Informed Consent Research Paper

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Abstract

Informed consent is the process by which health care professionals are expected to obtain valid consent from patients and research participants. It involves a process of giving information and making sure of an understanding of this information, a voluntary choice, and competence on the part of the patient (or research participant). The reasonable person standard is useful as it can ﬁt in to most situations by deﬁning what a reasonable person in that situation would be. This applies to newer issues such as a broad consent, but more importantly plays a role in cultural divergence and what a reasonable person in each culture would deﬁne as a standard.

Introduction

The process of informed consent is a relatively recent (post-WWII) phenomenon and has become a paradigm in clinical ethics and medical law. Before the Nuremberg trials, there was no proper process of informing patients and it was not seen as a medical obligation. In fact the early days of bioethics centered mostly on the paternalistic behavior of doctors who decided whether it was in the patients’ best interest or not to be informed about disease and other matters relating to treatment. Indeed the Nuremberg Code is considered a landmark document which ﬁrst recognizes the importance that in research patients must be duly informed about the research itself and its risk and that they had a right to refuse or consent (Moreno et al. 1998). As a code of practice, the Nuremberg Code serves as a symbolic document and cannot really be said to be legally binding. More inﬂuential was the Declaration of Helsinki in 1964. While the former document was drafted by lawyers, the latter is a document by the World Medical Association, and according to Moreno et al. (Ibid), it has been more relevant to practice although they cite the United States Department of Defense as adopting the Nuremberg Code in 1954 as the basis of its policy on the use of volunteers in research on atomic, biological, and chemical weapons. This was not the case for the infamous Tuskegee research on syphilis in which the isolated population was misinformed about the details of the experiment and the treatment being offered from the beginning and was not treated, by approval of the relevant boards, even when treatment for syphilis was available, as the scope of the trial was to understand the natural history of the disease, thus putting the research before the risks and well-being of the volunteers.

Western bioethics has focused primarily on principles such as respect for autonomy, and informed consent lends itself well in the discussion of autonomy. Along the past 50 years, there has been considerable debate whether these western “principles” are universal. Even Europeans tend to agree that there are more principles in health care than the four western principles of respect for autonomy, beneﬁcence, nonmaleﬁcence, and justice that have been promulgated in the United States. This is especially contentious when discussing informed consent in a global context. Nevertheless there are at least two historical stops which are relevant to mention in the establishment of the importance of informing patients and research volunteers before obtaining a proper consent. The ﬁrst is the landmark Belmont Report, commissioned by the US president (The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research 1979), which identiﬁed three principles of respect for autonomy, beneﬁcence, and justice. The principle of beneﬁcence was divided into beneﬁcence and nonmaleﬁcence by Beauchamp and Childress in their now famous book Principles of Biomedical Ethics, running into the 7th edition. In fact the second relevant landmark is the adoption of informed consent by authors in early important books on bioethics, not least that by Faden and Beauchamp (1986).

This research paper will focus on the conditions which make a proper informed consent process, focusing on general clinical practice, research, and the issue of autonomy in relation to informed consent in different cultures. Throughout ensues a general relevance of informed consent in a global perspective on the points being discussed.

Conditions For An Informed Consent Process

There is a general agreement that the process of informed consent must satisfy at least ﬁve conditions: information giving, the understanding of that information, the voluntary choice on the part of the patient (or volunteer in the case of research), the competence of the patient, and ﬁnally the actual giving of the consent itself.

Information

It is assumed that when a doctor prescribes an antibiotic to a patient, it is quite impossible to list all the information contained in the leaﬂet inside the box of the product. Much of this information may indeed be irrelevant or just put down for legal purposes. Having said that, there has been disagreement even within the European continent with northern countries insisting on more information than southern European countries. A general rule which can apply to all countries is the use of a “reasonable person standard,” by which one would imply a reasonable person within that country in which one is adopting the process.

Beauchamp and Childress have distinguished this standard from the professional practice standard and the subjective standard (that desired by patients) (Faden and Beauchamp 2008). Moreno et al. have taken this up for discussion as well (Ibid). In actual fact, the distinction is quite academic and a proper reasonable person standard will incorporate the other two by the very nature of what we mean by “reasonable” as a standard. In deciding what a reasonable person would want to know, we are not “averaging” out what a reasonable person is. People of course vary from one another. Thus, the professional body itself has to take into account what is ethically proper to tell patients. In Bolam v Friern Hospital Management Committee (1957), the British Court decided that a standard of care must be that which a responsible body of medical opinion dictates. Someone can only be negligent if they do not reach this deﬁned standard. This is called the Bolam test. The Bolam standard (Schwartz and Bergus 2008) has made this clear and is adopted as an ethical standard. The medical profession tends in its international bodies to err mostly now in favor of more information rather than less. When tested in a court of law however, it is the standard the profession would uphold when called in as experts which count. Therefore, to distinguish a reasonable person standard from a professional practice standard does not make much sense unless one is meaning the individual professional and not the profession as a whole. A simple example would mean the frequently asked question of whether a patient is allergic to penicillin. By reasonable “person,” we do not assume that persons are expecting this question. Rather we mean that once the medical profession has considered it important to ask about any known previous reaction to penicillin, then it has become a standard of care to ask that question. Then it is considered “reasonable” to ask that question and not doing so may make one liable to negligence if a harm caused could have been avoided had the question been asked.

On the other hand, the reasonable person standard does not exclude the subjective standard either. If a patient, for example, is diabetic, then it may be the case that that patient needs to be asked or told more information (if he or she has a cold, a syrup may not be ideal as it may increase the blood glucose). But this is not subjective at all when one considers the “reasonable person” as what a “reasonable diabetic” patient would want to know. Therefore, by reasonable person, and this perhaps is important in a now globalised ethics, we do not mean a uniform “least common factor” or a variant which does not vary from person to person. Rather it incorporates what people in a particular population would expect from their doctors while supplementing information which the medical profession (including its international guidelines) itself deems important for people to know. In the recent Ebola outbreak, doctors were informed of symptoms to look out for PLUS a recent travel history to an endemic country or contact with another person from such a country. This dictated the reasonable standard in this particular case.

Therefore, although the debate of these standards was mostly an American one, one can adopt the reasonable person standard as being of sufﬁcient value to vary from patient to patient and culture to culture and modiﬁed accordingly by the countries’ professional body which in turn is globally connected through bodies such as the WMA and WHO.

More important than an academic discussion however is that failing to impart sufﬁcient information may make one liable to malpractice and even negligence. It is opportune to distinguish here between malpractice and negligence as the terms are often confused. Negligence is a legal term derived from tort law. It involves having a standard of care, departing from this standard of care, a harm being caused, and the harm being directly linked (nexus) with the departure from that standard of care. Only the ﬁrst two of these four conditions need be satisﬁed, conversely, for an accusation of malpractice. This is important for Professional Medical bodies regulating doctors in different countries. In the United Kingdom, for example, it is the General Medical Council.

These bodies usually have to supervise doctors in order to protect patients. As opposed to courts of law, they do not wait for patients to be harmed. Rather if a patient or a colleague had to report a doctor for departing from a standard of care, which then reasonably may point to a potential of causing a harm, the medical body has an obligation to act by either warning or indeed penalizing. Malpractice in itself therefore does not constitute negligence and is not sufﬁcient in a court of law unless it can be connected to a harm (which then makes it negligence). In this age of information and relevance of paternalism, the proper amount of information empowers people to make an autonomous choice. That choice is not legally binding unless the patient has understood and made a voluntary choice.

Understanding

It is important at the outset to put the onus of the responsibility for understanding on the professional. Thus, giving a barrage of information without making sure that the patient (or research volunteer) has understood does not satisfy this condition. It is therefore a communication skills process more than anything else and in the case of research may warrant the intervention of a skilled professional as we shall further understand when discussing voluntariness. There can be no large print or small print in health care and the signing of a document such as an informed consent form can be a false security even though required legally by the hospital administration. By signing a consent form for surgery, one is simply consenting to be operated upon. Even if the consent form states that “everything” has been explained to the patient, we have seen when discussing the reasonable person standard that one cannot expect reasonable persons to know what it is they must understand. It is the responsibility of the doctor to impart the relevant information; and therefore, statements that “everything” has been explained do not make legal sense when there is no way of knowing what “everything” means. A patient who develops a complication, even if this is foreseen in a small percentage in the best of hands, but who has not been informed of that complication, can legitimately complain he or she was not informed. Thus, even though a thyroidectomy can damage temporarily or permanently the recurrent laryngeal nerve which innervates the vocal cord, a patient must be informed of this consequence. Respecting autonomy means that the patient has to become part of the decision process. Certainly if the patient is in a choir and must sing soon, they may want to postpone the operation if it is not that urgent.

Conversely informed consent in emergency situations is not only not always necessary but sometimes unethical. While it is proper to inform patients what the plan of action is, one has to realize that the situation may not be conducive for patients to understand. There may be confusion due to injury, fever, drugs, etc. Relatives may not always be immediately available and indeed may be very agitated themselves. This is of particular relevance when one is testing new drugs for emergency situations. We agree that research for new drugs is important – for example, a new drug for vascular accidents causing strokes or myocardial infarctions, but one cannot research those drugs in proper trials imposing an informed consent process. If one is having a heart attack, it is not proper to tell the patient at that point in time to decide whether he or she wants the conventional treatment or whether they would wish the new drug being tested. An anxious person may indeed suffer more anxiety causing more harm. Rather it is the Research Ethics Committee which makes a decision on behalf of the population which approves such research.

A Voluntary Choice

Making a voluntary choice is part of an autonomous process. It asserts the free will of an individual to receive treatment or participate in research. Of course there are situations in which it is not always possible for a person to act freely. A discussion of voluntariness must therefore discuss what conditions may inﬂuence the free will of the individual. Three conditions have been listed as affecting a voluntary choice which are sufﬁcient for a global purpose (Beauchamp and Childress 1994). These include coercion, manipulation, and persuasion. Other factors affect the competence of the patient and will be discussed further down.

Coercion is the forcing of an individual under pain of some form of penalty to take a certain course of action. Therefore, if a doctor implies to a patient that she will not take responsibility or not continue to look after her if she does not follow her advice, the patient cannot be said to make a voluntary choice. While this in itself is not uncommon in health care, there are two situations in which it is a danger and which globally today gives rise to concern. The ﬁrst is research. Many doctors do research themselves and unwittingly may make their patients feel coerced if they offer them the possibility of participating in their research. It is not difﬁcult indeed to imagine that a small percentage of patients will accept to participate in research not because they have understood or really wish to but because they have faith in their doctor. This coercion, albeit not malicious in intent, can induce people to make choices they otherwise may not have made. It is nevertheless a coercive force which can only be rectiﬁed by careful planning of the recruitment process into the research. The second is the cultural differences between western ideals and those of other countries. Several authors have written about the African continent where tribes tend to defer choices to the leaders and individuals may not have part in the decision-making process. Indeed this is the case for many public health measures such as vaccinations. Individuals defer their autonomy to a higher authority.

In this second situation, there is the balance of the legitimacy of such decisions as opposed to when such decisions are not thought to be in the best interests of individuals in the group. Thus, just as many western people may make an autonomous choice to act under the inﬂuence of a higher institution such as a church, or a professional (such as the advice of a lawyer), and whereas such decisions are sometimes taken on the faith one has in the institution or the individual, one can assume that people living in such communities, even though we speak about a cultural divergence, are indeed conscious of the choice they are making by deferring decisions to community leaders (or head of the family). This is not to say that pressure may not exist; it is merely accepting that even in western society, pressures to accept what the doctor is requesting or what one’s religious institution allows or forbids also constitute pressures not so easily avoided and which we accept. In this sense, the western world need not be shy to follow such guidelines and think that people are being coerced into action by their leaders. Once the latter enjoy the faith and trust of the community, they ought to be considered ethically licit.

Conversely some practices have created difﬁculties among western workers working in countries such as the African and Asian continent. A particular discussion is that of female genital cutting, a procedure practiced in many cultures and which is seen as a form of mutilation by many western people. This procedure is often practiced in unhygienic situations, without any form of anesthesia and at an age where the female cannot consent or refuse. The cries of the young lady are overcome by the ritual chants and cries of the female group. Recent guidelines (Public Policy Advisory Network on Female Genital Surgeries in Africa 2012) have recognized that these are cultural and cannot be universally condemned. Nevertheless, the practice has been outlawed in many countries. Can voluntary doctors working in these countries accede to requests by local leaders to have the procedure done in a sterile environment, under anesthesia and by a professional? Even the informed consent of the young lady, who would obviously prefer to be anaesthetized and have the procedure done by a surgeon, avoiding the possibility of the many known complications, is questioned not only on the basis of whether she really would want the procedure but also of whether it can be refused on grounds of moral objection. The main question which need concern us here is whether there is coercion; this must obviously be resolved in time by the women within the community itself and perhaps with the help of the global community to understand whether individuals are indeed succumbing to the procedure under duress. It is true, on the other hand, that circumcision is a ritual done mostly for religious reasons and ironically for hygienic purposes. To be called the son of an uncircumcised woman is an insult to people equivalent to the western version of being called the son of a prostitute.

One cannot blame a doctor working in such an environment, even if she is very much opposed to the practice, to accept to perform the procedure in order not to see the patient suffer and risk complications. It takes the courage to overcome personal moral objection and certainly not all will agree. But these decisions are best taken by the global community and orders given by the organizations sending health professionals in those areas.

The second inﬂuence on voluntary choice is manipulation. Manipulation is a thwarting of the truth in some way. It may range from falsely reassuring a patient that there are no side effects to worry about or a deliberate intent to keep some information away from a patient so that the patient accepts a proposition. Both are based on deception and both will make a voluntary choice, and thus an informed choice, impossible. In reality, unless there is deliberate deception, most difﬁcult situations can be avoided by training in communication skills. Thus, a doctor may reassure a patient that he does a particular procedure “hundreds of times a year.” If the reality is that he performs the procedure once a month on average, there is a clear thwarting of the truth even though the surgeon merely meant to reassure the patient. Rather it takes courage to be truthful and to understand that the worries of the patient are whether she is in good hands. Explaining that if she (the surgeon) were not qualiﬁed to perform such a procedure the hospital would not allow her would be a better way of handing reassurance without resorting to overt or covert manipulation.

Persuasion, the third condition, is more delicate to evaluate. On the one hand, a person who needs persuasion is not yet ready to make a voluntary choice. One may resort to giving more information and making sure that the patient has understood what has been explained. But if the patient further refuses to accept, then further persuasion will verge on the unethical. This is not so clear-cut however and applies to an adult population. What about children? We often make children accept to being examined or treated by being nice to them, playing with them, and complimenting their clothes or toys. Such actions are meant to gain their conﬁdence. We may also offer that “if they are brave,” we give them sweets. Such actions are culturally acceptable and no one will consider that the doctor used improper means to persuade the child. This issue is taken up again under the discussion of competence. Sufﬁce it to say that some countries, for example, the United Kingdom (Schwartz and Bergus 2008, 320), require children between 7 and 14 to at least assent to a procedure even though they cannot properly legally consent. Informed consent is considered possible in many legislations now even before legal ages of 18 because of the development of individual autonomy.

Competence

Of course to make an informed choice, one must be competent. Age, mental state, and controlling inﬂuences can all affect the competence of a person. Therefore, very young children are not competent to understand the signiﬁcance of a decision, and therefore, they must have a proxy, usually the parent or guardian. Older children must at least assent to a decision according to EU directives. It is not clear whether this means they must be competent and health professionals must use their discretion. Many countries face the problem of whether young people below the legal age can make competent choices without parental consent. Other countries assume that if the doctor considers the young person to be able to make an informed choice, then conﬁdentiality and treatment ought to be given. On a global level, this may tend to cause more problems where parents demand to know if they have been seen and treated by a health care professional.

There are indeed extremes in which countries face this situation. In the United Kingdom, one particular case allowed a 14-year-old to have an abortion without the need to inform or obtain consent of parents. In other countries, young people are forced into marriages when not allowed to make any choice of their own. Certainly, from a health point of view, on a global level, there can be general dialogue and consensus to allow young adults to visit doctors and be considered competent due to health-related problems such as substance abuse and sexual practices. Overcoming cultural practices may be taxing in these situations.

It should be noted that some people who are autonomous and able to make an informed choice are nevertheless vulnerable, compromising their voluntary choice and their competence. It is for this reason that many countries introduced a Vulnerable Persons Act, which often creates a support network around the vulnerable person to protect him or her from anyone wishing to abuse. This diffuses the power of attorney in many instances to several people among whom are professionals such as the person’s family doctor.

Informed Consent And Culture

In a request by a CIOMS Conference, Levine (2008) was asked to provide a “deﬁnition of informed consent which is widely applicable to different countries and cultures.” Since he felt that this cannot be done, he suggests a procedural approach. This applies mostly to research and proposes as a departure point that the standard deﬁnitions of the World Health Organization and the CIOMS are adopted. In the ﬁrst instance, he recommends Research Ethics Committees to be based in the community and that in most circumstances, they adopt these guidelines. Sometimes, it may be necessary for RECs not to be local, and in this case, they should have people from the community or consultants who are highly familiar with the customs. Secondly, if consent proposals do not conform to the international standards, then this should be justiﬁed by the research and reviewed and approved by a national ethical review body. In some instances, this can be justiﬁed; for example, where a nondominant person cannot give consent, this must be obtained from the dominant male. It would not be wise to exclude these women from a research or a procedure as long as one offers the possibility of declining, understanding as well that in some cultures this would be unthinkable. Ultimate responsibility remains with the REC.

Thirdly Levine proposes that an established international ethical review body provides advice, consultation, and guidance to national ethical review bodies when requested. Finally, in the case of externally sponsored research, the ethical review should start in initiating the country to ascertain that, even if a national ethical review board is to be consulted, and if there are modiﬁcations to the international standard, the initiating country remains with the right to either endorse or seek further consultation.

Broad Consent

One cannot conclude an article on informed consent without mentioning the latest problem faced in research – that of obtaining consent for samples from healthy people for the purpose of use in future research. With the rise of pharmacogenetics, many institutions and companies seek to have biobanks and indeed to be able to share information. There has been a debate even if a sample is information itself (since one has to manipulate the sample in such a way as to read the information). Blood in itself cannot give you genetic information without proper analysis. And yet once the blood sample is labeled, it has enough information. All that is needed is someone or something to “read” it. However, the main issue is how to obtain consent for an experiment which has not yet been conceived. Many suggest going back to the donor each time in order to explain the research and obtaining consent each time. This is very difﬁcult and will render much research either impossible or too expensive. Ways of obtaining a broad consent which is valid enough to proceed with research are still under study. One possibility is to categorize research and obtain an informed consent for each category. For example, one may consent to a category on research for innovative drugs or pharmacogenetics, but not consent to population studies. Indeed even therapeutic research can be categorized. Recital 26 of the EU directive is interpreted (Beyleveld and Townend 2004) that one has a right even to remove one’s anonymized sample from research if the research does not conform to one’s moral beliefs. A woman thus would have a right to remove her sample if the research concerns contraception, to which she may have a moral objection.

Asking for a broad consent without ways of ascertaining (or assuming) that the donor will consent to any research is naive and even deceptive. Most people will donate because they will want to help the advancement of therapy. There are clear differences between advancements of treatments from advancements of “science” (which is broader in intent) to advancement of “knowledge” (which is even more broad). Deﬁning what we mean by “broad” is therefore very important as even this has limits and parameters.

Conclusion

With globalization, the process of informed consent on a globalized ethics is one of the more controversial and contented issues, with countries found balancing that which is culture and that which related to human rights as understood within their own country. Conversely international watchdogs must see that countries conform to human rights standards even in research done in their own county. Even worse would be countries performing research in other countries and not conforming to the standards they would conform to in their own country of origin.

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