Devon Social Care Services - ACS and CYPS  Research Governance Framework

Contents
Background Information
Appendix 1 - Project Plan Format (relevant to all applications)
Appendix 2 - An Example Code ofGood Practice in Research
Appendix 3 - Application for Non-Research Project
Appendix 4 - Application for Research Project
Appendix 5 - Data Protection Guidance
Appendix 6 - Caldicott Guidance
Appendix 7 - Checklist used to Evaluate RGF Applications

Information and application pack for research, internal evaluation, service user and carer surveys and associated activities

Background

In December 2005 Devon Social Care Services - ACS and CYPS formed its research governance framework review panel in response to national requirements.  If you are intending to do some research, evaluation or survey work involving Devon’s service users and carers or social service staff you are required to submit an application to the RGF panel.

The Research Governance Framework (RGF) aims to:

• Regulate research, to protect participants from risk; and
• Improve the quality of research, to ensure that it generates valuable evidence.

The RGF sets about meeting these aims by:

• Setting standards in relation to ethics; science; information; health and safety; and finance; and
• Formalising roles and responsibilities of key agents in the research process: funder; sponsor; research employer and lead researcher; care organisation and responsible care professional.

The Framework covers all research that relates to the responsibilities of the Secretary of State for Health, and applies to England and Wales. As well as NHS research, this includes social care research undertaken by academic or independent researchers in or on behalf of social care agencies as well as research undertaken by the agencies themselves. In identifying whether the work will come under the RGF, the key issue is the means of access to these populations. If access is via  Devon Social Care Services - ACS and CYPS/care departments, or their contracted agencies, then the research will be covered by the RGF. If the research population is accessed via the records of another agency, however, or other department within the Council, then the research will not automatically be covered by the RGF.

Definition of research:

The definition of research adopted in the RGF is the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods

Research and related activities

In Devon our senior management team has agreed that it is as important to monitor the quality and ethics of evaluation and survey work as it is research.  The scope of out RGF process therefore includes:

“Any activity which involves the collection of information from, or about, individuals who are service users, carers, volunteers or employees of the Directorate.”

This covers:

• Consultation exercises that gather personal information;
• Evaluations;
• “Mystery Shopping”;
• Focus Groups;
• Reviews (including those conducted for best value exercises);
• Surveys;
• Student projects (including field research and data gathering related to dissertations.)  

It is important however to make our RGF process as streamlined as possible and not burden staff with over complicated documentation when they want to do a relatively simple evaluation or survey. We have therefore decided to use two parallel application processes, one for research and one for other related activities.

As an application you must first establish in your own mind which of these headings your intended project fits. If you are unclear then you can discuss this with Paul Grimsey, RGF Administratorr , tel 01392 384385, email paul.grimsey@devon.gov.uk

If you are a member of staff from any social care service within Devon County Council , the Devon Partnership Trust or the Learning Disability Partnership or an external researcher

Once you have decided which heading your activity comes under complete the relevant application form and return electronically to Paul Grimsey at the above email address.

If you are a Plymouth university MA student

At the moment as well as applying to the Devon Social Care Services - ACS and CYPS RGF Panel you are required to obtain ethics approval from your university who are acting in the capacity of your research sponsor. On this basis in recognition of your limited timescales the application will be “fast tracked”

If health patients or staff are involved

All applicants should note that if they intend that the scope of their project includes patients or staff of the health service you will also be required to seek approval from the Peninsula Primary Care Research Management & Governance Unit, Exeter Primary Care Trust, Dean Clarke House, Southernhay East, Exeter, EX1 1PQ,Tel: (01392) 207542

As well as the application forms this pack contains a number of resource documents that may be of assistance to you.

In a nutshell

• Decide what category your project comes under and who needs to grant you ethics approval
• Create a project plan which covers the essential information required
• Complete the relevant application form (see appendices 3 and 4). Ensure you attach all the relevant supporting documentation.
• Submit the application form to the RGF administrator by sending in the application electronically
• Await the decision – sometimes you will be required to amend the proposal in some way

Appendix 1 - Project Plan Format (relevant to all applications)
project plan format (23KB - pdf help)

Appendix 2 - An Example Code of Good Practice in Research
Researcher’s Code of Conduct developed by West Sussex County Council

Ethics

• The respect, dignity, rights, safety and well-being of participants must be of primary importance in the consideration of any proposed research.
• All proposed research project plans, involving Devon Social Care Services - ACS and CYPS which involve data concerning users, their relatives or friends, care professionals, volunteers, must be referred to the Research Governance Manager for appraisal prior to commencing the project.
• The arrangements for obtaining informed and written consent from participants must be considered as a matter of prime importance in the project plan. In cases where it is not possible to obtain a written signature directly from the participant, the researcher must take all reasonable steps to identify and obtain consent from a legal guardian or advocate. Approval of the arrangements must be sought from the appropriate reviewing body prior to commencing the research.

Informed consent includes:

• Giving participants as much information as is appropriate about the purpose of the study and it’s intended outcomes;
• Explaining clearly their rights and limits to their participation. E.g. location (if appropriate), time involved, etc;
• How the data will be used and stored etc;
• Raising participant’s awareness to any potential harm/risk in taking part ;
• Ensuring compliance is freely given;
• Ensuring participants are made aware of their right to withdraw or refuse to take part in a study without suffering any affect on their right of access to services;
• Giving consideration to obtaining informed consent from ‘vulnerable’ populations e.g. children, people with learning disability etc;
• Ensuring that all reasonable steps will be taken to assure confidentiality and anonymity. However, they should be informed that data which gives postcodes or other geographic data identifiers could lead to identification.

The issue of informed consent does not apply if data is collected through anonymous questionnaires.

If the method of collection of data is by observation, which relies on observing behaviour without the participant’s knowledge, such studies should only take place in a location in which people would normally expect to be in public view. If possible, an attempt should be made to obtain consent after the study has taken place. (Such requests will receive very close scrutiny by the Research Governance Review Panel given the ethical implications involved.)

• The design of the research must not discriminate against participants on the basis of sex, ethnic origin, religion, age, sexual orientation or disability. This may mean that special arrangements need to be made to ensure participation e.g. Braille, audio cassettes, plain English, translations in minority languages, payment of travelling expenses etc.
• Wherever appropriate, participants or their representatives should be given the opportunity to help with the research including, planning, data collection and analysis.
• During contact with participants, care must be taken not to raise expectations of services or to imply that resources will be available to meet their needs.
• Researchers have a duty to pass on requests for help or information to the appropriate agency in any situation which gives rise to serious concern, e.g. domestic abuse or child protection issues.
• An appropriate channel for registering any complaints must be identified to participants
• All data is confidential and should not be put to any use which may conflict with the original purpose for which it is gathered, without the informed and written consent of the participants.

Science

• All existing sources relating to the proposed area of study must be considered before undertaking any projects to avoid unnecessary replication of existing work;
• All project plans must be submitted to the Research Governance Manager for checking. No work can begin on the study until the appropriate level of approval has been granted. If the plan requires ethical approval (see page x) it will be reviewed by the Research Governance Review Panel.
• All data collected during the course of the research must be stored securely for an appropriate period to allow further analysis by the original researcher or others and also for the purposes of monitoring and the development of good research practice. This may require gaining the consent of the participants involved i.e. if there are any consequences for the participant from whom the data was originally collected.

Information

• Once appropriate approval has been granted, all information about the research and its findings should be made freely available.
• All results of the research need to be presented at an appropriate level e.g. in such a way that it is easily understood, using jargon free language.
• All research work should be open to critical review through accepted scientific and professional channels.

Health and Safety

• The safety of participants and of research staff must be given priority at all times and health and safety regulations must be strictly observed.

Participants:
Harm can arise from stress through participation, loss of self-esteem, psychological injury or other side effects. All researchers must assess potential risks as part of their Project Plan.

Researchers:

• Employing organisations are responsible for the safety of their staff. All researchers should carry identification and ensure that a system is in place so that your whereabouts are known. Contact should be made before any home visits and a risk assessment made.

Finance
Researchers must:

• Consult their employing agency or organisation regarding details of arrangements for compensation to themselves or anyone harmed by the research should the need arise, prior to submitting a project plan.
• Give details about any grants covering the study and estimates of any expenditure.
• State if anyone will profit financially from the results of the study.

You may also like to read the Devon Social Care Services - ACS and CYPS Research Group code of good practice available at: http://www.ssrg.org.uk/publications/policy/codeofpractice.asp

Appendix 3 - Application for Non Research Project
appendix 3 (23KB - pdf help)

Appendix 4 - Application for Research Project
appendix4 (35KB - pdf help)

Appendix 5 - Data Protection Guidance
appendix5 (30KB - pdf help)

Appendix 6 - Caldicott Guidance
appendix6 (25KB - pdf help)

Appendix 7 - Checklist used to Evaluate RGF Applications
appendix7 (37KB - pdf help)