HRA policy and procedure for managing complaints relating to third parties

V1.6

Last updated 24 March 2021

Background

The Health Research Authority (HRA) has a role to protect and promote the interests of patients and the public in health and social care research and is committed to providing a service in a professional, fair and courteous manner.

We encourage users of our service to let us know when our service does not meet their expectations and we have established a complaints policy and procedure for dealing with concerns when things go wrong. The HRA may also receive complaints from individuals which relate to the service they have received from, or the behaviour or conduct of, a third party.

This policy and procedure has been developed to provide a framework for dealing with complaints relating to a third party, such as sponsor or research team, which relate to research as defined in the UK Policy Framework for Health and Social Care Research and within the remit of the HRA.

Policy

The purpose of the policy and procedure is to ensure a standardised approach to the management of complaints which relate to the behaviour or conduct of a third party in relation to research as defined by the UK Policy Framework for Health and Social Care.

The UK Policy Framework for Health and Social Care sets out the responsibilities of the various parties involved in research (for example, Chief Investigators, Funders and Sponsors). The HRA will make clear to those raising a complaint concerning a third party the remit of the HRA and the extent to which the HRA is able to investigate the complaint.

Where the complaint relates to an area outside the HRA’s remit, the HRA reserves the right to decline to undertake a review.

This policy and procedure has been developed with consideration to the HRA’s six core values: Inspiring Leadership, Integrity, Trusted, Transparent, Collaborative and Empowering.

1. Purpose

The purpose of this policy and procedure is to set out the process the HRA will follow when complaints received by the HRA relate to the behaviour or conduct of a third party with regard to research. In particular the policy and procedure will:

set out how and when complaints relating to a third party may be received and acknowledged;
set out the process for conducting an initial investigation of a complaint relating to a third party to consider the extent to which the HRA is able to explore further;
set out how complaints relating to a third party should be recorded;
set out the remit of the HRA and the extent to which it is able to investigate the complaint relating to a third party;
redirect people to the appropriate organisation(s) to investigate the complaint if appropriate and outside the HRA’s remit;
set out the process and timelines for responding to a complaint relating to a third party or providing an update if a complaint is complex and requires further investigation;
set out how the HRA will work with other responsible parties, as set out in the UK Policy Framework for Health & Social Care, to reach a satisfactory conclusion to any investigation;
work in line with, and take account of, other HRA related policies and procedures;
set out how concerns and the outcome of investigations will be published on the HRA website;
provide guidance for managers and staff.

2. Scope

This policy applies to complaints raised with the HRA which relate to the behaviour or conduct of another responsible body or a third party. The HRA recognises its remit as set out in the Care Act 2014 and has published the UK Policy Framework for Health and Social Care Research which sets out clear roles and responsibilities for those involved in research. The complaint must therefore relate to research as defined under the Framework i.e. research approved or requiring approval by the HRA.

This policy excludes:

Complaints about the services provided by the HRA which are dealt with in line with the HRA Complaints Policy and Procedure;
matters which have already been fully investigated in accordance with this policy;
matters where legal or police proceedings are about to commence or are already underway;
appeals made against the decision of a Research Ethics Committee (REC) that are covered by the Research Ethics Service (RES) Standard operating Procedures (SOPs) appeal process;
protocol violations and other serious breaches that are covered by the SOPs;
representations made against the advice of the Confidentiality Advisory Group (CAG) that are covered by CAG processes;
anonymous complaints;
complaints which do not relate to research e.g. concerns regarding routine clinical practice.

Instances when this policy may apply include the following scenarios:

when participants inform the HRA about a complaint related to their experiences of participating in a study approved by the HRA. An example could be that whilst the study has been conducted in accordance with the agreed protocol a participant has some concerns about their participation in a study.
complaints about the services provided by the HRA which are dealt with in line with the HRA Complaints Policy and Procedure; nature of the protocol approved by the HRA, or there are concerns that approval has not been received from the HRA.

3. Reference documents

4. Responsibilities

The HRA Chief Executive has overall responsibility for ensuring that complaints raised with the HRA regarding the behaviour or conduct of another responsible body or a third party are managed in line with this policy and procedure.

The Head of Corporate Governance & Risk is responsible for the day to day handling of any third-party complaints. This will include:

arranging initial acknowledgement within 3 working days to confirm the complaint has been received and to confirm a formal acknowledgement will follow within 10 working days of receipt;
liaising with the Director of Approvals Service to conduct an initial investigation. This will explore:
- assigning a Complaints Lead who will be responsible for investigating the complaint;
- confirming timelines for when a response or update is required.igating the complaint;
- Confirming timelines for when a response or update is required.
providing formal acknowledgement of the complaint within 10 working days either confirming it is within the HRA’s remit to investigate and indicating when a response or update will be provided, or advising the complaint is outside the HRA’s scope and therefore no further action can be taken by the HRA. In this instance other responsible parties or organisation, who may be able to provide support, will be detailed where possible;
providing a response to the complainant within 25 working days of receipt where possible. This should provide a response to each individual point raised where applicable.
For instances where it is not possible to provide a response within 25 working days an update on progress will be provided to the complainant setting out the steps of the investigation thus far and likely timeframe for completion. An update on progress will be provided every 10 working days until the investigation can be closed.
Chairing the Complaints Management Group (CMG)
providing an annual report summary of complaints for review by the Leadership Team and HRA Board.

The Director of Approvals Service will be responsible for:

considering available resources within the team and assigning an appropriate individual as Complaints Lead to investigate the complaint;
Considering available resources within the team and assigning an appropriate individual as Complaints Lead to investigate the complaint;
providing feedback to the CMG, along with the Complaints Lead as appropriate, on the progress of open investigations, including any reasons for delay, and the likely timeframe for completion.

The Complaints Lead will be responsible for the investigation into the complaint. This will include:

liaising with the complainant as appropriate;
working with other responsible bodies, as defined in the UK Policy Framework for Health & Social Care Research, to investigate the complaint;
reviewing and checking that any processes related to the complaint raised are within the remit, role and responsibility of the HRA and have been carried out in accordance with relevant policies, procedures and standards;
seeking views from expert individuals as appropriate;
saving any documentation or evidence relating to the investigation to the relevant complaints folder on the g:drive;
drafting a summary of the investigation / response to the complaint detailing how each point raised by the complainant has been investigated and any outcomes.

The Corporate Secretariat Support Officer will be responsible for:

issuing acknowledgment, update and response to complaint letters as directed by the Head of Corporate Governance & Risk;
seeking updates on progress of the investigation from the Complaints Lead and relevant parties and reminding individuals of timelines;
managing the complaints folder on the g:drive including arranging access to relevant folders for the Complaints Lead to save documentation / evidence relating to the investigation;
devising a document naming convention and ensuring complaints leads follow the convention when saving documentation to the g:drive;
updating the third-party complaints log on a regular basis;
providing secretariat support to the CMG;
deputising for the Head of Corporate Governance & Risk during periods of absence.

A separate terms of reference is available for the CMG. In summary however the CMG will be responsible for:

considering resource requirements and supporting the Director of Approvals Service in assigning appropriate individuals;s;
Considering resource requirements and supporting the Director of Approvals Service in assigning appropriate individuals;
considering potential complaints, media enquiries, social media activity and other relevant enquiries;
sharing any lessons learnt from complaints with other staff in the HRA or research community.equired;
Sharing any lessons learnt from complaints with other staff in the HRA or research community.

CMG meetings are not minuted and provide opportunity for a verbal discussion to be held between members of the group regarding the above areas.

Individual staff are responsible for identifying a complaint relating to a third party and forwarding this to complaints@hra.nhs.uk inbox in a timely manner. The ‘Guide to support staff in identifying and handling certain communications, complaints and requests for information’ will support staff in identifying these concerns.

HRA will make the best endeavour to secure responses from third party organisations but has no control over the response timelines for other organisations. Where additional time is necessary to conduct a more comprehensive review involving third parties, HRA will communicate this to those individuals raising concerns.

5. Procedure

5.1 Receipt, acknowledgement and initial review

Complaints relating to third parties may be received via a number of routes and may be made verbally or in writing. Where a verbal concern or issue is raised the person raising the complaint may be asked to follow this up in writing or alternatively notes may be taken by the person receiving the initial complaint and confirmed back as an accurate record.

On receipt, complaints relating to third parties should be sent to complaints@hra.nhs.uk where the Head of Corporate Governance & Risk or the Corporate Secretariat Support Officer will provide an initial acknowledgment within three working days confirming receipt of the complaint.

An initial review by the Head of Corporate Governance & Risk, alongside the Director of Approvals Service will take place within 10 working days. The acknowledgement will make clear a summary of the complaint and outcome of the HRA’s investigation will be published on the HRA website. The following points will be considered as part of the initial review:

Considerations	Actions
Does the complaint raised include a complaint related to the standard or quality of services provided by the HRA?	If 'yes;, manage in line with the HRA Complaint Policy and Procedure (N.B. complaints raised may involve management through more than one policy and procedure. Where this is the case the points within a complaint will be split and addressed according to the relevant policy)
Does the complaint relate to the ethical opinion/CAG advice issued on behalf of HRA and require a review?	If 'yes', manage in line with appropriate Standard Operating Procedures.
Does the complaint relate to a breach?	If 'yes', manage in line with the HRA Breach Policy and Procedure
Does the complaint relate to third party conduct in research as defined by the UK Policy Framework for Health & Social Care Research.	Ascertain whether third party is investigating the issue/concern. If yes, advise the applicant that no action can be taken whilst the outcome of the third party investigation is awaited. If 'no', consider whether the concern/issue relates to an area within the HRA remit. If it does, arrange a meeting of appropriate individuals to consider further / assign a relevant Complaints Lead to investigate. If it does not relate to an area within HRA’s remit, no further action is required, send standard letter and close. Consider redirecting the applicant to an appropriate source to deal with their issue/concern.
Does the complaint relate to research reviewed by an HRA service (including non-research CAG applications)? This may include issues relating to publication.	If 'yes', acknowledge using appropriate standard letter within 10 working days and assign Complaints Lead to investigate. If no, consider whether the complaint relates to an area within the HRA remit e.g. a study which should have received REC review but did not. If it does, arrange a meeting of appropriate individuals to consider further / assign a relevant Complaints Led to investigate. If it does not relate to an area within the HRA’s remit, no further action is required, send standard letter and close. Consider redirecting the applicant to an appropriate source to deal with their issue/concern.
Determine whether the nature of the concern or issue raised could attract media or other attention.	If 'yes', alert the Head of Communications and raise at the next CMG. If appropriate, the Chief Executive should also be informed.

Once the initial investigation has taken place a formal acknowledgment letter will be sent to the complainant. This will either advise the complaint is outside the HRA’s remit and offer advice and guidance as to who may be able to help with the complaint or to confirm the complaint will be investigated by the HRA with a response or update to follow within 25 working days. This acknowledgement will clearly breakdown the areas which will be investigated as part of the complaint and make clear any areas which are outside the HRA’s remit and will not be investigated.

5.2 Investigation and action

The Complaints Lead will undertake the investigation, contacting the person raising the complaint to seek any additional information as required. The Complaints Lead should normally contact the relevant third party where the complaint relates to e.g. sponsor, to seek further information and ascertain if they are aware of the complaint and what actions are being taken. The nature of the complaint may be sensitive or it may be of a whistleblowing nature therefore the Complaints Lead should ensure confidentiality of the individual making the complaint is maintained, unless explicit consent to reveal their identity is received.

It should be noted that in the review of complaints related to third parties a number of other issues may be identified which need to be managed in line with more than one HRA policy and procedure, e.g. HRA Breach Policy & Procedure, and which could involve a number of stakeholders.

The Complaints Lead should establish a preferred method of communication with the person raising the complaint. An initial phone call may be preferable to establish the nature of the complaint raised and the desired outcome. The Complaints Lead should be clear with the person what is within and outside the remit of the HRA. Facts should be established in a systematic, timely manner.

The Complaints Lead should record any steps taken or any evidence received as part of the investigation and save this to the appropriate folder on the g:drive.

The following should be considered:

Considerations	Possible actions
Determine whether any HRA approvals or functions in relation to the concern or issue raised have been carried out in accordance with the relevant standard operating procedures, guidance and other related policies and procedures e.g. a review of minutes from the relevant REC meeting.	Undertake a review of REC minutes, letter of approval, review of HRA Assessment Review Portal (HARP) database etc. Investigate further, involving REC Chair, CAG Chair or Assessment / Assurance Team as necessary It may be appropriate to seek views of the REC and it may wish to review its favourable ethical opinion in light of any concerns. Any reconsideration of opinion or approval should be managed in line with SOPs (10.103) Any issues which could relate to a breach should be managed in line with the HRA Breach Policy and Procedure If appropriate refer to other relevant body e.g. Sponsor, Trust, Medicines and Healthcare products Regulatory Agency (MHRA). Alert relevant body that referral has been made.
Ascertain whether the appropriate third party (as set out in UK Policy Framework (e.g. sponsor / funder)) is already investigating the issue/concern.	If 'yes', advise the applicant that no action can be taken whilst the outcome of the third party investigation is awaited. If 'no', consider contacting the third party on behalf of the applicant to facilitate communication between parties. Also consider redirecting the applicant to an appropriate source to help support them with their issue/concern e.g. Health Ombudsman.
If third party is aware of complaint but not handling appropriately or satisfactorily.	Consider escalating to another contact within same third-party organisation. Consider seeking expert advice if any concerns are identified. The HRA reserves the right to maintain the anonymity of any experts or panels reviewing the information. Ensure the confidentiality of the individual raising the complaint is maintained at all times, unless specific consent is received from the individual to release their details to the third party.
If continued difficulty in resolving the issue/concern with the third party.	Consider other options including communicating to other stakeholders e.g. issues regarding the accuracy of publications may be escalated to the relevant journal.

The CMG will meet regularly to consider progress regarding any investigations and allow opportunity for the Complaints Lead to discuss any particular challenges or handling issues.

5.3 Final response

Those raising complaints with the HRA, irrelevant of whether those complaints are within the remit or responsibility of the HRA, have a right to a response which explains how their complaint has been reviewed and where appropriate, any action taken. Each point raised by the complainant will be responded to.

The HRA has developed standard letters to assist this process and to ensure clarity with regard to the remit and responsibility of the HRA.

The Complaints Lead should contact the relevant third party, where possible, prior to the release of any response to the complainant detailing the outcome of the investigation and any required action by the third party.

Appeals are not allowed. The outcome of the investigation is final unless any new information, not raised as part of the initial investigation, is brought to the attention of the HRA.

If the complainant is unhappy regarding the process or handling of the third-party complaint, but not the decision, a complaint may be raised under the HRA’s complaints policy and procedure.

5.4 Recording, reporting and monitoring

All complaints relating to third parties should be recorded on the Third-Party Complaints Log. The Log is maintained by the Corporate Secretariat Support Officer.

A new log will be started each year and complaints relating to a third party will be allocated a unique reference number.

A summary of the concern and outcome of the investigation, once closed, will be published on the HRA website. The identity of the complainant will not be published in line with the principles of the General Data Protection Regulation / Data Protection Act. The Head of Corporate Governance & Risk will share a copy of the information to be published with the complainant and any relevant third parties prior to release. Any challenges to the information to be published will be considered by the CMG and may be escalated to the Leadership Team for a final decision.

Annually the Head of Corporate Governance & Risk will produce a report for the Leadership Team and Board detailing the number and type of third-party complaints raised, and review and action.

6. Monitoring of activities covered by the procedure

The Leadership Team will receive a report of complaints received and managed in line with this policy and procedure on an annual basis.

Informal feedback received from any stakeholders, including that from REC and CAG Chairs, Members, Sponsors, other stakeholders and HRA staff will be used to monitor compliance with, and incorporate changes to, this procedure on an ongoing basis.

7. How lessons are learnt and incorporated into the procedure

The management and use of this policy and procedure will be reviewed every two years, or more frequently on request should an opportunity to improve the policy or procedure arise.

8. Management of documents and records

The Third-Party Complaints Log, related documentation and reports sent to LT will be retained for 3 years from date of closure in accordance with the HRA Records Retention Schedule. They will be retained confidentially on the shared drive in a restricted access folder. After three years the documentation will be reviewed, and if no longer needed, confidentially destroyed.

Minor modifications to this document may be signed off by the Head of Corporate Governance & Risk at any point. All major modifications or revisions must be signed off by the CMG.

The standard letters are retained on the shared drive for use by the Head of Corporate Governance & Risk and Corporate Secretariat Support Officer.

9. Supporting paperwork/forms

Third party complaints log
Standard letters
Guide to support staff in identifying and handling certain communications, complaints and requests for information.

10. Dissemination and publication of the document

This policy and procedure will be released on the HRA Hub Central Library and its release will be communicated via HRA News. The policy and procedure will also be published on the HRA website.

Screening Questions - HRA Equality Analysis and Privacy Impact Assessment

Equality and privacy screening questions

Equality and privacy screening questions	Answer: If the answer is 'yes', please complete as required the HRA Initial Equality Analysis and / or Initial Privacy Impact Assessment Template and copy and paste the completed assessment (s) below. This one document can be found on the Intranet.
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 GDPR / Data Protection Act, does this policy involve the use of Personal Information?	Yes
Author to type in name and date to verify analysis. If further analysis is required, the Director of Finance, Procurement & Estates must be informed.	NAME: Stephen Tebbutt DATE: 31/01/2020

Initial privacy impact assessment

What is privacy?

Question	Answer
Does the policy or procedure have an 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 patient led complaints related to third parties is very likely to involve the collection of personal information and possibly personally sensitive information as defined by the Data Protection Act / General Data Protection Act. It is also likely to involve the collection of confidential information. As such all related 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.	Yes

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 Director of Finance, Procurement & Estates.

Full Privacy Impact Assessment required? No