being  Promoting and respecting informed decision making  Preserving dignity  Maintaining privacy and confidentiality  Promoting justice  Being accountable Copyright © 2013 Elsevier Canada, a division of Reed Elsevier Canada, Ltd. 59  Critiquing the Ethics of a Study  Was study approved by the appropriate IRB?  Was informed consent obtained from subjects?  If subject is incompetent, did legally authorized representative give consent?  Were rights protected during sampling and data collection and analyses?  Was privacy protected during study and in final report?  Was benefit/risk ratio of the study acceptable? 60 60 Copyright © 2018, Elsevier Inc. All Rights Reserved.