Risk to Participant	Insignificant 	Minor	Moderate	Major	Catastrophic
	
Participants involved in the research. 

(Consider other risks that may not be listed here; please add in as appropriate)	No research involvement of human subject groups.

Subjects are NHS staff rather than patients.

	Subject group not considered vulnerable – able to give informed consent, may benefit from taking part.

	Participants with potential limited capacity to consent e.g. early stages of cognitive impairment limited English.

Specialist clinical areas with limited treatment options.

Healthy volunteers in studies with moderate risk attached to the intervention.

Patients with poorly controlled / complex illnesses.

	Participants with severely compromised capacity to consent – unconscious, young children, cognitively impaired.

Patients with poor prognosis / terminal disease & patients not likely to gain any benefit from taking part.

Healthy volunteers in studies with high risk attached to the intervention.

Mismanagement of patient care with long-term effects.

	Any study where side effects of the intervention have a realistic chance of being fatal or causing serious harm.

Intervention 

(Consider other risks that may not be listed here; please add in as appropriate)	Non-invasive procedures 

Questionnaire / interview or survey research with no/ little potential psychological impact.
 
Minor intervention e.g. taking blood or skin samples 

A data only study. 

	 Involves a clinical intervention which represents only a slight deviation from normal treatment and / or basic safety and efficacy testing has been carried out e.g. Phase 3 or 4 trials

Minor injury or illness, requiring minor intervention.	Involves a clinical intervention which represents a significant change from standard care.

Questions asked of participant may cause distress.

Moderate injury requiring professional intervention and /or an injury event which impacts on a small number of patients.

	Involves a clinical intervention which represents a significant change from standard care withholding of all / elements of standard care.

Basic safety and efficacy data not yet available for the investigational product e.g. Phase 1 and 2 trials 

Major injury leading to long-term incapacity/disability.

	Significant risk derived from single highly invasive clinical intervention or combination of interventions – e.g. surgical techniques, radiotherapy, cytotoxic drugs or combinations of the above 

An event which results in significant SARs.

Risk to Participant continued...	Insignificant 	Minor	Moderate	Major	Catastrophic
	
Consent

(Consider other risks that may not be listed here; please add in as appropriate)	Consent not necessary / REC and necessary national approvals to go ahead without it.

National Opt Out Scheme applies.  	Clearly defined process for informed consent with named designation of responsibility.

Clear defined recruitment process.

Clear and concise consent form and patient information sheet.
	Complex consent process / Unclear process for recording consent.

Complex patient information sheet.

Participants given limited time to consider taking part, in balance with the requirements of the study.

	Unclear provision for informed consent.

Consent does not cover all aspects of research.

Inexperience/inappropriate staff taking informed consent.

No explanation of recruitment process.

No identification of potential risks or hazards.
	No approved consenting procedure. 

Risk to Staff	Insignificant 	Minor	Moderate	Major	Catastrophic
	
(Consider other risks that may not be listed here; please add in as appropriate)

	No risk to staff within the duties required within the study e.g. data only studies.

Minimal injury requiring no/minimal intervention or treatment; no time off work.	Needle stick injuries. 

Minor physical injury or illness, requiring minor intervention requiring time off work for <3 days.

Infection / short term illness due to the research taking place.	Lone working with participants, within normal working hours.

Moderate physical injury requiring professional intervention requiring time off work for 4-14 days.

Verbal / mental abuse of staff member by participant in the research taking place. 

Staff member accesses data not part of the study / no legitimate reason to access.	Lone working with participants, out of hours and / at patient homes. 

Risk of harm through misuse of and / inappropriate training on equipment.

Major physical / mental injury leading to long-term incapacity/disability; requiring time off work for >14 days.

	Incident leading to death Multiple permanent injuries or irreversible health effects.	
Risk to Study	Insignificant 	Minor	Moderate	Major	Catastrophic
	
Investigator

Complexity of study must be taken into consideration in assessment of risk. 

(Consider other risks that may not be listed here; please add in as appropriate)	No local investigator
or minimal involvement e.g. recruitment only.

Experienced Principal / Chief Investigator supported by well trained and experienced team.

Study team have up to date training in GCP / governance / R&D SOP compliance.
	Experienced Principal / Chief Investigator, with small research team / limited support from collaborators, sponsors. 

	PI/ CI has limited experience of leading a study.

Inexperienced / stretched team.

Some awareness of governance issues.  

PI/ CI has not updated their R&D SOP compliance. 

	No prior experience of leading a complex study.

No evidence of governance/ R&D SOP / GCP awareness. 

Discrepancy between ethics application, patient information, consent and/or protocol/trial information.

Participant burden is extensive meaning recruitment could be difficult e.g., several onsite visits in quick succession, with overnight stays and lots of interventions.
	Previously investigated for fraud/misconduct or there is evidence to suggest the team is dysfunctional.
	
Protocol

Complexity of study must be taken into consideration in assessment of risk.

(Consider other risks that may not be listed here; please add in as appropriate)	Minor or insignificant patient involvement with clear rationale and scientific justification. 

Clear complete rationale and scientific justification.

Clearly defined proposal.

Clear guidance for protocol violation.

Independent expert and peer review with written summary.	Clear developmental background for investigational drug or device.

	Poor guidance for potential protocol deviations or errors.

Limited scientific background for study intervention.

No documentation of review process in line with Trust policy.

Complex protocol or invasive procedure.

	Potential for deviation from protocol.

No protocol violation contingency defined.

New/experimental treatment without clear scientific background.

	Previous instances of inappropriate / unauthorised deviation from protocol. 

Potential for Fraud.

Potential for violation of inclusion and exclusion criteria.

Major potential for deviation from protocol, which may result in harm to study subject.

Risk to Trust	Insignificant 	Minor	Moderate	Major	Catastrophic
	
Personal Data/ Information Governance

(Consider other risks that may not be listed here; please add in as appropriate) 	No personal data being used.	Data anonymised or pseudonymised.

No data sent outside EU.

Appropriate provision for archiving.

Data stored in secure site.
	Poorly defined processes of data recording and storage.

Archiving considered but no provision made.

Patient Identifiable Data (PID) going off-site.

	PID to be sent to sites outside EU. 

Potential for fabrication, falsification, distortion/omission or corruption of research data.

No limits on data access.

Archiving not considered. 

Data to be stored in open environment.

Study team not trained in IG.
	Previous breaches of data protection / confidentiality. 	
Finance

(Consider other risks that may not be listed here; please add in as appropriate)	No cost ramifications 

Fully funded research. 

All Excess Treatment Costs accounted for.	Partially funded research with directorate / R&D department picking up the excess (with approval from directorate). 

 	Under-costed. 

Partially funded – unclear who is picking up the remainder. 

Some, but not all, Excess Treatment costs accounted for.	Unfunded and/or unsupported by CRN. 

No defined contract with or between research organisations.

Excess Treatment costs not accounted for.
	Previously identified issues of poor costing or use of funds.

Previous instances of PI signing off contract without 
R&D input.	
Contracts

(Consider other risks that may not be listed here; please add in as appropriate)	Use of appropriate contract template as per IRAS recommendations with no changes to standard wording made.	Appropriate contract template used but insignificant modifications made to standard wording.	Appropriate contract template used with minor modifications made to standard wording.

Incorrect contract template used. 	Appropriate contract template used with significant & multiple modifications made to standard wording.

	No defined contract with or between research organisations.

Incorrect contract template used with significant changes made impacting the Trusts safety, operational and financial basis.
	
Risk to Trust continued…	Insignificant 	Minor	Moderate	Major	Catastrophic
	
Reputational (risk of reputational impact, both positive or negative, either through the taking part as a sponsor, site, PIC or through the completion of a study and its conclusions)

(Consider other risks that may not be listed here; please add in as appropriate)	Positive impact on Trust’s reputation as a result of running / conclusion of the trial/study
 
Significant positive impact on Trust’s reputation as a result of running / conclusion of the trial/study 

Positive media attention received 	minor / insignificant negative impact upon the Trust’s reputation as a result of running / conclusion of the trial/study

Indifferent media attention received 
	Moderate negative impact upon the Trust’s reputation as a result of running / conclusion of the trial/study

Mildly negative media attention received 
	Major negative impact upon the Trust’s reputation as a result of running / conclusion of the trial/study.  Some reputational damage

Negative /pessimistic media attention received 
	The negative impact upon the Trust’s reputation as a result of running / conclusion of the trial/study would be catastrophic and high risk

Significant negative media attention received and reputational damage

Risk
	Risk(s) Identified 	Mitigation(s) in place
	Initial Risk Rating Number (Risk vs Likelihood) before mitigation.	Residual Risk Rating Number (Level of Risk vs Likelihood) after mitigation.	
Risk to Participant

Risk to Staff 

Risk to Study

Risk to Trust

Overall risk rating				

Name of Composer: 									Risk Assessment score >15 counter reviewed by PI: 

Signature: 										Date of counter review where score is >15: 

Date composed: