Informed Consent Lecture Video PDF

INFORMED CONSENT In this lecture video we will be discussing a topic that is very important in behavioral healthcare. Informed consent is not only important in healthcare, but in the research context as well and as many behavioral healthcare majors are also focusing on research it’s important to un...

INFORMED CONSENT In this lecture video we will be discussing a topic that is very important in behavioral healthcare. Informed consent is not only important in healthcare, but in the research context as well and as many behavioral healthcare majors are also focusing on research it’s important to understand the foundations of consent. Slide Let’s start out with a question: can someone with schizophrenia provide valid consent? Schizophrenia is a very serious thought disorder, so many people believe that someone with schizophrenia just cannot provide consent, because they would never be in the right mind to do so. However, the correct answer is that it depends -- it depends on whether the person with schizophrenia has their psychiatric problems well- controlled or whether the person with schizophrenia is floridly psychotic and can’t think clearly. So what matters is that the person who’s providing consent meets the elements and requirements of consent, and not whether they have a particular disorder. The principle of obtaining consent before doing something to or with a person has a long history, however the formal acknowledgment of the principal of informed consent is a relatively recent phenomenon – just in the past 60 or 70 years. And the development and description of the elements of consent are most clear with consent to research, which is really analogous for treatment in behavioral healthcare and healthcare generally. Slide The federal regulations that govern research with human subjects are fairly clear in what is required to be disclosed to people before they participate in research, what kind of documentation is needed and what kind of special procedures are needed for particularly vulnerable people like children or impaired adults. The research regulations are based upon the principles covered in what’s called the Belmont report – which I asked you to read for this module, but we’ll also discuss next module when we discuss research ethics. While these regulation specify the specific items that should be disclosed and understood before consent to research can be considered informed and valid, they do not discuss the more foundational elements necessary for valid consent – that is, what criteria need to be met for valid informed consent. Slide The three elements that have been commonly accepted and agreed upon as necessary for valid consent are knowledge, voluntariness, and competence. Thus to be valid consent must be knowingly, voluntarily, and competently given. So let’s take each one of these and talk about the more detail. Slide The first element is knowledge. To be knowledgeable, reasonable and full disclosure of the purpose benefits risks and consequences of providing consent must be provided -- but that’s not enough -- not only does the 1 information need to be provided, but it’s also important that the information be understood. So it needs to be comprehended by the individual who is receiving the information. Slide So what information needs to be provided? The reading for this module outlined some of the elements that you might want to include in the treatment or healthcare context. Some of the elements include: diagnosis -- you want to know what is wrong or what’s going on; the nature and purpose of the treatment or procedures so you can understand what the physicians want to do; the benefits and risks so you can better weigh whether you want to do that procedure or not; alternatives and their benefits and risks – who knows, you may want do something else that might be more appealing to you; the risks and benefits of not doing anything so you can consider what might happen if we just wait and see with doing any treatment; and finally the healthcare professional may want also discuss things like the prognosis or what are the odds that things might get better or worse; limitations of the professional or facility -- maybe it’s a facility that doesn’t do many of this kind of procedure; the financial costs can be important to discuss as the individual might want to consider not doing it if the cost is high; and finally the professional provide advise if that’s requested -- this is not something you normally think about with informed consent, but physicians provide lots of advice and offer what they might do if they were in the same situation. Disclosure of information is not enough though. The information must also be understood. Just because you give information does not mean that the decision is informed and there is a particular tension in obtaining consent from persons with mental disability or cognitive disabilities. As we noted at the beginning of this video lecture, people with schizophrenia may be or may not be able to provide consent. They need to understand what they are agreeing to. So the information must be communicated in an understandable manner or mode, in the appropriate language of the person or subject whose consent is being obtained. Let me give you couple examples here. When I worked at another university, we had a study for which we created a wonderful consent process. We created a video that potential participants would watch to better understand the entire research process and the specific study we wanted them to participate in. It had all sorts of graphics and flashy visual effects that provided an incredible background on the study. We were very confident that our subjects were well-informed when they agreed to participate in our study. What happened on one particular day though, is a potential subject walked into our research lab, and this subject happened to be blind. We had to reconsider whether our wonderful consent process would adequately inform a blind person. Ultimately we decided that it would not there were too many visual effects that we used to get the information across. So what we did, is read through consent document with this person and helped them verbally to understand what the study was about and what they were agreeing to. Our flashy movie would have provided information but that information would not have been understood by this particular person. The same kind of situation can develop when language barriers are present. If a person’s primary language is Spanish, then providing a detailed English consent form may not be adequate. Again, the information needs to be understood in the appropriate language of the patient or subject. Now there are a number of factors that can affect comprehension. For example, personal factors such as a person’s mental disability or cognitive ability can impact the person’s ability to understand information. There are also interpersonal factors such as the process of obtaining consent that can impact a person’s ability to receive information and understand it. There are contextual issues that can impact understanding like the 2 readability of the consent forms or whether there are graphic enhancements to the consent process. Finally the process of obtaining consent itself can impact a person’s understanding of information. Slide So there are number of enhancements that may increase comprehension. For example the consent form can be improved by adjusting the reading level of the form studies have shown that many consent forms particularly in the medical context are written at a college level. This may be more difficult for some individuals to understand, so using functions in word processing programs like Microsoft Word that give the grade level or a readabiity score can be very helpful in making the consent forms more understandable. Graphic presentation and structure of the consent form can also improve it -- for example, grouping the information or putting boxes and highlights in, and using other graphic enhancements, can help a person to better understand what they are agreeing to. The consent process can also be enhanced to improve comprehension. For example, the way the person obtaining consent approaches the process can put the person giving consent more at ease. Or sometimes a third-party facilitator can be helpful -- for example, perhaps a family member can join in the consent process to help their loved one understand the information better. Finally, sometimes providing sequential testing and serial feedback can be helpful. This is where the person obtaining consent informally quizzes the person as they go long to make sure that the information is understood. Some professionals and researchers even use a quiz to assess understanding of the disclosures so that they can be more confident that the person consenting truly knows what they are consenting to. So, the first element of informed consent is knowledge and that is comprised of two parts -- first, the disclosure of information, and second, the understanding of that information. Slide The second element is voluntariness. In other words, the person must not be manipulated into giving consent. This seems pretty simple -- we can’t hold a gun to someone’s head and force them to give consent. But it’s a little more complicated than that. Slide There’s the idea of coercion and perceived coercion. The law has traditionally refused to recognize or enforce any legally significant act that is the product of force or coercion. So, for the courts, the issue is whether the particular set of circumstances was sufficiently coercive as to lead to the conclusion that, but for, such pressure, consent would’ve been withheld. A perfect example of this is the undue influence or persuasion that family or friends can have on somebody. A family member might approach their grandparent for example by saying, “grandma, it’s just a little test -- it’s not going hurt you and you can help yourself by doing this.” By putting pressure on a person it may unduly coerce them or influence them into agreeing to consent. But does this sort of thing happen often? Absolutely! It happens every day -- but that doesn’t mean that it’s valid consent -- it still needs to be voluntary. 3 Another example of coercion is when a person is in a coercive environment or institution. People in prisons will do almost anything to gain a privilege or to possibly be released early. So just being in that environment can make a situation so coercive that providing valid consent can be much more complicated. Other examples include giving something of inherent value to persuade somebody. When my son was younger, he would do almost anything if I gave him a Pokémon or Digimon card. Was that coercive? Absolutely! I wanted him to do something for me -- but if you do that in a professional context to obtain consent, then that might be unduly coercive. So, if you give an adult an iPad for doing a five-minute survey, that may be considered unduly coercive and thus the consent to participate would be invalid. I should note that people are compensated for their time to participate in research studies – but care needs to be taken to make sure it’s not so coercive as to make them do something they wouldn’t have otherwise, if they weren’t so influenced. A power imbalance can also be problematic. A teacher asking a class to do a study for them or a physician asking a patient to participate in a research project can be problematic, and ultimately mean that the consent is not valid because it was coerced or there was perceived coercion. When such dual roles occur, consent must be carefully obtained. So, the second element – voluntariness can sometimes not be as easy to obtain as you might think. You need to make sure that the person giving consent does not feel coerced. Slide The third element of valid consent is competence. A person must possess the capacity to receive, comprehend, and utilize the information provided in order to make a decision. Slide If I were to ask you: are you competent, many people would say of course I’m competent -- but when someone asks you are you competent, your response ought be “competent to do what” or “competent for what”, because none of us are competent to do everything. I’m not competent to dance in an Irish dance troupe. And many students would not be able to do that either, however I am competent to do many other things. So it’s important to know what the context of the question is. There are many different types of competency -- there is competence to stand trial, where someone needs to be able to participate in their own defense in order to be considered competent. There is competence to make a will. There is competence for treatment decisions, and competence for research decisions. There are many types of competence. Slide The type of competence that were talking about in the informed consent context is decisional capacity. A good example of the way that Florida defines decisional capacity is in its healthcare advanced directive statute and it reads “incapacity or incompetent means the patient is physically or mentally unable to communicate a willful and knowing healthcare decision. For the purposes of making an anatomical gift, the term also includes a patient who is deceased”. So if you are dead your incompetent – which kind of makes sense. Other states 4 have similar provisions to define decisional capacity and just like Florida they typically are very broad and very subjective. Determining whether someone can communicate a knowing healthcare decision is a very subjective concept. Over 20 years ago Grisso and Appelbaum set out to define components and create a more objective determination of competence for treatment decisions. They reviewed legal standards across the country and developed a four element model for determining a person’s competence to make treatment decisions. While no state has adopted these per se, their approach is very useful for behavioral health professionals to understand and to better assess competence of their clients. Slide Here is their four element model. The first element is the ability to communicate a choice and what they require is that it be a consistent choice. If it fluctuates, then you’re not communicating a choice. Also, if you’re in a coma or unconscious, you clearly can’t communicate a choice either, so you would be considered incompetent. The second element is the ability to understand relevant information. With informed consent you are essentially entering into a contract, so you must understand what you’re agreeing to. If you have cognitive impairment, or some other problem with understanding or processing information, you may not meet this element. However, this is one element that can be remediated with assistance. A facilitator or some kind of instruction or iterative feedback can be used to help someone understand the relevant information. The third element of Grisso and Appelbaum’s model is the ability to appreciate the situation and its consequences. This is about applying the information to their own situation. The ultimate decision is not important, but rather it’s the process that’s important. If a person says “Oh that could never happen to me” or “I understand what the issues are, but I’m special -- it could never happen to me”, than they may not be competent in making a decision about their healthcare. The fourth element is the ability to manipulate information rationally and this is simply whether a person can employ logical processes to compare the risks and benefits. Now there is a difference between an unconventional choice and the inability to rationally manipulate information. For example, someone could rationally choose herbal or prayer treatments as an alternative approach based upon their beliefs. However, if someone chooses a course of treatment because “the Earth is beautiful” or because ”I love wearing red dresses”, that might not reflect such a rational or logical process in comparing the risks and benefits. Again, it’s not the choice, but the process. So, by assessing these four elements, a professional can get an a better idea of the decisional capacity of a client or of a person who they are trying to obtain informed consent from. Okay in review. The three elements that are necessary for valid consent are first, knowledge, which has two parts: disclosure of information and understanding of that information; secondly, voluntariness, where the person cannot be under undue influence or coercion; and finally, competence, where the person has the capacity to make such a consent decision. If all three of these elements are present then the consent can be considered valid. Slide 5 Another issue that you may face in your professional careers is a situation when someone is not competent to consent but they still need your assistance. In that instance surrogate consent might be the appropriate avenue to take. There are fairly clear provisions in most state law including Florida about when surrogate consent is allowable. And will be discussing surrogate decision-making a little later in the semester. However at this point I’d like to make the distinction between consent and assent. When a minor, that is someone under the age of 18, needs assistance, they are not capable by definition of providing consent. They are, by law incompetent. Therefore the minors parent or guardian must provide consent for them. However, even though the parent or guardian consents the professional should also try to get assent from the child. Even though assent is not the legal agreement to participate or to receive services it’s important because you don’t want the incompetent person opposing what is happening to them. Now there are times where assent may not be needed – for example very few children want to receive a shot. In instances like that, assent may not be necessary – however whenever possible assent should be obtained. The same approach should be used with adults who are also found to be incompetent. Slide In research, consent is almost always required, except in a few defined circumstances. For treatment in healthcare and other contexts, there are a number of situations where consent is not required. These could be considered exceptions to the rule of consent. First, there are a number of situations where doing something without getting consent is authorized by law. For example police can impose sobriety tests on individuals who they believe might be driving drunk. Second, consent is not always needed in emergency situations, such as when treatment is required to preserve life or when consent can’t be obtained because the person is unconscious but still in need of medical attention. Good Samaritan laws in most states protect individuals who try to help others as long as the help is not reckless or negligent. Third, a person can wave their right to give consent under certain circumstances. Fourth, consent may not be needed in situations where the risks are known. These include commonly known risks or risks known from previous experiences. For example when you go to a laboratory where you’ve had blood drawn before, and you put out your arm, it may be assumed that you consent to them drawing your blood. They don’t need to obtain explicit confirmation from you. Finally, there is a more controversial exception to consent that is called therapeutic privilege. This is an exception that isn’t used much anymore, but you may still come across it in your professional life. Therapeutic privilege is the idea that a professional -- a physician or a psychologist or someone who is well-educated -- knows better than the patient or the client they are working with about what’s best for the patient or client. This may have been a good justification to not obtain consent many decades ago, however nowadays, with the information explosion that’s available on the Internet, patients and clients are better educated about the problems that they have. They are better advocates for themselves, and they can discuss issues with the professional they are consulting at a much higher level. So today it would be much more difficult for a professional to claim therapeutic privilege as a reason to not obtain consent from somebody. So those are some of the major exceptions to obtaining informed consent. Slide This concludes this video lecture on informed consent. 6