Chapter 9 Research Ethics PDF

CHAPTER 9 RESEARCH ETHICS ANIMAL RIGHTS  ANIMAL ETHICS DEFINITION: Animal ethics are simply "arguments concerning the right and wrong way to treat animals," to put it in the simplest words (BBC 2012: online). Through an examination of whether a course of action is for t...

CHAPTER 9 RESEARCH ETHICS ANIMAL RIGHTS  ANIMAL ETHICS DEFINITION: Animal ethics are simply "arguments concerning the right and wrong way to treat animals," to put it in the simplest words (BBC 2012: online). Through an examination of whether a course of action is for the moral benefit of animals, it examines the appropriateness of using animals in a variety of circumstances as a topic of study (Collins et al. 2008, p. 752). (including humans). It looks at ideas held regarding the status of nonhuman animals, thinking, and knowledge to explain nonhuman animal-human moral issues (Animal Ethics 2008: online). As a result, it addresses the question of the moral obligation that people have to provide care for non-animals as well as the appropriate level and scope of that care (Hstein et al. 2005).  ANIMAL WELFARE Animal welfare refers to an animal's overall quality of life and includes how well the animal is adjusting to his or her current circumstances and environment. According to World Animal Protection, human interactions with animals have an impact on animal welfare, and it is our responsibility to ensure that all animals are handled properly, humanely, and with respect.  5 DOMAINS OF ANIMALS WELFARE Nutrition – factors that involve the animal’s access to sufficient, balanced, varied, and clean food and water. Environment – factors that enable comfort through temperature, substrate, space, air, odour, noise, and predictability. Health – factors that enable good health through the absence of disease, injury, impairment with a good fitness level. Behaviour – factors that provide varied, novel, and engaging environmental challenges through sensory inputs, exploration, foraging, bonding, playing, retreating, and others. Mental State – by presenting positive situations in the previous four functional domains, the mental state of the animal should benefit from predominantly positive states, such as pleasure, comfort, or vitality while reducing negative states such as fear, frustration, hunger, pain, or boredom.  ANIMAL WELFARE AND RIGHTS IN MALAYSIA Since 1953, Malaysia has maintained a national animal welfare law, although it has drawn criticism for being lax and insufficiently implemented. Malaysia revised its animal welfare law in 2015, boosting animal protections and stiffening fines for animal abuse. Malaysian initiatives to protect animals seem to be solely focused on welfare rather than rights.  ACT 647 ANIMALS ACT 1953 An Act to amend and consolidate the laws for preventing the introduction into, and the spreading within, Peninsular Malaysia of diseases of animals; for the control of the movement of animals into, within and from Peninsular Malaysia; for the control of the slaughter of animals; for the prevention of cruelty to animals; for measures pertaining to the general welfare, conservation and improvement of animals in Peninsular Malaysia; and for purposes connected therewith. (30 April 1953)  ISSUES IN ANIMAL ETHICS Animal experimentation is never appropriate since it results in animal misery. The advantages to people have not been demonstrated. Any advantages for humans that come from testing on animals could come from other sources. Experiments on animals Rearing and killing animals for food Rearing and killing animals for fur/leather goods Hunting Entertainment Zoos Pet-keeping  HUMAN EXPERIMENTATION Human experimentation refers to a doctor's departure from accepted medical practice in order to learn something new or test a scientific theory on living beings. MALAYSIAN GUIDELINES ON THE USE OF HUMAN BIOLOGICAL SAMPLES FOR RESEARCH NATIONAL COMMITTEE FOR CLINICAL RESEARCH, MINISTRY OF HEALTH MALAYSIA  VOCABULARY NO TERM DESCRIPTION The sample or data have had all identifying information removed, such that it is 1 Anonymized tissues/samples not possible for the researcher using them to identify the individual to whom they relate. A biorepository where activates of receiving, processing, preservation, storage or 2 Biobank distribution human biological samples and cells are undertaken. It may also be responsible for procurement or testing of human biological samples and cells. Responsibility for safe keeping of samples and control of their use and eventual 3 custodianship disposal in accordance with the terms of the consent given by the donor and legal and good practice requirements. The terms human biological material, human biological samples, human material, material samples are used interchangeably and refer to all biological material of 4 Human Biological sample human origins, including organs, tissues, bodily fluids, teeth, hair and nails; but not established cell lines. Many of principles and approaches in this guidance could equally apply to extracted material such as DNA and RNA. All identifiable information about individuals, living or dead. This includes 5 Personal Information written and electronic records and information obtained from samples.  IMPORTANT ETHICAL ISSUES IN HUMAN EXPERIMENT Conducting research on stored/archived human biological samples which had been collected during routine investigation/treatment. Conducting research on biological samples prospectively collected from patients undergoing routine investigation or treatment. Conducting research involving planned prospective collection of human biological samples including those for the purpose of bio- banking.  ETHICAL PRINCIPLES: Beneficence (doing good) Non-maleficence (preventing or mitigating harm) Justice Fidelity and trust within the investigator/participant relationship Personal dignity of study participants or subjects Autonomy pertaining to both informed, voluntary, competent decision-making (informed consent) Privacy of personal information  HUMAN VOLUNTEER RESEARCH- INFORMED CONSENT Must get the approval IRB/IEC IRB/IEC Informed consent from the participating subjects must be obtained prior to conducting the study Approval The request for consent may include: Consent to the specific planned research Consent for storage and future use Informed Consent for access to medical records and information for data relevant to the bio-banking Consent Consent for re-contacting the subject for more data Researchers should decide at the beginning on the type of information that will be made available to the Feedback of patients and the community and this should be indicated in the submission to the IRB/IEC and included Research in subject information sheet Information IRB: Institutional Review Board IEC: Independent Ethics Committee  DRUG TRIALS (NIH, 2020) Clinical trials are human research studies that aim to evaluate a medical, surgical, or behavioral intervention. They are the primary means by which researchers determine whether a new treatment, such as a new drug, diet, or medical device (such as a pacemaker), is safe and effective in humans. A clinical trial is frequently used to determine whether a new treatment is more effective and/or has fewer harmful side effects than the standard treatment.  Other clinical trials look for ways to detect a disease early, sometimes before symptoms appear. Others investigate ways to avoid a health problem. A clinical trial may also investigate how to improve the lives of people who have a life-threatening disease or a chronic health problem. Clinical trials may investigate the role of caregivers or support groups. Before the Food and Drug Administration (FDA) allows a clinical trial to begin, scientists conduct laboratory tests and animal studies to assess the safety and efficacy of a potential therapy. If these studies yield positive results, the FDA grants permission for the intervention to be tested in humans.  PHASES OF CLINICAL TRIALS PHASES EXPLAINATION an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct Phase I trial drug dosage. more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works Phase II trial in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years  PHASES EXPLAINATION Gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. Phase III trial The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device. Drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Phase IV trial The side effects of a drug may not become clear until more people have taken it over a longer period of time  CONSENT IN DRUGS TRIAL If accepted into the trial, schedule a Study staff explain the trial in detail Once the questions is answered and The candidates will screened to make first visit (called the “baseline” visit). and gather more information about agree to participate, sign the informed sure he/she qualify for the trial. The researchers conduct cognitive candidate. consent form. and/or physical tests during this visit. The candidate may visit the research site at regularly scheduled times for new cognitive, physical, or other The candidates will be randomly The candidate and family members The candidate will continue to see the evaluations and discussions with staff. assigned to a treatment or control follow the trial procedures and report regular physician for usual health care At these visits, the research team group. any issues or concerns to researchers. throughout the study. collects information about effects of the intervention and your safety and well-being. QUESTIONS BEFORE DRUGS TRIALS About the Trial Medical care Cost and reimbursement After the trial ends Continue….. QUESTIONS DESCRIPTIONS What is this study trying to find out? What treatment or tests will I have? Will they hurt? Will you give me the test or lab results? What are the chances I will get the experimental treatment or the placebo? What are the possible risks, side effects, and benefits of the study treatment compared with my current treatment? How will I know if the treatment is working? How long will the clinical trial last? About the trial Where will the study take place? Will I have to stay in the hospital? Will you provide a way for me to get to the study site if I need it, such as a rideshare service? Can I do any part of the trial with my regular doctor? Is there a closer clinical trial to me? How will the study affect my everyday life? What steps ensure my privacy? Continue….. QUESTIONS DESCRIPTION How will you protect my health while I am in the study? What happens if my health problem gets worse during the study? Can I take my regular medicines while in the trial? Who will be in charge of my care while I am in the study? Will I be MEDICAL CARE able to see my own doctor? How will you keep my doctor informed about my participation in the trial? If I withdraw, will this affect my normal care? Continue….. QUESTIONS DESCRITIONS Will being in the study cost me anything? If so, will I be reimbursed for expenses such as travel, parking, or lodging? Will my insurance pay for costs not covered by the research trial, or will I need to pay out of COSTS AND REIMBURSTMENT pocket? If I don't have insurance, am I still eligible to participate? Will I need a study partner? If so, how long will he or she need to participate? Will my study partner be compensated for his or her time? Continue….. QUESTIONS DESCRIPTION Will you follow up on my health after the end of the study? AFTER THE TRIAL ENDS Will you tell me the results of the study? Whom do I call if I have more questions?