Seeking Consent Research Articles

Determinants of Project Sustainability in Kiambu County, Kenya

The devolved system of governance in Kenya has enabled County Governments to initiate various developmental-oriented projects in the counties. Most of the funds provided by the County Government are short-term and therefore do not consider funding of the project that will guarantee sustainability after funding has been withdrawn. As a result, most of these projects become abandoned or end up being a white elephant, yet a lot of money has already been spent. This study aimed to establish the determinants of sustainability of CFPs in Gatundu North Sub County in Kiambu County. The study was based on three theories, namely: stakeholders’ theory, theory of sustainability, and competence theory, all of which provided the framework of the study. The study targeted the following group of people: PMC members, project beneficiaries, the sub-county departmental heads, and chief officers’ in charge of the devolved functions. The study, therefore, targeted a total population of 100 respondents who included 30 PMC members, 50 project beneficiaries, ten head of departments and ten chief officers who in this case were engaged in the implementation of CFPs and they were, therefore, believed to possess relevant knowledge on the sustainability of the projects. The study adopted a descriptive research design. The instruments for data collection were semi-structured questionnaires and an interview guide. The semi-structured questionnaires were self-administered to the PMC members, project beneficiaries, and the sub-county departmental heads while the interview guides were scheduled for the chief officers. Questionnaires were tested to ascertain their reliability using Cronbach’s alpha with a limit of 0.6. The validity of the questionnaire was tested by use of content validity. Quantitative data were analyzed using descriptive statistics: mean, frequencies, percentages, and standard deviation. The data was analyzed using inferential statistics, which included Pearson’s Correlation analysis. Ethical considerations included the researcher seeking consent from the County Secretary and the administrative authority in Gatundu North, briefing the respondents on the purpose of the study and that information acquired would be treated with confidentiality and would remain anonymous. The study findings show that the four independent variables serve as determinants to the sustainability of county-funded projects in Gatundu North Sub-County. Project monitoring is the key determinant of county-funded projects. The government of Kiambu County, through the relevant stakeholders, should ensure that all the county-funded projects are properly monitored to ensure that they are sustainable and beneficial to the locals. Lastly, the County Government of Kiambu should focus much on hiring competent and experienced professionals to implement the projects.

THE CHALLENGES OF PEACEKEEPING IN AFRICA: A REVISIT

1. Introduction The most visible international response to Africa's armed conflicts was the proliferation of peace operations, which between 1990 and 2012 numbered more than 60, far more than in any other region. This period was also the most tumultuous in the history of peacekeeping. The operations assumed various shapes and sizes. They were authorized and conducted by various actors and international institutions. As instruments of conflict management, they produced decidedly mixed results. This was in large part because the United Nations (UN) and other institutions had to learn, while on the job, how to keep the peace in messy armed conflicts. These institutions also had to develop the relevant tools and structures as they went along. Peacekeeping in Africa after the Cold War was a way of trying to professionalise peace operations. Since peace operations are a reflection of international society's assumptions and priorities about conflict management and resolution, tracing their evolution provides an important barometer for the involvement of international engagement in Africa's violence. The results are instructive. The peace operations helped shepherd transitions from armed conflict to peace (among others in Liberia, Burundi, Sierra Leone, and Namibia). But peacekeepers failed to stop genocide in Rwanda and mass killings in Sudan, the Democratic Republic of the Congo (DRC), Angola and other African states. They also at times abused and exploited the local people they were supposed to protect. Perhaps the central explanations for this mixed record were that some mission mandates were tougher than others and some operations were given more resources than others. This article concludes that peacekeepers in Africa are often used as a substitute for an effective political plan and that peacekeeping missions are bound by the international legal requirement of seeking consent from the host governments, even when those governments constitute problems in several African armed conflicts. 2. Peacekeeping trends in post-Cold War Africa At the end of 2012, Africa had military based peace operations, involving more than 242 000 peacekeepers. The complex and multidimensional efforts necessitate the analysis of two intertwined issues: The first is the conflict management and resolution efforts carried out by African states and international institutions, while the second is those of non-African initiatives, primarily by the UN and the European Union (EU), although African governments are clearly involved in the UN activities and external actors are usually involved in African initiatives. The peace-making, peacekeeping and peace-building operations conducted by the UN and other non-African actors were in most cases considerably larger than those carried out by their African counterparts. Between 1990 and 2012 over 20 peace operations were conducted by African institutions. These involved the deployment of just over 74 000 uniformed personnel. Deployments by sub-regional institutions were mainly by the Economic Community of West African States (ECOWAS) and the Southern African Development Community (SADC), amounting to over 56 000 personnel, while over 18 000 were deployed as African Union (AU) peacekeepers. During the same period non-African institutions and actors, primarily the UN, conducted 35 peace operations on the continent. These involved the deployment of approximately 200 000 uniformed personnel of whom approximately 157 500 were UN peacekeepers while some 41 200 were deployed by other actors. 32 000 of these came from the United States (US)-led Unified Task Force for Somalia, 1992 and 1993. In the 21st century, the UN peace operations in Africa have accounted for some 70 per cent of its peacekeeping forces globally and cost the institution over US$300 billion. Peacekeeping in Africa unfolded in two distinct phases: before and after the AU was established. …

Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?

Background Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient’s concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well. Methods: Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control. Results: Both groups had very high patient satisfaction scores; there was no statistical difference between them. Conclusions: Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Consent in the time of COVID-19

The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments...

Informed consent in genomic research and biobanking: taking feedback of findings seriously

ABSTRACT Genomic research and biobanking present several ethical, social and cultural challenges, particularly when conducted in settings with limited scientific research capacity. One of these challenges is determining the model of consent that should support the sharing of human biological samples and data in the context of international collaborative research. In this paper, we report on the views of key research stakeholders in Ghana on what should count as good ethical practice when seeking consent for genomic research and biobanking in Africa. This study was part of a multi-country qualitative case study conducted in three African countries: Ghana, Uganda and Zambia under the auspices of the Human Heredity and Health in Africa initiative (H3Africa). Our study suggests that while participants are willing to give consent for their samples and associated data to be used for future research purposes, they expect to receive feedback about the progress of the research and about the kinds of research being undertaken on their samples and data. These expectations need to be anticipated and discussed during the consent process which should be seen as part of an ongoing communication process throughout the research process.

The amended EIA directive creates opportunities for public health

Abstract Environmental Impact Assessment (EIA) is conducted by the developer as part of the process of seeking consent to proceed with the project. The developer may be a public authority or a private company. The Directive for Environmental Impact Assessment (EIA) (2011/92/EU) was amended in 2014 (2014/52/EU). The changes are now transposed into national regulations across European Union Member States. These changes have an influence beyond EU borders, for example, through the policies of the European Investment Bank and the European Bank of Reconstruction and Development. The amendments to the Directive create both opportunities and challenges for public health. The opportunities stem from the changes that have been made to the Directive. Population and human health are now on the list of core topics that must be considered in an EIA. The other core topics to be assessed are each ‘determinants of health’, for example: biodiversity; land, soil, water, air and climate; and material assets, cultural heritage and the landscape. The Directive now requires the interaction between these factors to be considered. The amended Directive includes other issues that are relevant to human health, for example, climate change and vulnerability (exposure and resilience) to major accidents and/or disasters. The developer’s assessment must be prepared by Competent Experts. The changes also pose challenges. These are technical. For example, human health needs to be assessed within the framework of EIA. The changes also pose challenges to the public health workforce. There is a need to ensure there is capacity to participate in EIA. The EIA is typically prepared by the developer and reviewed by the competent authority. There is a role for public health expertise in these complementary activities. This presentation will focus on the opportunities created by the changes to the Directive and the opportunities this creates. It will also touch on the challenges.

Exploring the Role of Shared Decision Making in the Consent Process for Pediatric Genomics Research in Cameroon, Tanzania, and Ghana

Background: It is customarily perceived that in Africa, decisions around research participation may be based not only on individual reflection but also on discussions with others. Some authors have argued that such decision making is reflective of a more traditional communitarian African worldview; one critique of such a perspective is that it is lacking an empirical grounding. In this study, we explore decision making around enrollment in sickle cell genomics research in three countries in Africa, namely, Ghana, Cameroon, and Tanzania. Particularly, we focus on exploring the role of shared decision making with regard to participating in genomic studies. Results: We involved 64 participants in 15 individual interviews or in 49 focus-group discussions with research participants in rural and urban Tanzania (n = 20), Ghana (n = 30), and Cameroon (n = 14). We used a vignette to explore decision making around enrollment of children in sickle cell genomics research. Data were imported in NVivo11 and analyzed using thematic content analysis. Our findings indicate that the majority of the participants from both rural and urban settings prefer to make their own individual decisions and not consult with extended family or community leaders. Shared decision making was only considered necessary for individuals who were perceived to be in some way vulnerable. Conclusion: We found very limited support for shared decision making as the primary process for decision making about research participation. While consultation was considered important to support individual decision making, particularly when parents were perceived as vulnerable, there was no suggestion in our data that shared decision making would be a more important or valuable means of seeking consent for research participation in the African research context.

Language Translation Apps in Health Care Settings: Expert Opinion.

BackgroundCurrently, over 300 languages are spoken in Australian homes. People without proficient English from non-English speaking countries may not receive equitable care if their health care workers do not speak their primary language. Use of professional interpreters is considered the gold standard; however, for a variety of reasons, it is often limited to key aspects of care such as diagnosis and consent. With the emergence of mobile technologies, health care workers are increasingly using digital translation tools to fill this gap. However, many of these technologies have not been developed for health care settings and their use has not been evaluated.ObjectiveThis study aimed to evaluate iPad-compatible language translation apps to determine their suitability for enabling everyday conversations in health care settings.MethodsTranslation apps were identified by searching the Apple iTunes Store and published and grey literature. Criteria for inclusion were that the apps were available at no cost, able to translate at least one of the top 10 languages spoken in Australia, and available for use on iPad. Apps that met inclusion criteria were reviewed in 2 stages. Stage 1 was the feature analysis conducted by 2 independent researchers, where apps were evaluated for offline use, input and output methods, and number of languages. Stage 2 was the analysis of suitability for everyday communication in the health care setting, conducted by 2 independent professionals with expertise in translation and cross-cultural communication. Apps that enabled key aspects of care normally within the realm of professional interpreters, such as assessment, treatment and discharge planning, and seeking consent for medical treatments, were considered unsuitable.ResultsIn total, 15 apps were evaluated. Of these, 8 apps contained voice-to-voice and voice-to-text translation options. In addition, 6 apps were restricted to using preset health phrases, whereas 1 app used a combination of free input and preset phrases. However, 5 apps were excluded before stage 2. In addition, 6 of the 10 remaining apps reviewed in stage 2 were specifically designed for health care translation purposes. Of these, 2 apps were rated as suitable for everyday communication in the health care setting—culturally and linguistically diverse Assist and Talk To Me. Both apps contained simple and appropriate preset health phrases and did not contain conversations that are normally within the realm of professional interpreters.ConclusionsAll iPad-compatible translation apps require a degree of caution and consideration when used in health care settings, and none should replace professional interpreters. However, some apps may be suitable for everyday conversations, such as those that enable preset phrases to be translated on subject matters that do not require a professional interpreter. Further research into the use of translation technology for these types of conversations is needed.

Recruitment strategies in randomised controlled trials of men aged 50 years and older: a systematic review

ObjectivesTo identify and review evaluations of strategies to recruit men aged 50 years and over to randomised controlled trials (RCTs).DesignSystematic review and narrative synthesis.Data sourcesMEDLINE, EMBASE, CINAHL and ORRCA databases...

Human Biospecimens Come from People.

Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.

"As Long as You Ask": A Qualitative Study of Biobanking Consent-Oncology Patients' and Health Care Professionals' Attitudes, Motivations, and Experiences-the B-PPAE Study.

Consent to biobanking remains controversial, with little empirical data to guide policy and practice. This study aimed to explore the attitudes, motivations, and concerns of both oncology patients and health care professionals (HCPs) regarding biobanking. Qualitative interviews were conducted with oncology patients and HCPs purposively selected from five Australian hospitals. Patients were invited to give biobanking consent as part of a clinical trial and/or for future research were eligible. HCPs were eligible if involved in consenting patients to biobanking or to donate specimens to clinical trials. Twenty-two patients participated, with head and neck (36%) and prostate (18%) the most common cancer diagnoses; all had consented to biobanking. Twenty-two HCPs participated, from across eight cancer streams and five disciplines. Themes identified were (a) biobanking is a "no brainer"; (b) altruism or scientific enquiry; (c) trust in clinicians, science, and institutions; (d) no consent-just do it; (e) respecting patient choice ("opt-out"); (f) respectful timing of the request; (g) need for emotional/family support; (h) context of the biobanking request matters; and (i) factors for biobanking success. These findings reinforced previous findings regarding high public trust in, and support for, biobanking. An initial opt-in consent approach with the option of later opt-out was favored by patients to respect and recognize donor generosity, whereas HCPs preferred an upfront opt-out model. Factors impacting biobanking success included the context of the request for use in a trial or specific research question, pre-existing patient and HCP rapport, a local institution champion, and infrastructure. Patients and health care professionals (HCPs) who experienced cancer biobanking consent were overwhelmingly supportive of biobanking. The motivations and approaches to seeking consent were largely mirrored between the groups. The findings of this study support the opt-in model of biobanking favored by patients; however, HCPs preferred an opt-out model. Both groups recognize the importance of making the request for biobanking at an appropriate time, preferably with emotional or family support, and respecting the timing of the request and privacy of the patient. Biobanking success can be promoted by hospital departments with a research focus by identifying an institutional biobanking champion and ensuring local infrastructure is available.

Ethical challenges in research on post-abortion care with adolescents: experiences of researchers in Zambia

ABSTRACT Post-abortion care (PAC) research is increasingly being conducted in low- and middle-income countries (LMICs) to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion and community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance.

The surgical care practitioner seeking consent: An appropriate delegate?

Surgical care practitioners (SCPs) have become recognised as integral members of the surgical team in many healthcare establishments. Seeking informed consent either as the operating practitioner or on behalf of the surgeon, as their delegate, has becoming routine for many SCPs. Informed consent is a critical step in the patient's care pathway and fundamental in fostering shared decision making and safer surgical practice. The relatively recent case of Montgomery v Lanarkshire Health Board has highlighted a need for those practitioners seeking informed consent to critically examine their practice and revisit the founding principles of the process.

단사인(斷事人) 제도와 승가 분쟁 해결의 원칙

In this paper, we examine the process of the ‘ten points’ dispute centering on <italic>Sattasatikakkhandhaka</italic> (七百犍度) of <italic>Vinayapiṭaka</italic> and examined the content and significance of <italic>sammukhāvinaya</italic> (現前毘尼) and <italic>ubbāhikā</italic> (斷事人) system introduced to resolve this dispute. The <italic>ubbāhikā</italic> is a form of committee. It is to select the qualified persons from each side in dispute and delegate resolving the dispute to them. In the case of the ‘ten points’ affair, a total of eight people, four from each group, were selected. After reviewing and concluding the matter on the basis of Buddha’s dhamma and vinaya, it is the way of seeking consent from members of <italic>sammukhibhūtasaṃgha</italic> (現前僧伽) related to that dispute. It is the method that is applied when the first adjustment fails and the second adjustment is passed, but the second adjustment is not easy due to the split of opinions. Therefore, judging is not easy, so it can be seen as a method applied to sensitive matters that can break the harmony of Saṃgha. In this paper, we examine the progress of the ‘ten points’ dispute centering on Vinayapiṭaka <italic>Sattasatikakkhandhaka</italic> and examined the content and significance of <italic>sammukhāvinaya</italic> and <italic>ubbāhikā</italic> system introduced to resolve this dispute. At first glance, the <italic>ubbāhikā</italic> system is a form of committee, and may be considered as a system that applies the opinions of some members to other members by force. However, if we look carefully at the process of execution, we can see that this method is also designed for realization of harmony and harmony, which is the main ideology of Saṃgha.

The Ethical Concerns of Seeking Consent from Critically Ill, Mechanically Ventilated Patients for Research - A Matter of Possessing Capacity or Surrogate Insight.

Conducting clinical research on subjects admitted to intensive care units is challenging as they frequently lack the capacity to provide informed consent due to multiple factors including ICU acquired delirium, coma, the need for sedation, or underlying critical illness. However, the presence of one or more of these characteristics does not automatically designate a potential subject as lacking capacity to provide their own informed consent. We review the ethical issues involved in obtaining informed consent for medical research from mechanically ventilated, critically ill patients, in addition to the concerns that may arise when a legally authorized representative is asked to provide informed consent on behalf of these patients.

Supporting autonomy of nursing home residents with dementia in the informed consent process

Background In studies involving people with dementia, researchers have historically defaulted to seeking consent from a proxy, the assumption being that people with dementia are unable to provide their own informed consent. This choice denies people with dementia a voice in the consent process, thus disregarding their autonomy and agency. Recently, other options for improving the consent process have been explored. Objective This study aimed to determine whether nursing home residents with dementia could demonstrate an ability to provide their own informed consent as determined by the Evaluation to Sign Consent instrument. Methods As part of a larger study on the quality of life of nursing home residents, the Evaluation to Sign Consent was administered to 392 people diagnosed with dementia. Data on demographic variables, such as gender and age, as well as level of cognitive impairment, were also collected. Results Just over one-fifth (22%) of the residents with dementia were judged as having the capacity to provide their own informed consent to participate in this specific research project. Consistent with existing literature, capacity to consent was significantly, and negatively, associated with cognitive impairment. Conclusion This study demonstrates that assuming all people diagnosed with dementia are unable to provide informed consent for research on the basis of cognitive test scores, or on clinical assessment alone, potentially denies them the autonomy to make a decision that they may be capable of making. Research involving people with mild-to-moderate dementia needs to consider evaluating whether potential participants have the capacity to provide their own consent.

Research protocol for the Picture Talk Project: a qualitative study on research and consent with remote Australian Aboriginal communities

IntroductionResearch with Indigenous populations is not always designed with cultural sensitivity. Few publications evaluate or describe in detail seeking consent for research with Indigenous participants. When potential participants are not...

'It is an entrustment': Broad consent for genomic research and biobanks in sub-Saharan Africa.

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework.

An Alternative Consent Process for Minimal Risk Research in the ICU.

Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. Prospective cohort study. Five ICUs within a tertiary care hospital. Newly admitted ICU patients 18 years old or older. We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.