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Abstract

In addition to individual prior informed consent, the issue of obtaining community-level consent is receiving increasing attention. This is stimulated by advances in the omic sciences, acknowledgment that both the conduct and application of research results have impacts at the level of the community in which research is undertaken, acceptance that a community can have a moral status so that it can be the subject of bioethical reﬂection and analysis, and the continuing attention to research in developing countries. The communities that arise in health care research take many forms and exist in a multitude of local, global, or virtual contexts. Although developing a single ethics guideline suitable for all types of communities is problematic, it is nevertheless important to engage in developing a framework of principles and approaches that can be applied to decision-making on community assent on a case-by-case basis. The term “consent” is reserved in this essay for processes conducted with an individual; the term “assent” is preferred at the level of the community. The reasoning is that bioethics considerations on an individual level are sufﬁciently different from those on the community level to recommend using a different terminology.

Introduction

The entry starts by sketching the relationship and history of individual-focused informed and community assent, providing clariﬁcations and deﬁnitions regarding consent, assent, and community. Considerations are offered on the moral status of a community and the question if a community can be an agent capable of holding collective rights and duties. An overview is then made of the nuances and complexities that must be taken into account when making decisions regarding community assent and the problems of the practicality of conducting assent. In spite of the challenges of developing ethics guidance for community assent, some principles and approaches that can be applicable on a case-by-case basis will be identiﬁed, followed by a sketch of the main situations in which community assent is required. The position will be presented that community assent must be understood as being a process. The closing comments include reﬂections on the directions in which discussions on the ethics of community assent would do well to develop.

Background Of The Issue

Conducting an appropriate individual informed consent process has a central role in both the practice of medicine and the conduct of research, with securing prior, free, informed consent from all individuals being essential (but not sufﬁcient) to justify medical interventions. Discourses on community consent came to the fore in the 1970s, stimulated by controversial land use, mining, and dam building projects in developing countries that had not obtained indigenous communities’ agreement. The principle was established that communities have the right to participate and to give their free, prior, and informed consent throughout the whole project life cycle (World Bank 2004).

Historically, community-level reﬂections have mainly arisen in the area of population-focused public health regarding questions such as water ﬂuoridation and vaccination policy. The lobbying work and resulting engagement with the HIV-AIDs community starting at the end of the twentieth century have been an important stimulation of advances in community ethics reﬂections. Developments in the ethics of community assent are frequently driven in the twenty-ﬁrst century by developments in emerging omic sciences and the application of bioinformatics that enables the location or “creation” of new communities. Debates also continue to be driven by reﬂections on the impacts for a disadvantaged community where research is conducted and impacts that ﬂow from the research results on the community level.

Conceptual Clarifications And Definitions

The communities that arise in health care research take a great variety of forms, existing in a multitude of local, global, or virtual contexts, all set in a dynamic and competitive research environment. It is not surprising that there is no universal deﬁnition of “community” that does justice to all these contexts and factors. However, a “community” in a health context must as a minimum be based on a shared characteristic that impacts on health, such as a disease, family origin, geographic environment, economic situation, genomic characteristics, and health-relevant culture, ethnic background, or values.

For the sake of clarity, the term “consent” is henceforth reserved in this essay for processes conducted with an individual (or their duly appointed representative). Regarding the level of the community qua the interest of the community, the term “community assent” will be used. The reasoning is that the relevant bioethics considerations on an individual level compared to the community level exhibit differences that recommend using a different terminology.

Ethical Dimension

Moral Status Of Community

Can a community have a moral status so that it can sensibly be the subject of bioethical reﬂection and analysis; can a community be an agent capable of holding collective rights and duties held by a community qua the community, thus deserving respect and protection, with a particular set of community ethics principles being appropriate? Or should a community only be viewed as comprising a bundle of individual rights claimed collectively, therefore not deserving of any particular ethics analysis?

Weijer and Emanuel (2000) have developed a matrix framework for the systematic analysis of communities that illustrates the breadth of the differences between communities, indicating that it is difﬁcult to argue that all communities can readily be treated as a moral agent. However, another approach to identifying the moral status of a community is to make a distinction between a community as agent (i.e., the subject, the actor) and a community as a “patient,” i.e., a deserving recipient of ethical consideration. Accepting that not all communities have the cohesiveness to justify being a moral agent, granting a community the status of “moral patient” means that what is done to the “patient” is not a matter devoid of ethical content but can be evaluated as being right or wrong, with communities having varying degrees of vulnerability (requiring that protection measures be taken).

This essay accepts that a community can be a moral agent and be attributed collective group rights such as a right to sovereignty over their natural resources and can be deemed a moral patient deserving of protection, although all such claims require careful evaluation.

Community And Assent: Nuances, Complexities, Context, Practicalities

As hinted above, attempts to establish a generalized “ethics of community assent” is problematic when noting that the term “community” is applied to a wide variety of human associations in a myriad of situations. The horizontal axis of Weijer and Emanuel’s matrix framework (2000) lists seven types of community: aboriginal, geographic/political, religious, disease, ethnic/racial, occupational, and virtual (to which the author suggests a community deﬁned by a variation in the genome must be added). The vertical axis contains a number of community characteristics, several of which concern differences in community organization, decision-making structure, and cultural factors. It is therefore not surprising that the literature and normative documents surrounding community assent use different language and take different positions, some of which are now outlined.

Various verbs are used in the literature to describe the content of a community’s input (in addition to “assent”), such as agreement, approval, or permission. Verbs such as “to consult” are used, suggesting that a community can be given a more interactive role than simply being an assenting or dissenting gatekeeper and that varying power relationships can exist between a community and researchers. These reﬂections are particularly relevant in situations where the research originates outside the research communities (CIOMS 2009).

The literature also uses different terminology to denote who should take a decision on behalf of a community, e.g., a council of elders, a village council, the designated authority, the community leader, a community representative, and a community proxy. Should, however, principles of procedural justice be applied to evaluate which party can be accepted as decision-makers on behalf of a community, using the fairness and the transparency of the process that invested power as criteria?

One contextual nuance that must be examined when making decisions on community assent is to clarify who is deﬁning the community and why they are making this classiﬁcation. A community can be deﬁned by the community members themselves or be externally identiﬁed and deﬁned without obtaining the agreement of the members. This differentiation is relevant because “community” is a term that can never be dissociated from the social perceptions of the members or those people outside the community. (HUGO 2000). Whether a “community” has formed itself or been externally identiﬁed has implications for claiming or being attributed advantages and disadvantages and intrinsically involves exclusion and inclusion (Richter et al. 1999).

In addition to reﬂections on moral status, the feasibility of entering into an assent process with a community must be analyzed. Differences in the cohesion and structure of communities are often a practical constraint, i.e., if there is no clear instance that can credibly represent a community. This leads to the question if community consent is only justiﬁable if a community structure brings forth a representative authorized to make binding decisions on behalf of its members (Weijer and Emanuel 2000). Following on from this thought, is it conceivable that a community could have the moral status that would require that their assent be sought but lack the cohesion and structure to identify a representative? What process should then be undertaken? Practical obstacles do not necessarily nullify rights but can demand considerable ﬂexibility and sensitivity in ﬁnding ways to express a right, possibly by designing some form of consultation process.

Conducting research in an economically disadvantaged community (that has limited access to health care and a weak public health infrastructure) must be responsive to the health needs and the priorities of those involved in the research with the resulting beneﬁts being fairly shared and available to the population or community (CIOMS 2009). These stipulations arose from the need to prevent the exploitation of impoverished populations.

Ethics Principles And Approaches

It has been argued that a community can be a moral agent or patient in spite of the considerable nuances and complexity of a “community.” However, hopes of developing a single ethics guideline suitable for all types of communities may be “doomed to failure” (Weijer and Emanual 2000). It is nevertheless important to engage in collating and developing the ethics principles and approaches that can be applicable to community assent on a case-by-case basis. Therefore the main ethics principles and approaches that arise regarding community assent will now be outlined.

Mirroring the principle that underlies informed consent, namely, the principle of respect for persons, a backbone for community assent is the principle of respect for a community. One of the fundamental ways of expressing respect for persons is to show respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination (CIOMS 2009). The parallel approach regarding a community is to show respect for their self-determination.

Another way of expressing respect is to adhere to the principles of showing respect and sensitivity to local norms and traditions and to respect diversity (UNESCO 2001), subject to some conditions that are outlined below. Respect can be expressed by conducting some form of assent process, starting with sharing the necessary information (which at the level of a community is a challenge in itself).

The principle of respect for communities is also expressed by acting: to protect needy communities, especially in developing countries that are vulnerable, due, for instance, to a shortage of resources and access to health care. Both the act of conducting research and the results of research can create or exacerbate vulnerability. For example, geneticists and other -omic scientists increasingly direct their research toward a speciﬁc community, searching for genetic or genomic determinants of disease. If the research identiﬁes that some people have a disease predisposition, the result can be a vulnerability to employment and insurance discrimination.

The human rights discourse has some relevance for community assent: human rights can be placed into three categories: civil–political, socioeconomic, and a contested “third generation” category that represents the claims of peoples and groups. This third generation includes the self-determination of peoples, special rights regarding ethnic and religious communities (e.g., to the enjoyment of their own cultures, languages, and religions), and the right to development. Contested claims to development have been recognized in the 1981 African Charter on Human and Peoples’ Rights (Organization of African Unity 1986).

Finally, a teleological, consequentialist approach can be applied in deciding whether to undertake an assent process that requires identifying and comparing all consequences of so acting. In addition to health-related beneﬁts and possible risks resulting from research, the suggestion has been made that upholding a good relationship between researchers and their research community contributes to the success of an intervention and that conducting an appropriate assent process and committing to an appropriate level of community involvement impacts positively on successfully addressing the research question.

Application Of The Principles: Two Main Situations Where Community Assent Is Required

One of the main situations in which community assent is required is derived from the duty to respect and be sensitive to cultural diversity and culture. As the Nufﬁeld Council points out (2002), a characteristic of externally sponsored research carried out in developing countries is that there are often cultural differences between the researchers and the host country that should be respected (UNESCO 2005; EGE 2003). This is illustrated by the African Charter on Human and Peoples’ Rights (that came into force in 1986, being ratiﬁed by more than 40 African states) that reads that not only do individual rights exist but also duties toward the community (Organization of African Unit 1986).

However, if a duty exists to seek assent at the level of the community, the question that bioethics needs to address is how to reconcile the individualistic imperative of obtaining free and prior informed consent, with a duty toward a community that may be in conﬂict with the right to individual self-determination. The global consensus is that the duty to respect and uphold the principle of individual informed consent takes priority over the communal. The duty to respect and be sensitive to other cultures may not override the central requirement of respect for persons (which requires that we refrain from conducting research without individual consent). Although the importance of cultural diversity should be given due regard, such considerations are not to be invoked to infringe upon human dignity, human rights, and fundamental freedoms (UNESCO 2005). Obtaining freely given informed consent to participate in research must (if at all possible) be obtained from each participant even in diverse cultural contexts (CIOMS 2009).

The prima facie principle of respecting diversity, culture, and tradition should however not be ignored. The consensus is that this conﬂict be pragmatically resolved by amending the process so that the assent be obtained before approaching prospective subjects for their individual consent (EGE 2003).

Another justiﬁcation for conducting an assent process is one of prudence and practicality in situations where consent at the level of the individual is impossible or impracticable (Nufﬁeld 2007). The fact that obtaining consent would be costly or burdensome should not justify claims of impracticality or impossibility. A reasonable claim would be that pursuing individual consent cannot be done because the people cannot be identiﬁed or where pursuing consent would be so time consuming as to render the research project as being nonsensical or unable to fulﬁll its aim. The action that is required in this situation is to ﬁnd an appropriate representative or group (i.e., selected in a fair and just process), who should be informed and asked to give a surrogate or proxy assent. This justiﬁcation of assent has a different moral quality and foundation compared to conducting an assent process derived from showing respect for a community, prior to seeking individual consent.

Community Assent As Process And Partnership

The position has been established that informed consent must be understood as being a process and not a static event; the same can be asserted regarding community assent, particularly in the context of a research in a developing country. Procedural ethics principles of fairness, inclusivity, accountability, and transparency of processes and communication should be applied to the design and execution of an assent process; taking this action will contribute to conferring ethical and political legitimacy to a project (Dickert and Sugarman 2005). Once again, particular attention is needed to involve the community if the intervention originates outside that community or outside the country in which the community is located.

The terminology used to describe the relationship between community and the research team includes a partnership, a consultation, a participatory process, a shared responsibility, and a community as party in negotiations. This terminology suggests that a good community relationship is rather long term and interactive compared with assent being conducted as a closed process. This is congruent with the accepted norm of development ethics that developed country agents must act in a collaborative and capacity-and capability building manner with host countries. In addition to an assenting (or dissenting) role, concrete tasks for a community might include consultation on some points of a research protocol, formulation of compassionate use and incidental ﬁndings strategies, setting a strategy for access to data and samples during and post-project, etc.

An example of a country that has taken this approach is Uganda. The Ugandan research guidelines refer to community advisory boards (CAB) that should be established by study investigators (working with the locals) as a forum for facilitating dialogue between community members, study volunteers, and researchers. CAB members are largely identiﬁed from communities where research is to be undertaken through a stakeholder consultative process. (UNHRO 1998) The establishment of a CAB is “an opportunity to adopt a relationships paradigm that enables researchers to anticipate and address the context in which communities understand risks and beneﬁts, and individuals give consent. A CAB should provide a mechanism for community consultation that contributes to protecting communities, and fostering meaningful research particularly when no fairly chosen genuine representative exists for a population. (Quinn 2004).

Conclusion

Attempts to establish a generalized “ethics of communities” is problematic, with the term “community” being applied to a wide variety of human associations in a myriad of situations. The feasibility of entering into an assent process with a community may also be difﬁcult due to the considerable differences in the cohesion and structure of communities. However, practical obstacles do not nullify rights but demand ﬂexibility and sensitivity in trying to ﬁnd ways to express the rights that are due. The form and timing of assent needs to be reviewed according to the cultural and traditional norms that are prevalent in a research context. An assent process can fulﬁll a number of principle-based duties and perform a number of practical roles. For instance, Diallo et al. (2005) comment that following a community permission process should not be seen as competing with the individual informed consent process. It rather initiates and facilitates the process of disclosure for individual informed consent, fulﬁlling four requirements for the ethical conduct of clinical research in developing countries: the need to establish a collaborative partnership, the minimization of risks to the community, disclosure of information, and evidencing and demonstrating respect for subjects.

Looking to the future and some of the issues that are open regarding assent, the action to be taken if community assent is refused, thus robbing individuals of their rights to autonomous decision-making, is in need of reﬂection. The debate also needs attention as to whether communities should be involved in deﬁning research priorities, agendas, and questions rather than allowing academia, funders, and the commercial sector to drive decisions. A further point for ethics reﬂection is that a community may not only have rights and interests but also responsibilities toward research such as assuring the successful and acceptable completion of a project (UNAIDS 2004). Perhaps, acknowledging and empowering a community to be able to fulﬁll such responsibilities would be the ultimate way of showing respect for a community.

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