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

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

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

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

Management strategy / Monitoring
Hazards to Participants
Safety
Rights
Hazards to study
Hazards to researchers
Hazards to environment/community

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