Speaker 1: Hello, this is Henry Silverman and in this presentation I would like to discuss several issues regarding obtaining informed consent in research. So what is consent? In general, consent is defined as permission or approval for a transaction. The goal of an informed consent process is to provide sufficient information so that a participant can make an informed decision about whether or not to enroll in the study or to continue with their participation. There are several ethical principles in research. The foundation of informed consent is based on the principle of respect for persons. This requires two concepts. One requires autonomous authorization from competent individuals, and for those individuals lacking competence, we require proxy consent. Before participants can give their informed consent, there needs to be adequate disclosure of information. This is known as elements of informed consent, and there are essential elements and additional elements. This slide shows the basic elements of informed consent. First, participants need to know the purpose or the purposes of the research. They also need to know what interventions in the research are considered experimental. They need to know the risks of these experimental procedures, and they also need to know the potential benefits of the research to them from any interventions in the research, and they also need to know the potential benefits to society. They need to know what alternatives there are outside of the clinical research in case they decide to decline participation in the research. They need to know how their personal health information will be kept confidential, any availability of compensation for research injury. They need to have contact information regarding who to ask if they have additional questions about the research. They also need to have the contact information if they have questions about research injury, and they also need to have contact information regarding any questions about their rights. And finally, and most importantly, they need to know that their participation in this research is voluntarily, and they could withdraw from the research at any time. Additional elements of informed consent are shown in this slide. There should be a statement stating that there may be risks that are unforeseeable. They need to know the withdrawal criteria at which an investigator may withdraw subjects. They need to know what additional costs might accrue to them, and also the consequences if they decide to withdraw. They need to be told of any new findings that are discovered in other research that may have an implication on their continuing in the study, and also they need to be told the approximate number of subjects that will be enrolled in the study. So what constitutes a valid consent? This slide shows the elements of a valid consent. On the left-hand side, we see, as we have been discussing, there needs to be adequate disclosure of information. Also participants need to have the capacity to make decisions, and this involves understanding factual information about the disclosure. They need to appreciate how the information applies to their situation and their illnesses, and then they need to be able to commit or express a choice. And finally, as we see on the right-hand side of this slide, their decision needs to be voluntary. Regarding voluntariness, the participant should not feel pressured to sign the informed consent form. One should be able to make a free choice, and this involves that there be no coercion and no undue influence. So what should the research ethics committees or institutional review boards look for when they review research protocols? Well, they should be concerned about the cognitive capacity of individuals who will be targeted to enroll in the research, and they should also be concerned with the potential vulnerability of the research population that will also be targeted for enrollment. Vulnerability is defined as individuals who cannot adequately protect their own interests. Regarding decision-making capacity of individuals, or if individuals are believed not to be competent to make a decision, then there needs to be proxy or surrogate consent. Investigators and members of research ethics committee should be aware of populations that might be prone to be vulnerable, and this includes children, prisoners, pregnant women and fetuses, the cognitively impaired or the mentally ill, those who are financially impaired, and also the terminally ill. Regarding children in research, essentially children should not be disadvantaged by being enrolled in a clinical trial. So what does this mean? Well, if the research has no benefits, then the research should not present no greater than minimal risk to the child. Now if the research is greater than minimal risk, then the research must provide a compensating benefit. Other items to be aware of in children research is that one needs to have the permission of the child's parents or guardians, and if appropriately, the child should be able to give their assent to participate in research. So what is assent? Essentially as children become older, they should be provided more and more information about the research, and they should at least agree to participate in the research. For children under 7, they may be given very limited information about the research. For children between 7 and 11 years of age, they may be given increasing amount of information about the research, for example, about the risks and the benefits, and for minors between the ages of 12 and 17, they should be given increasing amount of information to provide their assent. One should also be aware of certain cultural issues that might exist in many low and middle income countries around the world. For example, individuals are reluctant to use written documents, and there may be a lack of acceptance of using signatures. Sometimes many participants feel that if they have to sign their name, they feel that they might be exploited or they might be signing a document that they don't have full understanding about. Also in many countries, there is a deference to authority, and hence many potential participants may not be able to ask questions from the investigator, and also in some countries, other individuals may take over giving permission, for example, tribal leaders and husbands. Also one needs to know that the primacy of autonomy as an ethical principle is a Western concept that is not accepted in all areas around the world. For example, in rural areas, who should give consent for research studies? Tribal leaders should give permission to enrolled individuals in the research, or should individuals give informed consent? Should individual informed consent be considered a universal principle around the world? So some take-home messages about informed consent. First informed consent is the fundamental ethical application of respecting persons, which involves respecting autonomy of persons who have the capacity to make decisions. There needs to be additional safeguards for persons who are prone to being vulnerable. A valid informed consent form should ensure adequate disclosure, understanding, and cognitive capacity of the potential participant, and there should also be voluntariness of the decision to participate, which means lack of coercion and undue inducement. I hope this presentation was useful. Thank you very much.