Improving care through research WAHT Research and Development

Improving care through research WAHT Research and Development 

As an NHS organisation we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

 

 

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research .

Any research involving patients has to be approved by the Health Research Authority. If any research involves processing your personal data, you will usually be contacted to see if you are willing to take part. Research will only use your data without contacting you if it has been formally approved under s251 of the National Health Service Act 2006 and the Health Service (Control of Patient Information) Regulations 2002. S251(12) specifically refers to medical research. The Health Research Authority publishes details of such approvals and you can find a list here. The National Data Opt-Out (below) applies to most of these approvals. If you do ask for this opt-out to apply the Trust may still contact you to invite you to participate in specific studies. You would not be identified personally in any published results, unless you agreed to this.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the Policy Framework at the  HRA

Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government.

Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.

 

Once you have agreed to take part in a research project or that your personal data may be used for research the Trust has a clear legal basis for using your personal data as set out in the next paragraphs under Article 6.1 (e) GDPR as research is recognised to be task carried out in the public interest.

The NHS has a statutory framework which provides a clear legal basis for research in the public interest. This is set out in:

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 under which NHS providers have legal duties to "improve the quality and safety of the services provided" and "assess, monitor and mitigate the risks relating to the health, safety and welfare of service users" under.

s14R NHS Act 1996 - where research is commissioned by a Clinical Commissioning Group under the duty to secure "continuous improvement in the quality of services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness"

The NHS Constitution (July 2015) made under s1 Health Act 2009 which NHS bodies must have regard to (s2). It includes a commitment, in the third of its seven guiding principles, to "… innovation and to the promotion, conduct and use of research to improve the current and future health and care of the population." The handbook to the Constitution refers specifically to the duties on the Secretary of State, NHS England and CCGs to secure continuous improvement in the quality of outcomes achieved by health services and in this context says: "The importance of innovation and medical research is underscored by this Principle as integral to driving improvements in healthcare services for patients."

Paragraph 13 of Schedule 1 of the NHS Act 2006 as amended by the Health and Social Care Act 2012 provides that "The Secretary of State, the Board or a clinical commissioning group may conduct, commission or assist the conduct of research into- (a) any matters relating to the causation, prevention, diagnosis or treatment of illness". This includes "power to do so by providing financial assistance or making the services of any person or other resources available".

s13L NHS Act 2006 gives the NHS Commissioning Board a duty to "promote research on matters relevant to the health service". Clinical Commissioning Groups have a similar duty under s14Y.

s66 Health and Social Care Act 2012 requires Monitor to have regard to "the need to promote research into matters relevant to the NHS by persons who provide health care services for the purposes of the NHS".

s72 NHS Act 2006 under which Foundation Trusts and other NHS bodies must co-operate with other NHS bodies in exercising their functions.

Most research requires the use of special category data including health information so the Trust also relies on the above legal bases together with Article 9.2 (j) of GDPR - processing is necessary for … scientific or historical research purposes.

 

For further information about how the NHS looks after your information when used for research please refer to the NHS Health Research Authority webpage.

 

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