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1.1.4 Framework for Health and Social Care Research

Contents

  1. What is the Framework for Health and Social Care Research?
  2. Why is it Needed in Social Care?
  3. What does the Framework for Health and Social Care Research Cover?
  4. What do we have to do to Comply with the Framework for Health and Social Care Research?
  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

    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 the Framework for Health and Social Care Research?

The UK Policy Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK. 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.

While all research is expected to meet the policy framework, it is recognised that there are important differences in the health and social care contexts.


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.

The Policy Framework on Health and Social Care Research is necessary as a means of assessing that research is carried out:

  • Only on useful topics;
  • Using 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 the Framework for Health and Social Care Research Cover?

Principle 1: Safety

The safety and well-being of the individual prevail over the interests of science and society.

Principle 2: Competence

All the people involved in managing and conducting a research project are qualified by education, training and experience, or otherwise competent under the supervision of a suitably qualified person, to perform their tasks.

Principle 3: Scientific and Ethical Conduct

Research projects are scientifically sound and guided by ethical principles in all their aspects.

Principle 4: Patient, Service User and Public Involvement

Patients, service users and the public are involved in the design, management, conduct and dissemination of research, unless otherwise justified.

Principle 5: Integrity, Quality and Transparency

Research is designed, reviewed, managed and undertaken in a way that ensures integrity, quality and transparency.

Principle 6: Protocol

The design and procedure of the research are clearly described and justified in a research proposal or protocol, where applicable conforming to a standard template and/or specified contents.

Principle 7: Legality

The researchers and sponsor familiarise themselves with relevant legislation and guidance in respect of managing and conducting the research.

Principle 8: Benefits and Risks

Before the research project is started, any anticipated benefit for the individual participant and other present and future recipients of the health or social care in question is weighed against the foreseeable risks and inconveniences once they have been mitigated.

Principle 9: Approval

A research project is started only if a research ethics committee and any other relevant approval body have favourably reviewed the research proposal or protocol and related information, where their review is expected or required.

Principle 10: Information about the Research

In order to avoid waste, information about research projects (other than those for educational purposes) is made publicly available before they start (unless a deferral is agreed by or on behalf of the research ethics committee).

Principle 11: Accessible Findings

Other than research for educational purposes and early phase trials, the findings, whether positive or negative, are made accessible, with adequate consent and privacy safeguards, in a timely manner after they have finished, in compliance with any applicable regulatory standards, i.e. legal requirements or expectations of regulators. In addition, where appropriate, information about the findings of the research is available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified.

Principle 12: Choice

Research participants are afforded respect and autonomy, taking account of their capacity to understand. Where there is a difference between the research and the standard practice that they might otherwise experience, research participants are given information to understand the distinction and make a choice, unless a research ethics committee agrees otherwise. Where participants’ explicit consent is sought, it is voluntary and informed. Where consent is refused or withdrawn, this is done without reprisal.

A formal, structured risk assessment is only expected where identified as essential. The risk:benefit ratio will normally be sufficiently described and considered as part of review processes such as research ethics committee review.

Principle 13: Insurance and Indemnity

Adequate provision is made for insurance or indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project.

Principle 14: Respect for Privacy

All information collected for or as part of the research project is recorded, handled and stored appropriately and in such a way and for such time that it can be accurately reported, interpreted and verified, while the confidentiality of individual research participants remains appropriately protected. Data and tissue collections are managed in a transparent way that demonstrates commitment to their appropriate use for research and appropriate protection of privacy.

Principle 15: Compliance

Sanctions for non-compliance with these principles may include appropriate and proportionate administrative, contractual or legal measures by funders, employers, relevant professional and statutory regulators, and other bodies.

Principles that apply to interventional health and social care research

In addition to the principles above, the following principles apply to interventional research only, i.e. where a change in treatment, care or other services is made for the purpose of research:

Principle 16: Justified Intervention

The intended deviation from normal treatment, care or other services is adequately supported by the available information (including evidence from previous research).

Principle 17: Ongoing Provision of Treatment

The research proposal or protocol and the participant information sheet explain the special arrangements, if any, after the research intervention period has ended (e.g. continuing or changing the treatment, care or other services that were introduced for the purposes of the research).

Special provision is not expected unless existing arrangements (e.g. professional insurance, membership of NHS Litigation Authority schemes) provide inadequate cover.

Principle 18: Integrity of the Care Record

All information about treatment, care or other services provided as part of the research project and their outcomes is recorded, handled and stored appropriately and in such a way and for such time that it can be understood, where relevant, by others involved in the participant’s care and accurately reported, interpreted and verified, while the confidentiality of records of the participants remains protected.

Principle 19: Duty of Care

The duty of care owed by health and social care providers continues to apply when their patients and service users take part in research. A relevant health or social care professional retains responsibility for the treatment, care or other services given to patients and service users as research participants and for decisions about their treatment, care or other services. If an unmanageable conflict arises between research and patient interests, the duty to the participant as a patient prevails.


4. What do we have to do to Comply with the Framework for Health and Social Care Research?

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 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 the Policy Framework.

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 (see Appendix 2: Research Checklist) 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.

Fill out and submit an Internal Research Proposal Form to QASM using the Internal Research Proposal Form (see Appendix 3: City of York Council, Adults, Children’s And Education Services, Children’s Social Care Research Proposal Form - Internal Research). 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 (see Appendix 4: Sources of Further Information).

Allow time for your proposal to go through the 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.


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

Social Services Research Group (SSRG)

SSRG are an independent network of individuals who provide a range of research information, planning and evaluation in social care and health services. SSRG members are drawn from a wide range of professional groups and organisations sharing a common interest in the work of the caring services. See Social Services Research Group 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.

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