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.

scholarly journals A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Provia Ainembabazi ◽  
Barbara Castelnuovo ◽  
Stephen Okoboi ◽  
Walter Joseph Arinaitwe ◽  
Rosalind Parkes-Ratanshi ◽  
...  
Keyword(s):  
Research Ethics ◽  
Study Design ◽  
Ethics Committee ◽  
Training Data ◽  
Ethical Review ◽  
Infection Model ◽  
Research Ethics Committee ◽  
Research Protocols ◽  
Study Designs

Abstract Background Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum to improve the quality of scientific and ethical review. Methods This was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies. Results We enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29). Conclusion Competence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review.

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.

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 Experiences of research ethics committee members and scientists of the research protocol review process in Uganda: a case study

2020 ◽  
Vol 12 (6) ◽  
pp. 541-542 ◽  
Author(s):  
Agnes Ssali ◽  
Fiona Poland ◽  
Janet Seeley
Keyword(s):  
Research Ethics ◽  
Review Process ◽  
Ethics Committee ◽  
Research Practice ◽  
Research Protocol ◽  
Sample Storage ◽  
Research Ethics Committee ◽  
Areas Of Concern ◽  
Protocol Review

Abstract Background We investigated how relevant and responsive scientists and research ethics committee (REC) members considered the research protocol review processes for health research practice in Uganda. Methods Interviews were conducted with five scientists and five REC members. Data were analysed thematically. Results How much to compensate for time, the amount of study information shared with volunteers and sample storage for future unknown research were areas of concern for REC members. Delays in getting feedback concerned scientists. Conclusions Researchers and REC members need to hold regular discussions to ensure the review process is relevant and responsive.

scholarly journals Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

2021 ◽  
pp. 155626462199221
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Research Ethics ◽  
Health Systems ◽  
Ethics Committee ◽  
Health Data ◽  
Data Reuse ◽  
Fundamental Importance ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Public Perspectives ◽  
Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

scholarly journals Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

scholarly journals Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e041695
Author(s):  
Catherine Elliott ◽  
Caroline Alexander ◽  
Alison Salt ◽  
Alicia J Spittle ◽  
Roslyn N Boyd ◽  
...  
Keyword(s):  
At Risk ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Research Ethics ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
National Implementation ◽  
General Movements

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

scholarly journals A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid‐19 Era

2021 ◽  
Vol 43 (5) ◽  
pp. 42-44
Author(s):  
Leonardo Tamariz ◽  
Fred J. Hendler ◽  
John M. Wells ◽  
Annette Anderson ◽  
Stephen Bartlett
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

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.

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