Last updated 24 March 2021
The HRA is committed to providing an excellent service in a professional, fair and courteous manner. We recognise though that there may be times when things go wrong, and this policy and procedure deals with concerns when they happen. We encourage people to let us know when our service does not meet their expectations and will strive to put things right and improve for the future.
All HRA managers and staff are responsible for dealing with potential complaints, issues, queries, concerns or formal complaints (either in writing or verbally) when they are raised. This includes reporting them in line with this policy and procedure in a timely manner. It may include undertaking an investigation, or supporting one, and taking action as a result of the findings.
The HRA supports and upholds the Parliamentary and Health Service Ombudsman Principles of Good Complaint Handling which are:
- Getting it right
- Being customer focused
- Being open and accountable
- Acting fairly and proportionately
- Putting things right
- Seeking continuous improvement.
This document sets out the HRA’s policy and procedure for complaints.
This policy and procedure applies to all directly employed staff, secondees, agency workers, contractors and volunteers including Research Ethics Committee (REC) and Confidentiality Advisory Group (CAG). This group is referred to in this policy as HRA staff and volunteers.
It applies to complaints made about services provided, procedures followed and the behaviour of HRA staff and volunteers.
The policy and procedure excludes:
- matters which have already been fully investigated in accordance with this policy;
- matters where legal or police proceedings are about to start or are already underway;
- any complaint arising out of the alleged failure of another responsible body or third party (covered under HRA’s third party complaint policy and procedure);
- complaints about the conduct of research projects which are addressed under the HRA’s third party complaint policy and procedure);
- potential breaches of study protocol or good clinical practice which are addressed under HRA’s Breach policy & procedure);
- appeals made against the decision of a REC that are covered by their standard operating procedures (SOPs) appeal process;
- representations made against the advice of the CAG that are covered by CAG processes;
- internal complaints about HRA staff or volunteers which will be addressed under the relevant HRA HR policies and procedures;
- complaints made by job applicants which may be addressed under the HRA recruitment and selection policies and procedures; and
- anonymous complaints.
A complaint is defined as a statement (either in writing or verbally) that:
- the standard and/or quality of service provided by the HRA
- a divergence from HRA procedures: and /or
- the behaviour of HRA staff and volunteers
is unsatisfactory or unacceptable and requires an investigation with a written response.
The HRA may receive and agree to undertake an investigation of issues involving an alleged failure of another responsible body or a third party, for example a researcher, research team or Clinical Research Organisation (CRO). These concerns are not recorded as a complaint against the HRA, and not included in the HRA complaints log. These issues are covered by our Third Party Concerns Policy (link)
This policy and procedure ensures that the complaints process:
- is easy to follow
- provides a speedy acknowledgement of concerns raised
- ensures complaints are investigated thoroughly and fairly
- keeps complainants informed if there are delays
- is fair to complainants and HRA staff and volunteers
- provides a full written response or other means of resolution where appropriate
- means that where appropriate lessons are learned and changes made to prevent recurrence and services improved.
- sets out how complaints should be received, acknowledged and investigated, how action should be taken (both immediate corrective action and longer-term preventative action) and how responses to complainants should be made
- sets out how complaints should be recorded
- provides guidance for managers and staff on how to manage complaints and to use the lessons learned to proactively improve services.
This policy and procedure is aimed at anyone who is directly affected by:
- the standard and/or quality of service provided by the HRA
- a divergence from HRA procedures
- the behaviour of HRA staff and volunteers
Complaints can be raised directly, or by an authorised representative of the complainant.
1.3 Roles and responsibilities
The HRA Chief Executive has overall responsibility for ensuring that complaints are managed in line with this policy and procedure.
The Head of Corporate Governance & Risk is the HRA Complaints Lead and is responsible for acknowledging the receipt of a complaint, assigning an Investigating Officer (where appropriate) to manage the complaint, reporting complaints to the HRA Board (including a summary of their investigation, action and outcome) and the management of the email@example.com email address and HRA Complaints Log. The Complaints Lead is responsible for notifying the relevant Director of any complaints in their Directorate. The Complaints Lead is also responsible for making sure that HRA staff and volunteers are aware of this policy and procedure.
The Investigating Officer is delegated the task of investigating the complaint according to the procedures set out below.
Any member of staff receiving a complaint is responsible for reporting it in accordance with the procedure.
The HRA encourages all staff who receive potential complaints, issues, queries or concerns to attempt to resolve these matters locally and in a timely manner to prevent formal complaints (see 2.1 Local Resolution below).
2.1 Local resolution
The HRA encourages all staff who receive potential complaints, issues, queries or concerns to try and resolve these locally and in a timely manner to prevent formal complaints being made. This procedure empowers staff who receive potential complaints to resolve them to the complete satisfaction of the person raising them. This will provide better resolution for both parties.
Where the potential complaint, issue, query or concern is straightforward and local resolution can be achieved, the person raising the potential complaint will be advised by the receiving staff member of the plan of action, an outline of the concerns to be addressed, the proposed timescale and action(s) to be taken. When this has been completed, an update should be provided in writing.
Taking into account the nature and severity of the potential complaint, issue, query or concern, the staff member should report the event to the Complaints Lead where possible.
2.2 Receipt and acknowledgement of complaints
A complaint should normally be made within 12 months of an incident occurring, or on the date on which the complainant becomes aware of the matter if this is more than 12 months after the incident. The time limit may be waived if the HRA considers there are good reasons for the delay and it is still possible to investigate the matter fully and fairly.
Complaints may be made verbally or in writing. Where a complaint is first raised via social media, the complainant may be asked to provide more information via email. Where a verbal complaint is made, the complainant may be asked to follow this up in writing. Alternatively notes may be taken by the person handling the complaint and these should be shared with and agreed by the complainant.
Complaints may be received directly by the Complaints Lead, by any member of staff or through one of the organisation’s communications channels which are not allocated to a single individual. Where a complaint is received by a member of staff it should be referred to the Complaints Lead as soon as it has been received.
The Complaints Lead will acknowledge written and verbal complaints within 3 working days using firstname.lastname@example.org.
2.3 Recording and delegation for investigation
The Complaints Lead will ensure that the complaint is logged on the HRA Complaint Log.
Complaints are numbered sequentially, with a new log for each financial year.
The Complaints Lead will assess whether a complaint falls within the remit of this procedure. If not, the complainant will be contacted and the decision explained.
Where appropriate, the HRA Chief Executive will be informed.
The Complaints Lead will review the complaint and may delegate it to an appropriate manager for investigation. They become the Investigating Officer.
Alternatively, the Complaints Lead may choose to delegate the complaint to a Director who may in turn delegate it to an appropriate Investigating Officer in their Directorate for investigation.
Any manager can be designated by the Complaints Lead or Director as an Investigating Officer. This is a temporary and time limited role for the purpose of drawing the complaint to a satisfactory conclusion. The Complaints Lead will ensure the Investigating Officer is provided with the necessary support and training as required.
2.4 Initial investigation
The Investigating Officer will introduce themselves to the complainant. An initial phone call is recommended to establish the reasons for the complaint and what the complainant would like to happen as a result of the complaint.
After this call, the seriousness of the complaint will be assessed to determine the extent of the investigation required and whether others need to be informed.
The complainant will then be advised of the expected timescale for the investigation.
At this stage, the Investigating Officer will again assess whether the complaint falls within the remit of this procedure. If not, the Complaints Lead should be informed who will ensure the complainant is contacted and the decision explained.
When things go wrong and a formal complaint is made, it is important to establish the facts of what has happened in a systematic, timely way. Investigations need to collect and examine evidence in a variety of ways, which may include;
- carrying out interviews or seeking information from HRA staff and volunteers as appropriate
- reviewing written and electronic records and copies of documents
- carrying out site visits
- taking expert advice.
If an investigation cannot be completed within 25 working days the complainant should be kept informed about the reasons for the delay and the expected timescale for completion.
Once all the evidence has been collected and assessed the Investigating Officer, working with the Complaints Leads, will decide whether there has been a deviation from established policies and / or procedures, the expected and intended level of service and / or the expected level of behaviour. They will conclude whether the complaint is upheld, partially upheld or not upheld and the complainant will be informed of the decision (see 2.6).
If the complaint was about a REC or other HRA Committee, the response from the HRA may be shared in advance with the Chair.
The Investigating Officer, working with other managers and staff as required, will take any immediate action required to resolve the complaint and will consider whether any further action or preventative action is needed to prevent recurrence. This may include, but is not restricted to, staff training, changes to practice, policies and procedures and a review of current and established ways of working with a view to improving services provided.
2.6 Responding to the complaint
Every complainant has a right to a response to their complaint which explains how their concerns have been resolved, what action has been taken to deal with the complaint and if appropriate, to prevent reoccurrence. They should know how to take the matter further if they are dissatisfied with the outcome of the complaint.
Each response to a complainant should include the following:
- a summary of each element of the complaint;
- details of the complaints policy followed;
- a summary of the investigation;
- details of key issues or facts identified by an investigation;
- conclusions of the investigation (whether the complaint is upheld, partially upheld or not upheld);
- what needs to be done to put things right (if appropriate);
- things done to prevent a reoccurrence (if appropriate);
- an apology, if needed;
- an explanation of what happens next (what will be done, who will do it and when); and
- information on what to do if the complainant is still dissatisfied.
The complaint response may be a letter or an email from the Investigating Officer and should be copied to the Complaints Lead. Alternatively, the Investigating Officer may provide a summary of the investigation to the Complaints Lead for sending to the complainant. It will be provided within 25 working days unless the complainant has been informed of any delays (See 2.5).
If the complaint involves an HRA committee the Chair will also receive a copy of the response.
2.7 Concluding action
Full details of the investigation, any action taken and the outcome, including any planned preventative action, should be provided to the Complaints Lead together with any related correspondence. These details may include investigation notes and/or the complaint response letter. Where the complaint response letter is sufficiently detailed separate investigation notes may not be required.
2.8 Appealing the outcome or handling of a complaint
If the complainant is dissatisfied with the outcome or how a complaint has been handled, they have the right to appeal, in writing, to the HRA Chief Executive within 28 days of receipt of the response providing reasons for the dissatisfaction. The HRA Chief Executive will establish an appropriate review of the appeal depending on the nature of the complaint and may elect to delegate the review to a senior HRA manager. This individual however should not have been involved in the initial investigation.
The Chief Executive (or delegated individual) will respond to the complainant providing details on how the appeal is to be reviewed, documented and communicated. The Chief Executive (or delegated individual) will review the documentation and may speak to any relevant individuals, including the investigating officer and complainant, as required.
The Chief Executive will aim to prepare a response within 25 working days. If a response to the appeal cannot be completed within 25 working days the complainant will be kept informed about the reasons for the delay and the expected timescale for completion. The response will set out whether the appeal has been upheld or not upheld, what remedial action has been identified and an apology if appropriate.
Once a response to the appeal has been issued by the Chief Executive the HRA complaint process is complete. No further appeals regarding the decision will be accepted unless any new or additional information is provided.
2.9 Complaining to the Ombudsman
Complainants who remain dissatisfied at the conclusion of the HRA complaint procedure may put their complaint to the Health Service Ombudsman.
Parliamentary and Health Service Ombudsman
Tel: 0345 015 4033
All material associated with a complaint is confidential. It is retained securely, with access being controlled and limited to nominated persons. The complainant should be made aware that potentially confidential information may be collected in the course of the investigation and that it will be retained confidentially.
2.11 Recording, reporting and monitoring
All complaints about the HRA will be recorded on the complaints log together with the timelines and action taken so that trends can be identified. The complaints log will be maintained by the Complaints Lead.
An annual complaints report together with the complaints log will be reviewed at the Leadership Team (LT) and HRA Board. They will be available on the HRA website as part of the publication of the HRA Board agenda, minutes and reports.
2.12 Monitoring and review
This policy and procedure will be subject to internal audit.
The management and use of this procedure is reviewed every two years.
Changes to improve it can be requested at any time and will be considered by the Complaints Lead, Complaints Management Group and LT as necessary.
Dissemination and publication of the policy and procedure
This policy and procedure will be released on the HRA Hub Central Library and its release will be communicated to staff via HRA News.
The policy will also be published on the HRA website.
Equality and privacy screening questions
|For every HRA policy (defined by the Equality and Human Rights Commission (EHRC) as a function, strategy, procedure, practice, project, or decision) please answer the questions below to determine whether further analysis is required.|
|Equality||With due regard to our Equality Duty, could this policy have the potential to have a detrimental impact on anyone with a protected characteristic?||No|
|Privacy||With due regard to the Data Protection Act / GDPR, does this policy involve the use of Personal Information?||Yes|
|Name and date to verify analysis||Stephen Tebbutt||23/09/2020|
Initial privacy impact assessment
What is privacy?
Privacy refers to freedom from intrusion and relates to all information that is personal or sensitive in nature to an individual
Does the policy or procedure
have any impact on privacy?
|If Yes please give details below of the impact and the actions being taken to address any adverse impact.||The receipt and investigation of complaints is very likely to involve the collection of personal information and possibly personally sensitive information as defined by the Data Protection Act. It is also likely to involve the collection of confidential information. As such all complaints information should be treated as confidential. To accomplish this the HRA applies access controls that restricts the disclosure of the information to nominated individuals and retains all information in a secure folder on the shared drive.||N/A|
If you have answered YES to the questions above and the answers do not mitigate and adequately address the adverse impact, you may need to complete a full PIA. Please consult the Head of Corporate Governance & Risk.
Full Privacy Impact Assessment required: No
|Version||Date of change||Reason for change|
|V 1.0 Draft||18/10/2011||
Updated to HRA version
to reflect the move to the HRA
|V 1.1 Draft||25/11/2011||JW comments added|
Approved by HRA SMG
& HRA Board
|V 2.0 Draft||28/02/2013||
To up-date the policy
in line with changes in the organisation, to combine the HRA and NRES
Complaints Policy and Procedure
|V 2.1 Draft||18/09/2013||
Addition of statement
regarding local resolution
Final amends after CMG
|V 4.0 Final||20/11/2013||
appeals process in policy & procedure. Additional changes requested by
Combine Policy and
Procedure in one document & minor amends
|V 4.2 Final||17/08/2015||
Minor amends after submitting
|V 4.3 Final||11/07/2016||Minor changes to scope|
|V 4.4 Final||22/02/2019||
Minor changes to
reflect change to personnel and supporting documentation
|V 4.5 Final||02/08/2019||
hra.complaints email address and notification of complaints to relevant
Director as standard
|V 4.6 Final||04/09/2020||
Inclusion of changes
recommended by complaints policy review group
|Janet Wisely||NRES Director||Version 1|
|Janet Wisely||NRES Director||Version 1.1|
|Joan Kirkbride||Operations Director||Version 2.0 Draft|
|Stephen Robinson||Complaints Lead||
Version 3.0 & 4.0
Final, 4.2, 4.3
|Sheila Oliver||Head of NRES||
Version 3.0 & 4.0
|OMG, CMG, EMT||Committees||
Version 3.0 & 4.0
|EMT||Directors and CEO||Version 4.1|
|LT||Senior HRA Management||Version 4.4|
|LT||Senior HRA Management||Version 4.6 Draft|
Distribution of approved versions
|Platform||Date of publication||Version released|
HRA intranet and
|09/09/2015||V 4.2 Final|
HRA intranet and
|11/07/2016||V 4.3 Final|
|HRA Hub||04/04/2019||V 4.4 Final|
|HRA Hub||02/08/2019||V 4.5 Final|
|HRA Hub||21/10/2020||V 4.6 Final|