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Research article
A Situational Analysis of Competences of Research Ethics Committee Members in Review of Research Protocols with Complex and New Study Designs in Uganda
Pauline Byakika-Kibwika
Infectious Diseases Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0757-1968
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This work is licensed under a CC BY 4.0 License. Read Full License
BACKGROUND Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both industry and the need to combat the emergence and re-emergence of infectious disease epidemics. This has broadened the spectrum of research proposals that need evaluation by Research Ethics Committees (RECs) with associated requirement for new expertise. We assessed the competencies of REC members in review of research protocols with complex and new research study designs to guide development of a training curriculum to improve the quality of review.
METHODS This was a cross-sectional study design, with quantitative and qualitative data collection methods. We used a structured pre-coded questionnaire to collect data on competencies of REC members in review of research protocols with complex and new research study designs. Research Ethics Committee members were also asked to outline a list of additional topics for which they needed training. Data from coded questions was entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed for quantitative data and findings were presented using percentages and frequencies.
RESULTS We enrolled 55/97 REC members from 6 RECs, 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 (6, 10.9%) and reverse pharmacology design (6, 10.9%,), and highest for cluster randomized study design (29, 52.7%) and implementation science research (29, 52.7%).
CONCLUSION There is lack of competence in review of research protocols with complex and new study design and our analysis suggests that additional training in this area is an urgent priority.
Keywords
Complex and New study designs, Research Ethics Committees, Competence
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CURRENT STATUS: Under Review
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Posted 25 Sep, 2020
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Invitations sent on 21 Oct, 2020
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On 21 Sep, 2020
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Subject Areas
Medical Ethics
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This preprint is under consideration at BMC Medical Ethics. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
A Situational Analysis of Competences of Research Ethics Committee Members in Review of Research Protocols with Complex and New Study Designs in Uganda
Pauline Byakika-Kibwika
Infectious Diseases Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0757-1968
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 25 Sep, 2020
No community comments so far
Reviewers invited
Invitations sent on 21 Oct, 2020
Submission checks complete
On 23 Sep, 2020
Editor invited
On 21 Sep, 2020
Editor assigned
On 07 Sep, 2020
First submitted
On 03 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Medical Ethics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
BACKGROUND Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both industry and the need to combat the emergence and re-emergence of infectious disease epidemics. This has broadened the spectrum of research proposals that need evaluation by Research Ethics Committees (RECs) with associated requirement for new expertise. We assessed the competencies of REC members in review of research protocols with complex and new research study designs to guide development of a training curriculum to improve the quality of review.
METHODS This was a cross-sectional study design, with quantitative and qualitative data collection methods. We used a structured pre-coded questionnaire to collect data on competencies of REC members in review of research protocols with complex and new research study designs. Research Ethics Committee members were also asked to outline a list of additional topics for which they needed training. Data from coded questions was entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed for quantitative data and findings were presented using percentages and frequencies.
RESULTS We enrolled 55/97 REC members from 6 RECs, 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 (6, 10.9%) and reverse pharmacology design (6, 10.9%,), and highest for cluster randomized study design (29, 52.7%) and implementation science research (29, 52.7%).
CONCLUSION There is lack of competence in review of research protocols with complex and new study design and our analysis suggests that additional training in this area is an urgent priority.
Figure 1