EM Risk assessment tool

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					MRC Experimental Medicine Tool Kit Risk Assessment Tool

Hazards to participants

For the participants’ safety
Hazards of the intervention
     Known or predicted adverse effects
     Unexpected adverse effects
     Failure to provide adequate clinical management of adverse effects
     Failure to provide adequate clinical management of patients’ underlying
         medical condition
     Failure to act appropriately upon health information discovered as a
         consequence of participating in the study
         Consider:
         Nature of the intervention
         Previous experience of intervention
         If chemical/drug/biological agent/medical device; Licensing status,
              indications, clinical experience, pharmacology, toxicology, quality
              control of manufacture, quality, purity, handling requirements and
              storage
         Staff training and experience
         Susceptibility of the population – disease, genetic, age, sex
         Blinding
         Clinical facilities available in the event of serious adverse event
         Clinical input – level and extent required

Likely risk/benefit ratio of the intervention(s) in the study population
           Consider:
           Non-therapeutic interventions and interventions not offering direct
               benefit to participants
           Minimal risk of harm
           Alternative study design
           Importance of study objective(s) (Declaration of Helsinki)
           Systems to monitor and review adverse effects
           Systems to maintain awareness of and to act on new knowledge

Hazards of assessment methods
     X-ray, biopsy, questionnaires etc
         Consider:
         Non-therapeutic studies or studies not offering direct benefit to
             participants
         Handling adverse health information from healthy volunteers
         Emotional issues


For the participants’ rights
     Entry to a study without fully informed consent
         Consider:
         Legal requirements




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         Vulnerability of the study group
         Identifying and approaching potential participants
         Consent process
         Participant information
         Training of those providing participant information and obtaining
             consent
         Payments and coercion

     Failure to act on patient’s request to withdraw from the study
          Consider:
          Communication and recording systems
          Required safety procedures / follow-up post withdrawal

     Failure to protect the privacy of participants
          Consider:
          Data protection and security systems
          Anonymisation
          Potential interaction with GP / NHS


Hazards to the study

To the completion of the study – recruitment and follow-up
         Consider:
         Feasibility, study population, numbers of subjects required
         Staff competence and experience
         Follow-up requirements
         Onerous protocols

To the validity of the results
     Study power and/or design
         Consider:
         Plausible / measurable effects
         Number of participants required
         Participants randomised or matched
         Need for professional statistical input
         Alternative approaches

     Major violation of eligibility criteria
        Consider:
        Importance to participant safety
        Importance to the study
        Need for checking and possible procedures
        Unduly restrictive/prescriptive eligibility criteria

      Fraud
         Consider:
         Potential
         Incentives – financial and non-financial




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        Consequences – size and severity of threat to study results
        Options for checking

    Randomisation procedure
       Consider:
       Robustness of procedure
       Potential for loss of allocation concealment / unblinding

    Outcome measure(s)
       Consider:
       Blinding (single, double)
       Validity of measure
       Reproducibility of measures
       Objectivity of measure
       Standardisation of assessment
       Potential for independent review
       Potential for simple external verification e.g. death certificate,
           laboratory investigation result

    Other data – completeness and accuracy
       Consider:
       Data type and complexity
       Study documentation
       Data collection method (paper, electronic)
       Data entry method
       Key data items
       Staff training
       Need for and options for verification

    Adherence to the protocol
       Consider:
       Complexity
       Staff training and research experience
       Barriers to compliance with intervention (for trial personnel and
           participants)

Hazards to researcher(s)

    Personal threat
        Consider:
        Nature of study group
        Environment research to take place in
        Training and experience of researcher(s)

    Compliance with the law
       Consider:
       Data protection
       Clinical trials
       Human tissue




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       Device trials
       Genetic modification
       Health and Safety

    Indemnity
        Consider:
        Employer’s policy and exemptions
        Approvals needed
        Need for non-negligent cover

Hazards to the environment / community

       Consider:
       Nature of agent used in intervention
       Relevant Regulatory framework(s)
       Level of containment
       Compliance
       Facilities
       Withdrawal of participants
       Study closure




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                          Management strategy   Monitoring
Hazards to Participants
Safety




Rights




Hazards to study




Hazards to researchers




Hazards to
environment/community




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posted:8/31/2012
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