Browsing by Author "Peterson, Kristin"

Now showing 1 - 8 of 8
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    Debating Ethics in HIV Research: Gaps between Policy and Practice in Nigeria.
    (Developing world, 2015-12-01T00:00:00Z) Folayan, Morenike Oluwatoyin; Peterson, Kristin; Haire, Bridget; Brown, Brandon; Audu, Kadiri; Makanjuola, Olumide; Pelemo, Babatunde; Marsh, Vicki
    HIV prevention is a critical health issue in Nigeria; a country that has one of the worst HIV epidemic profiles in the world. With 270,000 new infections in 2012, Nigeria is a prime site for HIV prevention research. One effect of the HIV epidemic has been to revolutionalise ethical norms for the conduct of research: it is now considered unethical to design and implement HIV related studies without community engagement. Unfortunately, there is very little commensurate effort in building the capacity of local persons to engage actively with researchers, and there is no existing platform to facilitate dialogue between researchers and communities engaged in research in Nigeria. In an effort to address this gap, we undertook a series of three community dialogues (Phase One) and two community-researcher interface meetings (Phase Two) in Nigeria. This paper aims to give an empirical account of the dialogue from these community engagement processes and provide a resulting critique of the implementation of research ethics practices in Nigeria. It is anticipated that the outputs will: (i) support researchers in designing community-based research protocols; (ii) inform ethics committees of key considerations during research protocol reviews from a community perspective; and (iii) inform policy makers and research sponsors about issues of primary concern to communities with respect to HIV research.
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    Ebola vaccine development plan: ethics, concerns and proposed measures.
    (BioMed Central, 2016-02-08T00:00:00Z) Folayan, Morenike Oluwatoyin; Yakubu, Aminu; Haire, Bridget; Peterson, Kristin
    The global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed. The recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola (such as in home care settings) are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics. Successful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. A public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites.
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    Ethics and HIV prevention research: An analysis of the early tenofovir PrEP trial in Nigeria.
    (WILEY, 2018-09-10) Peterson, Kristin; Folayan, Morenike O
    In 2004, the first ever multi-sited clinical trials studied the prospect of HIV biomedical prevention (referred to as pre-exposure prophylaxis-'PrEP'). The trials were implemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised concerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and protocol. While some of the disputes, especially those pertaining to community engagement mechanisms, were ultimately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scientific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized.
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    Ethics, emergencies and Ebola clinical trials: the role of governments and communities in offshored research.
    (Pan African Medical Journal, 2015-10-10) Folayan, Morenike Oluwatoyin; Peterson, Kristin; Kombe, Frances
    The Ebola Virus Disease (EVD) in West Africa has stimulated investments in EVD research. While these research efforts are most welcome, we are concerned about the potential to ignore effective community ethics engagement programmes and critical government regulatory agencies in light of the urgency to conduct clinical trials for EVD therapies and vaccines. We discuss the reasons why community engagement with various research stakeholders is essential, how community engagement should be conducted, and the potential consequences of failing to engage both communities and regulatory agencies by drawing on past experiences in the field of HIV research. We highlight the importance of a) capacity building to enable local researchers design and implement EVD research for future epidemics, b) the need to support community research literacy, and c) the need to build the competency of research regulatory agencies on the continent to address EVD therapy and vaccine research.
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    HIV prevention clinical trials' community engagement guidelines: inequality, and ethical conflicts.
    (Routledge Taylor and Francis group, 2020-06-05T00:00:00Z) Folayan, Morenike O; Peterson, Kristin
    In 2004 and 2005, the first clinical trials were launched to investigate the use of tenofovir for HIV prevention in Cambodia,Cameroon, Nigeria and Thailand. Controversies erupted over the ethical integrity of the research protocol. We reflect on the events that ledto the controversies and identified that scientific and ethical concerns raised by members of local communities at each of these sites wereerased by trialists, causing crisis that led to premature shut down the early PrEP trials. In the aftermath of these trials, the World HealthOrganisation, UNAIDS, and AVAC developed ethics guidelines intended to recognize the concerns as authentic, and developed guidelines toimprove researchers' engagement of communities in biomedical HIV prevention trial design and implementation. Our findings suggest thatthe ethics guidelines are limited in its ability to address power inequalities that leads to voice erasures and non-recognition of localcompetencies. Rather the ethical documents enabled trialists to gain a new sense of authority through the interpretations of ethical researchconduct enabling trialists regain power that can further entrench inequality and voice erasures. To address concerns with what seems anintractable problem, we suggested models of engagement for off-shored research may be the option.
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    HIV prevention clinical trials' community engagement guidelines: inequality, and ethical conflicts.
    (Global Bioethics, 2020-06-05T00:00:00Z) Folayan, Morenike O; Peterson, Kristin
    In 2004 and 2005, the first clinical trials were launched to investigate the use of tenofovir for HIV prevention in Cambodia,Cameroon, Nigeria and Thailand. Controversies erupted over the ethical integrity of the research protocol. We reflect on the events that ledto the controversies and identified that scientific and ethical concerns raised by members of local communities at each of these sites wereerased by trialists, causing crisis that led to premature shut down the early PrEP trials. In the aftermath of these trials, the World HealthOrganisation, UNAIDS, and AVAC developed ethics guidelines intended to recognize the concerns as authentic, and developed guidelines toimprove researchers' engagement of communities in biomedical HIV prevention trial design and implementation. Our findings suggest thatthe ethics guidelines are limited in its ability to address power inequalities that leads to voice erasures and non-recognition of localcompetencies. Rather the ethical documents enabled trialists to gain a new sense of authority through the interpretations of ethical researchconduct enabling trialists regain power that can further entrench inequality and voice erasures. To address concerns with what seems anintractable problem, we suggested models of engagement for off-shored research may be the option.
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    Stakeholders' engagement with Ebola therapy research in resource limited settings.
    (BMC Infectious Diseases., 2015-06-26T00:00:00Z) Folayan, Morenike Oluwatoyin; Brown, Brandon; Haire, Bridget; Yakubu, Aminu; Peterson, Kristin; Tegli, Jemee
    The current Ebola Virus Disease (EVD) outbreak in West Africa is the largest in history. As of February 18(th) 2015, 23,258 cases of EVD have been cumulatively reported from Nigeria, Senegal, Guinea, Liberia, Mali, Sierra Leone, Spain, the United Kingdom and the United States of America resulting in more than 9,000 deaths. It is therefore exigent to develop prevention and treatment therapies for EVD.
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    Stakeholders' engagement with Ebola therapy research in resource limited settings.
    (BMC Infectious Diseases, 2015-06-26T00:00:00Z) Folayan, Morenike Oluwatoyin; Brown, Brandon; Haire, Bridget; Yakubu, Aminu; Peterson, Kristin; Tegli, Jemee
    The current Ebola Virus Disease (EVD) outbreak in West Africa is the largest in history. As of February 18(th) 2015, 23,258 cases of EVD have been cumulatively reported from Nigeria, Senegal, Guinea, Liberia, Mali, Sierra Leone, Spain, the United Kingdom and the United States of America resulting in more than 9,000 deaths. It is therefore exigent to develop prevention and treatment therapies for EVD.