Human and Animal Research 1 What issues does this raise? 2 Issues? Individual autonomy Informed consent Incompetent patients Proxy consent Best-interest standard Vulnerable populations Ethical treatment of animals 3 Conceptual Issues In Human Research Therapy: Refers to a set of activities whose primary purpose is to relieve suffering, restore or maintain health, or prolong life 4 Examples of Therapy Medical treatment Diagnosis of preventive measures Vaccine injections 5 Primary aim of therapy To benefit the patient 6 Research Refers to a set of scientific activities whose primary purpose in to gain knowledge Humans / animals service as subjects 7 Therapeutic Research Research that also benefits (hopefully) the patient 8 Non-Therapeutic Research Research whose sole aim is to contribute to generalizable knowledge of issue The patient does not benefit 9 The Justification of Research Using Human Subjects 10 1. Utilitarianism Most commonly offered justification for human research is utilitarian 11 1. Human experimentation enhances the discovery of new diagnostic and therapeutic techniques that benefit most people 12 2. Controlled experiments are necessary for sound medical practice Controlled research experiments can rule out ineffective or harmful practices 13 2. Fairness or Gratitude 1. we all benefit from past research 2. without human subjects this research would not be beneficial 3. therefore we have an obligation to participate in future research 14 How do we reconcile The rights of the individual with furthering medical research? 15 The Protection Model There must be adequate protection for participants in research 16 The Access Model In the absence of effective treatment All groups should have access equal access to research AIDS Woman Minorities 17 Informed Consent Based upon deontological perspective Respect for autonomy and value of individual Self determination 18 Important Considerations 1. The Naturally Vulnerable Elderly Children Psychiatric patients 19 2. Egregious historical failures of researches to comply with informed consent Nazi researchers Tuskegee 20 3. Complexities in implementing informed consent Psychiatric patients Minorities Religious aspects 21 Proxy Consent Informed consent given on behalf of those who are incapable of giving consent Children Mentally ill Dementia Elderly 22 Question? When is it morally permissible for incompetent patients to participate in non- therapeutic research? 23 Minimal Risk? One view is that Incompetent patients should only be allowed to participate in research Where there is minimal risk to the patient 24 Class Specific Illnesses Some illness can only be studied with particular groups Infantile Autism Pediatric illnesses Alzheimers 25 The only way to develop cures for these diseases is to have research on these groups Most researchers argue that the potential gains outweigh the potential harms Therefore, Proxy consent is justified 26 Experimental Design 27 Placebo An inactive substance (often a sugar pill) given to a patient in place of medication. Clinical trials show that between 30% to 40% of people will show improvement when given a placebo because they believe it will work. 28 In drug trials, a control group is given a placebo while another group is given the drug being studied. That way, researchers can compare the drug's effectiveness against the placebo's effectiveness. 29 Randomized Clinical / Controlled Trials 30 A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control. The control may be a standard practice, a placebo ("sugar pill"), or no intervention at all. 31 Double-Blind Trial In a double-blind, placebo-controlled clinical trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. Administrator knows 32 Because patients don't know what they're getting, their belief about what will happen doesn't taint the results. 33 Because the researchers don't know either, they can't hint to patients about what they're getting, and they also won't taint results through their own biased expectations about what the results will be. 34 Because the outcomes are measured, RCTs are quantitative studies. The RCT is one of the simplest and most powerful tools in clinical research. 35 Moral Dilemmas What happens when researchers begin to have evidence that a certain therapy is working, but the trial in not complete? If they tell the patient, they will destroy the trial To not tell hurts the patient 36 Moral Dilemmas What about a clinical trial where a patient knows he / she may not get any drug at all, but a placebo? And they might die if they are not treated? 37 Developing Countries Sometimes trials are done in developing nations yet the drugs in question are too expensive to give to the population of that country What is the ethical justification for this? 38 Animal Research Is it moral to use animals in research? Do animals have moral rights? What characteristics are needed to have moral rights 39 If animals can be used in research, how important does the knowledge need to be for using them? 40 Ethical Principles 1. Minimizing animals pain, distress, discomfort 2. Alternatives used when possible 41 Speciesism Peter Singer: The view that your species is superior to all others Similar to racism, sexism, etc. 42