Proceedings of an expert workshop on community agreement for gene drive research in Africa - Co-organised by KEMRI, PAMCA and Target Malaria

Gene drive research is progressing towards future field evaluation of modified mosquitoes for malaria control in sub-Saharan Africa. While many literature sources and guidance point to the inadequacy of individual informed consent for any genetically modified mosquito release, including gene drive ones, (outside of epidemiological studies that might require blood samples) and at the need for a community-level decision, researchers often find themselves with no specific guidance on how that decision should be made, expressed and by whom. Target Malaria, the Kenya Medical Research Institute and the Pan African Mosquito Control Association co-organised a workshop with researchers and practitioners on this topic to question the model proposed by Target Malaria in its research so far that involved the release of genetically modified sterile male mosquitoes and how this could be adapted to future studies involving gene drive mosquito releases for them to offer reflections about potential best practices. This paper shares the outcomes of that workshop and highlights the remaining topics for discussion before a comprehensive model can be designed.

Proceedings of an expert workshop on community agreement for gene drive research in Africa - Co-organised by KEMRI, PAMCA and Target Malaria

Gene drive research is progressing towards future field evaluation of modified mosquitoes for malaria control in sub-Saharan Africa. While many literature sources and guidance point to the inadequacy of individual informed consent for any genetically modified mosquito release, including gene drive ones, (outside of epidemiological studies that might require blood samples) and at the need for a community-level decision, researchers often find themselves with no specific guidance on how that decision should be made, expressed and by whom. Target Malaria, the Kenya Medical Research Institute and the Pan African Mosquito Control Association co-organised a workshop with researchers and practitioners on this topic to question the model proposed by Target Malaria in its research so far that involved the release of genetically modified sterile male mosquitoes and how this could be adapted to future studies involving gene drive mosquito releases for them to offer reflections about potential best practices. This paper shares the outcomes of that workshop and highlights the remaining topics for discussion before a comprehensive model can be designed.

There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model

Challenging western research conventions has a strong documented history in Indigenous critical theory and Kaupapa Māori research discourse. This article will draw from the existing research in these fields and expand on some of the core critiques of the biomedical model in Māori research environments. Of interest are the tensions produced by an over-reliance on individual informed consent as the panacea of ethical research, particularly when the research concerns communities who prioritise collective autonomy. These tensions are further exacerbated in research environments where knowledge is commodified and issues of knowledge ownership are present. Continuing a critique of the informed consenting procedure, this article considers its role in emulating a capitalist exchange of goods and perpetuating a knowledge economy premised on the exploitation of Indigenous people, resources and knowledge. Finally, this article will consider emerging ethical concerns regarding secondary data use in an era of big data.

TINJAUAN TERHADAP DOKTER YANG MENANGANI PASIEN GAWAT DARURAT TANPA MENGGUNAKAN INFORMED CONSENT

<p>Abstract<br />This journal aims to determine the legal consequences of emergency medical treatment without informed <br />consent. This research is a normative perspective. As science is perspective, the science of law study law <br />purposes, the values of justice, the validity of the rule of law and legal norms. This research approach using <br />the statue approach. Legal materials research using primary and secondary legal materials. Mechanical <br />collection of legal materials research through library research / study documents and subsequently <br />analyzed by deduction, the analysis to draw conclusions from things that are common to be the case that <br />individual. Informed consent is mandatory before doctors perform medical procedures on patients. In the <br />absence of informed consent then there is no agreement before medical treatment. In the absence of <br />informed consent is the legal protection of the doctor and the patient is minimal and there is no agreement <br />between the patient and the doctor. Legal consequences arising in the absence of informed consent was <br />not inflict a loss of a doctor giving a feat obligation to the patient. <br />Keywords: Legal consequences; Informed Consent; Agreement; Exception</p><p>Abstrak<br />Jurnal ini bertujuan untuk mengetahui akibat hukum dari penanganan medis gawat darurat tanpa <br />menggunakan informed consent. Penelitian ini merupakan penelitian normatif yang bersifat perspektif. <br />Sebagai ilmu yang bersifat prespektif, ilmu hukum mempelajari tujuan hukum, nilai-nilai keadilan, <br />validitas aturan hukum, dan norma-norma hukum. Pendekatan penelitian ini menggunakan pendekatan <br />undang-undang. Bahan hukum penelitian ini menggunakan bahan hukum primer dan sekunder. Teknik <br />pengumpulan bahan hukum penelitian ini melalui studi kepustakaan/studi dokumen dan selanjutnya <br />dianalisis dengan teknik deduksi, analisis untuk menarik kesimpulan dari hal yang bersifat umum menjadi <br />kasus yang bersifat individual. Informed Consent merupakan hal yang wajib sebelum dokter melakukan <br />tindakan medis terhadap pasien. Dengan tidak adanya informed consent maka tidak terjadi perikatan <br />sebelum penanganan medis. Dengan tidak adanya informed consent maka perlindungan hukum terhadap <br />dokter dan pasien sangatlah minim dan tidak terdapat perikatan antara pasien dan dokter. Akibat hukum <br />yang timbul dengan tidak adanya informed consent ternyata tidak menimbulkan hilangnya kewajiban <br />dokter memberikan suatu prestasi kepada pasien. <br />Kata Kunci : Akibat Hukum; Informed Consent; Persetujuan; Pengecualian</p>

Ethical Research Practice or Undue Influence? Symbolic Power in Community- and Individual-Level Informed Consent Processes in Community-Based Participatory Research in Swaziland

In community-based participatory research (CBPR), community-level consent is assumed to enhance ethical rigor, when obtained prior to individual informed consent. However, community leaders’ permission to conduct research may influence individuals’ agency to decline participation. This article presents findings of a Bourdieusian analysis of ethnographic data documenting CBPR in rural Swaziland. The findings reveal that the “symbolic power” of leaders who provide community-level consent constrains individual agency and reproduces existing relations of power, if individual informed consent is simply a procedure. However, when informed consent is a process that introduces notions of autonomy and rights, it can disrupt power relations. Implications for ethical CBPR practice, and ethnography’s value for developing theory from real-world research ethics practice, are discussed.

In the Name of Population Well-Being: The Case for Public Health Surveillance

Surveillance is the radar of public health. Without tracking, often by name, the incidence and prevalence of both infectious and chronic disease, health officials would be unable to understand where and how to potentially intervene or what resources might be required to protect populations. Surveillance without individual informed consent has been challenged in the name of both bioethics and human rights. In this article we contend that a robust conception of public health not only justifies surveillance but, without disregarding the need to respect individuals, provides an affirmative duty to engage in surveillance. There may be social and political circumstances in which the names of those reported cannot be protected from unwarranted disclosure and misuse for ends that have little to do with protecting the public's health. But while the potential for misuse requires an ongoing, searching scrutiny of disease surveillance, remote or hypothetical threats should not serve to undermine this vital public health activity.

Informed consent and public health

During the past 25 years, medical ethics has concentrated largely on clinical medicine and the treatment of individual patients. This focus permits a view of medical provision as a (quasi–) consumer good, whose distribution can be or should be contingent on individual choice. The approach cannot be extended to public health provision. Public health provision, including measures for limiting the spread of infectious diseases, is a public good and can be provided for some only if provided for many. The provision or non–provision of public goods cannot be contingent on individual informed consent, so must be in some respects compulsory. An adequate ethics of public health needs to set aside debates about informed consent and to consider the permissible limits of just compulsion for various types of public good. It will therefore gain more from engaging with work in political philosophy than with individualistic work in ethics.

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.