How to reduce processing times for site-specific assessments from 29 to 5 days using a common-sense approach: it does not have to be that hard.

Researchers have reported limitations with research governance processes across Australia. This study aimed to streamline research governance processes across a local health district. Four basic principles were applied to remove non-value-adding and non-risk-mitigating processes. Average processing times were reduced from 29 to 5 days and end-user satisfaction was improved, all within the same staffing levels.

Perspectives of agriculture, nutrition and health researchers regarding research governance in Malawi. Using a leadership, ethics, governance and systems framework.

BACKGROUND: Research ethics is intertwined with and depends on building robust and responsive research governance systems alongside researchers. Globally there has been substantial investment in agriculture, nutrition, and health (ANH) research motivated by the need to improve health outcomes, such as micronutrient deficiencies in Sub-Saharan Africa. Although there has been a notable focus on ethical issues inherent in ANH studies, there has been scanty research examining researchers' attitudes related to ANH research. This study was conducted to explore the perspectives of researchers who conducted an agronomic biofortification study in Malawi. METHODOLOGY: In-depth interviews were conducted with a purposive sample of ten ANH researchers. Interviews were conducted online via Zoom, audio-recorded, transcribed verbatim, and thematically analysed using the Leadership, Ethics, Governance and Systems Framework. RESULTS: Four core aspects emerged: Leadership: The relevance of building ethics leadership and ethical competence among researchers. ETHICS: There is a need to develop a framework that operationalises core ethical values that can guide the implementation of ANH research. Governance: Research guidelines were perceived to be too generic to guide ANH research. Systems: Researchers' recommended the establishment of a specialised ANH research ethics committee. CONCLUSIONS: The findings highlight the significance of building ethics leadership and supporting ethical competency amongst researchers. Researchers recommended the development of tailored approaches rather than utilising generic governance systems and frameworks that are drawn from medical research and thus not fit for purpose in this field. In Malawi, specialised ethics review committees are needed to guide ANH research.

Advancing health through evidence assisted decisions with health policy and systems research program: a qualitative evaluation of a national health research grant management process in the Philippines.

BACKGROUND: Health policy and systems research (HPSR) has influenced Philippine policies, including tobacco control, mental health, and COVID-19. The Department of Health (DOH) Philippines and Philippine Council for Health Research and Development (PCHRD) launched the Advancing Health through Evidence-Assisted Decisions (AHEAD) with HPSR program in 2017, aiming to build a community of researchers and decision-makers committed to evidence production and utilization. Research systems employ grant management processes for transparency and accountability in research funding, preventing waste, fraud, and misuse of funds. METHODS: This study evaluated AHEAD-HPSR's grant management using surveys, interviews, and focus groups to document (1) grant administration processes implemented by DOH and PCHRD, and (2) experiences of grantees, program managers, staff, and policymakers. Data were initially analyzed through the USA Grant Accountability Office's Federal Grant Life Cycle, with new themes created as they emerged. The study identified processes and gaps in the research grant life cycle stages: design/redesign, pre-award, award, implementation, closeout, and research dissemination and utilization. RESULTS: Identification of research areas for the grant are identified using national and departmental research priorities. While Calls for Proposals are posted publicly, researchers that have previously worked with policymakers are contacted directly to submit proposals. The evaluation found that research is delayed by bureaucracies in grant administration, particularly in financial reporting and ethics review processes. Complying with the terminal financial report was identified as the most challenging part of the grant process due to immense auditing requirements. Grantees recommend the simplification of bureaucracy for fund release to enable them to focus on research work. CONCLUSION: This study contributes to the limited literature on health research grant management in developing countries. Valuable information and recommendations were contributed by stakeholders in this evaluation. These are manifestations of a continuing interest and desire to make health policy and systems research in the Philippines more robust and relevant. It is imperative for the program to continually evolve and build systems most applicable to its multidisciplinary context.

Ethical aspects of facilitating the recruitment of people with dementia for clinical trials: A call for further debate.

Under-representation of people with dementia in clinical research remains a significant obstacle to develop evidence-based practice guidelines and recommendation for dementia care and slows down the development of disease-modifying pharmacological interventions. This is partly due to the ethical challenges and complexities of recruiting people with dementia for clinical trials. The traditional approach adopted by research ethics committees and regulatory bodies has been to protect people with dementia as a vulnerable population from harms of participating in research. There are concerns that this approach is unduly rigid, precludes the conduct of necessary research, and has exclusionary, paternalistic and discriminatory ramifications. As such, there are increasing calls to shift to a new hybrid facilitative/protective approach. This paper identifies 4 strategies to operationalise the facilitative/protective approach in the context of dementia research. These are: (i) embedding dementia research in clinical care; (ii) increasing the recruitment of people at preclinical stages of dementia; (iii) streamlined proxy consent procedures; and (iv) advance research consent. I note that all 4 strategies hold the promise of facilitating the recruitment of people with dementia in clinical research. Nonetheless, they give rise to a diverse range of new ethical concerns and issues. This necessitates further scholarly work to explore possible ways to address the ethical concerns and issues arisen by the uptake of protective/facilitative approach. In particular, further research is necessary to clarify, to what extent, the said strategies ameliorate or increase the vulnerability of people with dementia.

Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register.

BACKGROUND: January 2019, the House of Commons' Science and Technology Committee sent letters to UK universities admonishing them to achieve compliance with results reporting requirements for Clinical Trials of Investigative Medicinal Products by summer 2019. This study documents changes in the clinical trial policies and Clinical Trials of Investigative Medicinal Product reporting performance of 20 major UK universities following that intervention. METHODS: Freedom of Information requests were filed in June 2018 and June 2020 to obtain clinical trial registration and reporting policies covering both Clinical Trials of Investigative Medicinal Products and all other clinical trials. Two independent reviewers assessed policies against transparency benchmarks based on World Health Organization best practices. To evaluate universities' trial reporting performance, we used a public online tracking tool, the European Union Trials Tracker, which assesses universities' compliance with regulatory Clinical Trials of Investigative Medicinal Product disclosure requirements on the European Clinical Trial Register. Specifically, we evaluated whether universities were adhering to the European Union requirement to post summary results on the trial registry within 12 months of completion. RESULTS: Mean policy strength increased from 2.8 to 4.9 points (out of a maximum of 7 points) between June 2018 and June 2020. In October 2018 the average percentage of due Clinical Trials of Investigative Medicinal Products that had results available on the European trial registry across university sponsors included in the cohort was 29%. By June 2021, this had increased to 91%, with 5 universities achieving a reporting performance of 100%. All 20 universities reported more than 70% of their due trial results on the European trial registry. INTERPRETATION: Political pressure appears to have a significant positive impact on UK universities' clinical trial reporting policies and performance. Similar approaches could be used to improve reporting performance for other types of sponsors, other types of trials, and in other countries.

How to streamline the low and negligible research ethics and governance review process from 80 to 10 days: submission to decision.

Most clinicians find research ethics and governance difficult and time consuming. This study aimed to develop a better local review process for low-risk research. We used real-time processing, leveraged local expertise and streamlined paperwork. As a result, turnaround times decreased from more than 80 days to 10 days, creating an efficient review process for low-risk projects.

Data protection, information governance and the potential erosion of ethnographic methods in health care?

With the most recent developments to the European General Data Protection Regulations (GDPR) introduced in May 2018, the resulting legislation meant a new set of considerations for study approvers and health-care researchers. Compared with previous legislation in the UK (The Data Protection Act, 1998), it introduced more extensive and directive principles, requiring anybody 'processing' personal data to specifically define how this data will be obtained, stored, used and destroyed. Importantly, it also emphasised the principle of accountability, which meant that data controllers and processors could no longer just state that they planned to adhere to lawful data protection principles, they also had to demonstrate compliance. New questions and concerns around accountability now appear to have increased levels of scrutiny in all areas of information governance (IG), especially with regards to processing confidential patient information. This article explores our experiences of gaining required ethical and regulatory approvals for an ethnographic study in a UK health-care setting, the implications that the common law duty of confidentiality had for this research, and the ways in which IG challenges were overcome. The purpose of this article was to equip researchers embarking on similar projects to be able to navigate the potentially problematic and complex journey to approval.

What the policy and stewardship landscape of a national health research system looks like in a developing country like Iran: a qualitative study.

BACKGROUND: The health research system (HRS) is an important national priority that requires a systematic and functional approach. Evaluating the HRS of Iran as a developing country and identifying its challenges reveals the stewardship-related role in how the whole system is operating well. This study aims to assess the HRS in terms of stewardship functions and highlight the enhancement points. METHODS: This study was carried out between March 2020 and April 2021 using a systematic review and meta-synthesis of evidence to examine the Iranian HRS stewardship challenges and interview 32 stakeholders, using a critical case sampling and snowballing approach which included both semi-structured and in-depth interviews. The interviewees were selected based on criteria covering policy-makers, managers, research bodies and nongovernmental organizations (NGOs) in health research-related fields like higher education, research, technology, innovation and science. All data were analysed using content analysis to determine eight main groups of findings under three levels: macro, meso, and micro. RESULTS: Analysis of the findings identified eight main themes. The most critical challenges were the lack of an integrated leadership model and a shared vision among different HRS stakeholders. Their scope and activities were often contradictory, and their role was not clarified in a predetermined big picture. The other challenges were legislation, priority-setting, monitoring and evaluation, networking, and using evidence as a decision support base. CONCLUSIONS: Stewardship functions are not appropriately performed and are considered the root causes of many other HRS challenges in Iran. Formulating a clear shared vision and a work scope for HRS actors is critical, along with integrating all efforts towards a unified strategy that assists in addressing many challenges of HRS, including developing strategic plans and future-oriented and systematic research, and evaluating performance. Policy-makers and senior managers need to embrace and use evidence, and effective networking and communication mechanisms among stakeholders need to be enhanced. An effective HRS can be achieved by redesigning the processes, regulations and rules to promote transparency and accountability within a well-organized and systematic framework.

Stakeholders' Experiences of Research Integrity Support in Universities: A Qualitative Study in Three European Countries.

Fostering research integrity (RI) increasingly focuses on normative guidance and supportive measures within institutions. To be successful, the implementation of support should be informed by stakeholders' experiences of RI support. This study aims to explore experiences of RI support in Dutch, Spanish and Croatian universities. In total, 59 stakeholders (Netherlands n = 25, Spain n = 17, Croatia n = 17) participated in 16 focus groups in three European countries. Global themes on RI support experiences were identified by thematic analysis. Themes identified were: 'RI governance and institutional implementation', 'RI roles and structures', 'RI education and supervision', and 'Infrastructure, technology and tools supporting daily practice'. Experiences of support differed between countries in relation to: the efforts to translate norms into practice; the extent to which RI oversight was a responsibility of RE structures, or separate RI structures; and the availability of support close to research practice, such as training, responsible supervision, and adequate tools and infrastructure. The study reinforces the importance of a whole institutional approach to RI, embedded within local jurisdictions, rules, and practices. A whole institutional approach puts the emphasis of responsibility on institutions rather than individual researchers. When such an approach is lacking, some stakeholders look for intervention by authorities, such as funders, outside of the university.

Standards of Conducts for Biostatisticians and Stem Cell Researchers: A Call for Self-formulated Aspirational Ethics Over Built-in Prohibitive Ethics.

We proposed the Standards of Conducts to provide a general framework that will serve as the basis for guiding each biostatistician and stem cell researcher to formulate their personal standards, rather than as rules with which they are required to comply. Given the responsibility and characteristics of their work, they are expected to maintain independence and work autonomously as professionals. Each of the Standards of Conducts comprises a preamble, mission and values to uphold, Standards of Conducts (10 items), and background. When one internalizes "self-formulated" standards, to make excuses for oneself would be akin to a self-betrayal; responsible actions can be anticipated. If one begins and continues to consider "who I am and what do I work for," this will become their inner energy, and a source of motivation and pride to inspire oneself. In addition, this aspirational style might help citizens to recognize the autonomous stance of the professional body and that they share the same values.

Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial.

Research in rapidly evolving policy contexts can lead to the following ethical challenges for sponsors and researchers: the study's standard of care can become different than what patients outside the study receive, there may be political or other pressure to move ahead with unproven interventions, and new findings or revised policies may decrease the relevance of ongoing studies. These ethical challenges are considerable, but not unprecedented. In this article, we review the case of a multinational, randomized, controlled perinatal HIV prevention trial, the "PROMISE" (Promoting Maternal Infant Survival Everywhere) study. PROMISE compared the relative efficacy and safety of interventions to prevent mother to child transmission of HIV. The sponsor engaged an independent international ethics panel to address controversy about the study's standard of care and relevance as national and international guidelines changed. This ethics panel concluded that continuing the PROMISE trial as designed was ethically permissible because: (1) participants in all arms received interventions that were effective, and there was insufficient evidence about whether one intervention was more effective or safer than the other, and (2) data from PROMISE could be useful for a diverse range of stakeholders. In general, trials designed to inform rapidly evolving policy issues should develop mechanisms to revisit social value while recognizing that the value of research varies for diverse stakeholders with legitimate reasons to weigh evidence differently. We conclude by providing four reasons that trials may depart from the standard of care after a change in policy, while remaining ethically justifiable, and by suggesting how to improve existing trial oversight mechanisms to address evolving social value.

The state of health research governance in Africa: what do we know and how can we improve?

BACKGROUND: The developments in global health, digital technology, and persistent health systems challenges, coupled with global commitments like attainment of universal health coverage, have elevated the role of health research in low- and middle-income countries. However, there is a need to strengthen health research governance and create a conducive environment that can promote ethics and research integrity and increase public trust in research. OBJECTIVE: To assess whether the necessary structures are in place to ensure health research governance. METHODS: Employing a cross-sectional survey, we collected data on research governance components from 35 Member States of the World Health Organization (WHO) African Region. Data were analysed using basic descriptive and comparative analysis. RESULTS: Eighteen out of 35 countries had legislation to regulate the conduct of health research, while this was lacking in 12 countries. Some legislation was either grossly outdated or too limiting in scope, while some countries had multiple laws. Health research policies and strategies were in place in 16 and 15 countries, respectively, while research priority lists were available in 25 countries. Overlapping mandates of institutions responsible for health research partly explained the lack of strategic documents in some countries. The majority of countries had ethical committees performing a dual role of ethical and scientific review. Research partnership frameworks were available to varying degrees to govern both in-country and north-south research collaboration. Twenty-five countries had a focal point and unit within the ministries of health (MoH) to coordinate research. CONCLUSION: Governance structures must be adaptive to embrace new developments in science. Further, strong coordination is key to ensuring comprehensiveness and complementarity in both research development and generation of evidence. The majority of committees perform a dual role of ethics and scientific review, and these need to ensure representation of relevant expertise. Opportunities that accrue from collaborative research need to be seized through strong MoH leadership and clear partnership frameworks that guide negotiations.

Use of Personal Health Information under Consent - Exempt Circumstances for Research: Views of the Australian General Public.

Many human research regulatory systems permit human research to be undertaken without first gaining informed consent. In the Australian context, a "waiver of the consent requirement" may be granted by a Human Research Ethics Committee where research would be otherwise "impracticable" and there is "no known or likely reason" for thinking participants would not have consented. In this article, results of a national survey of Australian adults are presented to illustrate the general public's view of such "consent-exempt" research. The results show that despite strong support for medical research, the general public is deeply reticent regarding consent exemption. Moreover, the results indicate that members of the general public do not believe there is a general obligation to participate in research, that the threshold for accepting consent exemption on the basis of "impracticability" is very high, and presumed consent can only be safely relied upon as a justification in very limited circumstances.

Ethical and research governance approval across Europe: Experiences from three European palliative care studies.

BACKGROUND: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research which does not involve non-medicinal products. AIM: To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceutical palliative care studies including adult participants in collaborative European studies. DESIGN: An online survey analysed using descriptive statistics. SETTING/PARTICIPANTS: Eighteen principal investigators in 11 countries conducting one of three European-funded studies. RESULTS: There was variation in practice including whether ethical approval was required. The time to gain full approvals differed with the United Kingdom having governance procedures that took the longest time. Written consent was not required in all countries nor were data safety monitoring committees for trials. There were additional differences in relation to other data management issues. CONCLUSION: Researchers need to take the differences in research approval procedures into account when planning studies. Future research is needed to establish European-wide recommendations for policy and practice that dovetail ethical procedures and enhance transnational research collaborations.

Global trends and gaps in research related to latent tuberculosis infection.

BACKGROUND: There is a global commitment to eliminating tuberculosis (TB). It is critical to detect and treat cases of latent TB infection (LTBI), the reservoir of new TB cases. Our study assesses trends in publication of LTBI-related research. METHODS: We used the keywords ("latent tuberculosis" OR "LTBI" OR "latent TB") to search the Web of Science for LTBI-related articles published 1995-2018, then classified the results into three research areas: laboratory sciences, clinical research, and public health. We calculated the proportions of LTBI-related articles in each area to three areas combined, the average rates of LTBI-related to all scientific and TB-related articles, and the average annual percent changes (AAPC) in rates for all countries and for the top 13 countries individually and combined publishing LTBI research. RESULTS: The proportion of LTBI-related articles increased over time in all research areas, with the highest AAPC in laboratory (38.2%/yr), followed by public health (22.9%/yr) and clinical (15.1%/yr). South Africa (rate ratio [RR] = 8.28, 95% CI 5.68 to 12.08) and India (RR = 2.53, 95% CI 1.74 to 3.69) had higher RRs of overall TB-related articles to all articles, but did not outperform the average of the top 13 countries in the RRs of LTBI-related articles to TB-related articles. Italy (RR = 1.95, 95% CI 1.45 to 2.63), Canada (RR = 1.73, 95% CI 1.28 to 2.34), and Spain (RR = 1.53, 95% CI 1.13 to 2.07) had higher RRs of LTBI-related articles to TB-related articles. CONCLUSIONS: High TB burden countries (TB incidence > 100 per 100,000 population) published more overall TB-related research, whereas low TB burden countries showed greater focus on LTBI. Given the potential benefits, high TB burden countries should consider increasing their emphasis on LTBI-related research.

Public involvement in health research systems: a governance framework.

BACKGROUND: Growing interest in public involvement in health research has led to organisational and policy change. Additionally, an emerging body of policy-oriented scholarship has begun to identify the organisational and network arrangements that shape public involvement activity. Such developments suggest the need to clearly conceptualise and characterise public involvement in health research in terms of governance. METHODS: We drew on an established health research system framework to analyse governance functions related to public involvement, adapting scoping review methods to identify evidence from a corpus of journal papers and policy reports. We drew on the logics of aggregation and top down configuration, using a qualitative interpretive approach to combine and link findings from different studies into framework categories. RESULTS: We identified a total of 32 scholarly papers and 13 policy reports (n = 45 included papers) with relevance to governance for public involvement. Included papers were broadly consonant in identifying the need for activity to specify and support public involvement across all four governance functions of stewardship, financing, creating and sustaining resources, and research production and use. However, different visions for public involvement, and the activity required to implement it and achieve impact, were particularly evident with respect to the stewardship function, which seeks to set overall directions for research while addressing the potentially competing demands of a system's many constituents. CONCLUSIONS: A governance perspective has considerable value for public involvement in health research systems, supporting efforts to coordinate and institutionalise the burgeoning public involvement enterprise. Furthermore, it highlights challenges for what is, ultimately, a highly political intervention, suggesting that diverse publics must be both involved within health research systems and enrolled as governors of them.

Public involvement and health research system governance: a qualitative study.

BACKGROUND: Interest in public involvement in health research projects has led to increased attention on the coordination of public involvement through research organisations, networks and whole systems. We draw on previous work using the 'health research system' framework to explore organisational actors and stewardship functions relevant to governance for public involvement. METHODS: To inform efforts in Ontario, Canada, to mobilise public involvement across the provincial health research enterprise, we conducted an exploratory, qualitative descriptive study of efforts in two jurisdictions (England, United Kingdom, and Alberta, Canada) where there were active policy efforts to support public involvement, alongside jurisdiction-wide efforts to mobilise health research. Focusing on the efforts of public sector organisations with responsibility for funding health research, enabling public involvement, and using research results, we conducted in-depth, semi-structured interviews with 26 expert informants and used a qualitative thematic approach to explore how the involvement of publics in health research has been embedded and supported. RESULTS: We identified three sets of common issues in efforts to advance public involvement. First, the initial aim to embed public involvement leveraged efforts to build self-conscious research 'systems', and mobilised policy guidance, direction, investment and infrastructure. Second, efforts to sustain public involvement aimed to deepen involvement activity and tackle diversity limitations, while managing the challenges of influencing research priorities and forging common purpose on the evaluation of public involvement. Finally, public involvement was itself an influential force, with the potential to reinforce - or complicate - the ties that link actors within research systems, and to support - or constrain - the research system's capacity to serve and strengthen health systems. CONCLUSIONS: Despite differences in the two jurisdictions analysed and in the organisation of public involvement within them, the supporters and stewards of public involvement sought to leverage research systems to advance public involvement, anticipated similar opportunities for improvement in involvement processes and identified similar challenges for future involvement activities. This suggests the value of a health research system framework in governance for public involvement, and the importance of public involvement for the success of health research systems and the health systems they aim to serve.

Supporting research readiness in social enterprise health services.

Health-based social enterprises are spun out of the NHS, yet continue to provide NHS-funded services. With the spin-out, however, formal processes for research governance were lost. Patients have a right to take part in research, regardless of where they access healthcare. This paper discusses the barriers to social enterprises undertaking applied health research and makes recommendations to address the need for equivalence of governance processes with NHS trusts.

Holding the Project Accountable: Research Governance, Ethics, and Democracy.

This paper seeks to address research governance by highlighting the notion of public accountability as a complementary tool for the establishment of an ethical resonance space for emerging technologies. Public accountability can render development and design process of emerging technologies transparent through practices of holding those in charge of research accountable for their actions, thereby fostering ethical engagement with their potential negative consequences or side-effects. Through practices such as parliamentary questions, audits, and open letters emerging technologies could be effectively rendered transparent and opened up to broader levels of scrutiny and debate, thereby contributing to a greater adherence of emerging technologies to ethics and moral consensus. Fundamental democratic practices could thus not only lead to better informed choices in design and development processes, but also contribute to more morally substantive outcomes.