Research Governance Approval Process

RESEARCH GOVERNANCE APPROVAL PROCESS

for conducting, hosting, or collaborating in children’s social care research

CONTENTS

Title / Page
1. Does your Project Require Research Governance Approval? / 2
2. Introduction / 2
Intended recipients / 3
Scope / 3
3. Submitting an Application / 5
Before Submitting an Application for Research Governance Approval / 5
Submitting an Application for Social Care Research Governance Approval / 5
The Research Governance Approval Process / 6
4. Flowchart: Birmingham Social Care Research Governance Approval Process / 8
5. References / 9
6. After Research Governance Approval has been Granted / 9
Collation of information on research projects / 9

1. DOES YOUR PROJECT REQUIRE RESEARCH GOVERNANCE APPROVAL?

2. INTRODUCTION

This procedure describes the research governance approval process for all children’s social care research.

The purpose of the procedure is to ensure that all requests for research access to children’s social care service users, carers, their families or friends, volunteers or staff are reviewed to check the research is safe, ethical and methodologically sound. Research governance review ensures that all research activity complies with the Department of Health’s Research Governance Framework for Health and Social Care (RGF) and legislation relevant to social care research.

The central purpose of the RGF is to protect participants by ensuring there are clear arrangements to identify and manage any risks associated with the study. To achieve this, the framework sets out 5 core principles of good research governance:

Ethics: ensuring the dignity, rights, safety and well-being of research participants;

Science: ensuring that the design and methods of research are subject to independent review by relevant experts;

Information: ensuring full and free public access to information on the research and its findings;

Health and Safety: ensuring at all times the safety of research participants, researcher and other staff; and

Finance: ensuring financial probity and compliance with the law in conducting research.

Intended recipients

The procedure is intended for:

Members of staff who will be conducting research involving access to children’s social care staff or to children’s social care service users, their relatives, family or carers, or to information held about them; and

External researchers (including students) who will be conducting research involving access to children’s social care staff or children’s social care service users, their relatives, family or carers, or to information held about them.

Scope

The scope of the RGF is research relating to the responsibilities of the Secretary of State for Health. Under the original RGF this would have included children’s social care as well as the National Health Service and adult social care. When responsibility for children’s social care moved to the Department for Education, Birmingham Children’s Trust continued to include children’s services within the remit of the local social care research governance approval process.

The RGF defines research as ‘the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’.

This includes research studies that aim to generate hypotheses as well as studies that aim to test them.

The procedure covers research undertaken by students, academic institutions, independent bodies and individuals commissioned by children’s social care as well as research undertaken by staff employed by children’s social care or its contracted agencies.

The procedure applies to all research which involves any of the following if they are accessed via or with the support of children’s social care services:

Users of children’s social care services provided or commissioned throughthe Directorate forPeople;

Carers, family or friends of users of children’s social care services provided or commissioned through the Directorate forPeople;

Any personal information held about individual users of social care services provided or commissioned through the Directorate forPeople or about their carers, family or friends;

Staff who work directly for children’s social care services or indirectly for a contracted provider of services in their professional capacity; or

Any personal information held about staff who work directly for children’s social care services or indirectly for a contracted provider of services in their professional capacity.

Where research is ongoing or repeated on a regular basis, written approval only needs to be obtained through this procedure on the first occasion, provided that no substantive changes are made to the research design or research tools. If substantive changes are made to the research design or research tools, the proposal must be re-submitted for approval.

Within children’s social care the following research-type activities do not require research governance approval but are the responsibility of the relevant manager:

service evaluations;

consultations;

audits; and

training course evaluations.

Research in children’s social care can only commence after written approval has been granted in accordance with procedures set out in this document.

Research projects that have been approved elsewhere e.g. through university ethics committee or the NHS National Research Ethics Service, still need to be approved through the Trust’s local social care research governance approval process before commencing.

Before allowing any researcher to approach service users, their family, friends or carers, or staff through children’s social care services, employees within the Directorate forPeoplemust satisfy themselves that the researcher has obtained appropriate written approval through the local social care research governance approval process. If in doubt, staff can ask the researcher for proof of approval.

Disciplinary action may be taken against staff who undertake research or allow research to take place within children’s social care without first ensuring that the research has received research governance approval.

Staff have an overriding duty of care and if they feel social care research that is being planned or is taking place may harm participants in some way; they have a responsibility to inform the Trust by emailing

Further guidance on whether work falls within the scope of the procedure is available by emailing

Further information is also available from the Trust’s website.

3. SUBMITTING AN APPLICATION

Before submitting an application for research governance approval

Research involving people aged 16 or over who lack capacity to make their own decisions (as defined by Section 2 of the Mental Capacity Act 2005) must first obtain approval for the proposal from the National Social Care Research Ethics Committee hosted by the Health Research Authority - . The National Social Car Research Ethics Committee is an ‘appropriate body’ for approving research that will involve people who lack capacity. Proof of this approval must be submitted when applying though the Trust’s local social care research governance approval process.

Research involving four or more different children’s services departments must first be approved by the Association of Directors of Children’s Services (ADCS) Research Group – Proof of this approval must be submitted when applying through the Trust’s local social care research governance approval process.

Research involving access to participants through any NHS organisation may require NHS approval. Researchers are advised to submit their research proposal to the relevant NHS organisation before applying through the Trust’s local social care research governance approval process.

Research undertaken for educational purposes, for example, as part of an undergraduate or postgraduate qualification must first be approved through the relevant university’s ethics approval process before applying through the Trust’s local social care research governance approval process.

The RGF is clear that “the decision whether or not to give permission for research in a care organisation rests with that organisation”. Therefore, obtaining approval in one of the ways detailed above is always in addition to, and not instead of, the need for approval through the Trust..

All researchers must be able to prove they hold current clearance from the Disclosure and Barring Service (DBS).

Submitting an application for social care research governance approval

The person proposing the research (from here on referred to as the ‘researcher’) will request a Word copy of the Research Governance Application Pack by emailing

The researcher will complete the Research Governance Application Pack and email the completed pack along with supporting documentation as specified in the application pack to . The application pack includes a checklist of supporting documentation required from researcher.

When the research is being carried out by a Birmingham Children’s Trust employee as part of their work, they must first ensure they have permission for the project from the relevant Head of Service.

The research governance approval process

Researchers will be notified by email within 5 working days of receipt that their completed Research Governance application form and supporting documentation has been received.

Details of the research application will be recorded for monitoring purposes on a spreadsheet held by adult social care services.

The research proposal will be reviewed by at least two Research Governance Advisors drawn from membership of the Research Governance Advisory Committee. This Committee includes representatives from adult social care staff, public health staff,children’s social care staff, adult social care service users, carers and academic staff from Birmingham universities. Staff with relevant specialist knowledge e.g. data protection from the Directorate forPeople may also be asked to comment on specific aspects of a project.

The Research Governance Advisors will:

Consider the feasibility of the proposed research;

Decide whether all issues in the research application have been addressed satisfactorily; and

Assess whether the research proposal meets the standards set out in the Department of Health’s RGF.

The Research Governance Lead may share information on research applications, and/or enter into correspondence or dialogue regarding merits of applications with other organisations at any time in order to facilitate the decision-making process.

Any initial concerns raised by the Research Governance Advisors will be discussed with researchers and modifications may be suggested to the design of the project or documentation.

The researcher will be emailed a letter notifying them of the outcome of the review within 20 working days of them answering all initial concerns raised by the Research Governance Advisors and providing all requested documentation.

The proposal will either be:

Approved;

Approved subject to conditions/modifications being made; or

Rejected.

No research activity may commence before written approval has been provided through the local social care research governance approval process.

When research has been approved through the local social care research governance approval process it will then need to be supported by local managers of the service area in which the research will be carried out. This is to ensure there is capacity within the service to support the research. Even with research governance approval it may not be possible to let research go ahead because of operational restrictions or lack of capacity within the service.

Where a proposal has been rejected, the reasons for this will be summarised in a letter to the researcher with recommendations, where appropriate, on how the proposal can be improved.

There is no automatic right of appeal against decisions made through this procedure. However, complaints regarding how an application has been handled should be sent, in the first instance, to .

If the researcher is still unhappy with the way their application was handled, they should send their concerns to the Director – Birmingham Health and Wellbeing Partnership.

4. FLOWCHART - BIRMINGHAM SOCIAL CARE RESEARCH GOVERNANCE APPROVAL PROCESS

5. REFERENCES

Research Governance Framework for Health and Social Care Research

Mental Capacity Act 2005

pdf version of Birmingham Children’s Trust and Research Governance application pack for information:

6. AFTER RESEARCH GOVERNANCE APPROVAL HAS BEEN GRANTED

If the researcher plans to make any changes to the research project after approval has been given, the research must submit written details of these changes to and receive approval for the changes before continuing with the project.

The researcher must email with details of any problems with the project that might lead either to delays in completing the project or to the project being abandoned.

On completion of the research, the researcher will email either a full copy of the research results or a Plain English summary to

Collation of information on research projects

Under the RGF the Trust has a duty to ensure there is “free access to information both on research being conducted and on the findings of the research”.

The outcome of the review will be recorded for monitoring purposes on a spreadsheet held by adult social care and also recorded on the Adult Social Care Evidence Bank.

Information about research projects and results of research will be reported in the Research Governance Annual Report. A copy of the latest report can be obtained by emailing

Page 1August 2012