1- Safeguards

Competency Definition: The individual understands how to apply ethical theory in the context of clinical research design and operations. They understand the rationale and value of research, but can also balance its harms and benefits by taking into account participants’ interests. They are able to provide sound and poised review of the likely risks and benefits of a study to the participant, and to adapt this review based on the specific community and setting. They should particularly keep in mind populations which might be vulnerable in different ways, including children, populations living in low-resource settings or experiencing an emergency situation. On a daily basis, research staff and clinical professional must apply ethics and ensure that the confidentiality and privacy of the participant is respected at all times.

Abilities

  • Describe and understand the history and evolution of the principles of ethical theory and the key documents related to human subjects in research

  • Ensure that the research is necessary; take a balanced view of the likely harms and benefits of a research project on the subject

  • Understand the need for ethical approval to be obtained before research activities are initiated

  • Ensure that payments or compensations for subjects for taking part do not constitute a coercion or undue influence

  • Demonstrate high integrity, and consistently respect and ensure confidentiality and privacy of research participants

  • Specialist setting (for vulnerable populations or emergency research during disease outbreaks): Conduct Rapid Ethical Appraisal if appropriate to weigh up the specific benefits and risks to a specific community, which may differ from place to place

Related competencies

Tasks based on this knowledge: Developing a protocol; Risk and safety management; Engaging with the community; Enrolling and retaining participants; Supporting and advising participants throughout the informed consent process

Similar knowledge: Good Clinical (or other) Practice; Research regulations

Required skills: Cognitive skills; Work ethic 

 

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Competency Definition

The individual understands the breadth of safety and risk issues that participants may face within a trial, and knows how to mitigate them. They fully understand the importance of relevant and timely reports during any type of safety breach, as well as standard safety reporting such as data safety monitoring (DSMB) report writing. They know how to handle adverse events putting participants at risk, including how to break the masking code in an emergency situation and how to ensure that participants will be providing care timely and accordingly. More broadly, the individual understands and manages risk throughout the study, and knows when to suggest actions to amend the study in view of current information and associated uncertainty and risk.

Abilities

  • Describe the various methods by which safety issues are identified and managed during clinical research; understand different types of AEs (SAEs, SUSAR, etc.), AE management and reporting

  • Set up Data Safety Monitoring Board (DSMB); write charter for Data Safety monitoring; write and submit report for DSMBs when applicable

  • Coordinate unblinding and other emergency procedures when necessary

  • Be responsible for risk mitigation strategies, associated action plan and issue resolution

  • Understand that the protocol must be complied with, except to eliminate immediate hazards and in exceptional circumstances

  • Immediately report protocol deviations or changes increasing risk to subjects

Related competencies

Tasks based on this knowledge: Developing study plans and documents; Analysing data; Controlling quality of research; Collecting accurate data; Providing clinical care; Ensuring appropriate use of IMPs; Reporting

Knowledge base: Research methodology (randomisation and blinding); Good Clinical (and other) Practice

Required skills: Cognitive skills

 

 

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Competency Definition: The individual understands the requirements for liability and insurance which may be required for different types of research studies, and knows the responsibilities of those involved (sponsor, investigator, funder), whether the study is commercial or non-commercial. They are able to plan and ensure appropriate cover for research projects, and report accordingly if claims are required.  

Abilities

  • Understand when insurance is required for clinical research

  • Understand the roles and responsibilities involved in planning appropriate liability/insurance cover

  • Secure appropriate insurance/liability for a study

  • Can report accordingly if a claim is required

Related competencies

Tasks based on this knowledge: Risk and safety management; Securing or maintaining contracts; Initiating study; Reporting

Knowledge base: Governance and organisational context; Research regulations

 

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