GENERAL RESEARCH GOVERNANCE - ETHICS
ADULT SERVICES DEPARTMENTAL PROCEDURE NO: 12/15Research Governance – External Approval Process
EFFECTIVE DATE: / 20 April 2016
CATEGORY: / General
SUMMARY: / This procedure sets out the Research Governance approval process for all external organisations and researchers who wish to conduct research and research-like projects involving staff, service users, carers, or family and friends of users of Adult Services. The procedure ensures that research is appropriately reviewed before it commences.
KEYWORDS: / Research Governance - Ethics
APPROVED BY: / Gary Smith, Assistant Director
DATE APPROVED:
PROCEDURES CANCELLED OR AMENDED: / 44/09 ‘Research governance – External Approval Process’.
AUTHOR: / Rachel Dittrich, Research Manager
Tel: 07545 415 319, email:
SPONSOR CONTACT: / Gary Smith, Assistant Director
SIGNED:
DESIGNATION: / Assistant Director
YOU SHOULD ENSURE THAT:-
§ You read, understand and, where appropriate, act on this information
§ All people in your workplace who need to know see this procedure
§ This document is available in a place to which all staff members in your workplace have access
PURPOSE
This procedure sets out the Research Governance process that all external organisations and researchers wanting to conduct research, or research-like activities, involving staff, service users, carers, and family and friends of users of Adult Services are required by the Department of Health to follow in order to obtain approval for the work to commence.
SCOPE
All research, and research-like activities (activities that utilise research methods or techniques), conducted and commissioned by researchers who are not employees of Hampshire County Council, or its contracted agencies, who wish to access service users, their family and friends, carers, staff (including volunteers) or their data, via Adult Services and its contracted agencies. This includes research that has not been commissioned by Hampshire County Council but is being undertaken by external agents in collaboration with in-house research staff or professionals.
There is a separate Research Governance procedure for research conducted and commissioned by individuals employed by Hampshire County Council Adult Services or their contracted agencies.
REFERENCES
Adams, R., Dominelli, L, and Payne, M. (eds.) (2005) Social work futures: crossing boundaries, transforming practice, Basingstoke: Palgrave Macmillan
Birmingham City Council (2007) Midlands Research Governance Application Pack
http://www.ripfa.org.uk/thenetwork/docs/rgf/Bham_RGF_APPLC_PACK.doc
Bournemouth Borough Council (2007) Research Governance Resource Pack
http://www.ripfa.org.uk/thenetwork/docs/rgf/Research_Governance_Framework_pack1.doc
Data Protection Act 1998
http://www.opsi.gov.uk/acts/acts1998/19980029.htm
Department for Constitutional Affairs (2007) Mental Capacity Act 2005 Code of Practice
http://www.dca.gov.uk/legal-policy/mental-capacity/mca-cp.pdf
Department of Health (2008) Guidance on nominating a consultee for research involving adults who lack capacity to consent
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_083133.pdf
Department of Health (2005) Research Governance Framework for Health and Social Care. Second edition
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962
Department of Health (2004) Research Governance Framework Implementation Plan for Social Care
http://www.dh.gov.uk/assetRoot/04/08/21/72/04082172.PDF
Freedom of Information Act 2000
http://hantsnet2000.hants.gov.uk/TC/cxdatapro/cxfoi/
Human Rights Act 1998
http://www.opsi.gov.uk/acts/acts1998/19980042.htm
Health and Safety Act 1974
http://www.hse.gov.uk/pubns/hsc13.pdf
Leathard, A. and McLaren, S (eds.) (2007) Ethics: contemporary challenges in health and social care, Bristol: Policy Press
McLaughlin, H. (2006) Understanding social work research, London: Sage
Mental Capacity Act 2005
http://www.opsi.gov.uk/acts/acts2005/20050009.htm
Mental Capacity Implementation Programme (2007) Making Decisions: a guide for people who work in health and social care. Second edition
http://www.dca.gov.uk/legal-policy/mental-capacity/mibooklets/booklet03.pdf
NHS National Patient Safety Agency/National Research Ethics Service (2007) Research involving adults unable to consent for themselves http://www.nres.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=321
Social Services Research Group (2008) Research Governance Framework Resource Pack for Social Care. 2nd edition (Draft)
Whittell, B. (2006) Wigan Council Department of Adult Services Research Governance Framework: Information and Application Process
Adult Services Research on Hantsweb: http://www3.hants.gov.uk/adult-services/aboutas/research.htm
Children’s Services Research on Hantsweb: http://www3.hants.gov.uk/childrens-services/about-cs/cs-research/research-governance.htm
Data Protection
http://hantsnet2000.hants.gov.uk/TC/hn2000security/dpa_staffguidelines.html
Equality and Diversity on Hantsweb: http://www3.hants.gov.uk/equality
AUTHORITY TO VARY
Assistant Director, Adult Services
DEFINITIONS
Research and research-like activities
The Research Governance Framework defines research as ‘the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’. The Social Services Research Group advises that, for the purposes of Research Governance, it is good practice to treat ‘research-like activities’ - activities which use research methods or techniques to collect information from, or about, employees or individuals who may be service users, their relatives or friends, accessed via Adult Services or its contracted agencies, in records or in person - as ‘research’. This means ‘research’ might refer to any pieces of work involving questionnaires/surveys, observation, focus groups, and interviews. It may also include work involving diaries and other methods of capturing data.
It can include any consultation, evaluation, audit carried out as part of a service review, non-financial audit or a stand alone piece of work designed to gain new knowledge or information. It can also apply to analysis of routinely collected data by external persons (see flow chart in section 2).
Research Governance
The procedure that has been developed from the framework to protect research participants by ensuring that there are clear arrangements to identify and manage any risks that are associated with a research study or activity. This includes:
· ensuring that research and research-like activities are conducted according to high ethical and methodological standards;
· clarifying the roles and responsibilities of the different agencies and individuals involved.
Research Governance Framework
A framework produced by the Department of Health in 2004 that provides guidance on good practice for research collaborations between researchers, health and social care agencies and research funders. Its full title is ‘The Research Governance Framework for Health and Social Care’. The Research Governance Framework applies to those service user/carer/staff populations that are the responsibility of the Secretary of State for Health. This means that it currently covers adult social care services and their contracted agencies: the people for whom the Director of Adult Services has a duty of care.
ROLES
All staff - To ensure that any research undertaken has approval of the panel prior to being involved or allowing it to take place. If in doubt, staff in Adult Services can ask the researcher to show their proof of approval given by the Deputy Director. Staff should tell researchers if they notice that a service user who lacks capacity to consent appears to be unhappy about any aspects of research that they are involved in. Researchers in your workplace must stop research with service users who lack capacity to consent to it if advised to by a consultee or if the service user appears to be unhappy with any aspects of the research (see section 5).
Managers - To ensure that any requests made by external organisations or researchers, that require access to users or staff for the purposes of conducting research are referred to the Research Manager or Research Development and Governance Panel, as the research can not commence without the approval of the panel. To nominate a ‘nominated consultee’ if requested by a researcher, when a researcher who has been approved to undertake research wishes to involve a person who lacks capacity to consent to it and the researcher has been unable to identify a ‘personal consultee’ to consult (see section 5).
Nominated consultees - To follow the guidance provided by the researcher.
Research Development and Governance Panel – To assess and review external research proposals that request access to Adult Services staff and service users, their carers, family and friends, and either approve, approve with amendments or reject whether the research projects can commence, on behalf of the Deputy Director, Adult Services. The panel meets monthly and will assess and review the proposals using the following criteria:
· Ethics;
· Science;
· Information;
· Health and Safety;
· Finance.
The panel will also ensure that information about approved projects is published on Hantsnet.
PROCEDURE
Contents
1 Introduction
2 What does Research Governance apply to?
3 Review and approval process
4 Research monitoring
5 Research involving people who lack capacity to consent: the role of personal and nominated consultees
6 Dissemination of findings
7 Complaints
8 Impact assessment
9 Safeguarding
10 Service User and Carer Involvement
11 Performance standards
Appendix 1 External Research Governance project plan form
Appendix 2 Research Risk Assessment Tool
1. Introduction
The Department of Health’s Research Governance Framework for Health and Social Care (RGF) sets out to encourage and sustain a research culture that promotes excellence in the conduct of research and reduces unacceptable variations in practice.
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;
· Finance: ensuring financial probity and compliance with the law in the conduct of research.
It is against these criteria that all research proposed by external organisations or researchers (not employed by the Council) and requiring access to Adult Services staff or its service users, carers, friends and family of service users, or their data, will be judged.
2. What does Research Governance apply to?
If the activity being proposed by an external individual or organisation, not employed by the Council, involves research techniques and requires accessing Adult Services (or its contracted agencies) staff, users, carers, friends and family of service users, or their data, it is likely that the work will be classified as research under the RGF and will require approval before the work can commence. In the majority of cases it will concern pieces of work involving questionnaires, focus groups, observation, interviews and surveys. It can include work labelled as ‘consultation’, ‘non-financial audit’ or ‘evaluation’. See ‘Research’ under ‘Definitions’ for more details.
To help identify whether a research or research-like activity requires Research Governance approval under the framework a flow diagram has been developed, see below.
If any member of staff has any concerns relating to any external requests for information, data or access to users or staff they should contact the Research Manager for advice.
Flow diagram for defining external research requiring Research Governance approval
*No need for RGF approval as long as a manager, or member of staff with designated responsibility, agrees to the information or data being released.
3. Review and Approval Process
On determining a piece of research requires prior approval from the Research Development and Governance Panel before it can commence, the individual or agency needs to contact the Research Manager, complete a Research Governance project plan form and submit it along with copies of any research tools to be used (e.g. draft questionnaires interview questions, participant information sheets).
This section outlines the procedure a proposal will follow, as part of the Research Governance process.
3.1 . Submitting a proposal
Prior to submitting a proposal:
· If the research is ‘intrusive’, as defined under the Mental Capacity Act, (this definition includes all kinds of research that would have required consent if the person had capacity, e.g. observation or the collection of personal data about an individual indirectly from another source), researchers who wish to involve people who lack capacity to consent must obtain section 30 approval from an appropriate body. This would be an NHS Research Ethics Committee or the National Social Care Research Ethics Committee. Researchers who wish to undertake research with NHS staff will need approval from an NHS Research Committee unless the work can be defined as ‘evaluation’ or ‘audit’. Proof of approval must be sent with the Research Governance project plan form. Researchers should be aware that NHS Research Ethics Committees can take 60 days to process applications.
· Researchers should closely read the guidance supplied on the form.
· Inexperienced researchers should also make sure they read some of the following in order to understand the ethical implications of research activities: Leathard, A. and McLaren, S (eds.) (2007) Ethics: contemporary challenges in health and social care, Bristol: Policy Press; McLaughlin, H. (2006) Understanding social work research, London: Sage; Adams, R., Dominelli, L, and Payne, M. (eds.) (2005) Social work futures: crossing boundaries, transforming practice, Basingstoke: Palgrave Macmillan.
3.1.1. Students
Students wishing to undertake research with Adult Services must contact the Research Manager via email () or telephone (07834123386) for an informal discussion prior to submitting a Research Governance project plan form. This is to ensure that all applications, when made, are operationally feasible. The student may be asked for details of the subject, why the research needs to be done, the collection method, and intended participants (including estimated numbers).
The Research Manager, in consultation with operational staff, will provide comments within a week in order to improve the operational feasibility of the proposed research or suggest alternative projects. If the proposed research seems plausible, they will send a Research Governance project plan form for the student to complete.
If the student then wishes to proceed they must gain approval from the relevant university research ethics committee and send the feedback from the committee with their completed Research Governance project plan form. When completing the project plan form they must take into account the comments and suggestions provided as discussion stage by the Research Manager.
3.1.2. Other researchers
Other researchers need only submit a Research Governance project plan form and their research tools. The form is available from the Research Manager (email: , tel: 07834123386).
3.1.3. Where to send your form
The completed form can be emailed to .
3.2. Acknowledgement
On receiving the completed form and documents, the details will be recorded on a central database for monitoring purposes and the applicant will receive an email acknowledging the receipt of the proposal.
3.3. Consultation with Senior Manager
Once the project plan form has been submitted, a copy will be sent to the relevant senior manager to check whether they have any objections to the research and to obtain their permission for the researcher to access staff or users. If permission is not granted then the proposals will be rejected at this stage.