| DAY 1| Wed, June 26, 2019 | |||||
| Unit 1|Social Sciences and Public Health Research ethics: History, Theoretical Approaches, and Ethics Principles | |||||
| Hours & Session no | Topic | Faculty | Learning Objectives | ||
| 0945-1000 | Registration and Refreshments | ||||
| 1000-1015 | Welcome & Inauguration | Directors, NCDS and HEaL Institute | |||
| 1015 -1030 | Course overview and introduction to course objectives; and Round of Introduction;, | HEaL Institute Colleagues | |||
| Session 1
1030 – 1200 |
Importance of Ethics in Human Health Research | Amar Jesani | Film Screening
♦ What is research? ♦ What are social sciences and their histories? ♦ History of ethics violations/challenges & Learnings |
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| Session 2
1200-1330 |
Morality, ethics, human rights and law: Challenges posed in research across disciplines | Sunita Sheel OR Srijit Mishra | ♦ To learn about the concept of ethics, facts, value, duties, morality,
♦ To recognize the relationship between ethics and law; ♦ Ethics and various disciplines – Basic Sciences, Medical or clinical Sciences, Social Sciences, Public health |
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| 1330-1415 | LUNCH | ||||
| Session 3
1415-1545 |
Bioethics: Theoretical approaches and perspectives | Srijit Mishra & Sunita Sheel | ♦ Theories: Deontology/Kant; Utilitarianism /Consequentialism, Virtue, Principlism
♦ Perspectives: Gender, marginalisation/vulnerability, care, culture/religion Case examples embedded in the presentation |
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| 1545-1600 | TEA | ||||
| Session 4
1600-1730 |
Social sciences: Positivist and non-positivist approaches; cultural and moral relativism vs universalism | Mala Ramanathan
& Srijit Mishra |
♦ To identify the potential ethical challenges in positivist and non-positivist approaches to research in social sciences
♦ To describe relativist approaches vs universalist approaches to resolving ethical dilemmas in research Case examples embedded in the presentation |
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| 1730 | END OF THE DAY 1 | ||||
| DAY 2| Thursday, June 27, 2019 | |||||
| Unit 2| Translating Research Ethics Principles into practice | |||||
| Hours & Session no | Topic | Faculty | Learning Objectives | ||
| 0930-1000 | RECAP of Day 1
Resolving Queries |
Participants and All faculty to respond to questions | |||
| Session 5
1000-1130 |
Informed consent (IC) | Sunita Sheel | Film Screening
♦ To learn the foundation of the principle of autonomy and IC ♦ To learn various components of IC process – voluntariness, information, comprehension, documentation ♦ To recognize process of consent taking and its salience ♦ To learn IC in various situations, and permissibility of IC waivers ♦ To know guidelines and laws; and specific challenges Group work for case studies or case study based discussions in plenary |
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| 1130-1200 | TEA | ||||
| Session 6
1200-1330 |
Privacy and confidentiality | Mala Ramanathan | Film screening
♦ To recognise the need for privacy and confidentiality in a research process ♦ To identify the challenges to privacy and confidentiality in both qualitative and quantitative research and ♦ To suggest some examples of good practices to meet such challenges to privacy and confidentiality in research Group work for case studies or case study based discussions in plenary |
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| 1330-1415 | LUNCH | ||||
| Session 7
1415-1545 |
Risks and Benefits assessment of research | Amar Jesani | ♦ Ethics principles and risk/benefits
♦ Various types of risks – frequency of their occurrence and magnitude ♦ Risk benefit analysis Case examples embedded in the presentation |
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| 1545-1600 | TEA | ||||
| Session 8
1600-1730 |
Justice and Equity in Research | Srijit Mishra | ♦ To learn and exploring ethics principle of justice; its importance in conceptualising research and in its conduct
♦ Research participant selection ♦ Vulnerability and fairness ♦ Right to post-research benefit Case examples embedded in the presentation |
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| 1730-1800 | FACULTY MEETING | ||||
| 1800 | END OF THE DAY 1 | ||||
| DAY 3| Friday, June 28, 2019 | |||
| Unit 3|Research ethics obligations and issues in relation to research designs and research | |||
| Hours & Session no | Topic | Faculty | Learning Objectives |
| 0930-1000 | RECAP of Day 2
Resolving Queries |
Participants and All faculty to respond to questions | |
| Session 9
1000-1130 |
Ethical challenges in quantitative research methods | Srijit Mishra
Mala Ramanathan |
♦ To recognise the ethical challenges posed by the application of methodological requirements of quantitative research in social science
♦ To suggest some possible ways to mitigate against the ethical challenges Case examples embedded in the presentation |
| 1130-1200 | TEA | ||
| Session 10
1200-1330 |
Ethical challenges in qualitative research methods | Mala Ramanathan | ♦ To recognise the ethical challenges posed by the nature of qualitative research in social science
♦ To suggest some possible ways to mitigate against the ethical challenges Case examples embedded in the presentation |
| 1330-1415 | LUNCH | ||
| Session 11
1415-1545 |
Ethical challenges in Action and Participatory social science action research designs | Sunita Sheel | ♦ To learn about action and participatory action research; and Monitoring and evaluation
♦ To identify and discuss specific ethical challenges in each design ♦ To suggest some possible ways to mitigate against the ethical challenges Group work for case studies or case study based discussions in plenary |
| 1545-1600 | TEA | ||
| Session 12
1600-1730 |
Ethical challenges in complex intervention – experimental research designs (Cluster randomised trials) | Mala Ramanathan
And Srijit Misra /Sunita Sheel |
♦ To learn about experimental and quasi experimental social science and public health research designs and longitudinal studies
♦ To learn about population-based Cluster Randomised Trials ♦ To recognize and discuss ethical challenges in each Group work for case studies or case study based discussions in plenary |
| 17:30 | END OF THE DAY 3 | ||
| DAY 4| Saturday, June 29, 2019 | |||
| Unit 4| Research Ethics Governance | |||
| Hours & Session no | Topic | Faculty | Learning Objectives |
| 0930-1000 | RECAP of Day 3
Resolving Queries |
Participants and All faculty to respond to questions | |
| Session 13
1000-1130 |
Research Ethics Committees (REC) | Amar Jesani | ♦ To recognize ethics guidelines and need for governance of research
♦ To recognize REC as a form of governance mechanism ♦ To learn about composition and structure of ethics review committees; ♦ To learn about their mandates, roles and responsibilities ♦ To know ethics review processes ♦ To Standard Operating Procedures of the REC and functions ♦ To recognize challenges faced by the REC |
| 1130-1200 | TEA | ||
| Session 14
1200-1330 |
Ethics of collaborative research | Sunita Sheel | ♦ To learn the salience of collaborative research in the contemporary context of global health research
♦ To recognize research ethics principles which inform collaborative research ethics discourse ♦ To learn about approaches to conceptualize and implement collaborative research in alignment with research ethics principles and obligations |
| 1330-1415 | LUNCH | ||
| Session 15
1415-1545 |
Data sharing | Sunita Sheel | ♦ To learn about the concept of data sharing and underlying ethics principles
♦ To learn about data transparency, including the public archiving of data for reanalysis by others from the peer community ♦ To learn about the risks involved in data sharing |
| 1545-1600 | TEA | ||
| Unit 5|Research integrity, reporting of research and publication ethics | |||
| Session 16
1600-1700 |
Conflict of interest (CoI) | Amar Jesani | ♦ What is Conflict of Interest?
♦ What are the types of conflict of interest? ♦ CoI of researchers, gatekeepers, institutions, RECs, etc ♦ Management of conflict of interest: disclosure requirements, recusing from position of decision making ♦ CoI and corruption |
| 1700-1730 | Preliminary discussion on protocols for review, including queries | Amar Jesani
Mala Ramanathan |
Formation of ERB committees comprising of course participants (three to four groups)
♦ For the faculty to form the ethics committees comprising of the course participants ♦ To know the process of reviewing the study protocols assigned to the groups ♦ To know the process of documenting deliberations and arriving at the decision on the research protocol |
| 17:30 | END OF THE DAY 4 | ||
| Day 5| Sunday, June 30, 2019 | |||
| (… Contd)Unit 5|Research integrity, reporting of research and publication ethics | |||
| Hours & Session no | Topic | Faculty | Learning Objectives |
| 0930-1000 | RECAP of Day 3
Resolving Queries |
Participants and All faculty to respond to questions | |
| Session 17
1000-1130 |
Integrity in research: Research misconduct, authorship credits | Amar Jesani and Srijit Mishra | Film screening
♦ To learn the concept of research integrity ♦ To learn the relationship between research and society’s trust ♦ To recognize various types of research misconduct: Plagiarism, fabrication, falsification, violations of participants’ rights ♦ To learn about publication ethics : Rights and obligations to publish, authorship credit and authorship sequence, and ghost authorship |
| 1130-1145 | TEA | ||
| Session 18
1145-1215 |
Reporting guidelines | Sunita Sheel | ♦ To learn various standards for reporting of the research findings
♦ To recognize the significance of and critique of reporting guidelines |
| Session 19
1215-1330 |
Mock ERB meetings | ♦ To learn the processes involved in serving on ERBs, responsibilities, and briefs of ERB via mock ERB
♦ To learn to deliberate research ethics issues in ERB meetings, to offer substantive justifications either in support of an argument/point of view, or offer a counter argument supported by substantive argument ♦ To learn the process of certifications and notification to applicant research team /researchers ♦ To recognize needs for on-going monitoring of projects |
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| 1330-1415 | LUNCH | ||
| Session 20
1415-1545 |
ERB Meetings Review Outcomes Presentation | Course participants
Moderated by Amar Jesani |
♦ To learn to present the outcome of ERB review outcome and defend it.
♦ To recognize the roles and responsibilities of ERB of educating applicant in research ethics and serving as sounding board for the peer community to discuss research ethics issues going beyond ethics review in compliance with regulations |
| 1545-1600 | TEA | ||
| Session 21
1600-1730 |
♦ Open and Written Evaluation
♦ Valedictory ♦ Course certificate distribution |
♦ For course organizers to know the areas of improvement in the course content, learning methods, allocation of time and related matters. | |
| 17:30 | END OF THE DAY 5 AND COURSE CLOSURE | ||