National Capacity |
Lack of national regulations in research ethics in several countries
Existing regulations do not fully address protections for vulnerable subjects
Low budget priorities for research funding and training
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Provide advice regarding the establishment of national guidelines in those countries lacking such documents and review existing guidelines to ensure comprehensiveness
Provide consultancy role to their Ministries of Health regarding regulatory oversight of RECs and conduct of clinical trials
Apply for EDCTP funding to strengthen capacity in national regulatory framework
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Institutional Commitments |
Inadequate institutional policies and procedures to instill values that promote ethical conduct in research (e.g., conflict of interest policies, appeal mechanisms, system of rewards and penalties, etc.).
Lack of degree programs (diploma and master’s) in ethics and research ethics
Insufficient research ethics content in curricula
inadequqte budgets for research ethics commities
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Help their institutions promote a culture of ethical conduct by incorporating organizational structures and processes that implement a set of shared values
Inclusion of ethics teaching in the curriculum
Development of degree programs in ethics and research ethics
Advocate for adequate REC budgets
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Research Ethics Committee Capacity |
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Help RECs develop standard operating procedures
Adopt policies that enhance REC functioning (e.g., protocol submission and review policies, training requirements)
Adopt quality assurance mechanisms
Conduct membership training
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Researchers’ Knowledge, Attitudes, and Practices in Research Ethics |
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Research Participants’ Awareness of Their Rights and Under- standing of Research |
Potential participants lack basic knowledge of research concepts, which reinforces presence of therapeutic misconception.
Many patients are not aware of their rights as patients; similar findings might be present for research participants.
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