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Coercion (Stanford Encyclopedia of Philosophy)
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Despite this potential barrier to adequate understanding, if they are willing to devote the time and effort to do so, researchers often are able to devise creative measures for overcoming these barriers. When we go and translate, we try to use, for example, immune cells, we talk about people who guard houses So you have a particular kind of watchman in your blood However, the authors of this study concluded that understanding abstract scientific concepts, such as double blinding and randomization, could be difficult.
Coercion and Consent: Studies on the Modern State
In some countries, a process of community education acts as a precursor to the process of obtaining individual consent. A physician then provided additional information and sought individual informed consent at the monthly vaccination session. When mothers attended the first child health clinic, they received an information sheet about the clinical trial to take home for discussion with their families.
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When a mother returned for the first vaccination, the trial worker explained the study again, and, if the mother gave oral consent, the trial worker signed the information sheet. Translation and back translation of a written consent form may be one way of ensuring that information is correctly disclosed; however, this may not always be effective. Jean Pape, a researcher from Haiti, who is also on the Cornell University faculty, described the complexity of this process. To be understandable to participants, the consent form had to be in the Creole language.
Yet, the document also had to be in French, the language of the Haitian researchers. Because the consent form had to be reviewed by the Cornell IRB, a translation in English was also required. NBAC also heard about the desirability of testing research participants to understand whether and how much they understood regarding the informed consent process.
This process includes a person who counsels potential participants about all aspects of the project, helps to develop a test questionnaire that all potential participants must pass before being given the actual consent form, and is available to address participants' concerns and questions. Despite the acknowledged difficulties of administering tests of understanding, NBAC supports the idea of incorporating these tests into research protocols.
When community representatives will not be involved, the protocol presented to the ethics review committee should justify why such involvement is not possible or relevant. Involvement of Others in the Informed Consent Process. In some cultures, investigators must obtain permission from a community leader or village council before approaching potential research participants.
Yet, it is important to distinguish between obtaining permission to enter a community for the purpose of conducting research and for obtaining individual informed consent. The need to obtain permission from a community leader before approaching individuals does not need to compromise the ethical standard requiring an individual's voluntary informed consent to participate in research.
Coercion and Consent: Studies on the Modern State
An ethical problem arises only when the community leader exerts pressure on the community in a way that compromises the voluntariness of individual consent. The reports commissioned by NBAC describe a number of situations in which community leaders have been involved in the informed consent process. Nevertheless, recruitment procedures in some cultures involve community leaders whose authority does not allow individual members of the community to refuse to participate in research for which the leader has National Bioethics Advisory Commission granted permission.
Also, in some settings, authoritarian governments may limit autonomous decisionmaking by their citizens, which may affect their participation inresearch. In NBAC's view, if a country's political system or a local situation makes it impossible for individuals' consent to be voluntary and that fact is known in advance, then, because U.
However, in no case may permission from a community representative or council replace the requirement of a competent individual's voluntary informed consent. During the course of its deliberations, NBAC sponsored a survey in which researchers who conducted international research were asked about the process of obtaining informed consent in different cultural settings. You can approach the individual after you have explained the research to the chief or local leader.
Then they explain the informed consent process to their people without exerting the pressure. The best evidence of the effectiveness of this approach is when people refuse to participate. That's a good sign. They are able to refuse.
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The people in the community are then extremely reluctant to withdraw from the trial because of the collective nature of community activities. One physician described "two levels" of consent or permission: "One is community and the other is individual When you leave [the Chief], the Chief is expected to open households so there is really another level of consent [in between] At the same time, there is some uncertainty on the part of the physicians interviewed about the extent to which individual agreement to participate is voluntary.
I have been conducting a study in an African city since Had we been noticed there, the tremendous corruption would have destroyed the study. However, working in an African village would be an entirely different matter. In that situation, a study could not be conducted without the approval and active support of the community leaders.
In Mali, the study was conducted in a remote rural area in which community leaders were heavily involved. In contrast, the Malawi study took place in a large city with an established health care system and a more educated population. In this latter setting, community consent at the national or institutional level is removed from individuals and the local community, and it seems likely that consent by community leaders would not have an undue impact on the decisions of individuals.
In addition, in an urban context, it is more difficult to identify appropriate spokespersons for the larger community, especially as individuals in urban areas tend to associate themselves with many different kinds of communities. It is customary although not required in some societies for other members of a potential research participant's family to be involved in the informed consent process. In most instances, the need to involve the family is not intended as a substitute for individual consent, but rather as an additional step in the process.
Researchers in other countries also have reported on their efforts to involve the family in the informed consent process in ways that do not undermine the standard of individual consent. Marshall reported, for example, that in Nigeria in areas where traditional cultural norms are strong, the permission of a woman's husband might be required before she can enroll in research. A Nigerian physician involved in a breast cancer study noted that cancer patients often need the approval of their husbands to participate in research.
subworssulce.tk However, the physician also emphasized that in such cases, the woman's individual consent is still essential. Indeed, there is consensus that having the capacity to decide is an important precondition or threshold element for informed consent Beauchamp and Childress ; NBAC In many cases, family members may be approached before asking an individual directly to participate in a research project.
However, seeking permission from family members without engaging the potential research participants at all clearly departs from the ethical standard of informed consent. Participants in the consensus conference came from a wide range of governmental and nongovernmental agencies. The Ugandan guidelines for research specifically prohibit an investigator from relying on the permission of a community leader for the participation of community members in research. The development and adoption of this requirement of individual consent necessitated a reexamination of various aspects of Ugandan customary laws, which traditionally have demanded the subordination of an individual's wishes to those of a specified family leader, usually the father or husband.
An individual's wishes could be further subordinated to those of the community or the tribe. Although these guidelines clearly require individual consent, it is not known whether this provision is always adhered to in practice. The guidelines include a provision that allows potential participants sufficient and adequate time to confer with anyone else of their own choosing to discuss the particular features of the research and to minimize the possibility that they may be subjected to undue influence or coercion.
These examples show that it is often possible to obtain individual informed consent, which may require and indeed benefit from the involvement of family or community members, while at the same time preserving cultural norms. Such involvement ranges from providing written information sheets for potential participants to take home and discuss with family members to holding community meetings during which information is presented about the research and community consensus is obtained. In nocase, however, may a family member's permission replace the requirement of a competent individual's voluntary informed consent.
Some cultures customarily require the permission of a woman's husband, if she is married, or her father, if she is unmarried, before she can enroll in a research protocol. A strict requirement that a husband must first grant per- mission before researchers may enroll his wife in research treats the woman as subordinate to her husband and as less than fully autonomous. If the requirement of spousal authorization, in addition to individual informed consent, were applied equally to enrollment of men and women as research participants, it would at least constitute gender equity.
But in cultures in which spousal authorization for participation in research is customary, it appears always to be the woman who must obtain her husband's permission. Much research is directed at conditions that affect both women and men. In reality, without involving the husband in the consent procedures, it may be impossible to conduct some research on common and serious health problems that affect only women.
In such cases, a likely consequence would be a lack of knowledge on which to base health care decisions for women in that country. The prospect of denying such a substantial benefit to all women in a particular culture or country calls for a narrow exception to the requirement that researchers use the same procedures in the consent process for women as for men, one that would allow for obtaining the permission of a man in addition to the woman's consent.
However, ethics review committees may accept a consent process in which a woman's individual consent to participate in research is supplemented by permission from a man if all of the following conditions are met:. In no case may a competent adult woman be enrolled in research solely upon the consent of another person; her individual consent is always required.
Voluntary Participation in Research. A fundamental principle of research ethics is the requirement that participation be voluntary-that is, "free of coercion and undue influence" National Commission However, among the most difficult requirements to ensure is the voluntariness with which participants consent to enroll in a study.
Pressure from a community leader, the power and authority of the medical professionals who serve as investigators, and the fear of loss of health benefits that people would normally expect to receive may compromise individuals' freedom to refuse to participate in research. The provision of medical care and treatment during a study may constitute an incentive for individuals to enroll in a study, but it should not be construed as a coercive offer that would unduly compromise the voluntariness of participation.
It is likely to be difficult to decide when a study design constitutes an undue influence. One definition states that "undue influence There are many circumstances that can cause undue inducements to participate in clinical trials, including offers of medical care not otherwise available or offers of money. Someone without access to medical care may be unduly influenced to participate in research simply to receive such care" CIOMS , This situation is likely to exist in developing countries in which large numbers of people have little or no access to medical care and treatment even for ordinary illnesses, a concern expressed to NBAC in testimony.
It is necessary, then, to answer the threshold question of whether the very offer to participate in research constitutes an undue inducement to citizens of developing countries who have little or no access to medical care and treatment Bernstein Even a placebo-controlled trial offers such individuals a 50 percent likelihood in a two-arm trial of receiving an intervention that, although unproven, may be beneficial. If the solution to this fundamental problem is to forgo research entirely in such places, it might make those populations worse off than they would be if research goes forward.
But the need to attempt such a balance can be avoided if a proper distinction can be made between acceptable inducements and those that constitute undue influence or coercion.