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1.1.4 Research Governance

RELATED DOCUMENT

Please also see Staff Guidance and Research Proposal Form.


Contents

  1. What is Research Governance?
  2. Why is it Needed in Social Care?
  3. What does Research Governance Cover?
  4. What do we have to do to Comply with RGF?
  5. What to do if you are approached by an external Organisation who want to involve Children’s Social Care in Research Activity
  6. What to do if you intend to undertake ‘In-house’ Research
  7. Further Information

    Appendix 1: Appendix 1: City of York Council, Adults, Children's and Education Services, Children's Social Care Research Proposal Form - External Research

    Appendix 2: Research Checklist

    Appendix 3: City of York Council, Adults, Children’s And Education Services, Children’s Social Care Research Proposal Form - Internal Research

    Appendix 4: Sources of Further Information


1. What is Research Governance?

Research Governance is the process by which the quality of research can be assured, and the rights, dignity and safety of those involved can be protected.

The Department of Health (DH) Research Governance Framework (RGF) for Health and Social Care published 2002 and updated 2005 covers the conduct of research in the NHS and social care. It aims to protect participants by ensuring there are clear arrangements to identify and manage any risks associated with a study. It calls for explicit agreement about roles and responsibilities, and draws attention to the law and good practice.

The RGF sets out basic standards for every party involved in research, in five key areas: ethics; science; information; health and safety; and finance.

While all research is expected to meet the standards of governance, it is recognised that there are important differences in the health and social care contexts. This recognition resulted in a separate implementation plan for social care. The implementation plan gives Councils with Social Services Responsibilities (CSSR's) three central responsibilities:

  • Ensuring dignity, rights, safety and well-being of researchers and service users, carers and staff participating in research;
  • Helping to safeguard the integrity of research, and upholding standards for ethical review and scientific quality;
  • Establishing transparent systems to approve, record and monitor all research activity.


2. Why is it Needed in Social Care?

All research carries an element of risk, balancing these risks against the likely benefits of high quality research is a major objective of good governance.

Research governance is necessary as a means of assessing that research is carried out:

  • Only on useful topics;
  • With sound methods;
  • With sufficient resources and expertise;
  • In ways that respect the dignity and self-determination of participants.

In addition, for local authorities, developing systems to assess, record and monitor research activity will provide the following benefits:

  • Helping to ensure that decision making is informed by better quality research;
  • Making it easier to prevent unnecessary duplication of research activity and enabling collaboration;
  • Ensuring public accountability and transparency for any research in which it is involved;
  • Helping to protect those for whom they have a duty of care from any possible harm arising from participation in research.


3. What does Research Governance Cover?

For the purposes of research governance, ‘research’ means the systematic application of established research methods and techniques to gather information on human participants in an explicitly planned way. This is a deliberately broad definition, designed to cover a wide range of data gathering activity.

CSSR's are the main care bodies involved in the process, but research in organisations providing services under contract to local Councils is also covered by RGF. Formally, the RGF extends only to adult social care services, although local authorities are encouraged to apply the same principles to research involving children’s services and other research activity involving human participants.

All research, internal and external, needs to be subject to good governance procedures. Councils are encouraged to develop basic systems for all research studies to assess risks presented and how these may be dealt with.

Whilst DH aim is ‘to protect participants by ensuring there are clear arrangements to identify and manage any risk associated with a study’, they do not wish to encourage the growth of cumbersome, overly bureaucratic processes at a local level.

The key task is to devise systems that will achieve safeguards for those who take part in research, while continuing support for research as an activity that can make an important contribution to the future of social care and to the well-being of service users.


4. What do we have to do to Comply with RGF?

At a minimum there are two basic requirements for local Councils to fulfil.

Firstly checks need to be made on all external research requiring access to service user/carer or staff populations, or personal data on them, in respect of whether the proposed study has:

  • Received independent ethics approval;
  • Been independently reviewed (favourably) for the quality of its methods;
  • An identified sponsor that is prepared to accept its research governance responsibilities;
  • Sound arrangements for the management of the project, including financial management.

In addition Councils need also to subject their internal research activity to an assessment of the level of risk involved. Where this risk is identified as high, it should be subject to scrutiny of both ethics and methods, consistent with the resources at their disposal.

Secondly, a record of all applications/assessments and their outcomes (covering both internal and external research) needs to be made and details kept on a local research register. Information about  approved research  may also  be sent to the Research Register for Social Care.

The Mental Capacity Act (MCA) 2005 has a number of implications for the practice and governance of research, most of which represent existing good practice. The Law provides safeguards for persons who lack capacity to give consent to research. Researchers will have to consult someone who is able to take an independent view of the incapacitated person’s interests, wishes and feelings. Care is needed when seeking consent from children and vulnerable adults. Arrangements must be made to ensure relevant information is provided in an appropriate written or pictorial format, and that the roles and responsibilities of parents, carers or supporters are clearly explained and understood. Research that seeks to involve people who lack capacity will need to address the following questions:

  • Why is it necessary to involve people who lack capacity in the research?
  • How are the researchers going to establish that participants lack capacity?
  • Are decisions about taking part going to be taken in the best interest of people lacking capacity?
  • How are people lacking capacity going to be helped to express their views about taking part in research?
  • What will happen if participants lose capacity during the course of research?


5. What to do if you are approached by an external Organisation who want to involve Children’s Social Care in Research Activity

All research requests from external organisations which request access to our service users, carers or staff, or their data should be forwarded to Quality Assurance Service Manager (QASM) who will ensure that an External Research Proposal Form (Appendix 1) is completed which will help us verify that the research proposal has:

  • An identified funder / sponsor;
  • Undergone an independent ethics/methods review;
  • Written agreements in place with all parties involved;
  • That all parties are aware of their responsibilities under RGF.

QASM will share all external research proposals with the Social Care Management Team (in their designated role as Research and Ethics Committee), and will seek further professional advice from the Marketing and Communications Team and/or the University of York as appropriate.

The research must not begin until approval, or any recommended changes to the research proposal, has been given.


6. What to do if you intend to undertake ‘In-house’ Research

Discuss the research proposal with your line manager.

Use the Research Checklist (Appendix 2) to ensure you have thought through all the issues.

Particular attention should be paid to:

  1. The requirements of the Data Protection Act and the Freedom of Information Act - failure to abide by the principles could result in a legal challenge;
  2. Equalities - researchers need to ensure that the methods used to conduct their research does not discriminate against hard to reach groups. Reasonable steps should be taken to make sure that particular groups of people targeted in a study are not excluded from participation because of their need, for example, translators/interpreters, inappropriate venues chosen for focus groups, format of questionnaire, etc.;
  3. Persons who lack capacity to consent being included in a study, and those who lose capacity during a study - the statutory framework can be found in the Mental Capacity Act 2005, section(s) 30-34;
  4. Before committing resources to a research project, staff and managers should search the  CYC Marketing and Communications Inclusive Consultation Database, and the SCIE National Research Register for Social Care (see Research Register for Social Care website) to check whether colleagues have researched the same/similar subject area to avoid duplication;
  5. If you need any help with this process contact QASM.

Fill out and submit an Internal Research Proposal Form to QASM using the Internal Research Proposal Form (Appendix 3). Any supporting documentation, for example, questionnaires, letters of consent, etc should be attached.

If the research proposal carries little or no risk, then the line manager will be able to approve the research. To assist managers to assess potential risk of research proposals, the DH Risk Assessment Toolkit is attached (Appendix 4).

Allow time for your proposal to go through the RGF scrutiny process and await approval or recommendations of changes before starting your research. Approval will usually be by e-mail from QASM.

Undertake your research project. If any changes need to be made to you original plan, or anything goes wrong during the research, you should inform QASM immediately.

Submit a report of your research findings to QASM. The research will be recorded on CSC Local Research Register, and may be may be recorded on the CYC Marketing and Communication Inclusive Consultation Database and  the National Research Register for Social Care, to be shared with colleagues.


7. Further Information

Sources of further information are listed (Appendix 5).


Appendix 1: City of York Council, Adults, Children's and Education Services, Children's Social Care Research Proposal Form - External Research

Click here to view Appendix 1: City of York Council, Adults, Children's and Education Services, Children's Social Care Research Proposal Form - External Research.


Appendix 2: Research Checklist

Click here to view Appendix 2: Research Checklist.


Appendix 3: City of York Council, Adults, Children’s And Education Services, Children’s Social Care Research Proposal Form - Internal Research

Click here to view Appendix 3: City of York Council, Adults, Children’s And Education Services, Children’s Social Care Research Proposal Form - Internal Research.


Appendix 4: Sources of Further Information

Sources of Further Information

The following websites may be useful to you:

The Department of Health

This is where you will find a copy of the document which sets out a framework for the governance of research in health and social care, first published in 2001, and updated in April 2005.

See the Department of Health website.

Social Services Research Group

This is where you will find a copy of the Resource Pack which was published in April 2005 to help with the implementation of RGF. A Draft Second Edition Resource Pack for Social Care has been published, though it is not available electronically.

See Network for Social Care Research website.

Research in Practice

This is where you will find a collection of information sheets and guidance notes for those applying to undertake research which agencies in the research in practice network have developed.

See Research in Practice website.

Social Care Online

This is where you can access the UK’s most complete range of information and research on all aspects of social care - for free. New content is added daily. It is drawn from a range of resources including journal articles, websites, research reviews, legislation and government documents, audio/visual material and service user knowledge.

See Social Care Online website.

The National Research Register for Social Care

The RRSC will record social care research that has been subject to independent ethical and scientific review. This will include ongoing and completed research, and research carried out by students and practitioners. It can be searched to obtain summary details of the individual studies and links to further information about them.

See Research Register for Social Care website.

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