The features and qualities of online training modules in research ethics: a case study evaluating their institutional application for the University of Botswana

Figures & data

Table 1. Characteristics of Identified Online Research Ethics Courses.

Online Courses	Goal	Layout/Design	Topics/Content	Teaching Methods	Assessment	Duration	Cost	Admission	Context/Relevance to UB
CITI (HSR – Biomedical)	Introduction to biomedical research with a focus on the protection of human subjects.	16 broad topics and sub-topics	Belmont Report and CITI History of Ethics of Human Subjects Research Basic Institutional Review Board (IRB) Regulations and –Review Process -Informed Consent -Social and Behavioral Research (SBR) for Biomedical Researchers Records-Based Research Genetic Research in Human Populations Recognizing and reporting unanticipated problems involving risks to subjects or others in Biomedical and or Protections Vulnerable Subjects – Research Involving Prisoners Vulnerable Subjects – Research Involving Children Vulnerable Subjects – Research Involving Pregnant Women, Human Fetuses and Neonates Avoiding Group Harm – US Research Perspectives Avoiding Group Harm – International Research Perspectives FDA –Regulated Research Research and HIPAA Privacy Protections	Online course using case studies, video, slide show presentation. This could complement an in-person training experience.	Students must pass each module quiz with 70% or above Award of Certificate upon completion	Three hours (3 h)	USD $3500/year paid by the institution for all the users or $110/course for independent learner	Undergraduate, graduate students to postdoctoral researchers, administrators and IRB members	Yes, topics are relevant to UB; in particular health scientists
CITI Program – HSR – Socio-behavioral-education	Introduction to social-behavioral-educational research with a focus on the protection of human subjects.	13 broad topics and sub-topics	Belmont Report and CITI Course Introduction History and Ethical Principles Defining Research with Human Subjects The Federal Regulations Assessing Risk Informed Consent Privacy and Confidentiality Research with Prisoners Research with Children Research in Public Elementary and Secondary Schools International Research Internet Based Research Unanticipated Problems and Reporting Requirements in Social and Behavioral Research	Online course using case studies, video, slide presentation. This could complement an in-person training experience.	Students must pass each module quiz with 70% or above Award of certificate upon completion of the course	Three hours (3 h)	USD $3500/year paid by the institution for all the users or $110/course for independent learner	Undergraduate, graduate students to postdoctoral researchers, administrators and IRB members	Yes, topics are relevant to UB; in particular, teachers and social scientists
Fhi360	Basic and accessible level of training appropriate for individuals from different professional backgrounds and world regions.	8 broad topics and sub-topics	The principles of research ethics The development of contemporary research ethics Informed consent Responsibilities of Research Ethics Committees Responsibilities of Sponsors and Researchers Community participation in the research process	Color slides for online presentation, case study analysis and discussion points, option for facilitator; if need be; additional resources and useful internet sites – easy to navigate through the course	Evaluation includes a post-test and a curriculum evaluation form. Award of certificate at the completion of the course	Not stated	FREE	Open to all researchers, IRB members and public	Yes the topics are relevant to UB; In particular – health scientists
TREEE	Basics of research ethics evaluation and the broader context of research ethics.	6 broad topics sub-topics	Historical Overview Core values and concepts of Ethics for Research Involving Humans Overview of normative frameworks applicable to health research involving humans National Instruments Institutional Requirements Introduction to Research ethics evaluation	Online lectures, case studies, text, videos, resources are available for students (also includes country specific national guidelines and IRB documents).	Students must get 70% or above on the self-assessment test Award of certificate	Not stated	FREE	Open to all who participate in research including IRB members, research teams in the social science and health sciences as well as political authorities etc.	Yes, topics are relevant to UB. About 148 participants from Botswana have been awarded certificates.
CITI Program (RCR)	A foundation for institutions that are working to promote Responsible Conduct of Research (RCR)	12 broad topics and sub-topics	Introduction to RCR Authorship Collaborative Research Conflicts of Interest Data Management Financial Responsibility Mentoring Peer Review Plagiarism Research Involving Human Subjects Research Misconduct Using Animal Subjects in Research	Online lectures, case studies, video, slide presentation. The CITI could complement an in-person training experience.	Students must pass each module quiz with 70% or above Award of certificate	Three hours (3 h)	USD $3500/year paid by the institution for all the users or $110/course for independent learner	Undergraduates, graduates and postdoctoral researchers, administrators, IRB members and other researchers	No. the course is focused more on responsible conduct of research.
Ethics of Human Subject Research- JHSPH	Ethics concepts as they apply to questions and challenges in conducting human subject research. The aim is to increase students’ knowledge and skills to recognize and consider ethical issues that arise in the conduct of human subject research.	12 broad topics and sub-topics	History of Research Ethics in US and South Asia Ethics Principles Ethics Framework Informed Consent: What it is and what it includes Informed Consent: What contributes to a Good Process Risk/Benefits Assessment Honesty in Science: Integrity and Authorship and Conflict of Interest Privacy/Confidentiality Justice: Applied	Online Lectures, Case studies, MP3 enhanced. Other useful resources are available for students	Not stated Information is not available on the award of certificate	Not stated	FREE	Not stated	No. Primarily focused on US and India case examples
University of Maryland	Ethical and regulatory aspects of human subjects research and skills needed to analyze ethical issues that arise in the conduct and coordination of research in domestic and international arenas	6 broad topics and sub-topics	Introduction ton Research Ethics -3 credits Issues in International Research Ethics – 3 credits Introduction to Ethical Theory – 2 credits Institutional Review Board – 2 credits Responsible Conduct of Research in International Affairs – 1 credit Ethics of Globalization – 1 credit	Online Lectures, Course work, Case analysis Other useful resources are available for students	Course work assignments Award of certificate.	One year, participants can start the program at the start of any term. Participants are given up to 3 years to complete	US$ 766 cost per credit hour for out of State learners	Undergraduates, graduates and postdoctoral researchers, administrators, IRB members and other researchers	Yes, however the course is only suitable for participants who can afford to travel to Maryland. This may not be feasible for majority of researchers
JHSPH Open Courseware	Ethics of human subjects research	8 broad topics and sub-topics	Ethical theory and principles History of research ethics Contemporary issues in research ethics Balancing the benefits and harms of participating in research Ethical issues in study design Informed Institutional Review Board Selection of research participants Ethical issues in vaccine research	Lectures, moderated discussions, case study analysis. Lecture materials, readings are available for students.	Participation in moderated discussions, informed consent exercise and written case analysis Award of certificate.	The course takes 8 weeks to complete	Not stated	Not stated	Yes, however, the course takes 8 weeks to complete which may not be feasible for majority of researchers
Global Health Training Centre	Not stated	14 broad topics and sub-topics	Introduction to research ethics Principles and Guidelines Evaluating risks and benefits Issues of study design Understanding vulnerability Obligations of research participants Engaging with the community Privacy and confidentiality Informed consent Other ethical issues Bio banks and genomic research Including people with disability Women in biomedical research Research in public health emergencies	Online course topics, case studies, videos. Resource library available and other resources	An inbuilt quiz to test knowledge. A minimum of 80% is required as pass mark Award of certificate.	Not stated	FREE	Course is designed and produced for WHO internal staff; but made available for all interested	Yes the topics are relevant to UB. Researchers in the health settings would benefit more from this course.
University of Montana	Foundation for institutions that are working to promote responsible conduct for research.	6 broad topics and sub-topics	Ethical issues in research – A framework Interpersonal Responsibility Institutional Responsibility Professional Responsibility Animals in Research Human Participation in research	Course topics, case studies. Resource library available	An inbuilt quiz to test knowledge Award of certificate	Not stated	FREE	Course offered to graduate students and investigators	A few topics are relevant to UB.

Key: Online Courses: Online courses reviewed (Introduction to Research Ethics); Goal: The overall goal of the course; Layout and Design – how the course is structured; Topics/Content: Topics covered; Teaching methods: Different types of teaching methods used; Assessment – How the course is assessed; Duration: Duration of the course; Cost – Fees charged; Admission: Admission requirements; Context – Relevance to Botswana context.

Table 2. Quality assessment matrix.

Criterion	Section A: Content
CRITERIA_1	A clear, complete course overview and syllabus is provided
CRITERIA_2	The course goals and objectives are clearly defined, measurable and aligned and state what the participants will know or be able to do at the end of the course
CRITERIA_3	The course content and assignments are of sufficient rigor, depth and breadth to teach the standards being addressed
CRITERIA_4	Information literacy and communication skills are incorporated and taught as an integral part of the curriculum
CRITERIA_5	Information concerning academic integrity are clearly stated
CRITERIA_6	Assessment and evaluation use multiple methods
CRITERIA_7	Learners have opportunity to communicate feedback regarding the course structure and content
CRITERIA_8	The grading policy and practices are clearly stated and easy to understand
CRITERIA_9	Learners are provided with a certificate upon successful completion of the course
	Section B: Layout and instructional design
CRITERIA_1	The course is organized into units and lessons
CRITERIA_2	The course unit overview describes the objectives, activities and resources that frame the unit
CRITERIA_3	Each lesson includes a lesson overview, content and activities and provides multiple learning opportunities for students to master the content
CRITERIA_4	Navigation cues are present, clearly identifiable
CRITERIA_5	The format is uncluttered making it easy for learners to understand the content
CRITERIA_6	Images and graphics are clear and optimized for efficient loading
CRITERIA_7	The content is broken into small, incremental learning steps and organizes in a logical, consistent sequence
CRITERIA_8	Case studies are used effectively in the text
CRITERIA_9	Students have access to resources that enrich the course content
	Section C: Technology
CRITERIA_1	The course architecture permits the online teacher to add content, activities and assessment to extend learning opportunities
CRITERIA_2	The course is easy to navigate
CRITERIA_3	Hardware, Web browser and software requirements are specified
CRITERIA_4	The course provider offers the course learner with technical assistance to manage the course
CRITERIA_5	The course uses video to reinforce learning
	Section D: Relevance to university of Botswana context
CRITERIA_1	The course is relevant to Botswana cultural context and educational set-up
CRITERIA_2	The course topics meet the needs of UB and Botswana research landscape
CRITERIA_3	The course is flexible to allow local materials to be added
CRITERIA_4	Blended approach could be infused into the course
CRITERIA_5	The course duration is reasonable
CRITERIA_6	The course is suitable for students and academic staff
CRITERIA_7	The course is free

Figure 1. Percentage of criteria receiving a score of meeting criteria, partially meet criteria and does not meet criteria for all online courses classified by sections. Key: Section A: Content, Section B: Layout and Instructional Design, Section C: Technology, Section D: Relevance to UB context.

Figure 2. Percentage of criteria receiving rating score for each of the selected online ethics course. Key course ID and ethics course name: 1, Introduction to the ethics of human subject research; 2, Training and Resource in Research Ethics Evaluation (TREEE); 3, JHSPH Open Courseware -Ethics of Human Subjects Research; 4, Family Health International (fhi360); 5, Global Health Training Centre – Research Ethics Online Training; 6, CITI Program – Responsible Conduct of Research (RCR); 7, CITI Program-Human Subjects Research (HSR – Biomedical); 8, CITI Program – Human Subjects Research (HSR – Socio-behavioral-education); 9, University of Maryland-Online Research Ethics Certificate; 10, University of Montana with Office of Research Integrity.

Table 3. Relevance to University of Botswana context: Overall scores.

Course	Meets criteria	Partially meets criteria	Does not meet criteria	Total
Training and Resource in Research Ethics Evaluation (TREEE)	7 (87.5%)	0 (0.0%)	1 (12.5%)	8 (100.0%)
CITI Program-Human Subjects Research (HSR – Biomedical)	6 (75.0%)	1 (12.5%)	1 (12.5%)	8 (100.0%)
CITI Program – Human Subjects Research (HSR – Socio-behavioral-education)	6 (75.0%)	1 (12.5%)	1 (12.5%)	8 (100.0%)
Family Health International (fhi360)	6 (75.0%)	1 (12.5%)	1 (12.5%)	8 (100.0%)
Introduction to the ethics of human subject research	4 (50.0%)	0 (0.0%)	4 (50.0%)	8 (100.0%)
Global Health Training Centre – Research Ethics Online Training	3 (37.5%)	2 (25.0%)	3 (37.5%)	8 (100.0%)
CITI Program – Responsible Conduct of Research (RCR)	3 (37.5%)	1 (12.5%)	4 (50.0%)	8 (100.0%)
University of Maryland-Online Research Ethics Certificate	3 (37.5%)	1 (12.5%)	4 (50.0%)	8 (100.0%)
JHSPH Open Courseware -Ethics of Human Subjects Research	3 (37.5%)	0 (0.0%)	5 (62.5%)	8 (100.0%)
University of Montana with Office of Research Integrity	2 (25.0%)	0 (0.0%)	6 (75.0%)	8 (100.0%)

Table 4. Ranking of online ethics courses based on the total scores received from all the assessment criteria.

Course	Scores				Total	Rank
	Section A	Section B	Section C	Section D
CITI Program-Human Subjects Research (HSR – Biomedical)	24 (88.9%)	24 (88.9%)	14 (93.3%)	21 (87.5%)	83 (89.2%)	1
CITI Program – Human Subjects Research (HSR – Socio-behavioural-education)	24 (88.9%)	24 (88.9%)	14 (93.3%)	21 (87.5%)	83 (89.2%)	1
Family Health International (fhi360)	25 (92.6%)	25 (92.6%)	11 (73.3%)	21 (87.5%)	82 (88.2%)	3
Training and Resource in Research Ethics Evaluation (TREEE)	23 (85.2%)	23 (85.2%)	12 (80.0%)	22 (91.7%)	80 (86.0%)	4
CITI Program – Responsible Conduct of Research (RCR)	24 (88.9%)	24 (88.9%)	14 (93.3%)	15 (62.5%)	77 (82.8%)	5
Introduction to the ethics of human subject research	23 (85.2%)	24 (88.9%)	14 (93.3%)	16 (66.7%)	77 (82.8%)	5
University of Maryland-Online Research Ethics Certificate	26 (96.3%)	24 (88.9%)	11 (73.3%)	15 (62.5%)	76 (81.7%)	7
JHSPH Open Courseware -Ethics of Human Subjects Research	24 (88.9%)	21 (77.8%)	10 (66.7%)	14 (58.3%)	69 (74.2%)	8
Global Health Training Centre – Research Ethics Online Training	15 (55.6%)	20 (74.1%)	11 (73.3%)	16 (66.7%)	62 (66.7%)	9
University of Montana with Office of Research Integrity	17 (63.0%)	18 (66.7%)	7 (46.7%)	12 (50.0%)	54 (58.1%)	10