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. Author manuscript; available in PMC: 2014 Jun 3.
Published in final edited form as: J Empir Res Hum Res Ethics. 2013 Dec;8(5):40–51. doi: 10.1525/jer.2013.8.5.40

TABLE 2. Aspects of Research Ethics Capacity: Existing Gaps and Future Directions.

Category of Capacity Gaps in Research Ethics Future Directions for Trainees
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

  • 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

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

  • 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

Research Ethics Committee Capacity
  • Suboptimal administrative structures that support REC functioning

  • Lack of policies that promote independence of ethics committees

  • Lack of member diversity

  • Lack of member training

  • 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

Researchers’ Knowledge, Attitudes, and
Practices in Research
Ethics
  • Inadequate researchers’ knowledge of research ethics

  • Suboptimal practices in research ethicsand responsible conduct in research.

  • Conduct training in research ethics and Good Clinical Practice

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.

  • Conduct research to document participants’ knowledge of research and awareness of their rights

  • Conduct awareness campaigns to enhance participants’ knowledge of their rights