Selections from a draft of the "Code of Conduct for Research Involving Humans" sponsored by the Medical Research, Natural Sciences and Engineering Research, and Social Sciences and Humanities Research Councils of Canada.
PHILOSOPHICAL ISSUES IN RESEARCH INVOLVING HUMANS
FUNDAMENTAL ETHICAL CHOICES IN RESEARCH INVOLVING HUMAN SUBJECTS
ETHICAL FRAMEWORK FOR THE CODE OF CONDUCT FOR RESEARCH INVOLVING HUMANS
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PHILOSOPHICAL ISSUES IN RESEARCH INVOLVING HUMAN SUBJECTS
1. Definition of Scientific Research and Forms of Human Involvement In It
The definition of scientific research which has been proposed by CIOMS reads:
"The term 'research' refers to a class of activities designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference."[1]
Research with human beings occurs when, with a view to acquiring generalizable knowledge, an idea or hypothesis is submitted to empirical test requiring the involvement of human beings. This involvement will vary in form in different disciplines operating by different methods.
Research may involve human beings by seeking information about the person, in a variety of ways (observations, visual tests, written responses, interviews, etc.) on a variety of questions. Thus information may be sought about personal habits (e.g., smoking, alcoholism, drug use, physical activity), or about life stories (e.g., education, group history, family genealogy, psychological problems), or about behaviours (e.g., nutrition, sex, delinquency). This type of involvement of a person, whether as an individual or part of a group, has to do with his or her ability in cognitive or psycho-affective expression. Such research is a matter for ethical consideration because it touches either on the private life of an individual or on the culture of a group. In other words, the research may affect a person's or a group's identity and self-esteem.
On the other hand, research may involve human beings by requiring their physical participation. Once again, different methods are used - clinical trials, laboratory tests, taking samples, etc. - each of them entailing, to varying degrees, observation and physical, chemical or psychological interference. In such procedures the whole human subject is implicated, both mind and body. A special case arises when the subject is ill, and thus a vulnerable and fragile agent. But in all these cases, ethical considerations are involved because the research affects the integrity of the body. Because of the potential risk to life, interference in a person's body requires a careful evaluation of both the benefits and the risks of harm for both the person and the group that is concerned.
[1}. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993.]
FUNDAMENTAL ETHICAL CHOICES IN RESEARCH INVOLVING HUMAN SUBJECTS
An answer to these questions can be found by moving to the terrain of ethics and examining the justifications that have been offered for research involving human subjects. They are of three different types.
1) On the one hand research involving human subjects has been justified by its usefulness for the individual subject of research (individual goods, personal values or goals). The individual can hope to gain some personal benefit from the research. Such benefit may be of various forms - an improved treatment of illness, more attentive care, more genuine concern from health care workers, a better understanding of the illness or of oneself, altruistic satisfaction, etc. And such benefit may be more or less significant, and more or less proportional to the risks or discomforts involved in the research. This type of ethical justification is powerful for the science of medicine, but much less so in history.
2) Secondly, research involving human subjects has been justified by its usefulness for society (social goods, the common good).And social usefulness may be understood here in various ways: usefulness for society at large, or for a particular group, or for a cultural community. The social benefits obtained are various (a drug for a sickness, epidemiological information about the incidence of a contagious disease, sociological or psychological information about lifestyles or about some aspect of cultural life belonging to a particular community, etc.). Whatever the results may be, they are justified by the fact that they are useful to society as a whole or to one of its parts, whether groups or collectivities. The kind of argument used here is utilitarian, working against the background idea that scientific research leads to general social progress. And the argument supposes that there exists some sort of invisible social self-regulating mechanism which balances scientific advance, social consequences, and the economy of the marketplace. This balance may be thought of as either short- or long-term.
3) Thirdly, research involving human subjects is justified as the acquisition of new knowledge for its own sake. This justification affirms the value of knowledge for its own sake. In other words, the ageless curiosity of human beings is legitimate in and of itself, a curiosity which seeks to understand the world and the place of human beings in the world. Acquiring new knowledge is the result of the search for truth. This type of justification is to be found more often in the humanities, for example, rather than in medicine, where research on how a disease works is more likely to be justified by claims about its utility to society in the long run.
The various scientific disciplines (from medicine to education) use one or more of these types of justification. Thus in medicine, for example, one appeals typically to the direct benefit to the individual and to social usefulness. In sociology, by contrast, one appeals to the social utility of the research, as well as to the value of knowledge for its own sake. These justifications can, of course, be in conflict with one another. Nevertheless their persuasive power is strong enough in our society to permit research involving human subjects, and to overcome any notion that absolute respect for the sacredness of human beings should preclude all research involving human subjects. Several types of fundamentalist religious movements uphold just such a notion and reject all research involving human beings, whom they consider sacred and untouchable.
In working out our attitudes to research involving human subjects in our society we try to sort out these values which we consider important: respect for human beings, individual and social utility, and progress of knowledge. And in fact, since we find that research involving human subjects gives rise to many benefits for society as a whole, we work rather on finding the concrete means of ensuring that respect is maintained for individual human beings or for groups.
Thus the ethical question becomes: how can scientific research respect the dignity of persons and avoid the various forms of dehumanization? Put another way, how can Kant's famous moral imperative -- act in such a way that you always treat humanity, whether in your own person or in the person of any other, never simply as a means but always at the same time as an end -- be translated into concrete measures?
It is a matter, then, of finding moral rules to govern research involving human subjects, rules which can be justified rationally and which can secure broad agreement in society. That is to say, one is not allowed to do just anything to human subjects; research methods must be constrained in some ways. Certain limits must be set. Certain ways of proceeding must be defined - ways that respect human beings, but that also respect the other values we have been considering - individual and social utility and the growth of knowledge.
In other words, there is a moral certainty and an internal rationality on the subject of scientific research involving human subjects which can be expressed in the form of Kant's imperative. It is morally unacceptable to treat another person merely as a means (an object, a thing), and by so doing, not respect his or her human dignity. In everyday life it is easier to identify serious failures to respect persons (not informing someone of their participation in research, not asking their consent, etc.) than to enact the positive respect that is due to persons with all its moral entailments.
Our shared moral principles are enshrined historically in the Universal Declaration on Human Rights (in Canada the spirit of this Declaration is to be found in the Canadian Charter of Rights and Freedoms). This Declaration provides a moral framework, as well as a nucleus of values. It is an ethical and juridical tool which allows us to denounce abuses and failures in the respecting of persons involved in scientific research. The rules for concrete application of the principle of respect for persons in particular situations are a matter for discussion. Everyone knows that it is morally required that one respect human persons, but how, concretely, does one proceed to live up to this requirement when the person before one is a psychiatric patient who is confused, violent, or dirty? How does one get from the general principle (the Kantian imperative or the Universal Declaration of Human Rights) to knowing what to do in particular cases (for example, getting consent from prisoners to study the incidence of the HIV virus in the prison population)?
ETHICAL FRAMEWORK FOR THE CODE OF CONDUCT FOR RESEARCH INVOLVING HUMANS
Accordingly, the approach taken in this framework is fundamentally heuristic as opposed to algorithmic. The intention is to guide and evoke thoughtful actions rather than to generate formulae or algorithms for ethical decision-making. This is very much in keeping with the best uses of the four familiar principles of health care ethics.
1) The first is respect for persons, which involves at least two fundamental aspects:
2) The second is the principle of non-maleficence -- do no harm to others. Sometimes this principle is best understood as an absolute prohibition of certain types of behaviour. For example, the notion of non-maleficence is expressed in various human rights provisions, such as those forbidding torture, genocide, and the exploitation of vulnerable groups (prisoners, children, the incompetent, etc.) in research. As well, certain types of research (e.g., germ-line genetic therapy) are prohibited provisionally because there is not enough information to adequately anticipate risk of harms. Usually however, the principle of non-maleficence is interpreted in light of the principle of autonomy and in terms of the harm / benefit ratio (see below). Ordinarily autonomous individuals or those with the moral right to speak for those who lack autonomy -- those who give third party authorization -- can waive rights not to be harmed usually in order to increase the probability of benefits that may accompany the risks of potentially harmful procedures. Not harming can be extended in some circumstances to an obligation to prevent and even remove harm caused by others. Still, non-maleficence has a negative or prohibitory moral flavour, which is to refrain from actions that harm, injure, or otherwise violate the fundamental rights of persons.
3) Third is the principle of beneficence or doing good to others. In contrast to non-maleficence, beneficence moves into the positive category of doing something to provide benefits for others. The potential good produced by research can be broadly sorted along three dimensions:
From a moral perspective, the last should be a function of the first two considerations and not an independent one. Focusing then on the first and second, it is important to recognize that there can be a tension between them. In particular research projects, overall social benefit and the advancement of knowledge may be produced at the expense of research subjects. As discussed below, it is essential to take a subject-centred perspective on both benefits and harms. Thus, it would be inappropriate in medical research to ignore aspects of harm (such as fear, anxiety, and inconvenience) and concentrate solely on 'hard' biomedical indicators, like morbidity and mortality.
Beneficence has particular relevance for researchers from helping professions (health care, social work, and psychology). The presence of these individuals as researchers can well carry with it the explicit or implicit promise of benefit to the research subject.
4) Fourth is the principle of justice one criterion of which is fairness in the distribution of benefits and burdens. In research this has particular relevance in cases where categories of individuals (in particular, women) have been excluded from research studies, much to their detriment. In the CIOMS 1993 Guidelines, justice in research on human subject receives the following consideration:
"In the ethics of research involving human subjects the principle (of justice) refers primarily to distributive justice which requires the equitable distribution of both the burdens and benefits of participation in research. Differences in the distribution of burdens and benefits are justifiable only if they are based on morally relevant distinctions between persons; one such distinction is vulnerability. 'Vulnerability' refers to a substantial incapacity to protect one's own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Accordingly, special provisions must be made for the protection of the rights and welfare of vulnerable people."
B. THREE CATEGORICAL QUESTIONS
The main ethical issues are divided into three principal categories. Issues in the first category focus on the scientific validity of the research. Issues in the second category concern the overall value of the research -- value in terms of benefit for the research subject, benefit for society, and the advancement of knowledge. The third category centres directly on research subjects themselves, including consent, harms and benefits, privacy confidentiality, and exploitation. It is essential that there be affirmative answers in all three categories:
A negative answer or "No" to any of these questions means the research cannot be ethically justified.
1. Question One: Scientific Validity
The scientific validity of a research project is integral to its ethical acceptability. Research with serious methodological faults, marred by fraud, or with other scientific flaws wastes valuable resources (whether public or private), damages the overall credibility of the scientific enterprise, and puts research subjects needlessly at risk. Thus, methodologically flawed research will not only fail to contribute to scientific knowledge, it may even subtract from such knowledge because the results of the research are misleading. This is not to say that either researchers or research evaluators (whether scientific or ethical) can anticipate all potential problems in the scientific area. However, those claiming expertise in relevant scientific areas, should be more able to make better informed judgements about the likely scientific validity, as well as about the scientific significance, of the research in question.
It is essential for members of REBs to have an understanding of the main scientific elements of a protocol since some of them may be indicative of potential ethical issues. A sampling of such issues would include:
2. Question Two: Overall Value
Scientific validity by itself is not enough to ensure that the research produces the moral benefits or goods indicated in the previous section (Philosophical Approach): benefits to the research subject, overall social benefits, and the acquisition of new knowledge. At appropriate points, various parties should seriously look at research in terms of such benefits. While this duty falls on research funders (in particular the granting councils) and law-makers, it also falls on universities and particularly on the researchers themselves. It is these parties who are most likely in the best position to make informed judgements about various aspects of the value of a research proposal, and in particular, of its prospective contribution to the acquisition of knowledge. It is important for administrators and funders to take appropriate steps to ensure accountability.
3. Question Three: Dignity and Respect
Assuming positive answers to the questions surrounding scientific validity and the overall value of the research proposal, it becomes crucial to examine the research proposal from a subject-centred perspective to determine if it treats research subjects with respect and dignity. In this connection, it is worth recalling three points made earlier:
First, it is research subjects and not researchers who are at risk. Second, there is no social obligation on the part of potential research subjects to participate in research. In many cases, it is appropriate to think of research subjects as hosts who invite the researcher as a guest. Third, the crucial question for researchers and others considering the ethics of particular research projects is: how can the overall value of the particular research project be secured without compromising the integrity, autonomy, and dignity of the research subjects being studied?
1. Competent Subjects
Competent subjects, those capable of self-determination, have the fundamental right to decide whether or not to participate in particular research projects. To meaningfully exercise that right, potential research subjects have to give their free and informed consent. Such consent is the lynch-pin of ethical research on human subjects in almost all cases (with some minor exceptions), such as anonymous information used in epidemiological studies -- for it is only with such consent that interventions that would otherwise be invasive or unwarranted become justified. The REB must play a vital role in making sure that the actual process used in particular research projects to secure the research subjects' consent will fulfill this crucial moral task.
Free consent is uncoerced consent. While coercion usually involves force or the threat of force, there can be coercive offers of benefits, especially where the benefits are essential to the well-being of the subject. For instance, this occurs where essential medical services are made conditional on research participation, or where prisoners are rewarded with special parole considerations for research participation. High risk Phase I trials raise a similar problem when research subjects are recruited with, what is for them, exceptionally high compensation for participation. As already indicated, a subject-centred perspective is essential. What is or is not coercive needs to be seen from the perspective of the research subject or the community. Those who are subordinate members of hierarchical groups may feel themselves coerced by a particular invitation to participate, whereas those in a dominant position may not. The question of coercive offers can apply in such mundane circumstances as research involving students enrolled in a psychology or a commerce course, as well as research regarding ethnic communities or minority groups. As a general rule, the greater the imbalance of power between the research population and the researcher or the institution sponsoring or permitting such research, the more care should be taken in making sure consent is genuinely free and uncoerced, e.g., experiments on prisoners. The same consideration applies to situations in which the researcher also acts in a therapeutic capacity (e.g., as the subject's physician or psychologist) for the subject may feel that consent to research is essential in order to maintain therapeutic benefits.
Research on collectivities or individuals from different cultural groups can raise acutely the question of the extent to which the consent of some members of a group is sufficient for ascertaining the consent of the remainder. There is the potential for researchers to find themselves torn between conflicting moral imperatives, such as, 'Do not impose the researcher's preferred patterns of decision-making on groups under study' versus 'Refuse to sanction oppressive relationships'.
It is also important that, whenever possible, potential research subjects be given adequate time and privacy to reflect on their participation in the research protocol. Recruitment of subjects should generally be restricted to situations in which the judgement of potential subjects does not risk being impaired or compromised - such as in conditions of severe stress. Researchers should be careful to avoid using the informed consent process to badger potential subjects into agreement.
To be morally significant, consent must also be adequately informed. Almost inevitably, researchers know more about the research than do potential subjects. Unless researchers or their delegates communicate significant information about the possible harms, benefits, and uses of research, the research subject is not in a position to give informed consent. While harms and benefits are discussed below, it is important to note that the subject must also be informed about the potential uses of research. This is essential not only for privacy and confidentiality but also because subjects have the right not to participate in research that they regard as morally objectionable.
Again, a subject-centred perspective is imperative; it is the subject's perspective on the morality of the research in question that matters, not the researcher's. Thus, research on particular religious or cultural groups requires knowledge of areas of value-sensitivity for those groups. Similar considerations apply to research involving the use of gametes, zygotes/embryos and fetuses and human tissues. From a subject-centred perspective, this information must be conveyed in ways that are:
As the first is insufficient without the second, care must be taken to ensure the accuracy and comprehensiveness of information that is 'translated' into the potential research subject's 'language'. As a general rule, research subjects' requests for further information should be honoured. Extra caution must be taken with research studies that involve partial disclosure (e.g., double-blind studies) and even more so with research involving deception. Furthermore, as the potential harms and benefits of research participation mount, it is important to find operational ways of determining that the potential subject has an adequate understanding of such harms and benefits. Handing a consent form to a patient who is just about to undergo surgery for a non-emergency condition is clearly inappropriate.
It is essential that consent be secured in a form that is meaningful to research subjects. In some cultures, for example, oral consent is regarded as far more important than written consent. So culturally appropriate forms of securing consent are essential. Similarly, oral consent may be appropriate in telephone survey research. The standard of informed consent is meant to be a realistic one. It is obviously not possible for researchers to anticipate every conceivable potential effect of their research on the subject, let alone convey such information to the subject in a way that facilitates meaningful choice. Indeed, flooding the subject with information about improbable and likely insignificant impacts of the research is likely to diminish the opportunity for meaningful choice. The moral standard set here has to be understood in terms of an asymmetry between what the researcher knows or should know about the likely impact of the research on a potential subject and what the potential subject is likely to know. Informed consent does not require omniscience on the part of either the researcher or the potential research subject. Rather what is wanted is that the researcher candidly disclose all significant information including, when appropriate, the lack of information about potential impacts. Further, it is not expected that researchers convey to potential subjects a full scientific understanding of the research in question. What is crucial is that the subject have the information she or he needs to make a meaningful choice.
In some cases, there are sufficient moral reasons for relaxing the requirement that a researcher candidly disclose significant information to subjects before research takes place. This is most easily justified when the research promises significant benefits to the subject relative to likely harms, and subjects (or the person giving third party authorization) are unable to or lack sufficient time to give consent. For example, some types of medical research in emergency conditions would fit this category. There is another broad range of research which may also be morally justifiable with appropriate safeguards. This category involves research in which prior candid disclosure of information to subjects would likely compromise the scientific validity of the research. For instance, research on social perception might be compromised if the researcher's hypothesis is revealed to subjects.
In order to permit such research, there are three ethically indispensable safeguards.
Finally, consent should be seen as a process that begins with initial contact with research subjects and carries through to the end of the study. It is not enough to assume that once consent has been obtained, the process is over. Subjects always have the right to withdraw from research and must be given continuing and meaningful (not merely pro forma) opportunities to do so. New information discovered in the process may be material to the subject's continuing consent. Such information must be conveyed in a timely manner.
2. Third Party Authorization
When potential research subjects are incompetent or have their capacity for self-determination significantly compromised, other means than free and informed consent of the subject have to be found to protect the subject's dignity. This is primarily done through third party authorization. From a moral point of view, this is second best. Another person purports to make a decision about what is in accord with the subject's wishes or according to that subject's best interests. By its very nature, such consent increases the risks of the mistaken or even malign misrepresentation of the subject's interests. There are moral, as well as legal, worries about who should give third party authorization. In some cases, the legally designated party may not be the person who has the best knowledge of the heretofore competent individual's preferences. Other kinds of research raise a somewhat different issue: whether the interests of parties related to the research subject have any standing. Should, for example, the decision of the relevant third party take into account the interests of family members when deciding whether or not to permit genetic testing on someone with a diagnosis of advanced Alzheimer's disease? In such sensitive areas of research, researchers and REBs should reflect carefully about the ethical, as well as the legal, aspects of third party authorization.
Yet to infer from this that there should be no experimentation on those who are temporarily (e.g., patients in a coma or infants) or permanently incapable (e.g., those in the later stages of dementia) of giving free and informed consent for themselves could deny the development of effective therapies for members of such groups. Moreover, such a systematic denial of research on those who are incapable of consenting for themselves could be unjust by denying classes of individuals (e.g., persons with severe mental handicaps or emergency room patients) the benefits of research.
Ethically, voluntarily accepted risk is strongly preferable to non-voluntarily imposed risk. As already noted, there are circumstances in which it is appropriate to perform research on subjects from whom consent cannot be secured (e.g., comatose patients). In such cases, it is important for there to be in place various safeguards, such as third party authorization, the right of research subjects to subsequently withdraw from research, etc. In research on human subjects there are no conditions under which harms may be imposed on unwilling subjects.
To accurately evaluate the ethics of a particular research proposal, it is essential to look at the potential harms and benefits for research subjects. Once again it is important to take a subject-centred perspective. In some cases, there may be a tension between the perspectives of the researcher and the subject on the issue of harm and benefit. In medical research, the researcher may be focused on specific physical outcomes without taking into account what those outcomes mean for research subjects. In such cases, it may be easy to overlook or minimize the subject's fear, anxiety, and embarrassment (e.g., at questions probing the subject's sexuality). The researcher may also ignore a variety of 'costs' that may be imposed on the subject -- time lost, transportation and child-care expenses, fear of lost reputation (in research that probes areas which are socially stigmatized) for example. There is also the risk that researchers ignore matters that have symbolic value to research subjects and concentrate solely on tangible losses. An adequate understanding of harm will take into account religious, cultural, or other values of research subjects. The issue of benefits may also become lost. Thus, social work research in nursing homes may provide subjects with an escape from their loneliness. This may or may not in a particular instance fall into the category of 'coercive' or 'undue' offers.
Potential harms are usually discussed in terms of 'risks,' where risks are understood as a function of the magnitude of some harm and the probability of its occurrence. A similar reading can be given to benefits.
The notion of acceptable risk or safety is important not only in the specialized context of therapeutic risk, but also generally for non-therapeutic research that poses potential harms to research subjects. For the former, it is appropriate to think in terms of a risk-benefit trade-off with harms and benefits accruing primarily to the research subject. For the latter, it is essential to think of degrees of risk, some of which are acceptable and others of which are not. Acceptable risk is an inherently normative concept. It is essential to ask, "Acceptable to whom, under what condition, and given what alternatives?"
As before, a subject-centred perspective is essential. It is the research subject's good or ill that is at stake. For example, the risks of a scar or hair loss in the case of cancer treatment may be felt as a great violation of the physical integrity of an adolescent of either sex (whose self-image is developing); whereas they may be perceived as less serious by an elderly person (since loss of hair is a usual and progressive phenomenon of ageing). Similarly, the inability to respond quickly in a memory task may threaten self-esteem in the elderly by producing feelings of humiliation and anxiety. As these examples indicate, harms and benefits can be psychological as well as physical. In either case, the appropriate perspective on the importance of these harms and benefits is that of the subject. Accordingly, it is not acceptable for researchers to substitute their own standards of acceptable levels of risk or benefit for those of their research subjects. This strongly suggests caution in cases where there may be contrasting cultural norms between researchers and research populations.
Still some research barely touches the lives of research subjects (e.g., mass anonymous screening of blood or tissue samples). In such cases, a more generic judgement can be substituted for one focusing on specific individualized concerns. The more significant the potential impact on particular subjects' lives, the greater the care that must be taken in conducting the research. Such care manifests itself in attention being paid to the particular subject. As well it requires careful attention to reliable quantitative and qualitative information in similar research populations.
Finally, appropriate care crucially requires a process of communication with research subjects about potentially harmful and beneficial aspects of the research. Part of this process is the timely disclosure of risks and benefits revealed during the course of research. Only with such an open communication process will it be possible to secure the free, informed, and continuing consent of research subjects.
E. PRIVACY AND CONFIDENTIALITY
Prominent among potential harms to research subjects are those involving invasions of privacy and violations of confidentiality. An essential part of the ethically acceptable research protocol is the appropriate measures that protect the privacy of research subjects and provide adequate safeguards for confidential research data. As already noted, a subject-centred perspective should be paramount in the determination of what is or is not private. Different cultural groups and different individuals may have different conceptions of what is or is not private or confidential. In some cases, it is the type of research that is morally sensitive (e.g., into sexual or psychiatric history). In other cases, even aspects of the researcher's identity may be seen as breaching confidentiality and privacy (thus, some research subjects may be much happier with a researcher of their own gender or status). In other cases, it can be context of research. Is there, for instance, an authoritarian or even oppressive institutional context (e.g., in some countries, police have used research data to track dissidents). Even the place of research (is the research conducted in a clinic for sexually transmitted diseases?) and the manner of the researcher (e.g., a researcher who "bullies" responses from participants) can be significant.
Informed consent is once again an essential consideration. Research subjects should be told what steps will be taken to respect their privacy and protect confidential data. As indicated in the discussion of harms and benefits, subjects should be told of any significant short-comings in privacy and confidentiality safeguards (including, for example, the right of authorities to subpoena research records) so that they can make an informed choice of whether or not to enter or continue with a particular research protocol.
Protecting confidential data requires taking reasonable steps in regard to collecting, storing, and collating such data. Various technological advances -- computers, linked databases, photocopiers, faxes -- have made this task more difficult in some respects while in other respects technology has offered ways of protecting confidential data and enabling data-retrieval that is important to the welfare of research subjects. It is important for researchers to remain abreast of relevant technological developments in order to devise appropriate safeguards. The task of data protection has also been made more difficult by the changing nature of research. Larger research teams and sometimes more interdisciplinary research teams create their own challenges. So too does the need for long-term and secondary studies where linked data is important to scientific validity and overall social benefit.
In this part of the Ethical Framework a subject-centred perspective has been advanced. In the process of spelling out considerations relevant to consent, harm and benefit and privacy and confidentiality, various groups of research subjects have been identified as raising special moral concerns. These include minors, subordinate groups in hierarchical societies, prisoners, and others. With such groups there is the danger of exploitation. While it would be paternalistic to conclude that no members of such groups can consent to participation, it is clear that there may be a need for special measures to ensure that consent is genuinely uncoerced.
This Ethical Framework has introduced three principal categories. Issues in the first category focus on the scientific validity of the research. Issues in the second category concern the overall value of the research -- value in terms of benefit for the research subject, benefit for society, and the advancement of knowledge. The third category centres directly on research subjects themselves, including consent, harms and benefits, privacy confidentiality, and exploitation. It is essential that there be affirmative answers in all three categories:
In understanding this Code, the following should be kept in mind: good ethical reasoning, like good scientific reasoning, must be more than a matter of the mechanical and dogmatic application of rigid rules to fact situations. Ethical reasoning requires thought, insight, and sensitivity. As in science, peer judgement is important. In the case of ethics, peers include more than fellow researchers. Ethical peers include the larger intellectual community and society at large, including research subjects. Securing the approval of an REB should be the occasion for more than simply jumping through another bureaucratic hoop. It should be an opportunity for informed ethical reflection and discussion with ethical peers.
With the ethics of human research, there is more at stake than the approval of particular research projects: there is the well-being and self-esteem of research subjects, the trustworthiness of the scientific community, and the moral integrity of researchers themselves.
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