An Essay on the Principle of Informed Consent versus the Significance of Trust for the Subjects of Biomedical Research [1]

- Jon Vegar Hugaas
Cand. Theol., Ph. D. Student
Departement of Philosophy, University of Bergen
Research Fellow, The Norwegian Teacher Academy, Studies in Religion and Education
Norsk L_rerakademi VH, Amalie Skrams vei 3, P.O. Box 74 Sandviken, N-5812 Bergen, Norway
homepage: www.nla.no/jvh
E-mail: jvh@vh.nla.no
Eubios Journal of Asian and International Bioethics 12 (2002), 65-70.
Introduction

In this essay I will give a survey of the background, justification and meaning of the principle of informed consent and evaluate the significance of information (i.e. disclosure and understanding) versus trust for the subjects that give their consent to participate in medical research projects. The first part will be a general disclosure of the background, justification and meaning of the principle of informed consent. This will make up the major part of the essay. In this part I will mainly rely on the Principle of Biomedical Ethics (4th ed.) by Tom L. Beauchamp and James F. Childress.[2] My references will also be to the Nuremberg code and the World Medical Association's Declaration of Helsinki.[3] In the second part, I will give a summary of an article presenting some of the results of the Advisory Committee on Human Radiation Experiments` Subject Interview Study,[4] which I believe are of great relevance to the subject matter. Finally, against this background, I will try to give a short evaluation of the significance of the aspect of disclosure and understanding versus the aspect of trust in the process of subjects giving their consent to participate in medical research trials.

The background, justification and meaning of the principle of informed consent

The Principle of informed consent is stated in the Nuremberg Code as follows with regards to permissible medical experiments: "The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision."[5] The World Medical Association likewise states in the Declaration of Helsinki that "In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participate at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing."[6] These two quotations are a documentation of the fact that the development in biomedical research ethics has taken a new turn in the second half of this century.[7] This new turn is partly due to the experiments of the nazi-doctors during the Second World War, but it also has to do with the disclosure of a continuing violation of human rights in the name of medical science in the decades thereafter.[8] The following survey of the meaning of, and the relation between, the three principles of respect for integrity, respect for autonomy and informed consent may illustrate what this new turn in biomedical ethics is all about, and provide an understanding of the justification and function of the principle of informed consent in medical ethics and medical research ethics regarding research involving human subjects.

Integrity, autonomy and informed consent

A definition of the principle of informed consent will be given later, together with a survey of the meaning and different elements of informed consent. At this point, I will focus on the meaning of the principles of respect for integrity and autonomy and the relation between the two principles and the principle of informed consent. This means that I will focus on the justification of the principle of informed consent. The principle of respect for integrity, as I intuitively conceive it, has to do with the idea that each human being is unique as a person, and that each human life therefore is of unique value and therefore must not be violated or humiliated in any way, and the basic principles of the Declaration of Helsinki, expresses this principle in the following way with regards to medical research involving human subjects: "The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity, and on the personality of the subject."[9] However, we may ask what this word "integrity" really means?

In Webster's Encyclopedic Unabridged Dictionary, we find the word integrity explained in the following three ways: (1) soundness of and adherence to moral principle and character; uprightness; honesty; (2) the state of being whole, entire, or undiminished; and (3) a sound, unimpaired or perfect condition.[10] A much similar explanation is found in The Oxford English Dictionary.[11] This means that the word integrity may be used with reference to at least three different notions. However, not all of them are of relevance to the principle of informed consent in medical ethics, as we shall see. E. D. Pellegrino describes the relevant meaning of the word integrity for medical ethics, as follows: "Integrity has two senses of significance for medical ethics. One sense refers to the integrity of the person, of the patient, and of the physician; the other refers to being a person of integrity. In the first sense, integrity is a moral claim which belongs to every human simply by virtue of being human. In the second sense, integrity is a virtue, a moral habitus acquired by constant practice in our relation with others. Integrity belongs to all persons as humans, but not all are persons of integrity. Each sense of integrity has important implications in medical ethics."[12]

It is the first of Pellegrino's two notions of integrity (i.e. the notion of integrity as a moral claim which belongs to every human simply by virtue of being human), that is of importance for the justification of the principle of informed consent. This indicates that a person's integrity has to do with his or her dignity as a human being: What ever violates our experience of dignity, and perhaps also other people's conception of it, also violates our integrity. Of course, there is a difficulty in explaining in more detail what this mean, but even though we may not be able to give a full explanation of the essence of the concept of integrity, it is still possible to get an adequate understanding of the principle of respect for integrity, merely by focusing on examples of what kind of actions that may violate a person's integrity. It has, for instance, been pointed out that a person's integrity is linked to his identity, and that these two concepts are closely related to each other in such a way that when a person interferes with another person's identity, he may also violate the integrity of this person.[13] The same can in many cases be said for the relation between the integrity and the autonomy of a person.

The principle of respect for integrity as described in the passage above, lies at the foundation of the principle of respect for autonomy. I hope, therefore, that by explaining the meaning and function of the principle of respect for autonomy, I will shed some further light upon the function of the principle of integrity as well. It is normally held that the principle of respect for autonomy is morally justified with reference to the principle of respect for integrity, even though one cannot say that the first one is logically derived from the second one. This means that one ought to respect a person's autonomy in order not to violate his or her integrity. But what is meant by the word autonomy? The word derives etymologically from old Greek and is a compound of the word autos, which means 'self', and the word nomos, which means 'law', 'rule' or 'governance'. Today the word "autonomy" is used in quite diverse meanings, and does not refer to a univocal concept. Tom L. Beauchamp and James F. Childress have therefore pointed out that "like many philosophical concepts, 'autonomy' acquires a more specific meaning in the context of a theory."[14] However, in an essay of this kind, I do not find myself at liberty to go in detail on this question, and will therefore focus merely on the common conditions that most of the theories of autonomy can agree upon.

It is then possible to say with the words of Beauchamp and Childress that "virtually all theories of autonomy agrees that two conditions are essential: (1) liberty (independence from controlling influences) and (2) agency (capacity for intentional action)."[15] But it should at the same time be noted that Beauchamp and Childress also points out that "disagreements exists over the meaning of these two conditions and over whether some additional condition is needed."[16] In addition to the two conditions of liberty and agency that are common to most theories of autonomy, Beauchamp and Childress also adds a third one as essential: "We analyze autonomous action in terms of normal choosers who act (1) intentionally, (2) with understanding, and (3) without controlling influences that determine their action."[17] This means that a person is autonomous when this person to a substantial degree is able to act according to these three conditions, liberty, agency and understanding.

We then may say that the principle of respect for autonomy, asserts that one ought to respect a person's choice and actions when they are not harmful to others and, in addition, performed according to these three conditions.[18] If this is not done, then one violates the person's integrity. Beauchamp and Childress states this principle in both a positive and a negative form. In it`s negative form it merely asserts as a broad and abstract obligation that "autonomous actions should not be subjected to controlling constraints by others."[19] In its positive form, however, it asserts the more affirmative demand that "respect for autonomy obligates professionals to disclose information, to probe for and ensure understanding and voluntariness, and to foster adequate decisionmaking."[20]

In this formulation we recognize the three aspects of liberty, agency and understanding, which may be said to provide a link between the principle of respect for autonomy and the principle of informed consent, as we shall see later on. This means that the principle of informed consent may be viewed as a means to an end in relation to the principle of respect for autonomy, in the way that one has to respect the principle of informed consent, in order to respect the principle of respect for autonomy.[21] This is a similar relation to the one we find between the principle of respect for integrity and the principle of respect for autonomy, i.e. that one in most cases has to respect the principle of autonomy in order to respect the principle of integrity. The two principles of respect for autonomy and integrity and the principle of informed consent form a triangle in biomedical ethics, in such a way that if we accept one of them, we accept them all, and therefore we cannot turn down one of them without turning down the others as well.[22] However, the most fundamental of the three is the principle of respect for integrity, which serves as a justification of the next one, the principle of respect for autonomy, which together with the first one, in turn serves as justification for the principle of informed consent.

The definition and elements of informed consent

The principle of informed consent in biomedical ethics states in a simplified form that a patient should not be submitted to a medical treatment and that a subject should not take part in a research projects if this submission or participation is not based on the voluntary and informed consent of the person or the subject, or in the case of incompetent persons,[23] of their legal appointed guardians. According to Beauchamp and Childress, the term "informed consent" is surrounded by considerable vagueness,[24] and I will therefore in this section try to give a definition of informed consent and focus on the different elements which are compound in the informed consent, in order to cast some light on this principle of informed consent. There are at least two senses of "informed consent" that must be explained in this context. In the first sense, informed consent is analyzable in the light of autonomous choice. With regards to the contexts of medical ethics and research ethics, this means that "an informed consent is an autonomous authorization by individuals of a medical intervention or of involvement in research."[25] An informed consent in this sense "occurs if and only if a patient or subject, with substantial understanding and in substantial absence of control by others, intentionally authorizes a professional to do something."[26] Here we find that the three aspects of liberty (absence of control by others), agency (capacity for intentional action) and understanding, which earlier in this paper were said to provide the link between the principle of respect for autonomy and the principle of informed consent, are necessary and sufficient conditions for an informed consent. But there also exist another conception of informed consent, which in real life perhaps has greater significance for the decisions that are actually made regarding the subjects' participation in therapeutic procedure and research activities. Informed consent may also be analyzed "in terms of the social rules of consent in institutions that must obtain legally valid consent from patients or subjects before proceeding with therapeutic procedures or research."[27] "Informed consent" in this sense merely refers to the institutionally or legally effective authorizations determined by prevailing rules.

The relation between these two concepts of informed consent is of such a kind that an informed consent in the first sense need not be an informed consent in the second sense, and vice versa. For instance, in the case of incompetent patients one may have an informed consent from the patient's legally appointed guardian and not from the patient himself. This would then be an informed consent in the second sense, but not in the first sense, since the patient does not give the consent himself. This kind of informed consent is mentioned in the Declaration of Helsinki as follows: "In the case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation."[28] This means that the three conditions of agency, liberty and understanding in these cases will have to be fulfilled by the legal guardian. We can also imagine cases where a minor, and hence legally incompetent person, are capable of giving an autonomous authorization, but not legally authorized to consent, and therefore not in a position to give an effective consent under prevailing institutional rules. This would then be a consent in the first sense, but not in the second sense. This is also mentioned in the Declaration of Helsinki, but as we see, the demands are stronger in this case: "Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian."[29] Even though there in some cases might be a gap between the two senses of informed consent, the legal and institutional rules are necessary, and cannot be dismissed. This does not mean, however, that they may be developed independently from the first conception of informed consent. Beauchamp and Childress "take it as axiomatic that the model of autonomous choice (the first sense) ought to serve as the benchmark for the moral adequacy of institutional rules."[30]

I will now turn to the question of which elements that are compound in the informed consent. A common procedure is then to divide the elements into information and consent.[31] The information component, is then explained as the disclosure of information and the comprehension of this information, while the consent component is explained as the voluntary decision, with absence of control by others, to be submitted to a recommended procedure. However, not all will be satisfied with this explanation. Beauchamp and Childress points out that it is possible to recognize not merely two, but seven elements in the informed consent. They divide these into the following three main groups: threshold elements (which constitutes the preconditions of the informed consent), information elements and consent elements. According to Beauchamp and Childress, then, the threshold elements are: (1) competence, to understand and make decisions and (2) voluntariness in deciding; the information elements are: (3) disclosure of material information, (4) recommendation of a plan, and (5) understanding of the information and the plan that is recommended; and the consent elements are: (6) decision in favor of a plan and (7) authorization of the chosen plan.[32] Later on I will comment on and give a short evaluation of the significance of the elements of information (i.e. disclosure and understanding) and the element of trust in the process of subjects giving their consent to participate in medical research trials. I will therefore in the following passages give a short survey of the elements of disclosure and understanding, starting with the element of disclosure.

According to Beauchamp and Childress, professionals are obligated to disclose a core set of information, that must include the following five elements: (a) "those facts or descriptions that patients or subjects usually consider material in deciding whether to refuse or consent to the proposed intervention or research;" (b) "information the professional believe to be material;" (c) "the professional's recommendation;" (d) "the purpose of seeking consent;" and (e) "the nature and limits of consent as an act of authorization."[33] They also add that if research is involved, "disclosures should generally be made as to the aims, methods, anticipated benefits and risks of the research, any anticipated inconvenience or discomfort, and the subjects' right to withdraw from the research."[34] There are, however, some problems attached to the element of disclosure, such as the question of standards of disclosure and the need for intentional nondisclosure.[35] I will not comment on the first one, but the second one needs an explanation in this context.

Sometimes intentional or deliberate nondisclosure may be necessary in clinical interventions because it benefits the patient, for instance as in the case of therapeutic use of placebos. Likewise, the researchers sometimes may have to perform types of research that are incompatible with complete disclosure. For instance, could vital research in fields such as epidemiology not be conducted if consent from subjects were required to obtain access to medical records. Beauchamp and Childress therefore asserts four conditions that are essential in order to justify such a use of deception or intentional nondisclosure in research: Deception should be used only if (1) it is essential to obtain vital information; (2) no substantial risk is involved; (3) the subjects are informed that deception is a part of the study; and (4) the subjects give their consent to participate under these conditions.[36] According to these criteria, the subjects should always have an understanding of the possibility of being deceived when participating in research which include intentional nondisclosure.

I will now turn to the third information element in the informed consent, i.e. the element of understanding. Beauchamp and Childress have, with regards to biomedical ethics, said that "in recent years the focus has shifted from the physician's or researcher's obligation to disclose information to the quality of a patient's or subject's understanding and consent."[37] In the task of giving a definition of understanding one meets with several problems, and there exist no consensus among scholars about the nature of understanding. In this context, however, I will settle with the definition that "one understands if one has acquired pertinent information and justified, relevant beliefs about the nature and consequences of one's action."[38] It is commonly accepted that it is difficult to find procedures to make sure that the patients or subjects really understand the information they are given. Beauchamp and Childress points out that the professionals must in one way or another try to draw analogies between the specialized information and "more ordinary events familiar to the patient or subject."[39] This does not, however, mean that the patients or subjects have to be exposed to the total amount of information available regarding the treatment or research, the ethical demand is only that they are adequately informed and have an adequate understanding of the information concerning the treatment or research. In order to achieve this goal, the professionals will have to use all their imaginative, empathic and professional skills. This means that they should be aware of, look for, and try to prevent problems of different kinds that might cast shadows on the patients' or subjects' understanding. Such problems can be related to the information processing,[40] for instance to the possibility of so called information overload, i.e. that the understanding of the patients or subjects are prevented e.g. by the use of unfamiliar terms, or to the possibility of underdisclosure, i.e. that the information that is given is inadequate or not comprehensive enough. A third problem connected to the information processing, has to do with the language used when disclosing information about risks.

Besides the problems of information processing there also is the problem of non-acceptance and false belief,[41] and the problem of so-called waivers.[42] The first one can be explained as a "breakdown in the ability to accept information as true or untainted, even if the person adequately comprehends the information."[43] A waiver, on the other side, is a person that "voluntarily relinquishes the right to an informed consent and relieves the physician from the obligation to obtain informed consent."[44] In the last sections of this paper, I will look at the significance of the aspect of trust in the process of giving consent. I will then also try to show that the two problems of non-acceptance and false belief and the problem of waivers in fact are closely linked to the element of trust in the consent process.

The significance of trust for the subjects who consent to take part in medical research

I will now look at the significance of trust for the subjects who consent to take part in medical research, but first of all I will give some comments on the concept of research and the intention behind the use of the principle of informed consent in biomedical research ethics. It is normally accepted that society have to conduct research involving human subjects in order to solve several of it`s major problems, and WMA Declaration of Helsinki therefore states that "medical progress is based on research which ultimately must rest in part on experimentation involving human subjects."[45] Normally, there are two kinds of research that involves human subjects, the first one is so called behavioral research, such as in psychology and sociology, and the second kind is so called biomedical research, which focus on the human body, that is, on the physical aspects of it. With regards to this second kind, the WMA has stated that "in the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research."[46] This means that there in principle also are two kinds of medical research, the one that are essentially diagnostic and therapeutic, which involves subjects who are ill, and the one that are purely scientific, which involves subjects that are healthy or subjects with an illness that are of no relevance to the experimental design. The principle of informed consent, however, is normative in all kinds of research involving human subjects and must in neither of them be omitted.

In this essay, the focus is said to be on the principle of informed consent and it`s relevance for the subjects that consent to take part in biomedical research in comparison to the relevance of the aspect of trust. This does, however, not imply that the content and conclusions of this essay is of no relevance to behavioral research. A central part of the information that is provided in the processing of informed consent in biomedical and behavioral studies, is the calculations of risks versus benefits. The intention behind the use of the principle of informed consent is that the research subjects should be able to make an enlightened decision based on a reasonable calculation of risks and benefits. Potential subjects may be asked to participate in different kinds of research with different possibilities of harm and benefit for the subject. In a simplified way, we can say that there may be: (a) research which involves a possibility of harm, and no possibility of benefit for the subject, for instance in the case of students (i.e. healthy persons) that participate in research projects; (b) research which involves both a possibility of harm and a possibility of benefit for the subjects, for instance in the case of patients with incurable illness, such as persons that are tested HIV-positive; or (c) research which involves as good as no possibility of harm, but a possibility of benefit for the subjects. The first mentioned would then typically be a purely scientific and non-therapeutic research, while the second and third would be a therapeutic or clinical research. It should also be mentioned that even though there is no possibility of benefit for the subjects in the purely scientific research, there should always be a possibility of benefit for society, in order for it to be ethically justified, as stated in the Nuremberg Code: "The experiment should be such as to yield fruitful results for the good of society."[47] Persons that participate as subjects in research of this kind, then, ought to be motivated by altruism (but unfortunately for them this is not always the case, sometimes they hope for more than merely the good of society).

As already mentioned, the intention behind the principle of informed consent is partly to secure that the potential subjects get an adequate understanding of the potential risks and benefits connected to the research. However, Beauchamp and Childress points out that "clinical experience and empirical data indicate that patients and subjects exhibit wide variation in their understanding of information about diagnoses, procedures, risks, and prognoses."[48] One of the studies that may give empirical weight to such a judgement, is reported in the article "Trust - The Fragile Foundation of Contemporary Biomedical Ethics" by Nancy E. Kass (et. al.),[49] which contains a survey of the results of the Subject Interview Study, one of three projects examining contemporary human subject research, initiated by the Advisory Committee on Human Radiation Experiments in USA. The Subject Interview Study, which in itself is a behavioral study, "enrolled almost 1.900 outpatients nationwide to determine their experience with and attitudes about research,"[50] and "approximately one hundred of the patients who enrolled in this study and reported having personal experience in medical research were interviewed a second time and in greater depth to gain further insight into their reasons for participating and their understanding of the research enterprise."[51] I will now give a short summary of the findings from these interviews and some of the conclusions that the authors of the article draws about the implications for conducting ethically sound research with human subjects. It should be noted that most of the patients in the Subject Interview study had experience from therapeutic research (65 of approximately 100 patients) and that this article focus predominantly on the experiences of this group. But this does not mean that the results are irrelevant to the ethics of purely scientific biomedical research, or even to behavioral research ethics, for that matter.

Based on the results from the Subject Interview Study, the article focuses on three questions: (1) Why do patients become research subjects; (2) how significant is the element of trust in the patients' decision to become subjects; and (3) what implications should the answer to these two questions have for the conduct of research? The answer to the first question is complex and may be divided into five parts. The Subject Interview Study showed that the patients became research subjects because: (a) they hoped for benefit; (b) the had resigned; (c) they had trust in the physicians recommendation; (d) they had trust in the hospital institutions; and/or (d) they had trust in the research activity. As for the first two, these were often closely connected: "The theme of hope was often wedded to despair."[52] In the last three reasons, we find that the element of trust reoccurs as a common factor. The Subject Interview Study also tried to map the impact of the disclosure of the benefits and risks and of the subjects' understanding of the benefits and risks on their consent. The results are described in the article as follows: "Comments about the consent process underscored the importance of trust in the experience of these patients. Many participants expressed that their decision to participate had been made before they had been given the consent form to sign. They knew they wanted to participate, they trusted that it was right, and the details described in the form, were not particularly relevant."[53] Apart from this the study also revealed that the consent in many cases were based on false belief concerning the potential benefits, that the subjects also tended to voluntarily relinquish (the problem of waivers) or ignore their right to an informed consent, and that they tended to consider the research as just another treatment option: "Through further discussion, however, it was evident that most respondents, while able to articulate the broad goals of research, viewed their own participation as simply another treatment option."[54] This indicates that the answer to the second question, must be that the element of trust in the patients` decision to become subjects are very significant, and that it in fact, overshadows the element of disclosure and understanding. The third question answered in the article asked for what implications the answer to the two first questions should have for the conduct of research? As an answer to this question, I will point out that the authors of the article conclude as follows: (a) that the clinicians "should be mindful of the tremendous influence they have over their patients;" (b) that the investigators "should make it clear that their primary loyalty is to future patients;" (c) that those who oversee research "should be humbled by the trust patients-subjects have in the research enterprise," and "continue to do their best to live up to that trust;" and (d) that the Institutional Review Boards should _take measures to assure that investigators do not overrepresent the benefits of research and that all consequences of the research that relate to the patient's 'good' be explained."[55] On a more general basis the authors of the article also asserts that the stories of the patients in the Subject Interview Study "suggests that the current emphasis in research ethics on analyses of benefits and risks and on subjects' autonomous decissionmaking is insufficient," and that "the paradigm must be enriched with a sensitivity to the profound trust participants place in researchers and the research enterprise."[56]

Evaluation of the element of trust versus the element of information

I will now in the very last section of this essay sum up and evaluate the significance that I think ought to be given to the element of trust in comparison to the element of information in the paradigm of biomedical research ethics. We have seen that the potential subjects' consent to participate in research trials may be due to trust in the physicians, the hospitals, the researchers and/or the research institution. This means that the element of trust can not be excluded as a motivating factor in the process of potential subjects giving consent. However, I believe that the fact that this is so, not necessarily does constitute a problem. A consent based on trust is surely not a bad thing per se, and there need not be a contradiction between a consent based on trust and a consent based on information, disclosure and understanding. Only when the consent is based exclusively on trust in the informants and not in the information that is given, may there be a problem. Of course, this depends on what super-ordinate paradigm one chooses for one's bioethical reasoning. I belong to the group who wish to give patient autonomy priority in preference to friendly authoritarianism. An awareness on behalf of the researcher of the significance of the element of trust in the process of giving consent may help stress the importance of informed consent and the fact that the researcher not just should be looking for any kind of consent, but for an informed consent as explained in the first part of this essay. Through the process of disclosing adequate information the researchers have an opportunity to sort out the waivers, the false-believers and the subjects that are most likely to base their consent exclusively on trust in the informant as a person, rather than on the actual information provided, and as result most likely will have an inadequate understanding of what is going to happen. In order to do this the researchers needs adequate guidelines and feed-back mechanisms that may secure the process of informed consent and make it clear whether the patients have got an adequate conception of the risks and benefits of the trial, or merely have a profound trust in the persons that conduct the research project. This can be done in different ways. In the case of literates one may develop better informed consent sheets that actually are understandable for the common man and woman, with questions that have to be answered in order for the persons to be allowed to participate in the trial, in the case of illiterates and perhaps also in the case of literates, one may use video recording of meetings with oral briefing and interviews, which together with the answers from the informed consent sheets, in turn may be handed over to an independent committee for evaluation. In addition to this, one may also gather the potential subjects in groups, where they receive information and get the opportunity to ask questions in order to enrich each others understanding. Of course, in some of the more simple and straightforward trials, this may seem like a much ado about nothing, but one nevertheless has to remember that the first principle of the Nuremberg Code states that "the voluntary consent of the human subject is absolutely essential" and that "the duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment."[57] Therefore, although it may constitute a temptation for the researcher that the subjects are inclined to trust the physicians/researchers more than relating to the information they receive, he or she has a moral and professional obligation not to take advantage of this, for instance by giving inadequate information or by giving the information in an inadequate way in order to get the consent that he or she wishes. When dealing with research involving human subjects one always has to remember that it is far harder to regain trust, once lost, than to squander it in the first place.[58]

Notes

1] This essay is a re-write of a paper submitted on the Ph.D.-course Ethics and Research Policy at Department of Philosophy at University of Bergen, Autumn 1999. The aim was not primarily to establish new knowledge but to provide an account of an important topic within Western biomedical ethics. However, it may be of a certain interest in another cultural context.
2] Tom L. Beauchamp & James F. Childress Principles of Biomedical Ethics, New York 1994, 4th Ed.
3] The Nuremberg Code. From Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946 \ April 1949. And World Medical Association Declaration of Helsinki, with amendments until the 48th General Assembly in the Republic of South Africa, October 1996. Both can be found in a copy of readings used in the course Ethics and Research Policy at Department of Philosophy at University of Bergen, Autumn 1999.
4] The article "Trust. The Fragile Foundation of Contemporary Biomedical Ethics" by Nancy E. Kass (et. al.) in Hastings Center report, September-October 1996, pp. 25-29. This article can be found in a copy of readings used in the course "Ethics and Research Policy" at department of Philosophy at University of Bergen, Autumn 1999.
5] The Nuremberg Code. From Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946 \ April 1949, op .cit.
6] World Medical Association Declaration of Helsinki, with amendments until the 48th General Assembly in the Republic of South Africa, October 1996, op. cit. Basic Principle No. 9. Italics are mine.
7] Cf. K. E. Tran_y: Medisinsk etikk i v_r tid, Bergen 1994, p. 32. In Norwegian.
8] Example given, as in the case of the Tuskegee Syphilis Study, cf. the article of Allan M. Brant "Racism and Research. The Case of the Tuskegee Syphilis Study" which was published in Hastings Center Report, December 1978, pp. 21-29. This can be found in a copy of readings used in the course Ethics and Research Policy at department of Philosophy at University of Bergen, Autumn 1999.
9] World Medical Association Declaration of Helsinki, with amendments until the 48th General Assembly in the Republic of South Africa, October 1996, op. cit., Basic Principle No. 6. Italics are mine.
10] Webster`s Encyclopedic Unabridged Dictionary of the English Language, Gramercy Books, New York 1996.
11] The Oxford English Dictionary, London 1989, explains the word as follows: (1) the condition of having no part or element taken away or wanting; undivided or unbroken state; material wholeness, completeness, entirety; something undivided; an integral whole; (2) the condition of not being marred or violated; unimpaired or uncorrupted condition; original perfect state; soundness; and (3) in a moral sense: (a) unimpaired moral state; freedom from moral corruption; innocence; sinlessness; or (b) soundness of moral principles; the character of uncorrupted virtue, especially in relation to truth and fair dealing; uprightness, honesty, sincerity.
12] E.D. Pellegrino "The Relationship of Autonomy and Integrity in Medical Ethics," in P. Allebeck & B. Jansson (ed.) Ethics in Medicine, New York 1990, p. 10. This quotation is borrowed from Margareta Andersson`s Integritet som begrepp och princip, _bo 1994, p. 30. In Swedish.
13] Cf. Tran_y, op. cit., p. 38. In Norwegian.
14] Beauchamp & Childress, op. cit., p. 121.
15] Ibid., p. 121.
16] Ibid., p. 121.
17] Ibid., p. 123. Italics are mine.
18] In this context one often use the terms "competence" and "incompetence." Beauchamp and Childress explain these concepts in such a way that a person is competent if he or she is psychologically and legally capable of adequate decisionmaking, and incompetent if not. This means that competence judgements distinguish the class of individuals whose autonomous decisions must be respected from those individuals whose decisions need to be checked and perhaps overridden by a surrogate. Competence in decisionmaking is therefore closely connected to autonomous decisionmaking and to questions about the validity of consent. However, competence is a threshold and not a continuum concept like autonomy. In biomedical contexts a person has generally been viewed as competent if able to understand a therapy or research procedure, to deliberate regarding major risks and benefits, and to make a decision in light of this deliberation. A person therefore has to be judged competent in order to give an legally accepted informed consent. Cf. Ibid., pp. 132-137.
19] Ibid., p. 126.
20] Ibid., p. 127.
21] The picture will of course be more complicated in the case of persons who are judged legally incompetent. In these cases one does not have to respect the autonomy of a person in order not to violate his integrity. This does however not imply that it is justified to violate the integrity of the incompetent person.
22] By this I do not mean to say that the principle of informed consent and the principle of respect for autonomy are logically derived from the principle of respect for integrity. Cf. Tran_y, op. cit., p. 41. In Norwegian.
23] Cf. note no. 17 and 20.
24] Beauchamp and Childress, op. cit., p. 143.
25] Ibid.
26] Ibid. Italics are mine.
27] Ibid., p. 144.
28] World Medical Association Declaration of Helsinki, with amendments until the 48th General Assembly in the Republic of South Africa, October 1996, op. cit., Basic Principle No. 11. Italics are mine.
29] Ibid. Italics are mine.
30] Beauchamp and Childress, op. cit., p. 144.
31] For instance, we find an example of this in Tran_y, op. cit., pp. 41-42. In Norwegian.
32] Beauchamp and Childress, op. cit., pp. 145-146.
33] Ibid., p. 147.
34] Ibid.
35] Cf. Ibid., pp. 147-157.
36] Ibid., p. 157.
37] Ibid., p. 142.
38] Ibid., p. 157.
39] Ibid., p. 158.
40] Cf. Ibid., p. 159-160.
41] Cf. Ibid., p. 160-162.
42] Cf. Ibid., p. 162-163.
43] Ibid., p. 160.
44] Ibid.
45] World Medical Association Declaration of Helsinki, with amendments until the 48th General Assembly in the Republic of South Africa, October 1996, op. cit., introduction. Italics are mine.
46] Ibid. Italics are mine.
47] The Nuremberg Code, op. cit., No. 6.
48] Beauchamp and Childress, op. cit., p. 157.
49] Hastings Center report, September-October 1996, pp. 25-29. This article can also be found in a copy of readings used in the course Ethics and Research Policy at department of Philosophy at University of Bergen, Autumn 1999.
50] Ibid., p. 25.
51] Ibid.
52] Ibid.
53] Ibid., p. 26. Italics are mine.
54] Ibid., p. 27.
55] Ibid., p. 28.
56] Ibid., p. 27. Italics are mine.
57] The Nuremberg Code, op. cit., No. 1. Italics are mine.
58] Italics are mine. The words are originally uttered by Sisela Book and quoted by Nancy E. Kass (et. al.) in "Trust. The Fragile Foundation of Contemporary Biomedical Research," p. 28 in Hastings Center Report, September-October 1996.
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World Medical Association Declaration of Helsinki, with amendments until the 48th General Assembly in the Republic of South Africa, October 1996.
Nancy E. Kass (et. al.) "Trust. The Fragile Foundation of Contemporary Biomedical Ethics" in Hastings Center report, September-October 1996, pp. 25-29.
Allan M. Brant "Racism and Research. The Case of the Tuskegee Syphilis Study" in Hastings Center Report, December 1978, pp. 21-29.
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The Oxford English Dictionary, London 1989.

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