Welfare Of Research Participants Research Articles

The ethics of clinical research in the era of COVID-19.

There is an urgent need for increased understanding of COVID-19 and strategies for its prevention, treatment, and mitigation. All participants in the research enterprise, including institutional review boards, have an ethical duty to protect participants and ensure that the benefits gained from such research do not conflict with the core principles that guided researchers prior to the pandemic. In this review, we discuss the ethical issues surrounding initiation and conduct of clinical trials, focusing on novel COVID-19 therapeutic, vaccine, or biospecimen research, using the principles of autonomy, beneficence, and justice. We discuss strategies to manage the practical challenges associated with the conduct of clinical trials, with an emphasis on maintaining the rights and welfare of research participants.

Position statement from the Editors of Anaesthesia and Anaesthesia Reports on best practice in academic medical publishing.

It is essential that academic publishing complies with the highest standards in terms of ethics, research conduct and manuscript preparation. This protects the rights and welfare of research participants, ensures the integrity of study results and aids the communication and dissemination of novel findings into clinical practice. This position statement outlines the current policies and practices of the Editors of Anaesthesia and Anaesthesia Reports in relation to academic medical publishing.

Disclosing Conflicts of Interest to Potential Research Participants: Good for Nothing?

The growing commercialization of science has raised concerns about financial conflicts of interest (COIs). Evidence suggests that such conflicts threaten the integrity of research and the well-being of research participants. Trying to minimize these negative effects, federal agencies, academic institutions, and publishers have developed conflict-of-interest policies. Among such policies, recommendations or requirements to disclose financial COIs to potential research participants and patients have become commonplace. Here, I argue that disclosing conflicts of interest to potential research participants fails to achieve the weighty moral goals that presumably ground such policies. This is so either because disclosure is simply a wrong means for achieving some of the goals in question or because, although disclosure could be an appropriate means for some of those goals, the way in which it is implemented prevents fulfillment of the desirable moral aim.

Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA

Objective To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. Method This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA. Results Some US academic health “centers” IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects’ research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection’s (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority. Conclusions REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

Post-approval process: A challenge for ethics committees.

Ethics committees (ECs) work toward upholding rights, dignity, safety, and well-being of research participants. They are also tasked with conducting oversight pre- and post-approval. ECs face various challenges in their functioning. Post-approval oversight is one of the major challenges, and various studies have stressed the importance of post-approval oversight. The aim of this study was to explore the challenges in the post-approval processes that are faced by the ECs and to suggest solutions to the most common challenges. We conducted a quantitative study contacting member secretaries of different ECs using an online Google Forms questionnaire. The questionnaire consisted of three domains and included questions about the description of the EC, conduct of post-approval activities, and challenges encountered during the post-approval process. We received responses from 61 member secretaries. We were able to identify challenges faced by the EC members in the post-approval process in the areas of site monitoring visit, review of post-approval submission (nonsubmission/incomplete submission/late submission of documents by PI, long time taken by reviewers, nonavailability of reviewers, nonadherence to timeline and too much paperwork), review of serious adverse events, and review of protocol deviations. Our study also noted the difference between accredited/assessed (National Accreditation Board for Hospitals and Healthcare Providers/Forum for Ethical Review Committees in the Asian and Western Pacific Region) ECs versus registered (Central Drugs Standard Control Organisation/Department of Health Research only) ECs by comparing the challenges.

FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS

Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect. The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review. Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process. By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.

Subsistence Farmers’ Understanding of the Effects of Indirect Impacts of Human Wildlife Conflict on Their Psychosocial Well-Being in Bhutan

Indirect impacts of Human Wildlife Conflict (HWC) are largely ignored, poorly understood, and scantly reported in the literature on HWC. Subsistence farmers in the Himalayan kingdom of Bhutan experience an increasing intensification of HWC impacts. Working across four districts representing different geographic regions of the country, we explored the perceived indirect impacts of HWC and how they affect the well-being and happiness of subsistence farmers using qualitative interviews (n = 48) and focus group discussions (n = 8). We conducted a qualitative thematic analysis. Based on respondent’s explanations, we coded the data according to effect of indirect impacts on human, social, financial, physical, natural, and psychological capitals. Mental distress, constant worries about food insecurity, fears for physical safety, frustration of movement restriction due to fear of being attack by wildlife, feelings of economic insecurity and anger over loss of crop and livestock due to wild predators affect the psychological health and well-being of research participants. Vulnerabilities related to gender and wealth status further deepen the effect of indirect impacts. Policies designed to address HWC should incorporate an understanding of the effects of indirect impacts of HWC and should focus on female-headed and poor households to reduce the negative effects of wildlife impacts.

Prevalence of Psychoactive Substance Use and Associated Behavioral Risks among Secondary School Students in Tanzania

This study aimed to investigate the prevalence of psychoactive substance use and associated behavioral risks among secondary school students in Tanzania. The study adopted a qualitative research approach. Data generated from semi-structured interviews with Heads of school, focused group discussions with teachers and students and documentary reviews were subjected to thematic analysis. Credibility, dependability, confirmability and transferability were considered to ensure trustworthiness. Rights and welfare of research participants and subjects were considered by the researcher. The most commonly used psychoactive substances among secondary school students were marijuana (cannabis), cigarettes and alcohol. Peer pressure, the family environment, the availability of substances in students localities are some of factors that influenced students to use psychoactive substances. The study recommends that the government should take special priority in banning the use of cannabis, cigarettes and alcohol, especially among secondary school students in order to minimize the prevalence of the use of psychoactive substances among secondary school students. School management and government at large need to establish drug control and prevention clubs in secondary schools so as to equip students with the necessary skills of knowing to resist temptations related to the use of psychoactive substances.

Brain banking in India: Relevance in current day practice.

Biobanks are set to become the norm. The explosion of new and powerful technologies like genomics and other multiomics has catapulted research from individual laboratories to multi-institutional and international partners. Today, with increasing life span, and the rising incidence of brain diseases, Brain Banks have become an invaluable source for unravelling the pathogenesis of several brain disorders, and develop effective therapies. The article briefly reviews the evolution of brain banking, rise of global networks, with a brief overview of steps involved from donor recruitment, protocols of processing, storage, annotation, and tissue distribution. The ethics of biobanking is one of the most controversial issues in bioethics, the key issues being consent, confidentiality, and commercialisation. Regulatory authorities in different countries and in India, the Indian Council of Medical Research has taken a lead to formulate new ethical guidelines for research involving human participants protecting rights, and well-being of research participants. Although brain banks have been established in the 1960s, in India, the first Brain Bank was established in 1995 at the National Institute of Mental Health and Neurosciences, Bengaluru. Now a network with two more Brain banks is being established in the country. The challenges and benefits of establishing the first Brain Bank as a National Research Facility in India is shared. For optimising available resources and promote brain banking, it is essential for medical professionals, and the public to perceive the crucial advantage in conversion of biological waste into invaluable resources for neuroscience. This will be the greatest "gift of hope" that we can offer for the future generations to overcome hitherto untreatable disorders such as dementias.

Physical activity and well-being of students of faculties medical and non-medical services during the Covid-19 pandemic

Physical activity has a positive effect on the human body, well-being and mental health. This is confirmed by the results of studies which show that regular physical exercise has a beneficial effect not only on the cardiovascular, muscular and nervous systems, as well as on mental well-being. The Covid-19 pandemic, which affected society as a whole, changed our lives. The pandemic has a social and economic scope, increasing the number of stressful situations that affect well-being. Aim of the research: The aim of the undertaken research was to check the level of physical activity and well-being of medical and non-medical students during the pandemic. Material and methods: The research used the method of diagnostic survey, with the use of the proprietary questionnaire and the International Physical Activity Questionnaire (IPAQ) as well as a 36-point Health Survey were used. The research group consisted of students of medical and non-medical faculties. Results: The research confirmed a decrease in physical activity and a change in well-being in students of both faculties. The vast majority of students (80%) noticed a change in well-being during the pandemic. Half of the respondents (50%) undertake physical activity to improve their well-being, and over 60% of the students declared that physical activity helps them maintain their well-being during the pandemic. Conclusions: The results of the conducted research indicate a negative impact of the pandemic on the physical activity and well-being of the respondents. There was a strong correlation between physical activity and the well-being of research participants. The greatest decrease in physical activity was observed in medical students (52.08%). On the other hand, students of non-medical faculties (54.17%) showed a lower level of well-being, and higher medical students (45.83%). It is advisable to take preventive measures through active physical activity in order to eliminate the negative effects of the pandemic.

Ethical and regulatory oversight of clinical research: The role of the Institutional Review Board.

The history of clinical research is, unfortunately, filled with examples of research studies that took advantage of and harmed research participants, to fulfill the research goals of scientists. Over time, we have created a system of ethical codes, principles, and regulations that are designed to prevent these abuses and to ensure that the rights and welfare of research participants are protected and honored. This review article will provide a brief history of clinical research ethics and ethical codes, outlining how those codes developed into the current regulatory requirements for the ethical oversight of clinical research. Understanding the current human subject protection systems will allow researchers to use best practices for planning and conducting rigorous, scientifically valid and ethical clinical studies. Understanding the history, principles, and foundations of the development of this system will equip researchers to understand what resources are available to them and how to make the best decisions when confronted with unique ethical situations in the conduct of their research.

Maneuvering the Institutional Review Board Process: A Guide for Critical Care Nurses and Researchers.

Institutional review boards (IRBs) exist to protect the rights and welfare of research participants. Critical care nurses and researchers may interface with IRBs directly or indirectly. Having an understanding of how the IRB process works will help nurses advocate for patients who may also be research participants and will help researchers facilitate approval of their research studies.

How to continue COVID-19 vaccine clinical trials? The ethics of vaccine research in a time of pandemic.

Between December 2020 and March 2021, the US Food and Drug Administration and the European Medicines Agency issued Emergency Use Authorizations and Conditional Marketing Authorizations for the distribution of the first COVID-19 vaccines. Although these vaccines were thoroughly assessed before their approval, regulators required companies to continue ongoing placebo-controlled clinical trials in order to gather further reliable scientific information on their safety and efficacy, as well as to start new studies to evaluate additional candidates. The aim of this paper is to present and discuss the ethical issues raised by the tension between the need to continue these types of clinical trials and the obligations related to the protection of the rights and well-being of research participants. Specifically, we question whether—how, and to what extent—fundamental principles governing research involving human beings can be applied to the current pandemic situation. We argue that continuing ongoing placebo-controlled clinical trials can be considered ethically justifiable only if all participants are adequately informed of any developments that may affect their willingness to remain enrolled, including the current situation of resource scarcity and the prioritization criteria established for vaccination. However, we also argue that currently approved vaccines, which are considered safe and effective enough to be administered to millions of people as part of the vaccination campaign, necessarily represent the “best proven intervention” currently available and, therefore, should be used as comparators in future studies instead of placebo.

Intra-Study Matching Considerations When Using Mixed Methods-Based Research Approaches: A Critical Dialectical Pluralistic Approach

The step of obtaining a sample(s) (i.e., sampling) in mixed methods-based research studies likely represents the least developed step in the research process, with only 21 Scopus-indexed works published on the topic to date. Consequently, the time is rife for mixed methods-based researchers to develop sampling designs that are more TREEful—that is, transparent, rigorous, equitable, and ethical—especially when sampling among/between phases/components. Because, more than the other 13 mixed methods-based research philosophies, critical dialectical pluralism especially is concerned with the welfare of research participants, and because the sampling step is subject to misuse and abuse of participants, the use of a critical dialectical pluralist lens to ensure that mixed methods-based sampling designs are as TREEful as possible has logical appeal. Therefore, in this editorial, we have provided a meta-framework,1 via a critical dialectical pluralism lens, for selecting samples for each of the following four types of relationships among/between phases/components identified by Onwuegbuzie and Collins (2007), namely, identical samples, parallel samples, nested samples, and multilevel samples. This lens has led to the identification of several options for minimizing, or at least reducing, what we refer to as identical sampling bias, parallel sampling bias, nested sampling bias, and multilevel sampling bias such that samples are optimally matched within a single mixed methods-based research study. In the context of mixed methods-based research, matching refers to the process of forming groups to make them as similar as possible with respect to extraneous or confounding factors (e.g., demographic variables [e.g., gender, age]; personality variables [e.g., resilience]; affective variables [e.g., motivation]). In particular, we outline the use of several matching techniques—specifically, exact matching, greedy matching, optimal matching, propensity score matching, subclassification, and magnitude coding—for addressing these different forms of bias. We encourage mixed methods-based researchers to explore using one or more of these matching techniques, whenever appropriate, regardless of their philosophical stance, in order to avoid researcher participants from being misrepresented.

Implementing a National Approach to Research Ethics Review during a Pandemic - the Irish Experience.

The surge of coronavirus disease 2019 (COVID-19) research studies involving human participants in response to the pandemic has meant that research ethics committees across the world have been challenged to adapt their processes to meet demand while retaining high standards of review. Ethics review during this pandemic remains essential to ensure the safety, dignity and well-being of research participants, however research ethics committees are now faced with new, and often complex, ethics considerations and logistical challenges. This Open Letter looks specifically at the Irish experience of establishing a national approach to research ethics review amidst a global pandemic. This represents Ireland's first National Research Ethics Committee, which provided the research community with an expedited and 'single national opinion' for ethics review for COVID-related research. The insights gleaned and lessons learned from the Irish experience may inform emergency responses to future pandemics or public health emergencies.

The Impact of COVID-19 on the State of Clinical and Laboratory Research Globally in Transplantation in May 2020.

The Impact of COVID-19 on the State of Clinical and Laboratory Research Globally in Transplantation in May 2020.

Implementing a National Approach to Research Ethics Review during a Pandemic – the Irish Experience

The surge of coronavirus disease 2019 (COVID-19) research studies involving human participants in response to the pandemic has meant that research ethics committees across the world have been challenged to adapt their processes to meet demand while retaining high standards of review. Ethics review during this pandemic remains essential to ensure the safety, dignity and well-being of research participants, however research ethics committees are now faced with new, and often complex, ethics considerations and logistical challenges. This Open Letter looks specifically at the Irish experience of establishing a national approach to research ethics review amidst a global pandemic. This represents Ireland's first National Research Ethics Committee, which provided the research community with an expedited and 'single national opinion' for ethics review for COVID-related research. The insights gleaned and lessons learned from the Irish experience may inform emergency responses to future pandemics or public health emergencies.

Evaluating the Quality of Research Ethics Review and Oversight: A Systematic Analysis of Quality Assessment Instruments

Background Research ethics review committees (RERCs) and Human Research Protection Programs (HRPPs) are responsible for protecting the rights and welfare of research participants while avoiding unnecessary inhibition of valuable research. Evaluating RERC/HRPP quality is vital to determining whether they are achieving these goals effectively and efficiently, as well as what adjustments might be necessary. Various tools, standards, and accreditation mechanisms have been developed in the United States and internationally to measure and promote RERC/HRPP quality. Methods We systematically reviewed 10 quality assessment instruments, examining their overall approaches, factors considered relevant to quality, how they compare to each other, and what they leave out. For each tool, we counted the number of times each of 34 topics (divided into structure, process, and outcome categories) was mentioned. We generated lists of which topics are most and least mentioned for each tool, which are most prevalent across tools, and which are left unmentioned. We also conducted content analysis for the 10 most common topics. Results We found wide variability between instruments, common emphasis on process and structure with little attention to participant outcomes, and failure to identify clear priorities for assessment. The most frequently mentioned topics are Review Type, IRB Member Expertise, Training and Educational Resources, Protocol Maintenance, Record Keeping, and Mission, Approach, and Culture. Participant Outcomes is unmentioned in 8 tools; the remaining 2 tools include assessments based on adverse events, failures of informed consent, and consideration of participant experiences. Conclusions Our analysis confirms that RERC/HRPP quality assessment instruments largely rely on surrogate measures of participant protection. To prioritize between these measures and preserve limited resources for evaluating the most important criteria, we recommend that instruments focus on elements relevant to participant outcomes, robust board deliberation, and procedures most likely to address participant risks. Validation of these approaches remains an essential next step.

Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research.

Evaluating the quality and effectiveness of the institutional review boards (IRBs) responsible for overseeing research involving human participants is critically important but perpetually challenging. Seemingly common-sense measures, such as the number of proposals approved with and without major modifications and the number of unexpected adverse events occurring in approved protocols, can be misleading indicators of participant protection, and regulatory compliance may not correspond to achieving ethical goals. These measurement challenges make it difficult to assess the validity of concerns about different IRB models. A group of U.S. senators recently raised questions about the increasing use of for-profit IRBs to review research proposals (as opposed to boards typically housed at academic medical centers and health care institutions) and, more specifically, about the growing trend of private equity ownership and consolidation of for-profit IRBs. Although all IRBs face pressure to speed reviews and none are entirely free of conflicts of interest, the private equity model is particularly susceptible to approaches that could undercut the ethical mission of IRBs to protect and promote the rights and welfare of research participants. Ideally, the quality of board oversight could be measured directly, rather than relying on the heuristic of board type; this article describes several current efforts toward this goal. In the meantime, one improvement may be to pursue a new model of IRB oversight: independent nonprofit boards that stand apart from research institutions, take advantage of business approaches to research review, and minimize conflicts of interest.

Ethics committees in the time of COVID-19.

ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. cross-sectional survey. the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.