With developed country governments and high resource institutions engaging in research in low- and middle-income countries, we argue that these entities have a moral obligation to help build and strengthen research infrastructure and capacity so local scientists and institutions can adequately conduct studies to understand and resolve the health burdens in low and middle income countries. We explore the moral justifications and motivations behind engaging in research capacity strengthening in the health sector in LMIC at multiple levels. (...) In highlighting these issues, this paper aims to initiate a global discourse around why capacity development in LMIC has a moral basis at the individual, institutional and system levels. (shrink)

There is growing interest in developing co-operation between adult literacy researchers and practitioners to further research skills and approaches. Canada’s National Literacy Secretariat has recently initiated a series of policy debates that suggested several possibilities: targeted research grants, research internships for practitioners, practical sabbaticals for researchers, support for networking between literacy researchers and practitioners, and joint seminars and workshops between researchers and practitioners. A common theme throughout these discussions is the need to develop critical thinking about both (...) collaborative research and adult literacy. In this paper we discuss two collaborative initiatives between university-based researchers and adult literacy groups in the provinces of British Columbia and Ontario. Each project was based on the notion of “research circles” and specifically designed to enhance research capacity and critical thinking about literacy research. (shrink)

Accounts of how research capacity in education can be developed often make reference to electronic networks and online resources. This paper presents a theoretically driven analysis of the role of one such resource, an online archive of educational research studies that includes not only digitised collections of original documents but also videos of contextual interviews with the original researchers, linked and presented using emerging 'semantic web' technologies. An exploration with a group of early career researchers in education of (...) how the archive might be used to support their own research activities is reported: this suggests that thinking about such online resources as elements of heterogeneous 'assemblages' may be useful in their design and in understanding their role in research training and research networks more generally. (shrink)

There is growing interest in developing co-operation between adult literacy researchers and practitioners to further research skills and approaches. Canada’s National Literacy Secretariat has recently initiated a series of policy debates that suggested several possibilities: targeted research grants, research internships for practitioners, practical sabbaticals for researchers, support for networking between literacy researchers and practitioners, and joint seminars and workshops between researchers and practitioners. A common theme throughout these discussions is the need to develop critical thinking about both (...) collaborative research and adult literacy. In this paper we discuss two collaborative initiatives between university-based researchers and adult literacy groups in the provinces of British Columbia and Ontario. Each project was based on the notion of “research circles” and specifically designed to enhance research capacity and critical thinking about literacy research. (shrink)

The question of capacity building in education has predominantly been approached with regard to the methods and methodologies of educational research. Far less attention has been given to capacity building in relation to theory. In many ways the latter is as pressing an issue as the former, given that good research depends on a combination of high quality techniques and high quality theorising. The ability to capitalise on capacity building in relation to methods and methodologies may therefore well (...) be restricted by a lack of attention to theory. In this paper we make a case for capacity building with regard to theory, explore the different roles of theory in educational research, and provide an outline of an agenda for capacity building with regard to theory. (shrink)

It is argued that future research capacity building for the social sciences needs to incorporate methods to accelerate the acquisition by researchers of holistic expertise relevant to their roles as researchers and as developers of others. An agenda is presented, based on a model of learning that highlights missing elements of current provision, and two approaches currently under development are described.

Science and technology are key to economic and social development, yet the capacity for scientific innovation remains globally unequally distributed. Although a priority for development cooperation, building or developing research capacity is often reduced in practice to promoting knowledge transfers, for example through North–South partnerships. Research capacity building/development tends to focus on developing scientists’ technical competencies through training, without parallel investments to develop and sustain the socioeconomic and political structures that facilitate knowledge creation. This, the paper argues, significantly (...) contributes to the scientific divide between developed and developing countries more than any skills shortage. Using Charles Taylor’s concept of irreducibly social goods, the paper extends Sen’s Capabilities Approach beyond its traditional focus on individual entitlements to present a view of scientific knowledge as a social good and the capability to produce it as a social capability. Expanding this capability requires going beyond current fragmented approaches to research capacity building to holistically strengthen the different social, political and economic structures that make up a nation’s innovation system. This has implications for the interpretation of human rights instruments beyond their current focus on access to knowledge and for focusing science policy and global research partnerships to design approaches to capacity building/development beyond individual training/skills building. (shrink)

This article presents a case study of successful research capacity building in the field of early childhood education in a non-research intensive, regional Australian university. In a context characterised by substantial political, economic and structural constraints, it illustrates a creative, strategic, and to some extent, transgressive approach to research capacity building inspired, in part, by concepts proffered by social theorist Gilles Deleuze.

A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a (...) child’s objection to research: the capacity-based model and the distress-based model. In the last part we present arguments for a broader and unified understanding of a child’s objection within regulations and practices. This will strengthen children’s rights and facilitate the entire process of assessment of research protocols. (shrink)

Psychiatric disorders can pose problems in the assessment of decision-making capacity (DMC). This is so particularly where psychopathology is seen as the extreme end of a dimension that includes normality. Depression is an example of such a psychiatric disorder. Four abilities (understanding, appreciating, reasoning and ability to express a choice) are commonly assessed when determining DMC in psychiatry and uncertainty exists about the extent to which depression impacts capacity to make treatment or research participation decisions.

Infectious disease outbreaks in residential care are complex to manage and difficult to control. Research in this setting that includes individuals who lack capacity must conform to national legislation. We report here on our study that is investigating outbreaks of scabies, an itchy skin infection, in the residential care setting in the southeast of England. There appears to be a gap in legislative advice regarding the inclusion of people who lack capacity in research that takes place during time-limited (...) acute scenarios such as outbreaks. We received inconsistent advice from experts regarding, in particular, the role of nominated consultees. There is a potential inequality for vulnerable populations who cannot themselves provide informed consent in terms of their access to participation in a range of health-related research. (shrink)

This paper draws on several projects over sixteen years which attempted to develop capacity in educational research at Addis Ababa University. It identifies what might be considered indicators of a thriving research environment as defined from a UK perspective, not simply the necessary skills and infrastructure requirements but also what might be considered 'academic' or 'intellectual' virtues. Having outlined specific project activities, our responses and mutual learning, the paper goes on to consider how such qualities might relate to (...) an Ethiopian academic setting where cultural norms and political contexts have tended to encourage silence and caution rather than critique and argument. Thus through these comparisons, I argue that research capacity building is not just a body of knowledge or set of techniques to be delivered through workshops, but is about the importance of developing a research culture which engages with the underlying attitudes that derive from the country context. (shrink)

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our (...) data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

Despite substantial research on overall decision-making capacity levels in schizophrenia, the factors that cause individuals to make errors when making decisions regarding research participation or treatment are relatively unknown. We examined the responses of 84 individuals, middle-aged or older, with schizophrenia or schizoaffective disorder. We used a structured decision-making capacity measure, the MacArthur Competence Assessment Tool for Clinical Research, to determine the frequency and apparent cause of participants’ errors. We found that most errors were due to difficulty (...) recalling the disclosed information, particularly the study’s procedures, potential risks, and purpose. Errors attributable to concrete thinking, psychotic symptoms, or perceived coercion were rarer. These results suggest that informed consent procedures for this population might be improved by providing information in a way that facilitates learning and memory, such as iterative disclosure of the information, corrective feedback, and emphasis of key points of the study—for instance, its purpose, procedures, and potential risks. (shrink)

The capacity-building strategy used by a US-based research organisation, the Pacific Institute for Research and Evaluation , to strengthen the system for the protection of human research subjects and the infrastructure of its international collaborating partner, the University of Liberia, are discussed. To conduct the much-needed biomedical and social science-based research-related activities in the future, this partnership is expected by PIRE to gradually evolve over time to strengthen the capacity of the local investigators and administrators of (...) the University of Liberia. Accordingly, a unique opportunity to share technology and resources with a post-conflict, resource-constrained country is created by this partnership. This capacity-building model to strengthen the protection of human subjects in research can also be replicated in similar resource-constrained international settings and, accordingly, our experiences and limitations are shared in this paper. (shrink)

The Mental Capacity Act will come into force in 2007. It sets out guidelines for the ethical review of research involving incompetent adults which will have an impact on the REC process. This paper attempts to explain the Act's requirements in a way that will give research ethics committees some clarity about what must be considered when reviewing applications. Potential difficulties have been highlighted with guidance as to how these might be resolved.

The Mental Capacity Act 2005 gives statutory force to the common law principle that all adults are assumed to have capacity to make decisions unless proven otherwise. In accord with best practice, this principle places the evidential burden on researchers rather than participants and requires researchers to take account of short-term and transient understandings common among some research populations. The aim of this paper is to explore some of the implications of the MCA 2005 for researchers working with 'vulnerable' (...) populations in health and social care settings. The Cyclical Consent Model is described and offered as a process by which researchers might develop good practice when engaged in research involving vulnerable people. (shrink)

This article outlines challenges to benefitting developing countries that are hosts of international research. In the context of existing guidance and frameworks for benefit‐sharing, it aims to provoke dialog about socioeconomic factors and other background conditions that influence what constitute benefits in a given host setting, and about the proportionality between benefits to hosts and benefits to sponsors and researchers. It argues that capacity‐building for critical thinking and negotiation in many developing country governments, institutions, and communities is a benefit (...) because it can help to overcome background conditions that impinge on equitable international research negotiations, partnerships, and benefits. Enhancing the capacity for both critical thinking and negotiation can, like other targets of capacity‐building, nurture respectful and trusting partnerships that benefit all stakeholders in international research. (shrink)

Background Researchers are required to determine whether a person has capacity to consent to a research study before they are able to participate. The Mental Capacity Act and accompanying Code of Practice for England and Wales provide some guidance on this process, but researchers have identified that it can be difficult to determine capacity to consent when a person has complex cognitive or communication needs. This study aimed to understand the experiences and opinions of researchers who recruit people with (...) dementia to research projects, to inform the future development of training resources. Methods A mixed method, cross-sectional, electronic survey was circulated via social media and research networks in England and Wales. The survey remained open for ten weeks and included open and closed questions exploring respondents’ confidence in determining capacity in the context of recruiting people with dementia to consent, their views on training and support they have experienced and their suggestions for future training and support needs. Results 60 respondents completed the survey from across England and Wales. Although 75% of respondents had experience of determining capacity to consent with people with dementia to research, only 13% rated themselves as feeling ‘very confident’ in this. Qualitative content analysis of open responses led to the generation of six themes, explaining researchers’ confidence, competence and future training needs in this area: (1) Researcher uncertainties, (2) Lack of time, (3) Balancing information complexity with accessibility, (4) Gatekeepers, (5) Existing enablers and (6) Envisioning future training. Conclusions Researchers would benefit from specific training in undertaking conversations around consent with people with dementia. People with dementia may have fluctuating capacity, and despite support from caregivers, researchers have little practical guidance on methods of determining a person’s ability to understand or appreciate the information they have provided during the consent process. Given the development of large complex trials within dementia research, there is an urgency to develop specific and practical guidance and training for researchers working with people with dementia and their families. (shrink)

This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that (...) are reinforced by upstream enabling conditions, which are in turn influenced by developmental conditions. Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our (...) data show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity (...) was analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area. (shrink)

The right to active participation by disabled people in academic research has been discussed at length in recent years, along with the potential for such research to function as a tool in challenging oppression and pursuing disability rights. Significant ethical, legal and methodological dilemmas arise, however, in circumstances where a disabled person loses the capacity to provide informed consent to such participation. In this article, I consider disability politics and academic research in the context of the Mental (...) Capacity Act 2005, which sets out in Anglo-Welsh law the circumstances and requirements for research participation by individuals lacking the capacity to provide informed consent. Drawing on my own perspective on research participation in relation to physical and psychosocial disability, I consider the implications of my potential future loss of capacity for my right to participate in disability-related research. I examine the barriers to such participation and suggest that partial solutions may be found in the advance decision-making and advance care-planning frameworks of the MCA 2005 and related policy, but that current legislative and policy frameworks nevertheless still curtail my rights with regard to research participation on loss of capacity to consent. In so doing, I seek to provoke debate concerning what this legislative provision means for the disability rights movement, and the possibilities and challenges it presents to the movement’s commitment to ‘nothing about us without us’. (shrink)

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and (...) capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations. (shrink)

BackgroundInformed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research.Methods53 subjects with DSM-5 diagnoses of a Substance Use Disorder and 50 non psychiatric comparison subjects participated in the survey from December 2014 to March 2015. This cross-sectional study (...) was carried out at a community-based Outpatient Treatment Center and at an urban-located Health Centre in Spain. A binary judgment of capacity/incapacity was made guided by the MacArthur Competence Assessment Tool for Clinical Research and a clinical interview. Demographics and clinical characteristics were assessed by cases notes and the Mini-Mental State Examination, the Global Assessment Functional Scale and the Clinical Global Impression Scale.ResultsNPCs performed the best on the MacCAT–CR, and patients with SUD had the worst performance, particularly on the Understanding and Appreciation subscales. 32.7 % SUD people lacked research-related decisional capacity. There were no statistically significant differences between the groups in terms of capacity to consent to research.ConclusionsThe findings of our study provide evidence that a large proportion of individuals with SUD had decisional capacity for consent to research. It is therefore inappropriate to draw conclusions about capacity to make research decisions on the basis of a SUD diagnosis. In the absence of advanced cognitive impairment, acute withdrawal or intoxication, we should assume that addicted persons possess decision-making capacity. Thus, the view that people with SUD would ipso facto lose decision-making power for research consent is flawed and stigmatizing. (shrink)

Research is crucial to improve medicine's ability to care for the sick, and this includes research on conditions affecting cognition. This article focuses on whether persons suffering from diseases affecting cognition can be enrolled in research when the purpose is to investigate the condition leading to this impairment. It also discusses when they may be enrolled and on the precautions which are necessary if they are. Protections for vulnerable persons in research have two components: fair subject (...) selection, and the specific care required to minimize wrongs to vulnerable persons once they are enrolled in research. Finally, the article examines, and rejects, the idea that there could be circumstances in which persons suffering from diseases affecting cognition could have an obligation to participate in research addressing these disorders. (shrink)

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality (...) care as a result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research (...) infrastructure. The model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care. (shrink)

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews the (...) views of social researchers engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

The emergence of vibrant research communities of computer scientists in Kenya and Uganda has occurred in the context of neoliberal privatization, commercialization, and transnational capital flows from donors and corporations. We explore how this funding environment configures research culture and research practices, which are conceptualized as two main components of a research community. Data come from a three-year longitudinal study utilizing interview, ethnographic and survey data collected in Nairobi and Kampala. We document how administrators shape (...) class='Hi'>research culture by building academic programs and training growing numbers of PhDs, and analyze how this is linked to complicated interactions between political economy, the epistemic nature of computer science and sociocultural factors like entrepreneurial leadership of key actors and distinctive cultures of innovation. In a donor-driven funding environment, research practice involves scientists constructing their own localized research priorities by adopting distinctive professional identities and creatively structuring projects. The neoliberal political economic context thus clearly influenced research communities, but did not debilitate computing research capacity nor leave researchers without any agency to carry out research programs. The cases illustrate how sites of knowledge production in Africa can gain some measure of research autonomy, some degree of global competency in a central arena of scientific and technological activity, and some expression of their regional cultural priorities and aspirations. Furthermore, the cases suggest that social analysts must balance structure with culture, place and agency in their approaches to understanding how funding and political economy shape scientific knowledge. (shrink)

This article investigates whether or not theories of justice from political philosophy, first, support the position that health research should contribute to justice in global health, and second, provide guidance about what is owed by international clinical research (ICR) actors to parties in low- and middle-income countries. Four theories—John Rawls's theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and Jennifer Ruger's health capability paradigm—are evaluated. The article shows that three of the four theories (...) require the conduct of health research for justice in global health. The theories help identify the ends of justice to which ICR is to contribute, but they cannot tell us how to organize ICR to promote these ends. Aside from Ruger's health capability paradigm, the theories also lack an allocative principle for assigning specific duties to specific actors. This creates difficulties for establishing obligations for certain types of ICR actors. (shrink)

The Mental Capacity Act 2005 placed for the first time research concerning adults lacking mental capacity upon a statutory footing. However, while the legislation which regulates the inclusion of such adults in ‘intrusive research’ safeguards researchers and research participants alike some controversy remains as to its implementation. This paper focuses upon two specific issues raised by the legislation. First, what constitutes ‘intrusive’ research and whether all issues concerning research involving adults lacking mental capacity should be (...) referred to NHS research ethics committees. Secondly, the role of one of the statutory safeguards–the ‘consultee’. These are individuals who are to be consulted regarding the inclusion of adults lacking mental capacity in research. It contrasts the ‘personal’ and ‘nominated’ consultees and considers whether there is a risk that the legislation may result in a new ‘quasi profession’ of consultees in the future. (shrink)

The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this (...) approach in the form of a case study from an institution in Africa. (shrink)

BackgroundCommunity engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda.MethodsWe conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to (...) collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis.ResultsSeventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24–70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity.ConclusionThough CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants. (shrink)

Myanmar has recently surfaced from total military rule and efforts at conducting research to enhance the health of the population has increased during the recent democratization process, both from the military and civil sectors as well as support from international agencies. International guidelines mandate that such research requires prior ethics review in accordance with international standards. Previous commentators have expressed concerns, however, regarding the degree of adequate training in research ethics for investigators, the optimal functioning of (...) class='Hi'>Research Ethics Committees, and the extent of responsible conduct in research in low and middle-income countries. Such concerns might also be applicable to Myanmar, especially since it has recently emerged from a long period of military rule where there has been lack of basic freedoms and human rights abuses. We herein review the current gaps in research ethics capacity in Myanmar, the status of the existing RECs and the current efforts to establish training programs to enhance capacity in research ethics. (shrink)

In applied ethics, and in medical treatment and research, the question of how we should treat others is a central problem. In this paper, I address the ethical role of assent in research involving human beings who lack capacity. I start by thinking about why consent is ethically important, and consider what happens when consent is not possible. Drawing on the work of the German philosopher Honneth, I discuss the concept of reification—a phenomenon that manifests itself when we (...) fail to observe or respond to our fellow humans’ need for recognition. I suggest that assent is a way of responding to this moral need for recognition, which exists independently of cognitive capacity. I will look at the circumstances in which consent cannot be obtained from human beings, and ask whether some of the same ethically important considerations that underpin the need for consent might be achieved through seeking assent. I discuss the ways in which this might be beneficial for researchers, for prospective research participants and for society at large. (shrink)

OBJECTIVES: Cognitive and sensory difficulties frequently jeopardize informed consent of frail elderly patients This study is the first to test whether preliminary research experience could enhance geriatric patients' capacity to consent. DESIGN/SETTING: A step-wise consent procedure was introduced in a study on fluid balance in geriatric patients. Eligible patients providing verbal consent participated in a try-out of a week, during which bioelectrical impedance and weight measurements were performed daily. Afterwards, written informed consent was requested. Comprehension, risk and inconvenience scores (...) (ranges: 0-10) were obtained before and after the try-out by asking ten questions about the study's essentials and by asking for a risk and inconvenience assessment on a ten-points rating scale. SUBJECTS AND RESULTS: Seventy of the 78 eligible subjects started the try-out and 53 (68%) provided written consent. The comprehension score increased from 5.0 (+/- 2.3) to 7.0 (+/- 1.9) following the try-out (P < 0.001). The number of subjects capable of weighing risks and inconveniences increased from 32 to 48 (P < 0.001). CONCLUSIONS: Research experience improved the capacity to consent, still enabling an acceptable participation rate. Therefore, experienced consent seems a promising tool to optimize informed consent in frail elderly subjects. (shrink)

This paper considers the meaning of the term ‘intrusive research’, as used in the UK Mental Capacity Act 2005, in relation to studies in which an informant is asked to provide information about or on behalf of a person who lacks capacity to consent, and who is not otherwise involved in the study. The MCA defines ‘intrusive research’ as research that would legally require consent if it involved people with capacity. The relevant ethical principles are that consent (...) should be sought from people who would be affected by a piece of research and that this requirement should be implemented proportionately. The critical question, for investigators and research ethics committees, is: would provision of the personal information specified in the research protocol significantly affect a person whose capacity is not impaired? If the answer to this question is ‘no’, then the study falls outside the definition of ‘intrusive research’, and the MCA does not apply. (shrink)

This paper considers the meaning of the term ‘intrusive research’, as used in the UK Mental Capacity Act 2005, in relation to studies in which an informant is asked to provide information about or on behalf of a person who lacks capacity to consent, and who is not otherwise involved in the study. The MCA defines ‘intrusive research’ as research that would legally require consent if it involved people with capacity. The relevant ethical principles are that consent (...) should be sought from people who would be affected by a piece of research and that this requirement should be implemented proportionately. The critical question, for investigators and research ethics committees, is: would provision of the personal information specified in the research protocol significantly affect a person whose capacity is not impaired? If the answer to this question is ‘no’, then the study falls outside the definition of ‘intrusive research’, and the MCA does not apply. (shrink)