Research Ethics Board of Health: a seven year review of the only ethics review board in Bhutan

2016 ◽  
Vol 2 (1) ◽  
pp. 25-29
Author(s):  
Mongal S. Gurung ◽  
Tashi Dema ◽  
Dorji Pelzom ◽  
Tashi Tobgay ◽  
Pakila Drukpa
Keyword(s):  
Research Ethics ◽  
Median Number ◽  
Progressive Increase ◽  
Ethical Review ◽  
Ethics Review ◽  
Health Related Research ◽  
Health Related ◽  
Research Ethics Board ◽  
Time Required ◽  
Ethical Clearance

Introduction: Research Ethics Board of Health (REBH), established in 2009, is the only ethics review board in Bhutan. The REBH was certified by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Forum for Ethical Review Committees in the Asian and Western Pacific Regions (FERCAP) in 2010 and recertified in 2013, and it received the Federal Wide Assurance (FWA) from the Office for Human Research Protections (OHRP), USA, in 2010 and in 2013. All researchers conducting health related research in Bhutan have to seek prior ethical clearance from REBH under the requirements of the National Health Policy 2011. Objective: The article aims to describe the performance of REBH, its standard and review procedure. Methods: A descriptive study of records and database of REBH from 2009 to 2015. Results: As of December 2015, the REBH has received 227 protocols with an average of 32 protocols per year. The median number of days for the initial review was 21 days (Min 0 days; Max 85 days). The median duration for approval of protocols from the date of receiving the application was 48 days. The average number of times the protocols were reviewed before issuing the approval letter was 2. Conclusions: There has been a progressive increase in the number of protocols submitted to REBH. This indicated an increasing research culture in Bhutan. It takes about one and half months to get an approval from REBH; therefore, researchers have to consider the time required for ethical clearance process while planning research projects.

A Novel Framework for Reflecting on the Functioning of Research Ethics Review Panels

2007 ◽  
Vol 14 (1) ◽  
pp. 99-116 ◽  
Author(s):  
Colin Macduff ◽  
Andrew McKie ◽  
Sheelagh Martindale ◽  
Anne Marie Rennie ◽  
Bernice West ◽  
...  
Keyword(s):  
Health Care ◽  
Nursing Education ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Rapid Change ◽  
Health Care Research ◽  
Ethical Review ◽  
Review Panel ◽  
Ethics Review ◽  
Research Ethics Review

In the past decade structures and processes for the ethical review of UK health care research have undergone rapid change. Although this has focused users' attention on the functioning of review committees, it remains rare to read a substantive view from the inside. This article presents details of processes and findings resulting from a novel structured reflective exercise undertaken by a newly formed research ethics review panel in a university school of nursing and midwifery. By adopting and adapting some of the knowledge to be found in the art and science of malt whisky tasting, a framework for critical reflection is presented and applied. This enables analysis of the main contemporary issues for a review panel that is primarily concerned with research into nursing education and practice. In addition to structuring the panel's own literary narrative, the framework also generates useful visual representation for further reflection. Both the analysis of issues and the framework itself are presented as of potential value to all nurses, health care professionals and educationalists with an interest in ethical review.

scholarly journals A reflection on research ethics and citizen science

2019 ◽  
Vol 15 (3-4) ◽  
pp. 1-10 ◽  
Author(s):  
Kathleen M Oberle ◽  
Stacey A Page ◽  
Fintan KT Stanley ◽  
Aaron A Goodarzi
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Citizen Science ◽  
Low Risk ◽  
Community Based ◽  
Research Methodologies ◽  
Ethics Review ◽  
Research Ethics Board ◽  
The One

Ethics review of research involving humans has become something of an institution in recent years. It is intended to protect participants from harm and, to that end, follows rigorous standards. Given recent changes in research methodologies utilized in medical research, it may be that ethics review for some kinds of studies needs to be reexamined. The purpose of this paper is to stimulate dialogue regarding the kind of review required for citizen science-based research. We describe a case study of a proposal submitted to our research ethics board and propose different approaches to proportionate review in research involving citizen scientists. In particular, we describe how problems with the term “participant” led to confusion in review of this study and examine the study in light of current Canadian guidelines. We suggest that the term participant and indeed the general approach to low-risk community-based studies such as the one described warrant reexamination.

scholarly journals A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana

2016 ◽  
Vol 14 (1) ◽  
pp. 1-14
Author(s):  
Dimpho Ralefala ◽  
Joseph Ali ◽  
Nancy Kass ◽  
Adnan Hyder
Keyword(s):  
Research Ethics ◽  
Ethics Training ◽  
Ethical Review ◽  
Human Beings ◽  
Training Requirements ◽  
Ethics Review ◽  
Research Protocols ◽  
New Findings ◽  
Research Oversight ◽  
Ethical Review Process

Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country (LMIC) settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana (UB) about the review of research protocols by local IRBs. Data were collected using a web-based survey (SurveyMonkey1). This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced high rates of approval at government ministries and UB, and generally believed that ethics review processes can help researchers themselves better understand and appreciate research ethics in general. Though only about one-quarter of respondents reported a more positive view of research ethics after interacting with the UB IRB, 56.5 percent reported no change. In contexts where IRBs have recently been established, it can be particularly important to document the perspectives of researchers in order to align expectations with capabilities, and identify areas where IRBs can improve operations. Future efforts to advance research ethics and ethical review in Botswana should include establishing research ethics training requirements and courses for researchers, increasing investment in IRBs and their training, further developing institutional and national research ethics policies, and formalizing agreements between IRBs and others involved in research oversight in the country to support coordinated review.

Health‐related Research Ethics and Social Value: Antibiotic Resistance Intervention Research and Pragmatic Risks

Bioethics ◽  
2019 ◽  
Vol 33 (3) ◽  
pp. 335-342 ◽  
Author(s):  
Christian Munthe ◽  
Niels Nijsingh ◽  
Karl Fine Licht ◽  
D.G. Joakim Larsson
Keyword(s):  
Antibiotic Resistance ◽  
Research Ethics ◽  
Intervention Research ◽  
Social Value ◽  
Related Research ◽  
Health Related Research ◽  
Health Related

scholarly journals Challenges in obtaining research ethics and governance approvals for an Australian national intersector, multisite audit study

2020 ◽  
Vol 44 (5) ◽  
pp. 799
Author(s):  
Kimberly Buck ◽  
Linda Nolte ◽  
Helana Kelly ◽  
Karen Detering ◽  
Craig Sinclair ◽  
...  
Keyword(s):  
Research Ethics ◽  
Health Sector ◽  
Aged Care ◽  
Single Site ◽  
Ethical Review ◽  
Multicentre Studies ◽  
Private And Public ◽  
Time Required ◽  
Multicentre Research ◽  
Ethical Review Process

ObjectiveThe aim of this study was to describe timelines and challenges encountered in obtaining ethics and governance approvals for an Australian multicentre audit study involving 100 public (n=22) and private (n=78) sites from three health sectors and all eight Australian states and territories. MethodsWe determined and compared the processes, documentation and number of business days required to prepare applications and obtain research ethics and governance approvals. ResultsIn total, the full ethics and governance process (calculated from the date the first application was started to the date the final approval was granted) took 203 business days (79% of the study timeline). Standard risk ethics applications (n=4) took a median of 17 business days (range 3–35 days) to prepare and 32 business days (range 17–67 days) to be approved; expedited ethics applications (n=4) took a median of 5 business days (range 1–20 days) to prepare and 10 business days (range 1–44 days) to be approved. Governance approvals (n=23) took a median of 27 business days (range 4–63 days) to prepare and 20 business days (range 4–61 days) to be approved. Challenges included the lack of a nationwide single-site ethical review process, the extensive time required to duplicate content across applications, variability in application requirements and submission systems, and contract negotiations. ConclusionFurther improvements are needed to reduce duplication and increase the efficiency of Australian ethics and governance review processes. What is known about the topic?The process for obtaining ethics approval for multicentre research has been streamlined through the introduction of single-site ethics review. However, the process of gaining ethics and governance approvals for national multicentre research continues to be time-consuming, resource-intensive and duplicative. What does this paper add?This is the first study to examine the challenges of obtaining ethics and governance approvals for a non-interventional multicentre study involving three health sectors (hospital, aged care, general practice), both private and public services and all eight Australian jurisdictions. Previous examinations of Australian multicentre studies have considered only one health sector, focused on the public system and/or were not national in scope. What are the implications for practitioners?Researchers and funders need to be aware of the considerable time, resources and costs involved in gaining research ethics and governance approvals for multicentre studies and include this in budgets and study timelines. Policy makers and administrators of ethics and governance review processes must address barriers to conducting multicentre research in Australia.

Developing a competency framework for health research ethics education and training

2021 ◽  
pp. medethics-2021-107237
Author(s):  
Sean Tackett ◽  
Jeremy Sugarman ◽  
Chirk Jenn Ng ◽  
Adeeba Kamarulzaman ◽  
Joseph Ali
Keyword(s):  
Research Ethics ◽  
Health Research ◽  
Formal Education ◽  
Ethics Education ◽  
Competency Framework ◽  
Competency Development ◽  
Competency Frameworks ◽  
Health Related Research ◽  
Health Related ◽  
Training Programmes

Health research ethics (HRE) training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement.

Research Ethics Committees in the Field of Health-Related Human Research — A European Perspective and the Case of Austria

2014 ◽  
Vol 21 (4) ◽  
pp. 387-400
Author(s):  
Verena Stühlinger ◽  
Michael Hackl
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Epidemiological Studies ◽  
Healthcare Research ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Research Committee ◽  
Institutional Review ◽  
Health Related Research ◽  
Health Related

Human subject abuse and patient harm through medical research have led to the establishment of Institutional Review Boards (irbs or Research Ethics Committees (recs)), who independently scrutinise research protocols. In the field of trials with medicinal products as well as trials testing medical devices, an obligation for submission prior to realisation is granted within Europe through European directives. However, regulation of other fields of health-related research, e.g., psychological trials, public health and epidemiological studies or healthcare research is the responsibility of eu Member States; and European laws differ widely. The article gives an overview of European regulations in the field of rec review requirements, critically analyses Austrian legislation in this field and describes an institutional solution for legislative gaps in Austria — the Research Committee for Scientific and Ethical Questions (rcseq). Finally, important European initiatives for the future are pointed out.

Attempting to standardise ethical review within the complexity of health-related research

2013 ◽  
Vol 9 (3) ◽  
pp. 269-277 ◽  
Author(s):  
Rosemary De Luca
Keyword(s):  
Clinical Trials ◽  
New Zealand ◽  
Full Range ◽  
Ethical Review ◽  
Review System ◽  
Competitive Edge ◽  
Health Related Research ◽  
Health Related ◽  
The Common ◽  
Review Criteria

Researchers in medicine, allied disciplines and elsewhere submit research proposals to an ethical review board before research commences. This paper argues that the effectiveness of review relies on reviewers using discernment and judgement when applying standardised review criteria so that they accommodate the full range of research projects. With reference to ethics literature, the paper identifies five imperatives in the development of review guidelines and processes. It examines case composition and analysis, and explores interactions between professional developers, researchers and reviewers to illustrate problems in the review process. It refers to the ethical review system in New Zealand and the report to parliament: Inquiry into Improving New Zealand’s Environment to Support Innovation through Clinical Trials (Health Committee 2011). Seeking to gain for New Zealand a competitive edge in clinical research, this report made 19 recommendations to improve the climate for clinical trials, ethical review included, in this country. The connection between these two case studies is the common endeavour to standardise the ethical review exercise, review systems and review processes. Cases with commentary are a recommended addition to guidelines documents to present research within its context and to demonstrate the complexity that a standardised ethical review does not always address.

scholarly journals Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046546
Author(s):  
Val Thurtle ◽  
Andy JM Leather ◽  
Haja Wurie ◽  
Edward Foday ◽  
Mohamed Samai ◽  
...  
Keyword(s):  
Research Ethics ◽  
Scoping Review ◽  
Low Income ◽  
Ethics Committees ◽  
Sub Saharan Africa ◽  
Research Ethics Committees ◽  
Related Research ◽  
Health Related Research ◽  
Health Related ◽  
Sub Saharan

IntroductionHealth research in low-income and middle-income countries, which face the greatest burden of disease, is a vital component of efforts to combat global health inequality. With increased research, there has also been concern about ethical and regulatory issues and the state of research ethics committees, with various attempts to strengthen them. This scoping review examines the literature on ethics committees for health-related research in sub-Saharan Africa, with a focus on regulatory governance and leadership, administrative and financial capacity, and conduct of ethical reviews.Methods and analysisWe will use the methodological approach proposed by Arksey and O’Malley and adapted by Levac et al and the Joanna Briggs Institute. Inclusion and exclusion criteria are based on the ‘Population–Concept–Context’ framework. Literature (from January 2000 to December 2020) will be searched in multiple databases including Embase and PubMed and websites of relevant organisations. All records will be screened by applying the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review flowchart: two reviewers will independently screen titles and abstracts, and full text of included records. Using an inductive approach, we will synthesise the literature, identify best practice and gaps in evidence on strengthening research ethics committees.Ethics and disseminationEthical approval is not required as the review will include only published literature. The findings will be published in a peer-reviewed journal and presented at stakeholder meetings and conferences.

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