ETHICS IN RESEARCH ver 2.pdf

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COPYRIGHT DISCLAIMER No part of this material may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the owner, except for personal academic use and certain other noncommercial uses permitted by copyright law. ETHICS IN RESEARCH  “DO UNTO OTHERS AS YOU WOULD HAVE THEM DO UNTO YOU.” – Golden Rule “FIRST OF ALL, DO NO HARM” – Hippocratic Oath “THOU SHALL NOT…” – Ten Commandments This is the common way of defining “ethics”: DEFINITION OF TERMS  RESEARCH - the systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions. ETHICS - moral principles that govern a person's behavior or the conducting of an activity. - norms for conduct that distinguish between acceptable and unacceptable behavior. RESEARCH ETHICS § Research ethics is specifically interested in the analysis of ethical issues that are raised when people/animal are involved as participants in research. § There are three objectives in research ethics. OBJECTIVES OF RESEARCH ETHICS The first and broadest objective is to protect 1 human/animal participants. The second objective is to ensure that research is 2 conducted in a way that serves interests of individuals, groups and/or society as a whole. Finally, the third objective is to examine specific research activities and projects for their ethical 3 soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent.  Importance of Research Ethics Promote variety of Help to ensure other important Norms promote that researchers moral and social the aims of research, such can be held values such as social as knowledge, accountable to responsibility, human truth and the public. rights, animal avoidance. welfare, etc.. 1 2 3 4 5 Promote the values Help to build public that are essential to support for research. collaborative work People more likely to such as trust, fund research project accountability, if they can trust the mutual respect and quality and integrity fairness. of research. Ethical Responsibilities of Researchers Carry out research in a competent manner Report results accurately Fairly acknowledge, in scientific communications, the individuals who have D contributed their ideas or their time and effort D Speak out publicly on societal concerns related to a scientist’s knowledge and expertise.  ETHICAL ISSUES TO CONSIDER BEFORE BEGINNING A RESEARCH GAIN PLAN CONSIDER INSTITUTIONAL CAREFULLY POSSIBLE APPROVAL & CONSULT ETHICAL ISSUES Any individual who wants to do research should inquire to the proper authorities, prior to starting research, about the appropriate procedure for institutional review. Prior to conducting any study, the proposed research must be reviewed to determine if it meets ethical standards. RISK A subjective evaluation of the risks BENEFIT and benefits of a research project is used to determine whether the research should be conducted. Ratio A researcher is obliged to seek to do research that meets the highest standards of scientific excellence. Are the benefits Is it worth it? greater than the risk? MINIMAL RISK AT RISK When the Potential risks in procedures or psychological activities in the research study are similar include risk of physical injury, to those social injury, experienced by and mental or participants in emotional stress their everyday life. Major Potential BENEFITS Major Potential RISKS to to Participants Participants Access to an intervention that otherwise be Physical Harm unavailable to them Comfort to discuss situation Boredom, fatigue, physical with friendly person discomfort Increased knowledge of Psychological or emotional themselves discomfort Social risks, Loss of privacy Satisfaction in helping others Monetary or material gains loss of time, Monetary costs  DEALING WITH RISK information they provide obtain preliminary data should be anonymous, or with the goal of if that is not possible, the identifying those who confidentiality of their might be at risk and to information should be exclude them from the maintained. actual study. The following research would normally be considered as involving more than minimal risk: Research involving vulnerable groups (such as children aged 16 and under; those lacking capacity; or individuals in a dependent or unequal relationship); Research involving sensitive topics (such as participants’ sexual behavior; their legal or political behavior; their experience of violence; their gender or ethnic status);  Research involving a significant element of deception; Research involving access to records of personal or confidential information (including genetic or other biological information, health issues); Research involving access to potentially sensitive data through third parties (such as students data);  Research that could induce psychological stress, anxiety or humiliation or cause more than minimal pain (e.g. repetitive or prolonged testing); Research involving invasive interventions (such as the administration of drugs or other substances, vigorous physical exercise or techniques such as hypnotherapy) that would not usually be encountered during everyday life)  Research that may have an adverse impact on employment or social standing (e.g. discussion of an employer, discussion of commercially sensitive information); Research that may lead to ‘labelling’ either by the researcher (e.g. categorization) or by the participant (e.g. ‘I am stupid’, ‘I am not normal’); Research that involves the collection of human tissue, blood or other biological samples. STRETCHING EXERCISE Elderly adults in a nursing home are given a battery of achievement tests in the dayroom at their home. A researcher seeks to determine if there is a decline in mental functioning with advancing age.  BASIC ETHICAL PRINCIPLES Maximize benefits and minimize harms Respect for Justice Persons Beneficence Individual autonomy Equitable distribution of protection of individuals with research risks and benefits reduced autonomy  RESPECT FOR PERSONS 1.People should be treated autonomous Autonomous means that a person can make his/her own decisions about what to do and what to agree to. Respect individuals that can make their own informed decisions about whether to participate in research. Individuals must be provided with complete information about a study and decide on their own whether to participate.  RESPECT FOR PERSONS 2. People with diminished autonomy should be protected Some people in society may not have the capacity to make fully informed decisions about what they do or happens to them (children, those with mental disabilities, who are very ill) Should be protected and only be included in research under specific circumstances, since they cannot make a true informed decision on their own.  INFORMED CONSENT “Persons explicitly expressed willingness to participate in a research based on clear understanding of the nature of research.” Social Contract Describe the research procedures clearly, any aspects of the study that might influence the individuals’ willingness to participate, and answer any questions participants have about the research INFORMED CONSENT Participants must be allowed to withdraw their participation Must not be pressured, given freely without any coercion or undue influence Participants must behave appropriately Informed consent must be obtained from legal guardians for individuals unable to provide consent Protects Privacy INFORMED CONSENT Consent is “informed” when research participants are able to fully understand the consequences of being in a study and make a decision about his/her participation Assent Form is for participants who might have trouble understanding the longer-and often more detailed – ‘informed consent’ Assent form allows them to say ‘yes’ or ‘no’ to research even if they do not understand INFORMED CONSENT Client/Patient/Student/and Subordinate Research Participants * Take steps to protect the prospective participants from adverse consequences of declining or withdrawing from participation * Course requirement for extra credit – inform about alternative activities in case students may not participate INFORMED CONSENT Dispensing with Informed Consent for Research * Study of normal educational practices, curricula, or classroom management methods * Anonymous questionnaires, naturalistic observations, or archival research for which disclosure of responses would not place participants at risk of civil or criminal liability * The study of factors related to job or organization effectiveness conducted in organizational settings; no risk to participants employability and confidentiality is protected. INFORMED CONSENT Offering Inducements for Research Participation * Researchers may fairly compensate participants for the use of their time, energy & knowledge, unless such compensation is refused in advance * Make efforts not to offer excessive/unreasonable rewards * When offered as an incentive for research participation, clarify the nature, risks & limitations INFORMED CONSENT Consent of the data subject refers to any freely given, specific, informed indication of will, whereby the data subject to the collection and processing of personal information about and/or relating to him/her. Consent shall be evidenced by written, electronic or recorded means. It may also be given on behalf of the data subject by an agent specifically authorized by the data subject to do so (RA 10173, Ch.1, Sec.1) INFORMED CONSENT The data subject or the individual sharing his/her personal information has to be fully informed several factors of the data collecting process. The list includes, but is not limited to: 1. The reason for use 2. Methods for access 3. The identity and contact details of the personal information controller 4. How long the information will be stored 5. Access to their rights INFORMED CONSENT What to include in the informed-consent form (APA’s Ethics Code, 2002) 1. The purpose of the research, expected duration and procedures 2. Participants’ right to decline to participate and to withdraw from the research once it has started, as well as the anticipated consequences of doing so 3. Reasonably foreseeable factors that may influence their willingness to participate such as risk, discomfort or adverse effects. INFORMED CONSENT What to include in the informed-consent form (APA’s Ethics Code, 2002) 4. Any prospective benefits 5. Limits of confidentiality, such as data coding, disposal, sharing and archiving, and when confidentiality must be broken 5. Incentives for participation 6. Who participants can contact with questions DECEPTION IN RESEARCH Occurs when researchers withhold information or intentionally misinform participants about the research. Considered necessary research strategy in some psychological research. Deceiving individuals in order to get them to participate. Weigh the costs of deception. DECEPTION IN RESEARCH 1.Researchers refrain from conducting research involving deception, except: 1.1 when researchers have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational, medical, or applied value; 1.2 when effective non-deceptive alternative procedures are not possible DECEPTION IN RESEARCH 2. Researchers do not deceive prospective research participants about the study that is reasonably expected to interfere their decision to give informed consent. Researcher ensure that level of risk, discomfort, or inconvenience that cause physical pain or severe emotional distress is not withheld from the participants. DECEPTION IN RESEARCH 3. Researchers have the duty to explain any deception as an integral feature of design and conduct of an experiment to those who participated in research as soon as possible, preferably at the end of their participation but not later than the end of data gathering. (PAP Code of Ethics, 2008, 2017) DEBRIEFING Researchers are ethically obligated to seek ways to benefit participants even after the research is completed. One of the best ways to accomplish this goal is by providing participants with a thorough debriefing. Debriefing benefits both participants and researchers. Researchers are ethically obligated to explain to participants their use of deception as soon as is feasible DEBRIEFING Debriefing informs participants about the nature of the research and their role in the study and educates them about the research process. The overriding goal of debriefing is to have individuals feel good about their participation. Debriefing allows researchers to learn how participants viewed the procedures, allows potential insights into the nature of the research findings, and provides ideas for future research. DEBRIEFING When deception has been used in research, debriefing is necessary to explain to participants the need for deception, to address any misconceptions participants may have about their participation, and to remove any harmful effects resulting from the deception. Debriefing also has the important goals of educating participants about the research (rationale, method, results) and of leaving them with positive feelings about their participation BENEFICENCE 1.Do no harm The purpose of research should never be to hurt anyone of find out information at the expense of other people. 2. Maximize benefits for participants and minimize risks for participants Researchers are obligated to do their best to minimize those possible risks & maximize the benefits of participants. JUSTICE This deals with the concept of fairness. Researchers designing trials should consider what is fair in terms of recruitment of participants and choice of location to conduct a trial. Encompasses issues related to who benefits from research and who bears the risks. JUSTICE People who are included in research should not be included merely because they are a population that is easy to access, available, or perhaps vulnerable and less able to decline participating. An experimental strategy that is likely to be used by many types of people should be tested in the very population of people who are likely to use it. JUSTICE Experimental research with control conditions, should be given the same treatment conditions to the experimental group, if proven to be effective after the research had been conducted. Indicates that questions being asked in trials should be of relevance to the communities participating in the study.  OTHER ETHICAL ISSUES This is the common way of defining “ethics”: RESEARCH WITH ANIMALS Animals are used in research to gain knowledge that will benefit humans, for example, by helping to cure diseases. Researchers are ethically obligated to acquire, care for, use, and dispose of animals in compliance with current federal, state, and local laws and regulations, and with professional standards. The use of animals in research involves complex issues and is the subject of much debate. REPORTING RESEARCH FINDINGS Investigators attempt to communicate their research findings in peer reviewed scientific journals, and the Ethical Committee of professional groups provides guidelines for this process. Decisions about who should receive publication credit are based on the scholarly importance of the contribution REPORTING RESEARCH FINDINGS Ethical reporting of research requires recognizing the work of others by using proper citations and references; failure to do so may result in plagiarism. Proper citation includes using quotation marks when material is taken directly from a source and citing secondary sources when an original source is not consulted. STEPS FOR ETHICAL COMPLIANCE Ethical decision making involves reviewing the facts of the proposed research situation, identifying relevant ethical issues and guidelines, and considering multiple viewpoints and alternative methods or procedures. Authors who submit research manuscripts to any scientific journal also must submit forms describing their compliance with ethical standards. ETHICAL DECISION MAKING IN RESEARCH  The research protocol for a study of a particular drug requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has CASE only 5 mice left to test. 1 However, he really wants to finish his work in time to go on a break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results. His actions would constitute a form of research misconduct, which the ethical standards defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive: honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct.  Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a CASE journal. The error does not affect the overall results of his research, but it is potentially misleading. 2 The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error. Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research. There are many other activities that others do not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as "other deviations" from acceptable research practices. Deviations – departure from accepted norms  Publishing the same paper in two different journals without telling the editors Submitting the same paper to different journals without telling the editors Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper.  Discussing with your colleagues confidential data from a paper that you are reviewing for a journal Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission Trimming outliers from a data set without discussing your reasons in paper  Using an inappropriate statistical technique in order to enhance the significance of your research Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work  Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field Giving the same research project to two graduate students or research assistants in order to see who can do it the fastest way  Dr. Santos is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on CASE demographics, environmental exposures, diet, genetics, and various disease outcomes such as 3 cancer, Parkinson’s disease (PD), and amyotropic lateral sclerosis (ALS). She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal.  She is planning to publish many other papers CASE from her dataset. She receives a request from 3 another research team that wants access to her complete dataset. They are interested in Conti. examining the relationship between pesticide exposures and skin cancer. Dr. Santos was planning to conduct a study on this topic.  Dr. Santos faces a difficult choice. On the one hand, the ethical norm of openness obliges CASE her to share data with the other research 3 team. Her funding agency may also have rules that obligate her to share data. Conti. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority.  It seems that there are good arguments on both sides of this issue and Dr. Santos needs to CASE take some time to think about what she should do. 3 Conti. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers. The following are some steps that researchers, such as Dr. Santos, can take to deal with ethical dilemmas in research:  What is the problem or issue? What is the relevant information? What are the different options? How do ethical codes or policies as well legal rules apply to these different options? Are there any people who can offer ethical advice? STANFORD PRISON EXPERIMENT The Stanford prison experiment (SPE) was an attempt to investigate the psychological effects of perceived power, focusing on the struggle between prisoners and prison officers. It was conducted at Stanford University between August 14–20, 1971, by a research group led by psychology professor Philip Zimbardo using college students. It was funded by the U.S. Office of Naval Research as an investigation into the causes of difficulties between guards and prisoners in the United States Navy and United States Marine Corps. The experiment is a topic covered in most introductory psychology textbooks. Guards and prisoners had been chosen randomly from the volunteering college students. Some participants developed their roles as the officers and enforced authoritarian measures and ultimately subjected some prisoners to psychological torture. Stanford Prison Experiment Many of the prisoners passively accepted psychological abuse and, by the officers' request, actively harassed other prisoners who tried to stop it. Zimbardo, in his role as the superintendent, allowed abuse to continue. Two of the prisoners left mid- experiment, and the whole exercise was abandoned after six days following the objections of graduate student Christina Maslach, whom Zimbardo was dating (and later married). Certain portions of the experiment were filmed, and excerpts of footage are publicly available. ETHICAL The experiment presented several ethical issues, ISSUES the most serious of which was that the experiment continued even when participants did not wish to continue. Despite the fact that participants were told they had the right to leave at any time, Zimbardo did not allow this during the experiment. Zimbardo was faced with the ethical dilemma that the experiment could possibly return outstanding results if continued, but it might also adversely affect the participants' well-being if not halted. Currently, there are ethical guidelines to be followed. The Stanford Prison Experiment led to the implementation of rules to preclude any harmful treatment of participants. Before they are implemented, human studies must now undergo an extensive review by an institutional review board (US) or ethics committee (UK) in accordance with the ethical guidelines by the American Psychological Association. These guidelines review whether the potential benefit for science outweighs the possible risk for physical and psychological harm. A post-experimental debriefing is now considered an important ethical consideration to ensure that participants are not harmed in any way by their experience in an experiment. Though Zimbardo did conduct debriefing sessions, they were several years after the Stanford Prison Experiment. By that time numerous details were forgotten; nonetheless, many participants reported that they experienced no lasting negative effects. Therefore, under current standards, the debriefing process should occur as soon as possible to assess what psychological harm, if any, may have been done and to rehabilitate participants, if necessary. If there is an unavoidable delay in debriefing, the researcher is obligated to take steps to minimize harm. THANK YOU!