Participating sites

Legally Trained Consultants

Compliance support for participating sites

Over the past century, scientific health research has played a vital role in most scientific and medical advances. Yet it is recent history that reveals how the large-scale processing of health data, when done appropriately, can more rapidly and effectively help find answers to today’s most pressing health-related questions.

Whether as part of a statutory duty or a private initiative, organisations are increasingly harnessing the power of data to produce meaningful health research capable of improving the care and treatment of health conditions for patients.

In the public sector, research is at the heart of the core functions of the National Health Service (NHS). From the statutory duty placed on certain NHS bodies to facilitate and promote research on matters relevant to the health service to the policy commitment made in the NHS Constitution “to innovation and to the promotion, conduct and use of research to improve the current and future health and care of the population[1], research walks hand-in-hand with the provision of direct healthcare to patients. After all, today’s research and innovations may very well become tomorrow’s standard of care.

As a result, a substantial part of all health research carried out in the United Kingdom is undertaken in the NHS, with significant participation of Acute, Mental Health and Specialist NHS Trusts and increasing engagement from community and primary care. Recent data reveals that more than one million participants were recruited to take part in UK-wide studies delivered by the National Institute for Health and Care Research (NIHR) in 2022/23. On top of that, an increasing number of studies is undertaken without the recruitment of participants using contextually anonymised data extracted from electronic health records.

[1] NHS Constitution, Principle 3.


We provide extensive support to public and private providers of health and social care, including General Practices (GPs), NHS Trusts, private hospitals and local authorities, that are asked to act as participating sites in health research studies sponsored or managed by commercial or non-commercial organisations.

Whether commissioned for a specific project or offered as part of a service package comprised of end-to-end support for the entire research process, our support may include:

  • developing procedural mechanisms for the purpose of assuring, from an information governance standpoint, research studies that require access to individuals’ data;
  • drafting Data Protection Impact Assessments (DPIA) to risk assess each individual research study;
  • reviewing Study Protocols, Integrated Research Application System (IRAS) forms, Patient Information Sheets (PIS) and Informed Consent Forms (ICF) to ascertain their compliance with legal and regulatory requirements;
  • drafting and reviewing contractual arrangements, including HRA-approved model contracts (e.g. model Clinical Trial Agreement – mCTA; model Non-commercial Agreement – mNCA) and bespoke agreements (e.g. Data Sharing Agreements and Data Processing Agreements), from a data protection standpoint;
  • drafting and reviewing International Data Transfer Agreements (IDTA) and carrying out Transfer Impact Assessments (TIA) to ensure compliance with the law in regard to international transfers of data.

If your organisation is looking to promote research by supporting studies undertaken by third-party sponsors, we are here to help you ensure that your organisation complies with data protection law and protects patients’ privacy and confidentiality.

Legally Trained Consultants

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Our Services

We provide a full data protection and information governance consultancy service to all our clients who engage with us. We provide flexible packages and services to make sure that you only pay for what you need, so you aren’t paying for unnecessary services. Whatever you and your organisation need, we are here to help.

Data Protection Advice and Consultancy

Data Protection Impact Assessment (DPIA)

External Independent Reviews


Data Protection Officer Services

Fair Processing Materials

Data Protection Health Check

Assistance with Policy Development

Data Security and Protection Toolkit (DSPT)

Record of Processing Activities (ROPA) & Information Asset Registers (IAR)

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