Managing REC Members: Recruitment and Appointment Policy

Background

Research Ethics Committees (RECs) review health and social care research applications to assess whether the proposed research is ethical and should go head. To do this, REC members must collectively have the knowledge and skills to be able to review the ethics of a research application. For Clinical Trials of Investigational Medicinal Products (CTIMPs), the members must collectively have the knowledge and skills to be able to review the science, medical aspects and ethics of a research application. REC members must also reflect the views of the public, including the views and experiences of patients and carers.

RECs must have at the minimum five members. To be able to operate in line with the REC Policy Document and the Standard Operating Procedures (SOPs) for RECs, within the five members, the REC must have a chairperson, a lay member and a current or previously UK registered healthcare professional or social care professional for social care applications. REC members are allocated a designation using the REC Member Designation Criteria to allow the HRA to meet this requirement. Part of this requirement also reflects meeting quorum outlined in the Clinical Trials Regulations which need for RECs that review CTIMPs must comply.

The Health Research Authority (HRA) is the appointing authority for the 64 Research Ethics Committees (RECs) in England. The HRA currently oversees the recruitment and appointment of approximately 900 REC members who are volunteers (i.e., they do not receive payment for their role). The REC service currently experiences a 20% turnover in membership.

The HRA recognises and actively promotes the benefits of a diverse workforce and is also committed to treating those individuals in voluntary roles who support the HRA with dignity and respect regardless of race, gender, disability, age, sexual orientation, religion or belief.

The HRA has an Equal Opportunities Policy which requires the fair and equal treatment of all. The HRA wishes to ensure that all individuals, including its volunteers, are recruited, trained based on ability and the requirements of the role.

In addition to incorporating the HRA’s Equal Opportunities policy this document also reflects the following guidance where applicable:

• Seven principles of public life (previously known as the Nolan principles) where applicable to volunteer REC members
• Recruiting and managing volunteers in NHS providers: a practical guide (NHS England)
• NHS Employers guidance (with regards to identification checks for volunteers)
  

Scope

This policy describes the principles and broad approach to recruiting Research Ethics Committee (REC) members in a way that is fair, simple, responsive and trusted.

In addition to recruitment, this policy also includes the management of appointments including second terms, extensions, transfers and breaks in membership.

Whilst this document outlines the principles and broad approach to the recruitment and managing of appointments for REC members, detailed working instructions will accompany this policy that will set out step by step process.

This document applies to the recruitment and appointment of REC members in England and can be applied by the REC appointing authorities across the other UK nations. The principles can also be applied to recruitment and appointment of members to the Confidentiality Advisory Group (CAG).

This policy does not include the recruitment and appointment to REC chairing roles as this activity is covered by the Policy and Procedure for the Appointment of REC Chairs and Vice Chairs.

Roles and responsibilities

The Health Research Authority is the Appointing Authority for REC members in England and has the overall responsibility for the recruitment and appointment of REC members in England.

The Head of Approvals Support and Improvement (ASI) as the Appointing Authority Lead actively oversees this responsibility on behalf of the HRA, overseeing the REC service and the ASI Team who support the REC service. The Head of ASI is responsible for ensuring that the REC service operates in line with HRA policy, the REC policy document and REC SOPs and meets business need. The Head of ASI will make service level decisions, such as final approval of recruitment campaigns and addressing complex recruitment and appointment issues.

The Member Engagement and Development Manager is responsible for commissioning recruitment campaigns in line with REC service need. The Member Engagement and Development Manager will oversee the Member Support management team to ensure that RECs are correctly constituted, and member appointments are managed in line with this policy, this includes second terms, extensions, transfers and breaks in membership. The management team will also be responsible for recruiting staff to conduct the informal discussions ensuring that they have completed interview training. The Member Engagement and Development Manager will be the point of escalation for Member Recruitment and Support Officer.

The Member Recruitment and Support team is responsible for the day-to-day recruitment and appointment of REC members, including the processing of applications, setting up informal discussions, carrying out the second stage identity checks and issuing appointment letters. The Member Recruitment and Support Officer will be the point of escalation for the Member Recruitment and Support Team.

The ASI team and other HRA teams will help with the recruitment and appointment of REC members when required, for example, taking part in informal discussions.

The REC Approvals Team will be responsible for receiving new members and making sure that they have access to local REC information including meeting dates and rotas. The team will also be responsible for escalating queries regarding members’ appointments including those relating to REC member designations and requests for breaks in membership to the Member Support Team.

The Communications Team will support the Member Engagement and Development Manager by creating and running REC member recruitment campaigns, including the creation of recruitment material and social media posts in line with Government guidance.

NHS Business Services Authority (NHS BSA) is responsible for conducting the REC Member ID checks and ensuring the checks align with Government guidance. The HRA’s Human Resources Team will be the point of escalation for queries regarding NHS BSA and REC member ID checks.

Principles and purpose

This policy ensures that the recruitment and appointment of REC members is:

Fair and inclusive
The Research Ethics Service should reflect the diversity of the adult population of society and the HRA will take steps to encourage applications for membership from those who are under-represented.

The processes to recruit REC members will be in accordance with the HRA’s Equality and Diversity policy, and will not discriminate, either directly or indirectly, based on whether a potential volunteer has a protected characteristic as defined by the Equality Act 2010. The protected characteristics are age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex and sexual orientation.

The HRA recognises that some aspects of the REC member role may discourage some people from applying, such as digital working and the need for privacy when taking part in REC meetings.

Reasonable adjustments will be made whenever possible to support those applying for a REC member role.

Simple
The HRA recognises that the recruitment and appointment process for REC members should be proportionate to their volunteer role and should remove barriers to joining a REC.

The HRA recognises that situations may change and our appointment processes must be flexible to make volunteering with the HRA a good experience and to help retain our volunteers.

Responsive
Due to the size and turnover in REC membership, REC meeting requirements and mandatory timelines for the review of research applications, the recruitment of REC members must be flexible and responsive to REC service need.

Trusted
To promote transparency and thus maintain a trusted service, the HRA will:

• Publish this policy on the HRA website to demonstrate the robust process for recruiting and appointing REC members
• Ensure that REC members declare interests upon appointment and the declaration is updated on a regular basis
• Store recruitment and appointment documentation and related correspondence on a secure IT platform in line with the HRA’s records retention policy

Recruitment

The HRA welcomes applications for REC membership, and whenever possible, vacancies to join a REC will be announced on HRA communication channels, such as the HRA website, HRA social media and HRA newsletters.

Sometimes, due to service need or in response to REC member demographic data, there may be a need to run targeted recruitment campaigns, for example, to recruit healthcare or social care professionals, lay members or members from an underrepresented group. Whenever possible, targeted campaigns will be created with support of representatives from the relevant group.

Information about how to apply to join a REC (including a copy of this policy) and access to the application form will be made available on the HRA website with a contact email to request further information if required. On rare occasions, applications may be discouraged, for example, due to limited vacancies, to manage an excess in applications or during a period of sensitivity.

The HRA will use an online application form and ensure accessibility through features such as scalable text, screen reader compatibility and clear and consistent page structure. The online application form will be in line with the Web Content Accessibility Guidelines (WCAG).

The application form will request information pertinent to the volunteer role. Information about qualifications will only be requested when an applicant has indicated that they have professional experience in health or social care / research. When the applicant provides a professional registration number, this will be checked with the corresponding professional register. When the applicant confirms that they are a retired healthcare or social care professional, a check will take place to ensure this is evidenced in the employment history and qualifications sections of the application form.

On receipt of a completed application form, the applicant will be sent an assessment and invited to an informal discussion with a member of staff. The member of staff conducting the informal discussion will have completed interview training.

The informal discussion will ensure that the applicant understands the role and can accommodate the commitment involved, is able to carry out a simple ethics review and work online and is willing to accept the volunteer agreement. Applicants who are unable to meet this criterion will not be appointed. The informal discussion will also ascertain any reasonable adjustments to help the member carry out the REC member role.

Successful applicants will be required to complete a two-stage identity check in line with NHS Employers guidance for recruiting volunteers. In line with this guidance, applicants unable to complete the ID check will not be recruited.

Once the ID check has been successfully completed, the applicant will be:

• assigned a member designation using the REC Member Designation Criteria and Decision Tree
• allocated a REC based on the applicant’s availability and REC service need
• issued a first term appointment letter
• provided with relevant information and induction training to conduct their REC member role
• provided with log-on details to access HARP / Plan and Manage Health and Care Research to set up their account, accept the volunteer agreement and then access REC meeting documents

Appointments

The first term of appointment for a REC member will be for a period of up to five years. At the end of this period, and with the agreement of the HRA, the member may be appointed for a further term of up to five years. REC members will usually serve no more than 10 years on a REC and on completion of their second term, may be offered the opportunity to transfer to another REC.

On occasion, a REC member’s second term maybe extended if the REC has low membership, their designation is required to achieve the REC meeting requirements, there is a need for the member’s expertise, or to provide stability if there has been an influx of new REC members.

If a member is transferred to another REC, the appointment process detailed above will be repeated.

Only members who have met the expectations detailed in the volunteer agreement and have no unresolved member management issues will be considered for a transfer or extension. When members have not met this criterion and they reach the end of their second term they will normally be processed as a leaver.

With the permission of the HRA, members may also join more than one REC at the same time. When this is agreed, there is no need to repeat the recruitment process but the process regarding the terms of appointment will be carried out for the member for each REC. Only members who have met the expectations detailed in the volunteer agreement and have no unresolved management issues will be considered for membership on multiple RECs. The outcome of issues raised and managed under the Managing REC Members: Support and Concerns Policy, particularly with regards to conduct, may affect all the REC member’s appointments.

REC member appointments can be terminated by the HRA at any point in time in line with the Managing REC Members: Support and Concerns Policy.

Newly appointed REC members will be required to accept the volunteer agreement when they log on to HARP / Plan and Manage Health and Care Research for the first time and then every time the volunteer agreement is updated. Those who do not accept the volunteer agreement will not be able to continue as a REC member.

Within four weeks of their appointment, the REC member is required to complete a Declaration of Interest Form. The member will be asked to revisit this information on an annual basis and if anything changes at any time.

Changes to appointment

During their appointment, a REC member may change their profession and / or UK professional registration which could affect their REC member designation and, on rare occasion, their appointment.

Members are therefore expected to inform the HRA if they start to work in healthcare or social care or become involved in the setting up or conducting of health / social care research. The HRA will remind members of this expectation on a regular basis and upon notification, will revisit the member’s designation to make sure that it is correct and revisit the REC’s constitution to ensure that REC meeting requirements can be achieved.

Members who are UK registered health or social care professionals are required to inform the HRA if at any time during their membership they:

• become the subject of a fitness to practice investigation or proceedings by a licensing or regulatory body in the UK or in any other country
• are removed from the professional register or if conditions are made on their registration by a fitness to practice committee or licensing or regulatory body in the UK or in any other country
• they stop their professional registration

Notification of an investigation or changes to registration made by a fitness to practice or licensing or regulatory body will be escalated to the Head of Approvals Support and Improvement. Where necessary, the Head of Approvals Support and Improvement may consult with the Director / Deputy Director of Approvals and the HRA’s Company Secretary. The notification of an investigation may require the member’s appointment to be suspended pending outcome of the investigation. The outcome of the investigation may require the member’s appointment being terminated.

Other issues raised and managed in accordance with the Managing REC Members: Support and Concerns Policy may also result in the member’s appointment being suspended and in rare circumstances terminated.

Breaks in REC membership

A REC member can request a break at any point during their REC membership.

A break in membership will be considered if the break is more than four months but less than two years. Once a break in membership is agreed, the member’s appointment will be adjusted to reflect the period of the break and the member’s appointment letter amended and reissued.

Breaks in service will be handled sensitively and in line with the HRA’s Equality and Diversity Policy.

The HRA is committed to facilitating breaks in membership wherever possible but must balance this with ensuring that the Research Ethics Service can be delivered. When a break cannot be accommodated and no alternative arrangements can be put in place, the member will be encouraged to resign with a view to rejoining the REC service at a later date. Examples when a break in membership will not be accommodated include low membership and / or when the break will impact on the REC achieving the meeting requirements.

Leavers

Although members may resign from their REC member role at any point, we ask that they provide us with at least three months’ notice whenever possible to allow succession planning.

Leavers will be encouraged to complete a survey, and their feedback will be used to help improve the REC service.

A leaver process will be followed to ensure that the member is removed from the REC service, including access to the HRA’s digital platforms, and their data stored in line with the HRA’s record retention policy.

Requests to rejoin a REC

REC members who have resigned from the REC service are welcome to reapply if they had previously complied with the volunteer agreement and were not managed under the Managing REC Members: Support and Concerns Policy.

When the applicant has met the above criteria, the Member Engagement and Development Manager will assess each request on a case-by-case basis taking into consider the period that has lapsed since REC membership and the need for a repeat ID check. Options include submission of an updated CV and appointment or invitation to an informal discussion. Where the period exceeds six years, the applicant will be required to repeat the full recruitment process.

HRA Staff and REC membership

To promote transparency, ensure that the REC is independent from any organisation when issuing a decision and avoid conflicts of interest, HRA staff are not eligible for REC membership.

To maintain transparency, staff previously employed by the HRA will only be eligible to apply to join the RES in a different UK nation. This will be a reciprocal agreement across the UK nations.

Feedback and complaints

The HRA welcomes feedback from REC members. The HRA will use information from its surveys and its member feedback process to inform and develop its recruitment and appointment processes.

Applicants who wish to raise a concern about the recruitment and appointment process will be sign posted to the Member Engagement and Development Manager. Formal complaints will be handled by the HRA complaints team.

Reference Documents

Below is a list of reference documents:

• UK Research Ethics Committee (REC) Policy Document
• Policy and Procedure for the Recruitment, Selection and Appointment of REC Chairs and Vice-Chairs
• The Medicines for Human Use (Clinical Trials) Amended Regulations
• HRA Equality & Diversity Policy and Procedure
• HRA Complaints Policy and Procedure
• Managing REC Members: Support and Concerns Policy
• REC Member Designations Criteria and Decision Tree
• REC Member Decision Tree

Management of the policy

This document will be reviewed every three years to ensure that it is up to date.

Minor changes and updates to this policy, such as updates to staff / team titles and changes in responsibilities will be approved by the Head of Approvals Support and Improvement.

Changes to the principles and the broad approach to the recruiting and managing REC members will be approved by UKREDG.

Supporting documents

The following documents support the implementation of this policy:

• Working instructions
• Email templates
• REC Member Designations Criteria and Decision Tree
• Informal discussion outcome form
• Volunteer Form
• Guidance for ID checks
• Appointment Letters
• Volunteer agreement

Dissemination and publication of the document

This policy will be published on the HRA website and a copy stored in the Central Library on SharePoint.

Approvals staff will be informed about the policy and subsequent updates via the Directorates existing communications channels.

REC members will be informed about the policy and subsequent updates via the REC Member Information Exchange.

No other copies should be stored on SharePoint and/or One Drive apart from a word version on the appropriate HRA SharePoint workspace allowing review and amendments by the owner/author.

Screening Questions - HRA Equality Analysis and Data Protection Impact Assessment

Screening questions within policy documents

The screening questions below must be placed in every relevant document. In policy and procedure documents for example, it will be placed at the end just before the Document Control section.

For EIAs, this is to ensure that no policy is published without one. For the Data Protection Impact Assessment, this is an initial short screening form to decide whether or not a full DPIA is required.

Equality and Data Protection Impact Assessments

For every HRA policy (defined by the Equality and Human Rights Commission as a function, strategy, procedure, practice, project or decision), please ensure the following assessments have been completed:

Equality assessment screening question

Has an Initial Equality Impact Assessment been carried out?

Answer: Yes

Data Protection assessment screening question

Has a Data Protection Impact Assessment (DPIA) been carried out?

Answer: Yes