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Ethics Human Conduct

THE ETHICAL CHALLENGES RELATED TO DESIGNING A RESEARCH PROJECT IN A SPECIFIC FIELD OF CLINICAL PRACTICE

INTRODUCTION-

Ethics is a branch of philosophy dealing with values relating to human conduct, actions or behavior with respect to the rightness and wrongness of certain actions and to the goodness and badness of the motives and ends of such actions. (http://dictionary.reference.com/browse/ethics)

Prof. Tangwa of the University of Yaoundé defines ethics as being limited to the acts, actions and behaviors that are free, purposive, intentional and liable to impact on other creatures. He says that it is plausible to argue that if only a single individual existed in the universe that individual would have no need for ethics or morality as anything he choose to do would be right or rather neither right or wrong.(Tangwa, 2008)

Every society where research is been carried out demands that the researcher plays his role in a manner that will publicly be acceptable even when the confines of that acceptability are ill-defined. Ethical challenges in research are sometimes unavoidable and usually go un-noticed during the course of the research. The job of ensuring that the participant's rights are not violated is the sole responsibility of the researcher.

Chilengi (2008) explains this responsibility of the researcher by arguing that if the participants understands and accepts that the research is ethically motivated or is intended for their own good and ultimately that of their community and society at large, they may decide to commit themselves to the success of the research.

I will begin the discussion by defining certain key terms; this will be followed by a brief overview of a clinical research project and its ethical challenges.

DEFINITION OF TERMS

Participant - The human participant is a living individual about whom an investigator conducting research obtains.

1. data through intervention or interaction with the individual, or

2. identifiable private information

(University of Illinois - IRB)

In other words, this is the individual upon whom the researcher performs the study.

Serodiscordant Couple - The term serodiscordant couple is usually used to refer to relationships where one partner is living with HIV and the other is not. Technically speaking, however it can be used for any relationship where one person's blood test positive for a virus and the other does not. (http://std.about.com/od/glossary/g/serodiscgloss.htm)

Having understood these terms lets move on to understand the ethically challenges that a researcher may face whilst designing the below project.

CLINICAL RESEARCH PROJECT TOPIC TITLE

Designing a group based intervention to promote condom use in HIV serodiscordant couples.

A research topic originally carried out by McGrath et al. and reviewed by Marshall, P.A. {2007} both of the Case Western Reserve University.

Description-

This research project will involve the enrollment of participants from a Nigerian village who had been identified as being infected with HIV. These men and women will be asked to bring their primary sexual partners for HIV counseling and testing. Any couple determined to be serodiscordant, will be individually consented and enrolled for participation.

ETHICAL CHALLENGES

Research Challenges with sensitive issues

A research on HIV may be regarded as a sensitive one because according to Draucker et al (2009) a research might be classified as sensitive if identification of the study participant would result in stigmatization and dissemination of findings could harm a social group. He defines a sensitive topic as “one that potentially poses for those involved a substantial threat, the emergence of which renders problematic for the researcher and/or the researched, the collection, holding, and/or dissemination of research data”.

Research participants are often not willing to discuss very sensitive subjects like their HIV status or condom use except they know how the information will be used and are assured that their anonymity and status will be not be revealed.

There is also the risk that exploring sensitive topics might induce or exacerbate emotional distress in the individual, particularly if the issue is related to traumatic and stigmatized events like revealing ones HIV status to a partner or to other members of a social group.

Griffin & Balandin explains McCarthy's (1998) article as regards personal topics like.

According to them, and I quote McCarthy argued against putting private issues beyond research bounds, provided that people were “willing to share their experiences and certain conditions are in place to ensure their contributions are respected as individuals and they are not exploited”.

Informed Consent

Marshall (2007) argues that there are universal challenges involved in achieving truly informed consent for trials from individuals with low level of education and who are stigmatized from AIDS.

In designing this research project, the HIV infected participants have to disclose their HIV status to their partners who in turn must be willing to receive counseling and testing to determine their HIV status.

Mystakidou (2009) suggests that obtaining a truly informed and culturally relevant consent is fundamental to ethical research conduct and of particular importance in populations of non-Western societies, where illiteracy and unawareness of medical rights prevail. In these societies, he mentions that it is therefore questionable if informed consent is properly implemented and if the prospective subjects understand the concept, its process of administration and its implications.

Carrying out a research of this kind in a village where literacy level is low could present as an ethical challenge.

Obtaining a signed informed consent is not a guarantee that the participant has truly understood the proposed research and Crigger et al. (2001) explains that research conducted on populations in developing nations might present an ethical challenge because they might not have sufficient knowledge of the research implications and even when they do, a lot goes unnoticed.

Providing adequate and comprehensible information remains the principle pre-requisite of the informed consent process and all study-related procedures should be presented in a language understood by the participant thus enabling him/her to fully comprehend the design, risks and potential benefits of the clinical study. Hence the subjects might be unable to assimilate the study information. (Crigger et al., 2001)

Language can limit communication between the researcher and participants leading to misunderstanding and miscommunication about the intents and details of the research which may appear to be an ethical challenge.

Marshall & Rotimi (2001) also dealt with issues of language barrier and illiteracy as an ethical challenge in research. They observed that acknowledgement of research consent by natives was difficult since most participants where not learned.

Disclosure of seropositivity to partner - Stigma and Discrimination, privacy and confidentiality

The stigma and discrimination associated with the HIV epidemic can affect the participants while screening the population for the disease, hence the researcher should take into consideration an individual's right to refuse HIV testing and subsequently participation (Mystakidou, 2009).

A major requirement for the research was that the participants had to disclose their HIV status to their partners; this raises an ethical challenge like the privacy right for sexual risk information of ones HIV status.

The willingness of the partner to get involved in the research and give his consent might also be questioned.

Since the research will be conducted in a focus group, the thought of discussing such personal details with other participants may be an ethical challenge. This is because most traditional norms and culture in Africa condemn the discussing of such issues in public. Hence, it is suggested that requesting or insisting on condom use may be regarded as a violation of their cultural norms and practices due to different cultural dynamics pertaining to sex, since condoms are considered to be associated with unfaithfulness, promiscuity and extra-marital affairs

Mystakidou (2009) mentions that women consenting for research are subject to their husband's control, religious coercion or social hierarchies which are conditions under which free informed consent is not feasible to obtain and that women are more prone to discrimination from their partners, families and community members.

The Community

Every community is made up of individuals with different social, cultural and traditional values. In carrying out a research on HIV in a developing country, certain rural areas may face the challenge of a non-existing Ethics Review Committee {ERC} who are unable to conduct reviews on the research and take responsibility of the rights of the participants and especially the risk and benefits of the research to the community and the scientific/moral integrity of the research design.

Marshall (2007) proffers a solution; she mentions that individuals who are knowledgeable about the cultural environment probably a native of the community could serve as a “local context reviewer” to represent the committee. But the selection of an ERC member still remains a challenge as the professional competence and qualification of the representative is a thing of concern.

She mentions that even when consent has been obtained, research into HIV prevention in a culturally diverse setting requires local knowledge of the cultural taboos, privacy policy, gender roles and sensitive nature of sexual issues.

Because of cultural barriers, research participants in the developing world might give consent that is uninformed by Western standards. In most settings in Africa due to cultural barriers, truly voluntary and valid informed consent may be difficult to obtain (Mystakidou, 2009)

Incentives for study participation - Participant's autonomy

Human research in developing countries of the world where the rights of the individual is not protected creates an ethical challenge. While carrying out a research of this kind, the right of the participant to self-autonomy needs to be respected.

The researcher needs to decide whether or not he has to get involved in the treatment of his HIV positive participants.

In the area of HIV/AIDS, the possibility of access to treatment plays an important role in motivating individuals to participate in research.

“The voluntary nature of consent for participation may be questionable when individuals feel compelled to participate in a project in-part because they believe that if they do not , their medical care will be affected” (Marshall, 2007)

Some individuals and communities may be vulnerable to exploitation because of their poverty or social status hence the choice of whether or not to consent to participation in the research might be influenced by whether the researcher offers incentives in the form of money or Anti-retrovirals. Because apart from been educative, the research might have no direct financial benefits to the subject. In such a case where the participants are poor, an ethical dilemma arises where incentives in any form may induce participants to enroll in the research despite having little understanding of the research methodology.

CONCLUSION

Research ethics deals with how the researcher treats his participants or volunteers.

To reduce the ethical challenges in a research, the participant's should be provided with sufficient information prior and during the research. If conducted in a rural setting, the services of local chiefs or interpreters should be sought before commencement of the study.

A belief that individuals have the capacity to exercise free will to act voluntarily and with self determination is an essential aspect of the ethical principle of respect for persons. This principle of respect for persons is governed by the principle of beneficence which is an obligation that the researcher acts in a way that benefits the health and well-being of participants in the study and non-maleficience which involves the obligation to do no harm.

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