[a | Research Methods Unit 5 Research EthicsLesson 1: The Basics a Ethics is a systematic study of value concepts, ‘good’, ‘bad’, ‘right’, ‘wrong’ and the general principles that justify applying these concepts O Itis one of the most crucial areas of research, with deception, misconduct and abuses in research increasingly becoming a crucial area of discussion O Research ethics primarily deals with: © Interaction between researchers and the people/animals they study © Collaborative relationships among researchers © Mentoring relationships © Intellectual property © Fabrication of data and PlagiarismLesson 1: The Basics kp a Ethics are norms of conduct that distinguish between acceptable and unacceptable behavior O Most societies have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws Oo However, an action may be legal but unethical or illegal but ethical 0c Ethics may also be defined as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues a Many different disciplines, institutions, and professions have norms for behavior that suit their particular aims and goalsLesson 1: The Basics EE ee 1.2 Why is Research Ethics Important? o These norms promote the aims of research, such as knowledge, truth, and avoidance of error Ethical standards promote the values that are essential to collaborative work such as trust, accountability, mutual respect, and fairness Ethical norms help to ensure that researchers can be held accountable to the public Ethical norms in research help to build public support for research (the quality and integrity of research attracts more funding) It also promotes other moral and social values (human rights, animal welfare, compliance with the law, health & safety)Lesson 2: Research Ethics Explained a Research ethics when dealing with human participants 0 Three basic ethical principles for research involving human beings: 1. Respect for persons/autonomy: a. Respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination; and b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or vulnerable be afforded security against harm or abuse (Nuremberg Code 1979) People will not be used simply as a means to achieve research objectives; rights to privacy and confidentiality.Lesson 2: Research Ethics Explained 2. Beneficence: 0 The ethical obligation to maximize benefits and to minimize harms 0 Proscribes the deliberate infliction of harm on persons (principle of non-maleficence — “do no harm”) 3. Justice: 0 The ethical obligation to treat each person in accordance with what is morally right and proper, to give each person what is due to him/her. 0 “Distributive justice” — research participants should share in the benefits of the knowledge gained. o “Vulnerability” — a substantial incapacity to protect one’s own interests. A special provision must be made for protection of their rights and welfare.Lesson 2: Research Ethics Explained a a Sponsors of research must refrain from practices that are likely to worsen unjust conditions or contribute to new inequities. 0 They should not take advantage of the relative inability of low- resource countries or vulnerable populations to protect their own interests. a Justice also requires that the research be responsive to the conditions or needs of vulnerable participants. O It is necessary to evaluate the potential costs and benefits of a research before designing the study. c “Respect for Communities” — researcher's obligation to respect the values and interests of the community in research and, wherever possible, to protect the community from harm.Lesson 2: Research Ethics Explained a Informed Consent co A process by which a study participant voluntarily confirms his/her willingness to participate in a particular trial/study, after having been informed of all aspects of the trial/study that are relevant to the study participant’s decision to participate. Goal of informed Consent 0 To make sure that the study participant has understood and made choices freely whether to begin or continue participation in a study Essential Elements of Informed Consent: © Information: objectives/purpose, invitation to participation, explanation of procedure, discomforts and risks, expected costs and benefits, provision of care and compensation in case of injury, voluntary participation/withdrawal, etc.Lesson 2: Research Ethics Explained co Comprehension: Use of local language with simple & clear language, short words & sentences, and avoiding technical terms while preparing consent forms. a Autonomy of study participants and consent: Legal capacity to give consent; free power of choice, without undue force, fraud, deceit, duress, constraint or coercion. G Signature is required but the process is more important o Researcher need not have relationship with participant O Significant new information regarding the study has to be communicated and further consent requested o Researcher needs to answer all questions raised by participant and give time to consider all optionsLesson 2: Research Ethics Explained A Privacy and Confidentiality Oo Need to know which types of information can and cannot be shared with a third party with/without the consent of the study participant. Two kinds of information: 0 Individually Identifiable: directly identify the individual or could be used to identify an individual. a De-identified: those without individual identifiers such as names, geographic information, dates including birth, death admission and discharge dates, telephone numbers, mail addresses, etc. 0 The confidentiality of records that could identify study participants and may be used to “stigmatize” them should be protectedLesson 2: Research Ethics Explained OO Research on/with vulnerable groups requiring special protection: c Special populations: fetuses, pregnant women and human in virto- fertilization, prisoners and children a Uncomprehending participants: mentally retarded, uneducated, senile, unconscious or dying, etc. 0 Sick study participants: persons with chronic illness, depressed persons, suffering persons, dying, etc. c Dependent participants: May be patients, students, employees, prisoners of researcher; or poor persons 0 Minority groups © Participants in special circumstances: victims of sexual abuse, domestic violence, war; HIV-AIDS cases, etc. Examples of Deception and Misconduct in Research: (Read text pp. 111 - 114)Lesson 3: Codes and Policies for Research Ethics EE eee Underlying Principles of Ethics Codes: 0 Honesty: in reporting data, results, methods and procedures, and publication status. Do not fabricate, falsify data. Do not deceive 1 Objectivity: Avoid bias in experimental design, data analysis & interpretation, etc. Disclose personal/financial interests affecting research Integrity: keep promises and agreements, strive for consistency Carefulness: avoid careless errors and negligence Openness: share data, results, ideas, tools, resources oO.6UO UO hUO Respect for Intellectual Property: Honor patents and copyrights; Get permission for unpublished data/methods; Give credits and acknowledgments; Do not plagiarizeLesson 3: Codes and Policies for Research Ethics i eee Underlying Principles of Ethics Codes (Cont...): a Confidentiality: protect confidential communications, personnel records, trade or military secrets cl Responsible Publication: publish for the sake of advancing research and scholarship; avoid wasteful and duplicative publication c Responsible Mentoring: help to educate, mentor, and advise students; allow them to make their own decisions Respect for Colleagues Social Responsibility Non-discrimination Competence: maintain and improve own professional competence Legality: familiarize self with and obey relevant laws and policies Animal Care and Protection of Human study Participants oooagd6undoddvcuanoUUdDd Ethical Decision Making in Research (Case Studies) Read Text pp. 116 - 121