Joseph Ali

A comparison of online versus on-site training in health research methodology: a randomized study.

AbstractBackgroundDistance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses.MethodsSubjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline.ResultsBaseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14).ConclusionOn-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

Integrating ethics, health policy and health systems in low- and middle-income countries: case studies from Malaysia and Pakistan

Scientific progress is a significant basis for change in public-health policy and practice, but the field also invests in value-laden concepts and responds daily to sociopolitical, cultural and evaluative concerns. The concepts that drive much of public-health practice are shaped by the collective and individual mores that define social systems. This paper seeks to describe the ethics processes in play when public-health mechanisms are established in low- and middle-income countries, by focusing on two cases where ethics played a crucial role in producing positive institutional change in public-health policy. First, we introduce an overview of the relationship between ethics and public health; second, we provide a conceptual framework for the ethical analysis of health system events, noting how this approach might enhance the power of existing frameworks; and third, we demonstrate the interplay of these frameworks through the analysis of a programme to enhance road safety in Malaysia and an initiative to establish a national ethics committee in Pakistan. We conclude that, while ethics are gradually being integrated into public-health policy decisions in many developing health systems, ethical analysis is often implicit and undervalued. This paper highlights the need to analyse public-health decision-making from an ethical perspective.

Research ethics capacity development in Africa: Exploring a model for individual success

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.

A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results

Background: Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Methods: Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. Results: 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Conclusions: Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples.

Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda

Noncommunicable diseases (NCDs) account for two-thirds of all deaths globally, with 75% of these occurring in low- and middle-income countries (LMICs). Many LMICs seek cost-effective methods to obtain timely and quality NCD risk factor data that could inform resource allocation, policy development, and assist evaluation of NCD trends over time. Over the last decade, there has been a proliferation of mobile phone ownership and access in LMICs, which, if properly harnessed, has great potential to support risk factor data collection. As a supplement to traditional face-to-face surveys, the ubiquity of phone ownership has made large proportions of most populations reachable through cellular networks. However, critical gaps remain in understanding the ways by which mobile phone surveys (MPS) could aid in collection of NCD data in LMICs. Specifically, limited information exists on the optimization of these surveys with regard to incentives and structure, comparative effectiveness of different MPS modalities, and key ethical, legal, and societal issues (ELSI) in the development, conduct, and analysis of these surveys in LMIC settings. We propose a research agenda that could address important knowledge gaps in optimizing MPS for the collection of NCD risk factor data in LMICs and provide an example of a multicountry project where elements of that agenda aim to be integrated over the next two years.

The ethics of health systems research in low- and middle-income countries: A call to action

The increasing conduct of health systems research (HSR) in low- and middle-income countries (LMICs) has not been matched by concurrent work to clarify the fields ethical dimensions. To begin to address this gap, a two-day workshop on the ethics of HSR in LMICs was convened at Johns Hopkins University in June 2013. Participants included health systems researchers, philosophers, lawyers, bioethicists and institutional review board members from Botswana, Uganda, the UK, USA and Zambia. Based on discussions from the workshop, the paper affirms that, while HSR in LMICs raises ethical issues in relation to constructs (i.e. consent, risk, equipoise) common to international clinical research, the nature of the issues that arise often differ between the two fields. Three salient features of HSR and the ethical considerations associated with each of them in LMICs are described to demonstrate this point. Recommendations for institutional review boards’ oversight of HSR in LMICs are presented. Finally, a call is made for further action to develop thinking and guidance around the ethics of HSR in resource-poor settings.

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.

Evaluating international research ethics capacity development: an empirical approach.

The us national institutes of health, Fogarty International Center (NIH-FIC) has, for the past 13 years, been a leading funder of international research ethics education for resource-limited settings. Nearly half of the NIH-FIC funding in this area has gone to training programs that train individuals from sub-Saharan Africa. Identifying the impact of training investments, as well as the potential predictors of post-training success, can support curricular ***decision-making, help establish funding priorities, and recognize the ultimate outcomes of trainees and training programs. Comprehensive evaluation frameworks and targeted evaluation tools for bioethics training programs generally, and for international research ethics programs in particular, are largely absent from published literature. This paper shares an original conceptual framework, data collection tool, and detailed methods for evaluating the inputs, processes, outputs, and outcomes of research ethics training programs serving individuals in resource-limited settings. This paper is part of a collection of papers analyzing the Fogarty International Centers International Research Ethics Education and Curriculum Development program.

Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

ABSTRACT PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

Ethics Considerations in Global Mobile Phone-Based Surveys of Noncommunicable Diseases: A Conceptual Exploration

Mobile phone coverage has grown, particularly within low- and middle-income countries (LMICs), presenting an opportunity to augment routine health surveillance programs. Several LMICs and global health partners are seeking opportunities to launch basic mobile phone–based surveys of noncommunicable diseases (NCDs). The increasing use of such technology in LMICs brings forth a cluster of ethical challenges; however, much of the existing literature regarding the ethics of mobile or digital health focuses on the use of technologies in high-income countries and does not consider directly the specific ethical issues associated with the conduct of mobile phone surveys (MPS) for NCD risk factor surveillance in LMICs. In this paper, we explore conceptually several of the central ethics issues in this domain, which mainly track the three phases of the MPS process: predata collection, during data collection, and postdata collection. These include identifying the nature of the activity; stakeholder engagement; appropriate design; anticipating and managing potential harms and benefits; consent; reaching intended respondents; data ownership, access and use; and ensuring LMIC sustainability. We call for future work to develop an ethics framework and guidance for the use of mobile phones for disease surveillance globally.