Ethical issues in action-oriented research in Indonesia

2017 ◽  
Vol 24 (6) ◽  
pp. 686-693 ◽  
Author(s):  
Rini Rachmawaty
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committee ◽  
International Standards ◽  
Local Health ◽  
Human Subject Research ◽  
Research Ethics Committee ◽  
Oriented Research

Background: Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. Objectives: This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. Methods: A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Results: Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Discussion: Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Conclusion: Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies understand the research ethics on human subjects and apply it into their practice.

scholarly journals Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048395
Author(s):  
Morag E Taylor ◽  
Chris Todd ◽  
Sandra O'Rourke ◽  
Lindy M Clemson ◽  
Jacqueline CT Close ◽  
...  
Keyword(s):  
Older People ◽  
Research Ethics ◽  
Process Evaluation ◽  
Ethics Committee ◽  
Community Dwelling ◽  
Innovative Technology ◽  
Local Health ◽  
Research Ethics Committee ◽  
Personal Impact ◽  
The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

scholarly journals Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017148 ◽  
Author(s):  
Frances Rapport ◽  
Patti Shih ◽  
Rebecca Mitchell ◽  
Armin Nikpour ◽  
Andrew Bleasel ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Services ◽  
Research Ethics ◽  
Surgical Intervention ◽  
Refractory Epilepsy ◽  
Ethics Committee ◽  
Local Health ◽  
Health Services Use ◽  
Research Ethics Committee ◽  
Resective Surgery

IntroductionOne-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays.Methods and analysisMixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records’ reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012–2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services’ use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3).Ethics and disseminationEthical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers.

Confidentiality in participatory research

2014 ◽  
Vol 23 (4) ◽  
pp. 442-454 ◽  
Author(s):  
Elmira Petrova ◽  
Jan Dewing ◽  
Michelle Camilleri
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Field Work ◽  
Research Process ◽  
Ethics Committee ◽  
Ethical Challenges ◽  
Ethical Guidelines ◽  
Case Study Methodology ◽  
Research Ethics Committee ◽  
Practice Development

Aim: This article presents key ethical challenges that were encountered when conducting a participatory qualitative research project with a very specific, small group of nurses, in this case with practice development nurses in Malta. Background: With the small number of nurses employed in practice development roles in Malta, there are numerous difficulties of maintaining confidentiality. Poorly constructed interventions by the researcher could have resulted in detrimental effects to research participants and the overall trustworthiness of the research. Generally, ethical guidelines for research exist to reinforce validity of research; however, there is not an established consensus on how these strategies can be utilised in some types of qualitative field work. Research design: The researcher used an exploratory case study methodology. The sample consisted of 10 participants who were interviewed twice using face-to-face interviews, over a period of 2 months. Ethical considerations: The study was ethically reviewed by the University Research Ethics Committee and the Faculty Research Ethics Committee, University of Malta. The participants referred to in this article have been given adequate information about the study and their consent has been obtained. Discussion: Numerous strategies for ensuring confidentiality during recruitment of the participants, during data collection, during transcription and data analysis and during dissemination of research results assisted the researcher in responding to potential and actual ethical issues. Conclusion: This article emphasises the main strategies that can be used to respond to ethical challenges when researching with a small easily identifiable group. The learning discussed here may be relevant to or even transferable to other similar research studies or research contexts. These methods fostered a greater credibility throughout the research process and predisposed the participants to greater trust, and thus, they disclosed their experiences and speak more freely, thus enhancing the quality of the study.

scholarly journals Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review

2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Pornpimon Adams ◽  
Sukanya Prakobtham ◽  
Chanthima Limpattaracharoen ◽  
Sumeth Suebtrakul ◽  
Pitchapa Vutikes ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committee ◽  
Malaria Research ◽  
Research Ethics Committee ◽  
Document Review

Ethical Issues in Research Involving Employees and Students

2020 ◽  
Author(s):  
David B. Resnik
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committee ◽  
Undue Influence ◽  
Research Ethics Committee ◽  
Direct Benefits ◽  
Potential Benefits

Employees and students often participate in research conducted or supported by investigators at their organizations or institutions. Most of these studies do not provide direct benefits to participants, but some do. While these studies offer potential benefits for society, they raise ethical issues related to coercion, undue influence, privacy, confidentiality, and risk. Investigators should pay special attention to these issues when designing and implementing studies. Relatedly, research ethics committee members should address these issues when reviewing or overseeing studies. This chapter will both review the ethical issues related to including employees and students in research and discuss some practices and policies for protecting their rights and welfare.

scholarly journals Training Needs Of Research Ethics Committee Members In Cameroon Regarding Research Participant Protection

2021 ◽  
Author(s):  
Ingrid Marcelle Koutio Douanla ◽  
Paul Nyibio Ntsekendio ◽  
Frank Forex Kiadjieu Dieumo ◽  
Felicité Tabala Naah ◽  
Fernando Kemta Lekpa ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Ethical Issues ◽  
Research Participant ◽  
Ethics Committee ◽  
Training Needs ◽  
Research Protocol ◽  
Ethical Evaluation ◽  
Research Ethics Committee ◽  
Research Protocols

Abstract Background The capacity of the Research Ethic Committee (REC) members to review research protocol is one of the frequently raised problems. The purpose of this study was to assess training needs of members of research ethics committee in Cameroon regarding research participant protection.Methods It was a cross-sectional descriptive study conducted in all the regions of Cameroon during the last quarter of the year 2020, assessing training needs of REC members’ ethical evaluation of health research protocols. Data were collected from all eligible REC members by trained and supervised surveyors using a well designed questionnaire integrated in smartphones via ODK-collect. The data were analyzed by estimating proportions with 95% Confidence Interval using the EpiInfo software version 7.2.2.6.Findings Out of the 79 ethics committee members reached, 64 (81.01%) accepted to participate including 28 (43.75) female. The result showed that,21 (32.81%) of ethics committee members were not trained in research ethics evaluation including 68.75% not exposed to training on research participants protection during clinical trials. A given fraction of respondent was not aware of the existence of key national regulations (25%) and international guidelines like the Helsinki Declaration (32.81%). Participants identified and ranked their priorities in terms of training needs in research participant’s protection, national text regulating research in Cameroon, evaluations’ procedures of research protocol, organization of research in Cameroon, and protection of participants in research involving the transfer of biological materials. The workshop and e-learning courses were seen to be the main accessible source of training.Conclusion Not all ethics committee members received training on ethical principles regarding research ethics review, review process and monitoring of research protocols, and on ethical issues associated to each study design including clinical trials. These gaps and the needs perceived by participants are to be taken into account when setting up a training program for RECs members on ethical evaluation in Cameroon.

scholarly journals Addressing ethical issues in H3Africa research – the views of research ethics committee members

2015 ◽  
Vol 9 (1) ◽  
Author(s):  
Jantina de Vries ◽  
◽  
Akin Abayomi ◽  
Katherine Littler ◽  
Ebony Madden ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committee ◽  
Research Ethics Committee

Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee

2021 ◽  
pp. 155626462110254
Author(s):  
Thana Khawcharoenporn ◽  
Wilaiwan Chimkhong ◽  
Varanya Roestpricha
Keyword(s):  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committee ◽  
Principal Investigator ◽  
Research Protocol ◽  
Human Subjects Research ◽  
Research Ethics Committee ◽  
Informed Consent Form ◽  
Quality Of Research

A pre–post study was conducted to evaluate the utility of template documents specifically created to assist research protocol submissions to a Thai research ethics committee (REC). A total of 172 protocols during the 2014–2016 preintervention period were matched to 172 protocols during the 2017–2019 postintervention period by type of principal investigator and REC review category. The intervention was associated with a significant reduction in initial REC requirement deficiencies in the information sheet and informed consent form, resubmission turn-around time by the principal investigator, and time form protocol submission to REC approval. The most significant postintervention improvements were for information about the consent process and listed risks of study participation. In this study, utilization of a structured protocol template with guidance instructions was associated with measurable improvement in the quality of research protocol submissions and REC review process.

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