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.

Research Ethics Board/Institutional Review Board Variability and Other Ethical Challenges in Multi-Site Research Involving Participants on the Autism Spectrum

2019 ◽  
pp. 77-86
Author(s):  
Mackenzie Salt
Keyword(s):  
Research Ethics ◽  
Vulnerable Populations ◽  
Autism Spectrum ◽  
Ethical Review ◽  
Ethical Challenges ◽  
Adults With Autism ◽  
Institutional Review ◽  
Research Ethics Boards ◽  
Multicentre Research ◽  
Ethical Review Process

Doing research at multiple sites can create ethical challenges for researchers, especially those working with vulnerable populations. During the ethical review process, different research ethics boards can disagree on interpretations of research ethics concepts such as capacity to consent, vulnerability, and autonomy. In this chapter, experience in conducting a multi-year, multicentre study involving studying the communication skills of adults with autism is discussed, and the ethical challenges that arose are addressed, focusing on ethical challenges of recruiting participants from multiple sites and detailing interactions with the various research ethics boards involved. Advice and suggestions are provided for other researchers on how to address some of the challenges in doing multicentre research involving participants from vulnerable populations.

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.

scholarly journals Conflicting interests: Critiquing the place of “institutional reputation” in research ethics reviews

Aporia ◽  
2020 ◽  
Vol 11 (2) ◽  
pp. 27-34
Author(s):  
Jean Daniel Jacob ◽  
Thomas Foth
Keyword(s):  
Research Ethics ◽  
Review Process ◽  
Human Subjects ◽  
Ethical Review ◽  
Ethical Standards ◽  
Research Ethics Review ◽  
Conflicting Interests ◽  
Conducting Research ◽  
Ethical Review Process ◽  
Institutional Reputation

Going through Research Ethics Boards (REB) and being held accountable to the highest ethical standards to conduct research with human subjects is commonplace. The goal of such a process helps ensure the selection and achievements not only of morally acceptable ends, but also of acceptable means to those ends when conducting research. Ultimately, REBs must pass judgment about the acceptability of harms and benefi ts to participants as they relate to research processes and outcomes. In this paper, we explore the implication of integrating “institutional reputation” as a category of analysis in the ethical review process. Informed by a recent Research Ethics Board (REB) review, we seek to engage with the readership in a constructive refl ection on the concept of institutional reputation as a source of confl icting interests in research ethics review process.

scholarly journals Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial

2007 ◽  
Vol 33 (2) ◽  
pp. 113-118 ◽  
Author(s):  
C M Seiler ◽  
P Kellmeyer ◽  
P Kienle ◽  
M W Buchler ◽  
H-P Knaebel ◽  
...  
Keyword(s):  
Review Process ◽  
Ethical Review ◽  
Multicentre Studies ◽  
Surgical Trial ◽  
Ethical Review Process

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.

Human research ethics committees members: ethical review personal perceptions

2021 ◽  
Author(s):  
Boris Handal ◽  
Chris Campbell ◽  
Kevin Watson ◽  
Marguerite Maher ◽  
Keagan Brewer ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Human Research ◽  
Human Research Ethics ◽  
Personal Perceptions

The Digi-Table Method as a Tool for Reflecting on Research Ethics

2021 ◽  
Vol 66 (Special Issue) ◽  
pp. 177-177
Author(s):  
Wim Van Der Molen ◽  
◽  
Els Maeckelberghe ◽  
◽  
◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethical Review ◽  
Scientific Integrity ◽  
Societal Impact ◽  
Educational Tool ◽  
Human Beings ◽  
Review Committee ◽  
Learning Content ◽  
Ethical Review Committee

"concepts and processes by means of a digitable. It is a tool for familiarizing users with complicated and complex issues, learning content, and addressing the more methodical aspects didactically. In this project, we have adapted the DTM for reflecting on research ethics, i.c. research with human beings and its ethical requirements and the review by the medical ethical review committee (MREC). A MREC reviews research proposals based on various (ethical) requirements and requires researchers to understand the ethical consequences and societal impact of their research. Before writing their own proposals, it is important for students to know and understand these ethical requirements and the process through which research proposals are reviewed. In order to train this, we prepared the digitable to simulate the review of a research protocol by an MREC and adapted it into an existing assignment on research ethics for master students. The students were informed of our aim and the use of DTM as an educational tool, and asked for consent. We invited them to critically assess the activity and we ensured participation would not influence their grade. The students reported a better understanding of the medical ethical review and felt it would improve their own work. From the educator’s perspective, the quality of argumentation of the review was much improved compared to previous years. The DTM as an educational tool is now a standard element in different master courses on scientific integrity. "

Sign in / Sign up

Export Citation Format

Share Document