research governance framework scotland

Guidance on research governance and ethical research practice

This document offers guidance to help social service organisations develop systems and processes to ensure good research governance and shared ethical principles for conducting social services research in Scotland.

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Transcript: Research Governance in Social Care

Research scotland management team, talks about the development of a research governance framework (rgf)..

Podcast Episode: Research Governance in Social Care

Category: Social work (general)  

Speaker(s):

• Irina McLean
• Michelle Drumm

What follows is a transcription of the audio recording. Due to differences between spoken and written English, the transcript may contain quirks of grammar and syntax.

MD - Michelle Drumm IM - Irina McLean

Irina McLean, Project Leader with NHS Research Scotland Management Team, is currently leading the development of a Research Governance Framework (RGF) which will meet the needs of Scotland’s Social Care Services employers, staff and service users and their families. The Public Bodies (Joint Working) (Scotland) Act 2014 sets the context for the integration of adult health and social care in Scotland. Underpinning the introduction of the Act was a commitment to ensure the consistent provision of quality, sustainable care services for the increasing numbers of people in Scotland who need joined-up support and care. The Scottish Government recognises that for successful reform and effective integration of health and social care sectors collective ethical and accountable research practices are required. The new RGF is currently being defined through a process of engagement. Irina tells us more about the work she is doing…

MD. So, Irina Mclean is here with us today to talk about research governance in social care. Welcome Irina, it’s lovely to meet you.

IM Thank you for having me Michelle.

MD Would you just like to describe to me the research that you are doing, and I know you are also developing a research governance framework. So, do you want to briefly describe what the research is that you are doing?

IM Thank you for asking this Michelle, I know it’s sounds a bit complicated and to separate those things I suppose I should start by describing what research governance is and why there is a need for research governance framework. So, research governance framework mainly concerns setting standards which should improve research quality and safeguard the public. It involves enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring lessons are learned and preventing poor performance and misconduct. In 1 sentence it’s difficult to describe, but establishing baseline for what quality research is, that’s what I’m hoping to talk about and that’s what I am hoping to achieve through my piece of work. A lot of research in the social care sector involves direct interactions with people and if researchers, or people who are involved with projects, are not doing it ethically an either we are not doing it respectively and in the same way as services protect service user’s rights, in the same way research governance protects service users rights when they are involved with any research activity, making sure that access to their information is justified, access to their time is respectful and generally the principles of a good research include respect and accountability. Why do you need to speak to these people? What is it you are looking to achieve? It’s not chat, we are looking to generate some knowledge as a result of our involvement with people who kindly agree to give their time to researchers.

MD I suppose increasingly service users are getting involved in research now. I suppose in the past that wasn’t always something that used to happen.

IM This is a very point on today’s agenda. Mainly in the land of participatory research and social care research, more and more, luckily I can see it happens more and more in the social care world that social researchers see the benefits of involving service users, not exercising research upon them, but doing it with them where people with lived experiences are prepared to share their views, they should be involved in setting the agenda and that’s where participatory research in today’s social care world is pivotal.

MD Tell me, what is exactly is research governance framework? Is that something written on paper? Is it something you look at? Is it a diagram? What is a framework?

IM Interesting. I wish I knew the answer, because framework for research in the UK has many facets, different ways of looking at what a research governance framework is. There is a standard set of rules, or is it a live document, or is it an actual approach? So, at the moment we have research governance framework which has been introduced in 2017 in UK and it covers health and social care research. That replaced UK country specific frameworks and introduced a bit of an integrated approach to principles and standards, but nevertheless, with respect to social care, the research governance framework differs in it’s applicability within in each home nation simply because of difference in legislations and also because of different stages of integration of health and social care, which happen amongst 4 nations.

MD So, you have been doing this research now since October 2018, what are you finding so far?

IM Very exciting journey. It has been very colourful and very fruitful. A lot of information which leads to local processes associated with research activities and mainly their pathways, that’s what I concentrated on, and engagement with the project has been different across the country and in some areas there is evidence of fantastic pieces of work being undertaken by local authorities, 3rd sector, academia, and very strong approaches are being held accountable by people who undertake research. However, in some areas research is not viewed as a priority and engagement in these areas has, therefore, been challenging and I am not going to give you an answer to why this is happening because this is not what the project is about, I’m not here to judge or find any faults within organisations. I am here to find the common theme which we could engage with for health and social care integration to flow, for that evidence to be gathered, therefore, we can see how successful integration is and what changes service users are witnessing and how service is delivering that support to people, how they nee a bit of a hand or maybe they have got practice to share, which should be celebrated.

MD So, this research governance framework underpins the implementation of health and social care, so you are talking about how integration is happening across local authorities and 3rd sector and, as part of that, this research governance framework is integral to integration working?

IM Spot on, and you said earlier that you know nothing about social care and health integration, you nailed it Michelle, thank you.

MD A little bit maybe.

IM That’s the best way of describing it. We can’t shy away anymore from the fact that integration is marching upon us, it’s happening and essentially, to connect that gap of understanding of interface between health and social care and as a result of health and social care research in Scotland, that’s what is needed and those ideas, solutions, best practice, methods, across both sectors, they need to be shared but there has to be a safe space for those ideas and best practices to be shared, so almost that platform, so that’s how I see my piece of work, creating a platform, avoiding multi-layers, avoiding adding yet another layer for a researcher who wants to undertake a project. I’m hoping that platform will generate interest and actually that best practice will stem from there.

MD And there must be some challenges to this in terms of, the practitioners may see this framework as something that is an extra layer, perhaps?

IM I’m not sure the practitioners will see it as an extra layer, I’m sure practitioners might, as any human being, which is natural, any practitioner might see something new coming their way potentially being anxious about it, but from my experience in the last nearly 7 months, practitioners are very welcoming of my work and they are particularly welcoming of principles and standards of that basic threshold of what quality of research should look like. So, almost that helping hand to guide, not direct but to guide, and if I may, to go back a bit into how the project was born, when I mentioned the UK social care and health research governance framework which exists from 2017, the Scottish Government’s Chief Scientist Office and participating agencies recognised that the existing UK wide framework does not support, that much, the areas of methodology and ethical approaches related to social care research and, therefore, the stirring group to develop a Scottish social care research governance framework was born and me, as a project leader, I am really just a medium of gathering and disseminating that information. Going back to how important and how equal both sectors are, health and social care and the process of integration, I would like to talk a bit about NHS research and development facilities and also about existing NHS approval structure through the research ethic committees. So, basically NHS has a very strong structure associated with research processes and there is an integrating research application system, which is currently used for medical research projects and has a number of limitations for social care project applications, however, the positive spin on it is that the system is undergoing a major review process and, therefore, a potential opportunity to provide feedback on the social care research landscape in Scotland is possible and I am really hopeful that NHS colleagues and people from a medical world of research are going to work together with social care researchers because, at the end of the day, we are only working towards 1 outcome and that’s the wellbeing of service users, patients, people. So, that’s why those processes exist in processes in local authorities, 3rd sector, NHS, in essence, it’s about bringing things together to create a positive evidence, which could be used for supporting people, patients, service users.

MD It’s back to protecting people again, isn’t it?

IM Absolutely, and creating that safe environment for researchers wanting to do research and for people wanting to participate. So far we were able, together with the stirring group, to engage with, or address several things. First part of the project involved establishing the actual scope for the type and areas of social care research which takes place in Scotland and to look at what should be covered by the research governance framework. Following the scope establishment, I started undertaking a mapping exercise amongst 32 local authorities and convening a series of discussions and type of consultations with the existing research community. What I am doing just now is developing guidance for individual researchers and agencies who conduct social care research in Scotland and engaging with a wider stakeholder community to hear from them to receive some feedback because, at the end of the day, it has to work for them, not for me, and the last and exciting bit, not the least but, the dissemination workshop will be taking place in September where researchers from both health and social care background will be able to get together to address existing practices and processes.

MD And is this an event that is open to anyone to attend or is it something that is invite only?

IM Absolutely to anybody at this stage. I’m really welcoming to hear from anybody who has a project in place and please don’t be scared to come forward, even if a project you are working on or you were involved with, hasn’t quite worked out because that would give us a fantastic base to look at things which probably haven’t flown or haven’t happened the way they should and that will allow colleagues from both health and social care sectors to do a bit of homework and to look where we are going with it next. So far I can say, not to give away too much, we have a very exciting project from Northern Ireland coming this year and they are examples with us.

MD So, different organisations across sector from places like Norther Ireland, Scotland, are coming together to provide presentations about what they are doing around research governance in social care?

IM Absolutely, and I am hoping that people will work really hard on the day because, as a result of it, it’s really about practitioners doing research, what is missing, what should be put in place, and that sort of gathering will help people bounce ideas and do a bit of brainstorming and share things which probably haven’t been successful, but use it as a learning curve.

MD Ok, will there be a follow up event for these people or is it just a 1 off thing that you will bring people together?

IM At the moment it’s a 1 off but obviously the follow up paper will be written particularly on the views shared on the day.

MD Ok, what date in September? Where is it being held?

IM It’s 9th September, I believe a Monday, and it will be held in Victoria Quay in Edinburgh and please get in touch if you think that your project, or project you are involved with or going to be involved with, fits the bill and we would love to hear from you.

MD Great, ok. Let’s hope you get some people interested and along on the day. If there is 1 key message or ask of people, who are listening today, around this whole research governance framework, what is that?

IM I would be struggling to keep it to 1, but if I have to, the 1 message to take away from today’s conversation would be, don’t be put off by thinking that it is all theory, it’s all processes, it’s not relevant to me or the agency I am working for. It really is because at the end of the day it is very black and white, research is happening in both sectors in health and social care only to achieve better outcomes for people we support, there isn’t anything else behind it. Therefore, principles and good governance is only there to support what you are doing as a researcher, as a practitioner. You don’t have to be at university, you don’t have to be in a research lab to undertake any piece of research. How little or big it is, those principles will help you to get where you want to get and keep you right, keep people you are working with safe, that’s what we are aiming at with this project.

MD So, if you are listening today and you are involved or thinking about some research that involves people who are using services or carers Irina would love to hear from you and if you are interested in attending the event on 9th September also please get in touch. Irina, thank you for coming in today to talk to us about the research you are doing and best of luck going forward.

IM Thank you.

Transcript Copyright: This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License

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Social Care Online

The Social Care Online website/service has now closed down, it closed in March 2024 and the data was last updated in early 2023.

Social Care Online was first launched in May 2005 by the Social Care Institute for Excellence (SCIE). Previously it was known as the Electronic Library for Social Care (eLSC). Content originated from the National Institute for Social Work library and included resources dating back to the 1980s.

Social Care Online’s bibliographic data will continue to be available via the combined  Social Policy and Practice database  a subscription-based service. Please refer to your organisation’s information and library service for further information about this database and alternatives to Social Care Online relevant to your research interests.

Freely available alternative sources of information include:

• Kings Fund Library Database  for information relating to health and social care management and policy, systems, services and leadership.
• NSPCC Library catalogue  for safeguarding, child protection, child abuse and neglect.
• AgeInfo  – information resource provided by the Centre for Policy on Ageing Library Service, covering social gerontology.

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About accord.

The Academic and Clinical Central Office for Research and Development (ACCORD) is a partnership between the University of Edinburgh and NHS Lothian Health Board. NHS Lothian has an excellent international reputation for its clinical research activities, while Edinburgh University is Scotland’s top-ranked research institution and one of the UK’s leading research universities. By drawing together key research management staff from these organisations, ACCORD provides streamlined access to professional advice, expert regulatory support and world class clinical research infrastructure. We support researchers and commercial companies throughout the UK and internationally to conduct their clinical research. This partnership is underpinned by the first joint Research Framework Agreement in Scotland.

ACCORD supports around 1000 projects every year, ranging from small student studies to complex interventional investigations and multi centre international trials. We work very closely with industry to deliver a growing portfolio of commercial studies across a broad spectrum of disease and we provide advanced infrastructure to enable the development and execution of increasingly complicated and innovative projects. Providing a single point of entry for researchers throughout the lifecycle of their studies, our aim is to ensure that we all meet research governance and regulatory requirements, fulfilling legal, ethical and scientific obligations, whilst nurturing and attracting world class research.

Clinical research governance

Mrc policy on the uk policy framework for health and social care research.

To ensure that health and social care research in the NHS is conducted to high scientific and ethical standards, the  UK policy framework for health and social care research defines broad principles of good research governance . The UK policy framework was released in October 2017 by the Health Research Authority to replace the previous research governance frameworks of England, Wales, Scotland and Northern Ireland.

The Medical Research Centre’s (MRC) policy on the UK policy framework details our requirements of MRC-funded researchers in universities or other research organisations undertaking work in the NHS or with NHS partners.

These requirements, which focus mainly on research sponsorship, are part of MRC’s terms and conditions for research funding.

There is a different policy for  sponsorship of clinical trials of medicines .

Requirements for MRC-funded research by other organisations

UKRI expects the host institution, the research organisation, to nominate itself as sponsor or to make alternative arrangements.

All new grant and fellowship applications for clinical research funding must include details of the sponsorship arrangements made by the research organisation.

Sponsorship of clinical research in MRC institutes and requirements for directors

UKRI will accept sponsorship responsibilities under the UK policy framework for clinical research led by UKRI employees at MRC institutes.

Institute directors are authorised to accept sponsorship responsibilities on behalf of UKRI. An MRC institute should not accept sponsorship responsibilities if they rightly belong elsewhere.

There is a different policy for  sponsorship under the clinical trials regulations .

Under the UK policy framework sponsorship is project-specific and does not automatically extend to new work which has not been assessed by the MRC. However, it does accommodate reasonable changes within the scope and duration of the approved project or those required by research ethics committees.

Institute directors may agree to co-sponsor clinical research projects with another research organisation under certain circumstances, subject to appropriate agreements and controls, and providing that:

• another organisation is not better placed to undertake the sponsor’s duties
• one or more UKRI employees act as principal investigator and accept responsibilities for the design or conduct (or both) of the study
• the research proposal has been peer reviewed and approved for funding by the MRC
• an MRC institute is able to exercise the sponsor’s duties.

Directors of MRC institutes must ensure that there is clear and systematic documentation of all projects for which the institute has sponsorship responsibilities. This includes approvals of the study and any amendments by regulatory authorities and research ethics committees. This information should be immediately available on request.

Directors of MRC institutes must ensure that quality, risk management and monitoring systems are in place.

MRC institutes should have appropriate research governance systems, in which responsibilities are allocated, accepted and carried out within a sound research and project management framework.

Agreements and systems should be in place and documented with NHS organisations and other collaborative or partner organisations, including commercial organisations.

Naming UKRI as sponsor on ethics committee applications

If the conditions are met, MRC institutes should:

• name UKRI as the sponsor on Research Ethics Committee applications;
• provide relevant details for a member of staff within the institute who is responsible for sponsorship (the sponsor representative).

Further guidance on how MRC institutes should implement sponsorship responsibilities can be found on the  MRC Regulatory Support Centre’s sponsorship and indemnity page .

Contact the MRC Regulatory Support Centre

Email:  [email protected]

Last updated: 17 June 2022

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UK Policy Framework for Health and Social Care Research

Introduction and background

1.  Context

2.  Purpose

4.  Implementation

5.  UK-wide responsibilities

6.  Development, status and maintenance

7.  Audience

8.  Principles that apply to all health and social care research

• Principles that apply to interventional health and social care research

Responsibilities

9.  Responsibilities of individuals and organisations

• Chief investigators

Research teams

• Contract research organisations
• Research sites

Regulators of professions

• Other regulators
• Health and social care providers

Glossary and Appendices

Appendix 1: remits, appendix 2: laws, appendix 3: relationship between principles and responsibilities, 1. context .

1.1. The Health Research Authority (HRA) and the UK Health Departments (The four UK Health Departments are the Department of Health (England), the Department of Health (Northern Ireland), the Scottish Government Health and Social Care Directorates and the Department for Health and Social Services (Wales)) are committed to an environment where:

• patients, service users [1] and the public (including carers, relatives of patients and service users and healthy volunteers) are given, and take, the opportunity to participate in health and social care research and to get involved in its design, management, conduct and dissemination, and are confident about doing so;
• safer, more efficient or more effective treatments, care and other services are developed and tested through ethical and scientifically sound research for the benefit of patients, service users and the public;
• applying to do research is simple and getting a decision is quick, with predictable timelines;
• researchers find it straightforward to do high-quality, ethical research;
• commissioners and providers of health and social care appreciate how health and social care research benefits patients, service users, staff and the public, and make their resources available for research;
• industry sees the UK as a great place to do health and social care research, and increases its investment for the benefit of patients and service users;
• money from charities and other research funders goes into carrying out research, not into navigating needless bureaucracy or duplicating previous work; and
• research projects get registered, the data and tissue they collect can be made available for future analysis, with adequate consent and privacy safeguards, and research findings (i.e. the findings that the research was designed to produce; for guidance on incidental and other health-related findings, (see  Wellcome policy position ) get published and summarised for those who took part in them.

1.2 Research is a core function of health and social care. It is essential for our health and well-being and for the care we receive. Research should improve the evidence base, reduce uncertainties and lead to improvements in care. Evidence; ( BMJ Content ), (BMJ Content), (Journals Content) suggests the quality of current care may be higher in organisations that take part in research, adopt a learning culture and implement research findings. Improved care can give people a better quality of life and the country benefits from more money and jobs if the UK environment for research attracts international research funders to invest and carry out their research here. Research develops the skills of staff in our universities, businesses and health and social care. It also involves patients, service users and the public in the pursuit of knowledge that may benefit them and others, not only by their participation in research but also by their involvement in setting research priorities, in the design, management, conduct and dissemination of research, in public engagement about research, as members of research approval bodies such as research ethics committees or in funding research through taxes and charitable donations.

2.1   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 that take account of legal requirements and other standards. These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate (This means having an approach to mitigating risks that gives at least the same consideration to the risks that arise if the research does not take place as to those that arise if it does, and the same consideration to their likelihood as to their impact. The risk appetite should favour the research taking place. The prevailing focus should be on the risks to the potential participants and the target population, not on the reputational risks), assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.

2.2   This policy framework sets out principles and responsibilities at a high level that take account of relevant legislation in the UK. It will be supported by operational arrangements and guidance provided by the HRA and the Devolved Administrations, working in collaboration to ensure a consistent approach to co-ordinating and standardising regulatory practice. This will achieve compatibility across the UK for the management and conduct of health and social care research (Although this document is relevant to all health and social care research, its legal remit does not generally encompass children’s social care research in England or Scotland, except where the project also involves health research, adult social care research or children’s social care research in Northern Ireland or Wales.)

3.1 For the purpose of this policy framework, research is defined as the attempt to derive generalisable or transferable (NB This definition involves an attempt at generalisability or transferability, i.e. the project deliberately uses methods intended to achieve quantitative or qualitative findings that can be applied to settings or contexts other than those in which they were tested. The actual generalisability or transferability of some research findings may only become apparent once the project has been completed) new (Including new knowledge about existing treatments or care) knowledge to answer or refine relevant questions with scientifically sound methods (Projects that are not designed well enough to meet this definition are not exempt from this policy framework – paragraph 9.10.a.) This excludes audits of practice and service evaluations. It includes activities that are carried out in preparation for or as a consequence of the interventional part (This means the part of the research where a change in treatment, care or other services is made for the purpose of the research. It does not refer to other methodological ‘interventions’, e.g. issuing a postal survey) of the research, such as screening potential participants for eligibility, obtaining participants’ consent and publishing results. It also includes non-interventional health and social care research (i.e. projects that do not involve any change in standard treatment, care or other services), projects that aim to generate hypotheses, methodological research and descriptive research. Projects whose primary purpose is educational to the researcher, either in obtaining an educational qualification or in otherwise acquiring research skills, but which also fall into the definition of research, are in scope of this policy framework. Activities that are not research according to this definition should not be presented as research and need not be conducted or managed in accordance with this framework. A decision tool that provides a definitive answer about whether a project counts as research under this policy framework is available at the HRA decisions tool . 

3.2 This policy framework applies to health and social care research that is within the responsibility of the HRA or Devolved Administrations' Health Departments (appendix 1 ). This includes: 

• research concerned with protection and promotion of public health;
• research undertaken in or by (including health or social care research funded by any of the UK Health Departments) a UK health Department, its non-Departmental public bodies or the NHS (References to the NHS include Health and Social Care (HSC) in Northern Ireland) and social care providers (Reference to NHS and social care providers include contractors providing services under contract with care providers or commissioners (including services purchased by service users from their own resources or their ‘personal budget’), e.g. general practitioners (GPs), privately run treatment centres, care homes, magnetic resonance imaging (MRI) services); and
• clinical and non-clinical research, research undertaken by NHS or social care staff using the resources of health and social care providers and any research undertaken within the health and social care systems (including research involving prison health services) that might have an impact on the quality of those services.

3.3 The activity of involving patients, service users or the public in the design, management, conduct or dissemination of research should not be managed as though it is research in its own right. Information on arrangements and controls relating to public involvement is available from INVOLVE .

3.4 This document draws on relevant sources (These sources include legislation (appendix 2) and other publications about good research practice, such as the ADASS/SSRG resource pack for social care , ESRC Framework for Research Ethics , the principles of ICH GCP , the previous Research Governance Frameworks, RESPECT Code of Practice , UUK Concordat to support research integrity  and WMA Declaration of Helsinki ) but cannot exhaustively compile all the principles, requirements and standards that may be issued separately by individual bodies with an interest in research. In particular, it does not repeat requirements and expectations that apply generally and are not specific to health and social care research, such as professional standards or legislation regarding age of legal capacity, equality, health and safety, Welsh language, whistle blowing etc. It remains the responsibility of those to whom relevant legal requirements and professional standards apply to ensure that they also meet those requirements and standards, in line with the guiding principles set out in this policy framework.

3.5 The principles and responsibilities set out in this policy framework are deliberately at a high level and apply to health research and social care research equally. However, health research and social care research can be different in nature, scale, setting, volume and funding, as well as in the mix of stakeholders, organisational context and range of academic disciplines. Individuals and organisations with responsibilities under this policy framework are therefore expected to take appropriate account of these differences when reflecting the principles and responsibilities set out in this document in their own policies, procedures and practice.

4. Implementation

4.1 This policy framework largely sets out what is (or should be) already happening. It is therefore not expected to add to the workload of researchers or others with responsibilities under this framework. The intention is to remove unnecessary bureaucracy for researchers, both in what the framework expects of them directly and what it expects of others that then affects them. Implementation of this high-level policy framework is supported by national operational policies and guidance, standard operating procedures (SOPs) and operational platforms. Individuals and organisations with responsibilities under this policy framework are expected to adopt these operational provisions wherever relevant, not design their own, and should reflect in their existing policies, procedures and practice the principles and responsibilities set out in this policy framework and in the relevant operational provisions. The operational provisions which support implementation of this policy framework include (The HRA provides these by agreement with the Devolved Administrations for UK-wide use)

• resources for researchers and sponsors - HRA planning and improving research page;
• expectations and requirements for research ethics committee review, and standards and guidance for research ethics committees;
• information for patients, service users and the public; and 
• systems for applying for and managing research approvals - the Integrated Research Application System (IRAS) at My Research Project and the HRA Assessment and Review Portal (HARP).

4.2 These operational provisions support people with responsibilities for the management and conduct of research to comply with this policy framework. They also encourage the pursuit of high-quality research that:

• involves patients, service users and the public appropriately in its design, management, conduct and dissemination;
• meets the needs of patients, service users and the public;
• accesses participants and information quickly and efficiently;
• minimises the risk of harm to participants and protects their confidentiality in accordance with their consent, where required, and the law; and 
• produces findings that will improve the evidence base and may lead to better health and well-being.

5. UK-wide responsibilities

5.1 The policy framework reflects the relevant legislation in the UK and takes account, where relevant, of the application of this legislation in each UK country while supporting UK-wide compatibility and consistency. The policy framework is consistent with recognised ethical standards and with models of good practice as they apply to particular types of research involving human participants (References to participants include people whose data or tissues are involved in a research project.) In reflecting these, the policy framework has taken care to recognise the value of their proportionate application to different types of research.

5.2 In accordance with the Care Act 2014 and with the agreement of the Devolved Administrations (The Devolved Administrations include the Department of Health (Northern Ireland), the Scottish Ministers and the Welsh Ministers), this policy framework replaces the Research Governance Frameworks previously issued in each of the four UK countries.

5.3 Although responsibilities for health and social care services have been devolved to the administrations in Northern Ireland, Scotland and Wales, the four UK Health Departments are committed to maintaining compatible standards for research ethics (Covered separately in Governance arrangements for research ethics committees, SOPs and guidance – see HRA about us page , management and conduct across the UK. Otherwise, cross-border research could be undermined by incompatible expectations between England, Northern Ireland, Scotland and Wales. With the agreement of the Devolved Administrations and/or, where applicable, the UK Ethics Committee Authority (UKECA) (UKECA is the body that establishes, recognises, monitors and approves the standard operating procedures of research ethics committees that review clinical trials of investigational medicinal products. UKECA’s members are the HRA, the Department of Health (Northern Ireland), the Scottish Ministers and the Welsh Ministers), the HRA may publish policy, guidance and procedures that are UK-wide. Except where otherwise stated, these UK-wide publications, including this document, apply to all health and social care research (Apart from research that is wholly in children’s social care in England or Scotland, which is outside the remit of the HRA and the Scottish Government Health and Social Care Directorates). While ensuring UK-wide compatibility, these documents take into account where legal and operational differences do exist (appendix 2 for details) and proactively address them to minimise their potential impact on cross-border research

6. Development, status and maintenance

6.1. This policy framework has been developed in partnership between the four UK Health Departments and the HRA. It applies in England, Northern Ireland, Scotland and Wales.

6.2. In accordance with Section 111(6) and (7) of the Care Act 2014, the status of this document is statutory guidance to which local authorities, NHS trusts and NHS foundation trusts in England must have regard (This means deviating only when there is a justified reason for doing so). Compliance with this guidance by them and other health and social care providers (such as independent contractors in primary care and private and voluntary organisations providing services under contract) also helps bodies that commission care to fulfil their legal duty under the Health and Social Care Act 2012 to promote the conduct of research.

6.3. Maintenance of the policy framework is undertaken by the HRA in conjunction with the Devolved Administrations. It will be updated on a regular basis to link to relevant references and will be revised in light of significant developments (e.g. changes in clinical trials regulation) or otherwise at intervals agreed between the HRA and Devolved Administrations.

7. Audience

7.1. This document is aimed primarily at individuals and organisations with responsibilities for the management and conduct of research. Summaries for different audiences, such as patients, service users and the public, are available on the HRA website.

8. Principles that apply to all health and social care research 

8.1 The following statement of principles serves as a benchmark for  good practice that the management and conduct of all health and social care research in the UK are expected to meet.

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 - see   HRA Planning and Improving Research page .

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 (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 9: Approval 

A research project is started only if a research ethics committee and any other relevant approval body (i.e. the HRA, the Administration of Radioactive Substances Advisory Committee (ARSAC), the Human Fertilisation and Embryology Authority (HFEA) or the Medicines and Healthcare products Regulatory Agency (MHRA)) 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 (Either directly, or indirectly through the involvement of data or tissue that could identify them) 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.

Principle 13: Insurance and Indemnity 

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

8.2 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).

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 (Who may or (particularly where the research team is not local to the research site) may not be a member of the research team) 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.

9. Responsibilities of individuals and organisations 

9.1 There should be clear designation of responsibility and accountability with clear lines of communication between all those involved in research. Communication pathways should be clear in terms of what, how, who, when and why, with documented (Any documentation should be proportionate. Roles and responsibilities should be agreed and understood by all the relevant parties but are not expected to be re-documented separately if their description for the purpose of review processes such as research ethics committee review is sufficient) roles and responsibilities. Dialogue and collaboration have a central role within a research project. Clear, upfront discussion of issues and agreement of principles and procedures for each project are essential to its effective conduct and success, as well as mitigating some risks. All individuals and organisations with responsibilities under this policy framework should understand the value of research to health and social care and recognise the importance of co-operation and shared endeavour as critical to its success. Those with experience of good practice in the management and conduct of research are encouraged to share their knowledge with novices.

Chief investigators 

9.2. The chief investigator is the overall lead researcher for a research project (Outside the UK the term Coordinating Investigator or Investigator may be used). In addition to their responsibilities if they are members of a research team, chief investigators are responsible for the overall conduct of a research project, including:

• a) satisfying themselves that the research proposal or protocol takes into account any relevant systematic reviews, other research evidence and research in progress (Research studies may replicate previous research, but should acknowledge the reason for doing so), that it makes effective use of patient, service user and public involvement where appropriate and that it is scientifically sound, safe (i.e. that the risk of harm has been minimised as much as possible and is not expected to outweigh the benefits), ethical, legal and feasible and remains so for the duration of the research, taking account of developments while the research is ongoing;
• b) satisfying themselves that the research proposal or protocol has been submitted for appropriate independent expert (‘peer’) review (For educational research, the chief investigator will be a supervisor who may provide an appropriate level of review) and revised in light of that review;
• c) satisfying themselves that, if expected or required, the proposal has been submitted for review by and obtained approval from a research ethics committee and any other relevant approval bodies;
• satisfying themselves (For multi-site projects, this may be delegated to the principal investigator at each research site) that everyone involved in the conduct of the research is qualified by education, training (Training should be appropriate and proportionate to the type of research undertaken, and should cover the responsibilities of researchers set out in relevant legislation and standards – HRA planning and improving research page )
• d) and experience, or otherwise competent, to discharge their roles in the project;
• e) satisfying themselves that the information given to potential participants is in a suitable format and is clear and relevant to their participation in the research and, where consent is required, to their decision-making about taking part in the research – HRA decision tool . 
• f) adhering to the agreed arrangements (paragraph 8.10) for making information about the research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee);
• g) adhering to the agreed arrangements (paragraph 8.11) for making data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after the research has finished (Funders or others may set expectations about making data and tissue available);
• h) starting the research only once the sponsor has confirmed that everything is ready for it to begin;
• i) adhering to the agreed procedures and arrangements for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct, the participants’ safety and well-being and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments; and
• j) adhering to the agreed arrangements for making information about the findings of the research available, including, where appropriate to participants.

9.3. Students should not normally (Exception is made for an experienced care practitioner or manager undertaking an educational qualification for continuing professional development or a doctoral-level study while employed by a health or social care provider or a university, or for a researcher undertaking a doctoral-level study in receipt of a fellowship) take the role of chief investigator at any level of study, as this function should be undertaken by supervisors or course leaders.

• a) Relevant supervisors (or course leaders, where different) should be encouraged to develop and lead research projects that individual students at master’s level and below can contribute to at different stages. Undergraduate students should only conduct research projects in isolation that involve direct contact with patients, service users or the public in a health or social care setting if on-site supervision arrangements mitigate any risks.
• b) A research culture should be fostered amongst relevant undergraduate students by encouraging an awareness of health and social care research, research ethics and public involvement, and enabling them to develop skills in research methods. Students from courses that are not primarily related to health and social care, such as business studies or IT, who wish to undertake research involving patients or service users, their data or tissue, or the public in a health or social care setting should have a co-supervisor with relevant experience that will help them understand the care context and the associated research process.
• c) The contribution of students to the development, conduct and reporting of the research should be appropriately acknowledged like that of other contributors, e.g. in accordance with journal editors’ authorship criteria.

9.4. Research should (Or must, if there is a legal requirement, e.g. in the case of clinical trials of investigational medicinal products) be conducted in accordance with a research proposal or protocol – a document that describes clearly what will be done in the research. This is important so that the researchers can all understand consistently what they are supposed to do and so that the research can be properly analysed and, if necessary, reproduced. Public involvement (i.e. working in collaboration with patients, service users or the public in the design, management, conduct or dissemination of research) plays an important role in research design and planning. Well-planned and well-written research proposals, protocols and procedures are key to carrying out research successfully. They help avoid subsequent amendments (Where research deliberately entails modifying parameters or procedures during its course (e.g. adaptive clinical trials, iterative approaches in qualitative research), amendments should be avoided by the proposal or protocol specifying the adaptation schedule and processes up front), which are time-consuming and costly for the funder, the researchers and the approval bodies. However, high-quality research proposals, protocols and procedures are only effective if they are followed. Not adhering to the research proposal or protocol has the potential for adverse impact and reputational risk to all parties involved. For research participants, this compromises any informed consent given; for the researcher, it creates a scientific risk that the research data (or their credibility) may be compromised; and for sponsors, there is often a financial and resource implication, particularly where a suspension to recruitment or extensive investigation are involved.

9.5. Research proposals, protocols and procedures should be clear, comprehensive and easily accessible to the research team. Good document management and version control are essential so that, for instance, the same single version of the research proposal or protocol is being followed in the same way by everyone involved. Otherwise, the data collected could not be reliably compared, undermining the findings of the research. There is often an expectation or requirement for documents to be revised and updated during the lifespan of studies and these expectations and requirements may come from various organisations. It is important to ensure that changes to the research proposal or protocol are submitted for review, if expected or required, by a research ethics committee and any other relevant approval bodies and, if approved (Or if they give effect to urgent safety measures), that they are introduced uniformly across all relevant research sites.

9.6. The research team is the group of people involved in the conduct of a research project. It may include care professionals, academics, patients and service users, members of the public, research professionals, students and/or scientists. Research team members’ accountability should be clearly agreed between them and their employer(s) (Or directly with the sponsor, where this accountability does not arise in the context of their employment, e.g. in the case of research team members who are patients, service users or the public) and documented, especially where multiple disciplines, collaborating organisations or patients, service users and the public are involved in a single research team. For multi-site research, a single research team led by the chief investigator may undertake the activity at all the sites, or there may be different research teams at different sites, led either by the chief investigator or by a principal investigator who takes responsibility for the conduct of the research at the site. Research teams are responsible for:

• a) demonstrating to chief investigators and sponsors their suitability to conduct the research;
• b) acquiring any particular knowledge and skills in order to conduct the research;
• c) conducting the research according to the approved research proposal or protocol and any complementary information (such as the research ethics committee application form), in compliance with any applicable regulatory standards and guidance;
• d) providing information in a suitable format for potential participants that is clear and relevant to their participation in the research and, where consent is required, to their decision-making about taking part in the research; and
• e) ensuring participants’ safety and well-being in relation to their participation in the research (e.g. by asking questions about the patient’s experience with the research intervention) and reporting adverse events where expected or required.

9.7. Where consent is sought:

• a) potential research participants should be provided, normally by the research team, with the information (Guidance on preparation of participant information, including proportionate arrangements, is available at  www.hra-decisiontools.org.uk/consent ) they need to help them decide whether they wish to take part in research or not, and should be given reasonable time to reach their decision. The information should be provided in a suitable format. Unless otherwise justified (e.g. by feedback from public involvement), the information should include a concise explanation of relevant research evidence and research in progress that shows why the proposed research is justified;
• b) a permanent and accessible copy of any information sheet should normally be made available to all participants; and
• c) consent should be documented and available for inspection by relevant regulators.

9.8. Proportionality should be applied to the provision of information to potential research participants (Guidance on applying a proportionate approach to the process of seeking consent is available at HRA Planning and Improving research page ). The more research deviates from established practice or otherwise detrimentally affects the balance between the anticipated risks and benefits, the greater the amount of information that needs to be provided to potential participants. By the same token, the closer the research is to standard practice, the less need there is to provide patients and service users with detailed and lengthy information. For instance, pragmatic trials looking at the effectiveness of routinely used standard treatments should be facilitated so that patients can be recruited in a way that complies with the law but does not unduly burden either patients or the care professionals seeking their consent.

9.9. The funder is the organisation or group of organisations providing funding for the research project. The funder is normally the sponsor in the case of commercial research. The funder is responsible for:

• a) assessing (or arranging for assessment of) the scientific quality, the relevance of the research to the target population and, if appropriate, the value for money of the research as proposed, involving patients, service users and the public where appropriate in funding decisions;
• b) reviewing information about the attribution of costs to confirm that costs to all parties (including excess treatment costs) have been identified and described in accordance with national guidance – Government Publications Guidance where applicable, and that the costs are not disproportionate compared to the value of the output;
• c) considering (with advice if necessary) whether the research is really achievable within the settings as a whole in which it is intended to be carried out, particularly in view of the priorities and constraints in health and social care if the research will have an impact on care provision;
• d) making ongoing funding conditional on a sponsor and relevant approvals (paragraph 8.9, including footnote 26) being in place before the research begins (but not before initial funding is released, as some funding may be needed in order to put these in place); and
• e) using contracts (e.g. model agreements, where applicable – see  UKCRC Governance and conditions of funding to promote compliance with this policy framework, in particular to encourage arrangements (paragraphs 8.10 and 8.11) for making information about research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee) and for retaining and making accurate findings, data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after it has finished.

9.10. The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. All health and social care research has a sponsor. The sponsor is normally expected to be the employer of the chief investigator in the case of non-commercial research or the funder in the case of commercial research (The employer or funder is not automatically the sponsor; they explicitly accept the responsibilities of being the sponsor). The sponsor has overall responsibility for the research, including:

• a) identifying and addressing poorly designed or planned research and poor-quality research proposals, protocols or applications and ensuring that research proposals and protocols: - take into account systematic reviews of relevant existing research evidence and other relevant research in progress, - make appropriate use of patient, service user and public involvement and - are scientifically sound (e.g. through independent expert review) (For educational research, the scientific validity and quality may be established by the chief investigator (i.e. the supervisor) at a level appropriate to the nature of the course), safe, ethical, legal and feasible and remain so for the duration of the research, taking account of developments while the research is ongoing;
• b) satisfying itself that the investigators, research team and research sites are suitable;
• c) ensuring that roles and responsibilities of the parties involved in the research and any delegation by the sponsor of its tasks are agreed and documented;
• d) ensuring 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; and
• e) ensuring appropriate arrangements are made for making information about the research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee); agreeing appropriate arrangements for making data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after it has finished; and ensuring arrangements for information about the findings of the research to be made available, including, where appropriate, to participants (For educational research, registration, accessibility of data and tissues, and dissemination may be limited to institutional arrangements);
• f) ensuring that, where expected or required, the research has approval from a research ethics committee (Whether outright or following a provisional opinion, resubmission or appeal) and any other relevant approval bodies before it begins;
• g) verifying that regulatory and practical arrangements are in place, before permitting the research to begin in a safe and timely manner;
• h) putting and keeping in place arrangements for adequate finance and management of the research project, including its competent risk management and data management;
• i) ensuring that effective procedures and arrangements are kept in place and adhered to for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments.

9.11. Sponsors of clinical trials of investigational medicinal products have particular legal duties – see the HRA Planning and Improving Research  page for details.

9.12. Universities and colleges should accept the role of sponsor for all educational research conducted by their own students, unless the student is employed by a health or social care provider that prefers to take on this role. Sponsors of educational research should ensure that supervisors can and do carry out the activities involved in fulfilling this role. Where the academic supervisor cannot adequately satisfy the sponsor’s oversight responsibilities due to location or expertise, the sponsor should agree co-supervision arrangements with a local care practitioner.

Contract research organisations 

9.13. A contract research organisation (CRO) is a person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of the sponsor’s activities. A sponsor may delegate any or all of these activities to a CRO, but the ultimate responsibility, e.g. for the quality and integrity of the research data, always resides with the sponsor (This does not prevent appropriate CROs from acting as the sponsor’s legal representative – see the HRA Planning and Improving Research page. The CRO is responsible for implementing quality assurance and quality control in respect of the activities delegated to it. Any activity that is delegated to and assumed by a CRO should be specified in writing. Any activity not specifically delegated to and assumed by a CRO is retained by the sponsor.

Research sites 

9.14.Research sites are the organisations with day-to-day responsibility for the locations where a research project is carried out. In health and social care research, they are often providers of health or social care and/or the employer of members of the research team. Research sites are responsible (Where the location of the research is wholly independent of any of the individuals and organisations with responsibilities under this policy framework, e.g. a public or private space that is not under contract for the research, such as a public library or a café), these responsibilities fall instead to the principal investigator’s employer, except 9.14.b, which is waived) for:

• a) demonstrating to relevant approval bodies and sponsors that the location is suitable for the research;
• b) being aware of all research activity being undertaken in or through the site;
• c) ensuring that the roles and responsibilities of individuals at the site and any collaborating parties are agreed and documented for individual research projects; and
• d) satisfying themselves (e.g. by taking assurances from others in a position to give them) that, if expected or required, the research has approval from a research ethics committee and any other relevant approval bodies before research participants take part (including indirectly, through the involvement of data or tissue that is likely to identify them).

9.15.  Research sites (Where the location is independent as above, ‘principal investigator’s employer’ should be read for ‘site’ in paragraphs 9.15 and 9.16, except 9.16.f, where ‘research team’ should be substituted) should have confidence in accepting assurances from other bodies about the compliance with relevant legislation and national standards of proposed research activities, without duplicating review of those proposals. Accepting assurances carried out to national standards reduces the organisation’s risk of misunderstanding or misinterpreting its obligations. The HRA indemnifies NHS research sites that accept assurances from the HRA against any claim covered by the NHS Litigation Authority arising as a result of incorrect assurances. If an NHS organisation undertakes its own checks that duplicate the assessments made by the HRA, the organisation will be liable for its own decisions made on the results of those checks and any consequences of those decisions. Organisations remain responsible, including through monitoring and training, for ensuring that the research activities are conducted in accordance with their applicable legal obligations.

9.16. Research funding should not be wasted, and the production of evidence to inform future care should not be hampered or delayed by poor information or processes at research sites:

• a) Research sites are expected to make information available about their capacity and capability to support different types of research so that sponsors can tell quickly and easily where they should place their studies to best effect e.g.  NIHR Policy and Standards page .
• b) Research sites are expected to keep themselves in a position to be able promptly, efficiently and proportionately to assess their ability to take part in an individual research project. Research sites should have good, up-to-date working knowledge of their research capacity and capability. When undertaking any additional enquiries in deciding whether to take part in a specific research project, those enquiries are expected to be proportionate and timely.
• c) If a site needs to put in place additional arrangements to support a specific research project at the intended location, that process should take into account the views of the sponsor and research team about the timetable for starting the research at that location, particularly for multi-centre projects.
• d) Research sites are expected to accept reliable assurances from others in a position to give them. This includes assurances about the ethics and safety of the research project, its compliance with the law and other standards (e.g. confidentiality), the suitability of contracts and costings and the competence, character and indemnification of members of the research team who are not substantively employed at the site, including patients, service users and the public. Decisions about research team members’ suitability should not be based on inappropriate HR processes, such as disproportionate training expectations (e.g. GCP or health and safety training for individuals, roles or projects that do not need it), irrelevant occupational health checks (e.g. vaccination history where there is no contact with patients or service users) or duplicative checks of character.
• e) Research sites should take steps to avoid disproportionate ‘one size fits all’ processes and duplication of effort, especially in requesting and assessing information, e.g. when research sites are involved in multi-centre projects or when they do repeat business with chief investigators, sponsors etc already known from previous projects.
• f) Research involving participants who get transferred to another research site is expected to be facilitated by the transferring site (A transferring site will have been a research site for the project. Where an organisation is simply identifying participants for research taking place elsewhere, it does not count as a transferring site) providing all relevant information to the receiving site to support the receiving site’s continuation of the research. The transfer of participants from a transferring site should be correspondingly well managed by the receiving site.
• g) Where there is an urgent need or small window of opportunity for relevant ethical research, such as public health emergencies, quick co-operation among relevant parties to facilitate the research is expected.
• h) Research sites may designate staff to facilitate these activities that fulfil their responsibilities under this policy framework. Such staff may act as a shared resource across more than one site.

9.17. Regulators of professions such as the General Dental Council, General Medical Council, General Pharmaceutical Council, Health and Care Professions Council and Nursing and Midwifery Council are responsible for professional standards and for ensuring compliance with these standards, e.g. by assessing fitness to practise. These standards normally apply to, and should therefore treat, the professionals’ research activity in the same way as their provision of care, teaching etc. In cases where research misconduct also constitutes professional misconduct, the regulator of the relevant profession retains its responsibility for taking action, alongside any action taken by other bodies such as other relevant regulators, the researcher’s employer and the police.

Other regulators 

9.18. Regulators are statutory bodies that oversee particular activities according to their functions, which are set out in legislation. There are a number of regulators in the UK with a remit for activities related to health and social care research (the HRA) or to health research only (the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the Medicines and Healthcare products Regulatory Agency).

• a) The HRA, HFEA, MHRA and the Administration of Radioactive Substances Advisory Committee all have a role in co-operating with each other to approve research, and with the HTA (which licenses storage of tissue for research, not the research itself). This co-operation is underpinned by agreements between these bodies which set out how they work together to improve and simplify the regulatory environment, or arrange for one body to perform functions on behalf of others.
• b) The HRA and the Devolved Administrations work together to co-ordinate and standardise the regulation of health and social care research.

9.19. The HRA has a specific role to ensure the following:

• a) The regulation of health and social care research is proportionate, so that research that is clearly lower-risk gets processed accordingly.
• b) Guidance for researchers is provided by the HRA on behalf of the Devolved Administrations for UK-wide use.
• c) Applications to all the key research approval bodies are made through a single UK-wide Integrated Research Application System provided by the HRA.
• d) Guidance is provided in one, easily accessible location.
• e) Responses to applicants are standardised and timelines are predictable.
• f) That HRA takes responsibility and liability for approvals where checks have been carried out only by the HRA and not by other organisations.

9.20. Employers are the organisations employing the chief investigator and members of the research team (Excluding employers of people whose role in the research is not part of their employment, e.g. research team members who are patients, service users or the public.) The chief investigator’s employer is normally the sponsor in the case of non-commercial research. Employers may also be funders, research sites and/or care providers. Employers are expected to:

• a) encourage a high-quality research culture, including - ensuring employees are supported in and held to account for conducting research in a professional manner, including research integrity, and - ensuring effective management of employees and their work, including employees’ safety, well-being, work environment and facilities, - ensuring financial management and calculation of costs in support of financial probity and - ensuring agreement with their partners (This is particularly important for jointly funded posts and other dual employment, e.g. care professionals who also have a university role) (e.g. funders, sponsors, collaborators, commercial partners, network members, integrated board etc) and employees about accountability and division of responsibilities, including arrangements for any intellectual property arising from research;
• b) ensure researchers understand and discharge their responsibilities;
• c) follow good HR practice, including in the provision of assurances about researchers’ suitability (paragraph 9.16.d; also 9.2.d, 9.6.a and 9.10.b); provide written procedures, supervision and training that support accountability and effective collaboration; encourage care with financial resources; raise awareness of the wider environment within which health and social care research is conducted; and bridge any gap between employees’ current competence and the competence needed for their work; and
• d) take proportionate, effective action in the event of errors and breaches or if misconduct or fraud are suspected.

9.21. Employers of research staff should ensure appropriate individual learning and competence. This includes acknowledging existing experience, qualifications and skills, rather than just giving training. Relevant training given should have measurable learning outcomes that are competence-based and directly linked to the competencies demanded by the employee’s role and the procedures (such as SOPs) relevant to that role. It is important to confirm that individual members of the research team have an adequate level of awareness of the correct procedures, what those entail and the importance of following them. It is also important to understand the wider context of any error or breach that does occur. Systems should be in place not only to enable the identification of failures or breaches but also to place responsibility with the relevant party. For instance, if an error or breach occurs owing to insufficient time to complete a number of tasks, providing training will not in itself solve the problem or reduce the risk of a repeat. Lessons learnt from experience should be identified and implemented, including through incorporation into training and personal development.

9.22. It is important to encourage open and honest reporting. It is widely recognised in health and social care that a culture of openness and honesty encourages safety. Incident reporting is important in all research and is strongly encouraged so that lessons can be learnt and improvements made. Errors can only be rectified and improvements made to reduce adverse impacts and increase the quality of research outcomes if they are reported in a timely way. For this to be truly effective, a culture of openness and honesty is essential, with a focus on improvement rather than blame.

Health and social care providers 

9.23. Providers are organisations that provide health or social care. This includes organisations providing services under contract with NHS or local authority providers or commissioners (Including purchasing of services undertaken directly by those receiving care or support, from their own resources or from their ‘personal budgets’, i.e. local authority funding managed by or on behalf of the service user), e.g. general practitioners (GPs), privately run treatment centres, care homes or magnetic resonance imaging (MRI) services. Providers’ involvement in research is generally as research sites, when they may also be the employer of members of the research team and responsible for research participants’ care. A provider is normally the sponsor for non-commercial research if it is the chief investigator’s employer. Health and social care providers may also provide services to research sites, such as identifying potential participants or making information available for research elsewhere. Where research participants are recruited independently of providers (e.g. patients identified through a disease charity or staff identified through a professional society), those providers have no decision to make about taking part in the research unless they are also research sites. In addition to any responsibilities they may have in their capacities as sites, employers and/or sponsors, providers should recognise the importance of research in improving treatments, care and other services and their outcomes by:

• a) promoting opportunities to take part in health and social care research - see  NIHR News and NIHR Support  pages for examples;
• b) retaining responsibility for the care of their patients and service users as research participants, including agreeing any associated excess NHS tariff treatment costs - see  NHS England page for guidance; and
• c) having regard to this policy framework according to their legal duty under Section 111(7) of the Care Act 2014 (Applies in England to local authorities, NHS trusts and NHS foundation trusts) and contributing to the fulfilment of their commissioners’ legal duties to promote research under the Health and Social Care Act 2012.

Glossary and Apendices

This policy framework applies to particular areas of health and social care in each UK country, according to the remit of the relevant body: 

Similarities and differences in application across the UK of the legal requirements reflected in this policy framework are as follows:

The relationship between the principles of good practice in the management and conduct of social care research and the responsibilities of individuals in the organisations are set out below:

[1] This document uses the term ‘patients and service users’ to mean recipients of health care, social care or other services and support provided by or on behalf of health or social care organisations) and the public (including carers, relatives of patients and service users and healthy volunteer

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Research Ethics Structure in Scotland

Research Ethics Service Annual Reports for Scotland are available to download here:

• April 2019 - March 2020
• April 2018 - March 2019
• April 2017 - March 2018
• April 2016 - March 2017

The Research Ethics Service in Scotland is a part of the UK-wide national service aimed at facilitating research, whilst simultaneously protecting the rights, safety, dignity and well-being of people participating in research in the NHS. The service is supported by the Scottish Government’s Chief Scientist Office (CSO) and the Health Research Authority (HRA) to:

• Provide robust and responsive ethical review of research by RECs
• Provide ethical guidance and management support to RECs
• Deliver a quality assurance (QA) Framework for the research ethics service
• Deliver training and support for researchers and REC members
• Work with colleagues in the wider regulatory environment to streamline the processes for approving research
• Promote and support transparency in research.

Structure of Research Ethics in Scotland

There are currently 12 Research Ethics Committees (RECs) in Scotland, hosted in the four Nodal Regions:

• North – Aberdeen
• South East – Edinburgh
• East – Dundee
• West – Glasgow.

RECs operate independent of researchers, sponsors and funders and each REC consists of up to 18 volunteer Lay and Expert members. This ensures they are able to put participants at the heart of their review.

In addition to research studies requiring full ethical review by an NHS REC, each Nodal REC centre also provides advice on projects which could be deemed as clinical audit, service development/evaluation, surveillance and usual practice (Public Health). Governance of the RECs is provided by the NHS Health Board, the CSO, the Health Research Authority (HRA) and the United Kingdom Ethics Committee Authority (UKECA). Nodes also support full ethical review committees and sub-committees for each of the RECs which cover all other committee work including proportionate review; responses to Provisional Opinion; substantial amendments; and assessment of breaches and serious adverse events. Each Nodal centre supports research ethics committees and provides advice and training for researchers.

Each Nodal centre can provide advice to researchers and sponsors in line with HRA guidance. For example:

• Whether your project may be considered research, audit or service evaluation, in conjunction with Sponsor and others, as appropriate
• Whether the study requires NHS ethical review
• What type of ethical review is required
• What other approvals may be required
• Current guidance on ethical issues, for example, recruitment and consent.

Training for Researchers

National training available at the Health Research Authority Learning pages , Clinical Research Training Scotland and from your local Ethics Node.

How to Apply for Approvals and Further Guidance

Full review applications need to be submitted at least two weeks in advance of the meeting. Applications suitable for proportionate review will be allocated to the next available meeting in any UK REC. Attendance at a full REC meeting is expected, therefore you should choose a REC that you can make yourself available for.

NB: It is possible to teleconference into some committees. Please check the contact list below and give your preference when the nodal ethics office staff contact you about the time and venue for the meeting.

NB: Only one REC in Scotland can consider applications under the Adults with Incapacity (Scotland) Act 2000. This is Scotland A REC, which is hosted within South East Scotland by NHS Lothian.

Ethics - Contacts

Advice on current applications, including queries on individual studies, should be directed to the relevant REC Manager. 

All other queries should be directed to the relevant Scientific Officer.

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Research Data Scotland – Information Governance Progress

August 12, 2021 by Kate Lyne No Comments | Category Research Data Scotland , Uncategorized , Working in statistics

Research Data Scotland (RDS) is a collaboration between the Scottish Government, Scotland’s leading academic institutions and public bodies. Our aim is to improve economic, social and environmental wellbeing in Scotland. We will do this by enabling access to and linkage of data about people, places and businesses for research in the public good.

Our Progress

Currently RDS is moving from development stage to establishing itself as an organisation and beginning to deliver an initial baseline service (see the Outline Business Case ). We will ensure that data access decisions are made effectively whilst being:

• Transparent
• Accountable

The first step in this development is to deliver a balanced, efficient and user friendly Information Governance approach. This must be trusted and respected by research users, data controllers, Government and ultimately the public at large. These values need to be at the heart of the development of RDS to enable the public centred innovation and research it aims to assist.

RDS will play a key role in unleashing the value of data and supporting data-driven innovation. It will focus on making data more easily accessible for research which brings public benefits for the people of Scotland. Our ambition for RDS is backing this up with real action. To ensure that data access processes are seen as enablers and not liabilities.

Information Governance

Information Governance is not a new concept. For RDS, Information Governance means an opportunity to facilitate access to data by ensuring data sharing is handled legally, safely and efficiently. All applications to use data are scrutinised by at least one independent panel which takes a view on the public benefit verses risk to privacy.

If Information Governance is not done well, crucial research may not happen or be significantly delayed. This can result from outdated processes which are unresponsive to new and emerging requirements. Currently feedback from researchers shows that it could be faster and less burdensome, a sentiment also shared by many data controllers.

By building on Scotland’s established and trusted data access and privacy preserving processes, we are confident that RDS can develop a more streamlined Information Governance approach for public sector data. We will achieve this by working closely with research users, partner organisations, and data controllers. Engaging in an open dialogue to achieve a process that works for everyone will create an innovative and appropriate governance framework for RDS.

In the short term we have identified three, initial key steps that will form the ground work of the RDS Information Governance framework.

• Review the improved guidance, standard instructions and process for researchers applying to access data.
• Set up an overarching suite of documentation templates so that data access processes are standardised for RDS users as much as possible and
• Coordinate data access requests from multiple data controllers.

In the medium to long term, we will look at a more streamlined pathway for accessing data. We will  develop themed portfolios of research ready data sets, aligned to key policy and research challenges. This more streamlined access pathway will apply to certain types of data held in a secure format in an environment where specific controls are in place. This approach is following the Five Safes Framework .

Our ambition is that over time the majority of research proposals can go through this route. This will provide a complementary method of accessing data with the potential to rapidly deliver linked data for more standard projects.

We are confident that we can develop a governance approach that streamlines and simplifies processes, without diluting proper governance. We will work closely with our key delivery partners including PHS , NRS , EPCC , SCADR and the wider academic community to ensure the best possible processes are implemented. This will involve trialling processes, and documentation, taking on board the feedback from our trials and working collaboratively with our partners.

Meeting our key principle

In everything we do on Information Governance we will ensure to uphold the RDS key principle of trustworthiness. This includes but is not limited to:

• Reducing complexity wherever possible.
• Increasing transparency around the data being held in certain secure environments, who is accessing data sets and for what purpose.
• Building on the clear and published policies at each stage of data processing and
• Proportionate use of data.

We will continue covering Information Governance at the Research Data Scotland new user forum next week. Register for the event using the following link https://bit.ly/3CJwdTW . For more information on Research Data Scotland visit www.researchdata.scot

Tags: Data Access , data linkage , Information Governance , Office of the Chief Statistician , RDS , Research Data Scotland , Scotland , statistics

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The Research Excellence Framework (REF) is the UK’s system for assessing the excellence of research in UK higher education institutions (HEIs).  The last exercise was held in 2021 and the next will take place in 2029.

SFC, Research England , the Higher Education Funding Council for Wales  and the Department for the Economy (Northern Ireland) conduct the REF jointly.

The purpose of REF is:

• To provide accountability for public investment in research and produce evidence of the benefits of this investment.
• To provide benchmarking information and establish reputational yardsticks, for use within the Higher Education sector and for public information.
• To inform the selective allocation of funding for research.

In Scotland the results of REF inform allocation of the Research Excellence Grant (REG).

The four funding bodies are currently developing the REF 2029 exercise in close consultation with the sector.

Further information is available on the REF website or by emailing [email protected] .

Latest news

Update on the development of approaches to the assessment of People, Culture and Environment in REF 2029 , published on 25 January 2024.

Initial decisions next steps December 2023 – REF 2029 were published on 7 December 2023.

Initial decisions and issues for further consultation were published in June 2023, with consultation responses invited by 6 October 2023.

A further consultation on the assessment of people, culture and environment in REF 2028 closed on 1 December 2023.

Future Research Assessment Programme

The Future Research Assessment Programme (FRAP) was initiated at the request of UK and devolved government ministers and funding bodies. This significant piece of work, launched in May 2021, was led by the four funding bodies and aimed to explore possible approaches to the assessment of UK higher education research performance following REF 2021.

Through dialogue with the higher education sector, the Programme sought to understand what a healthy, thriving research system looks like and the role that a national assessment model can have as its foundation. The work strands included evaluation of REF 2021, understanding international research assessment practice, and investigating possible evaluation models and approaches. The Programme aimed to identify evaluation approaches that can encourage and strengthen the emphasis on delivering excellent research and impact, and support a positive research culture, while simplifying and reducing the administrative burden on the HE sector.

An international advisory group was established to guide the funding bodies in their evaluation and consultation activities.

The results of the Future Research Assessment Programme inform the development of REF 2029.

The last research excellence framework was carried out in 2021. REF 2021 built on the REF exercise carried out in 2014, taking into account the recommendations of an independent review into that assessment process.

The results of REF 2021 were published on 12 May 2022.

The funding bodies commissioned a thorough programme of evaluation of REF 2021 . This included a review of the exercise’s costs and benefits, analysis of impact case studies (an element of the REF submission which aims to demonstrate the impact of university research beyond academia), and analysis of research outputs submitted to the REF.

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Building a connected, agile, sustainable tertiary education and research system for Scotland.

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A research strategy for Scottish education

Identified priorities for a research strategy to support improvement in Scottish education, particularly regarding schools.

A Research Strategy for Scottish Education: Summary

Introduction and Purpose

The four priorities for Scottish Education set out in the National Improvement Framework and Improvement Plan [1] are:

• Improvement in attainment, particularly in literacy and numeracy;
• Closing the attainment gap between the most and least disadvantaged children;
• Improvement in children and young people's health and wellbeing;
• Improvement in employability skills and sustained, positive school leaver destinations for all young people.

The overriding purpose of this Research Strategy is to help deliver these priorities by developing the research infrastructure, a knowledge base of 'what works' and the capacity of the system to use evidence.

This approach has been formulated following the recommendations of Improving Schools in Scotland: An OECD Perspective - the 2015 review by the Organisation for Economic Co-operation and Development ( OECD ) of Curriculum for Excellence ( CfE ). In it, they argue for a more coherent approach to using data across the school system, in order to drive improvement.

We believe that each level of the education system in Scotland has a vital role in harnessing the power of evidence and data in order to deliver continuous improvement in the education system. Leadership at system, local authority, school and class level is key to ensuring that effective collaborative approaches are in place to learn lessons for successful interventions. In particular:

• The Scottish Government and Education Scotland must work effectively with national bodies such as GTCS , SCEL , ADES and SCDE to ensure that international evidence is effectively sourced and made available to the school system;
• Local authorities must collaborate effectively with school leaders and teachers to identify patterns in outcomes across their areas, design and deploy appropriate interventions and monitor impact to learn lessons for improvement, feeding success and learning back into the national policy context;
• School leaders must collaborate with their teachers and support staff, parents, children and young people to identify patterns and outcomes within their schools, design and deploy appropriate interventions and monitor impact to learn lessons for improvement;
• Teachers must collaborate with their support staff, parents, children and young people to identify patterns and outcomes for individuals. In addition, they are expected to design and deploy appropriate interventions, and monitor impact to learn lessons for improvement;
• All levels must show leadership and exemplify inquiry to those above and below them, seek to collaborate, and commit to learning from data and evidence, whether gathered routinely, or to attest to specific interventions. They should promote a culture of sharing their lessons candidly and seek to use these as an opportunity for improvement in a spirit of mutual support.

Combining this coherent approach to data with research to effectively share the lessons of international evidence, to identify effective interventions, establish 'what works' in the Scottish context, and continuously learn from the data that is gathered, will help deliver the four priorities. This data driven approach will be combined with a focus on increasing the levels of collaboration and communication between all actors within the education system. This will further the development and dissemination of best practice approaches in Scottish education, and a strengthening of the research enivornment in Scotland as a whole.

The role of independent research, which can challenge the system and command credibility with the full range of stakeholders, is vital in ensuring that Scottish education is seen to be working effectively, and well-positioned to tackle the challenges of the future.

This document sets out the broad objectives for research activity we have identified following the recommendations of the OECD review and discussions with a range of academic and education stakeholders.

The research challenge

In order to support the delivery of the National Improvement Framework and Improvement Plan and to ensure that research activities make a difference, actions will be focused on:

• Supporting the research infrastructure through better access to data and training of researchers;
• Effective commissioning and dissemination of evidence on "what works" and improving system performance; and
• Improving the understanding of the use of data and evidence at all levels of the school system.

Key actions

These three areas are the key themes for potential projects to deliver improved research evidence to underpin the achievement of the four priorities. In particular:

Supporting research infrastructure and independent research

• Promoting the use of existing datasets through easier access, networks with academic colleagues and promoting collaborative research;
• Developing improved data on Health & Wellbeing and ensuring that new data is gathered on social background and the non-attainment aspects of CfE .

System characteristics and performance: What works and what has worked?

• Deploying the best available international evidence through partnership with the Education Endowment Foundation;
• Translating international lessons into the Scottish context and developing new Scottish research evidence;
• Examining the capacity and structure of education professionals to receive and implement the lessons of research and recommend necessary changes.

Empowering practitioners to produce and use evidence and data

• Study how to make best use of data produced in the schools system, e.g. through the National Improvement Framework or school-level assessments;
• Ensure that the best evidence effectively informs the knowledge mobilisation strategy being developed by Education Scotland as well as associated actions;
• Promote opportunities for academic and practitioner collaboration and interchange at all levels of the system.

Delivery and costs

Significant research activity is already underway. This Strategy both clarifies its direction and sets out potential additional activity to add value to the implementation of the National Improvement Framework. Key existing projects include:

• Continued participation in the Programme for International Student Assessment ( PISA ) for 2018;
• Development of Health & Wellbeing data as set out in the Improvement Plan.
• Development of a partnership with the Education Endowment Foundation to support the National Improvement Hub hosted by Education Scotland;
• Completion of the 2016 round of the Behaviour in Scottish Schools Research;
• Evaluation of the Scottish Attainment Challenge.

A full action plan for research in 2017-18 will be developed following the first meetings of the National Advisory Group and Academic Reference Group in mid 2017 and consideration by the International Council of Education Advisers.

Given the Strategy's relevance to the Framework's key objectives, governance arrangements for the Strategy will be developed in conjunction with partners, building on existing programme management structures that support the National Improvement Framework.

A National Advisory Group containing key partners, including those who manage existing research programmes and data, will advise on development and delivery of the Strategy. The group will work closely with groups with similar interests, such as Education Scotland's Knowledge into Action Strategic Stakeholder Group, in order to ensure maximum synergy and minimise duplication.

Academic input and scrutiny will come from two organisations, firstly through regular reporting to the International Council of Education Advisers, and an Academic Reference Group containing a wide selection of academics who will be invited to comment on progress and suggest the future direction of research.

The purpose of this Strategy is to contribute to the achievement of the aims in the National Improvement Framework and improving the capacity of the education system in Scotland to produce and use research, evidence and data.

The current research strategy is primarily focused on the work that is being conducted in schools and school age children. However the aim is to expand the focus of the strategy in the long term is to encompass the full educational journey in Scotland

We will review its impact on an annual basis and formally evaluate after five years.

Email: Jonathan Wright

Phone: 0300 244 4000 – Central Enquiry Unit

The Scottish Government St Andrew's House Regent Road Edinburgh EH1 3DG

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Research Data Scotland: Developing trustworthy information governance

Categories: Governance , ADR Scotland

Written by Research Data Scotland 17 August 2021

Research Data Scotland is a collaboration between the Scottish Government, Scotland’s leading academic institutions, and public bodies, including ADR Scotland . The Research Data Scotland team discuss the service's progress and next steps.

Research Data Scotland (RDS)'s aim is to improve economic, social and environmental wellbeing in Scotland by enabling access to and linkage of data about people, places and businesses for research in the public good.

Our progress

Currently, RDS is moving from development stage to establishing itself as an organisation and beginning to deliver an initial baseline service (see the  Outline Business Case ). We will ensure that data access decisions are made effectively whilst being:

• Transparent
• Accountable

The first step in this development is to deliver a balanced, efficient and user friendly Information Governance approach. This must be trusted and respected by research users, data controllers, Government and ultimately the public at large. These values need to be at the heart of the development of RDS to enable the public centred innovation and research it aims to assist.

RDS will play a key role in unleashing the value of data and supporting data-driven innovation. It will focus on making data more easily accessible for research which brings public benefits for the people of Scotland. Our ambition for RDS is backing this up with real action. To ensure that data access processes are seen as enablers and not liabilities.

Information governance

Information governance is not a new concept. For RDS, information governance means an opportunity to facilitate access to data by ensuring data sharing is handled legally, safely and efficiently. All applications to use data are scrutinised by at least one independent panel which takes a view on the public benefit verses risk to privacy.

If information governance is not done well, crucial research may not happen or be significantly delayed. This can result from outdated processes which are unresponsive to new and emerging requirements. Currently, feedback from researchers shows that it could be faster and less burdensome, a sentiment also shared by many data controllers.

By building on Scotland’s established and trusted data access and privacy preserving processes, we are confident that RDS can develop a more streamlined information governance approach for public sector data. We will achieve this by working closely with research users, partner organisations and data controllers. Engaging in an open dialogue to achieve a process that works for everyone will create an innovative and appropriate governance framework for RDS.

In the short term, we have identified three initial key steps that will form the groundwork of the RDS information governance framework:

• Review the improved guidance, standard instructions and process for researchers applying to access data.
• Set up an overarching suite of documentation templates so that data access processes are standardised for RDS users as much as possible.
• Coordinate data access requests from multiple data controllers.

In the medium to long term, we will look at a more streamlined pathway for accessing data. We will develop themed portfolios of research-ready datasets, aligned to key policy and research challenges. This more streamlined access pathway will apply to certain types of data held in a secure format in an environment where specific controls are in place. This approach is following the  Five Safes Framework .

Our ambition is that over time the majority of research proposals can go through this route. This will provide a complementary method of accessing data with the potential to rapidly deliver linked data for more standard projects.

We are confident that we can develop a governance approach that streamlines and simplifies processes, without diluting proper governance. We will work closely with our key delivery partners including Public Health Scotland , National Records Scotland ,  EPCC  (University of Edinburgh), the Scottish Centre for Administrative Data Research and the wider academic community to ensure the best possible processes are implemented. This will involve trialling processes, and documentation, taking on board the feedback from our trials and working collaboratively with our partners.

Meeting our key principle

In everything we do on information governance, we will ensure to uphold the RDS key principle of trustworthiness. This includes but is not limited to:

• Reducing complexity wherever possible.
• Increasing transparency around the data being held in certain secure environments, who is accessing data sets and for what purpose.
• Building on the clear and published policies at each stage of data processing.
• Proportionate use of data.

We will continue covering information governance at the Research Data Scotland new user forum on 17 August 2021, 13:00-15:00. Register for the event to share you views .

Find out more about Research Data Scotland.

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