Research Sponsorship

All research in health and social care that involve NHS patients, their tissue or information, staff, equipment or other resources of the NHS. There are similar requirements for research involving social care practitioners, clients and resources, where this falls under the Secretary of State for Health’s remit.

Any organisation that is a legal entity may declare itself as a sponsor. While the Clinical Trials Regulations allow for individuals to become sponsors, Nottinghamshire Healthcare NHS Foundation Trust do not permit their staff to take personal responsibility in such areas because of the risks and legal liabilities involved.

The sponsor is the individual or institution that takes responsibility for the initiation, management and financing (or arranging the financing) of the study. The sponsor must satisfy itself that the study meets the relevant standards and ensure that arrangements are put and kept in place for management, monitoring and reporting.

Sponsors can formally delegate one or more of the elements of sponsorship for example, to the chief investigator, clinical trial unit or another third party, but the sponsor remains accountable for all aspects of sponsorship whether delegated or not. The sponsor must implement procedures to ensure appropriate oversight of all delegated functions. This can be achieved by:

1. Assessing that individuals or organisations delegated sponsor functions are appropriately qualified and competent to perform those functions;
2. Ensuring all parties are aware of their roles and responsibilities (by clearly defining them in contracts or agreements);
3. Maintaining lines of communication to ensure the obligations of all parties are being met (for example by receiving progress reports).

The factors which determine sponsorship include: the nature of the funding body, the employer of the chief investigator and the duty of care to patients:

1. Where a commercial organisation (such as a pharmaceutical company) funds a study for which it retains ownership of the intellectual property rights, the company invariably acts as the sponsor.
2. Where a study is funded by a research council, medical charity or other non-commercial body, the funder may be willing to act as the sponsor, particularly where it also employs members of the research team or retains an interest in any intellectual property that is generated. It is important to note that funders do not automatically accept the role of sponsor and where this is the case, the grant application will need to confirm details of sponsorship arrangements.
3. Where an investigator undertakes a study on behalf of his/her employing institution and the funding body is unwilling to act as the sponsor, the employing institution may act as the sponsor.
4. Where an investigator undertakes a study in which the participants are owed a duty of care by the host rather than the investigator’s employing institution, the host institution may act as the sponsor. However, the duty of care remains the responsibility of the host institution, irrespective of whether they are the sponsor.
5. Under the Clinical Trials Regulations, it is possible for an individual investigator to take on the role of sponsor. However, many institutions prohibit their employees from doing so, in view of the potential risks this might involve.
6. If no one is willing to take on the sponsor role, the study may not proceed.

The sponsor is responsible for ensuring that specific duties are performed, properly distributed, allocated and accepted by investigators and their employing institutions and care organisations, and for the governance of the research study from conception to completion, including design, management, and finance.

The sponsor satisfies itself that appropriate checks have been undertaken to ensure that the study meets the relevant standards, and makes sure arrangements are put and kept in place for authorisation, management, monitoring and reporting.

Full details are contained in the UK Policy Framework for Health and Social Care Research and the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031), which should be consulted for further information.

The Sponsor is responsible for ensuring that arrangements are in place to indemnify the Investigator(s) against claims for harm arising from negligence. The employer of the Investigator(s) may also be liable for non-negligent harm to study participants. NHS bodies are unable to provide indemnity for non-negligent harm. Certain other kinds of sponsor (e.g. universities) may be able to offer indemnity for non-negligent harm but the need for insurance against this risk will be determined by an NHS ethics committee following consideration of the risks associated with a particular study.

It should be noted that the Clinical Trial Regulations do not alter existing liabilities or introduce additional liabilities on the parties involved in the management of clinical trials.

According to the UK Policy Framework for Health and Social Care Research, universities and colleges should accept the role of sponsor for all educational research conducted by their students unless the student is employed by a health or social care provider that prefers to take on this role. Nottinghamshire Healthcare NHS Foundation Trust does not sponsor research associated with masters degrees and will not sponsor PhD's where these are not part of a programme grant or other work that is already sponsored by the Trust. The preference in these cases is that the PhD is sponsored separately by the awarding university to ensure alignment with the student's supervisor.

The following potential costs need to be discussed with your Sponsor prior to submitting applications for funding or regulatory approval:

• Study specific central trial co-ordination and management
• Contract management across sites
• Green light approval
• Site Initiation Visit (SIV)
• Close out
• Delivery team
• Compliance Review
• Pharmacy technical review
• Risk proportionate monitoring
• Emergency contact
• Safety and compliance reporting
• Archiving centrally and site level
• Training
• Trial registration fees
• Trial fees (MHRA, CTA etc)
• The Medicines and Healthcare products Regulatory Agency (MHRA) inspection – costs associated
• Trial supplies – manufacture and labelling, concealment, storage, transportation.

For all clinical trials and clinical investigations (including CTIMPs, device studies, etc.), it is expected that a signed agreement between the sponsor and the host organisation will be in place before the research commences at the site.

For studies under HRA Approval, the HRA Initial Assessment Letter (and HRA Approval letter) will specify the appropriate agreement for each site type in a study. The document might be the Organisational Information Document, an unmodified model agreement (e.g. mCTA) or another document provided by the sponsor. 

There are several different model agreements, and you should use the one that is most appropriate for your study type and sponsorship arrangements. For more information visit the IRAS website.

A Sponsor organisation is exposed to potential risks in the following areas:

• Roles and Responsibilities - Failure to allocate responsibilities, ensuring formal arrangements around sponsorship. 
• Financial - insufficient funding to enable the programme of work/study to be completed.  Also the potential for claims for damages from individuals who participated in the research.
• Legal - Prosecution by MHRA or other regulatory authority for breach of Clinical Trials Regulations, failure to comply with conditions of ethical approval, or failures in pharmacovigilance
• Reputation - e.g. adverse publicity arising from failure of the study, failure to meet required standards of Good Clinical Practice (GCP) to satisfy MHRA auditors, or from prosecution as outlined above.

A detailed risk assessment will always be performed when planning a new study and practical advice on risk assessment can be found on the NIHR Clinical Trials Toolkit webpage.

A sponsor is legally responsible for ensuring that a number of requirements of the EU Clinical Trials Directive are met. These legal responsibilities are defined in the UK Clinical Trials Regulations, Parts 3-5, and are summarised below:

Part 3 - authorisation and ethics committee opinion:

• Request clinical trial authorisation (CTA), amend the request
• Produce undertaking to allow inspection of premises in third countries if required
• Give notice of amendments to CTA, make representations about amendments
• Give notice of amendments to the protocol
• Give notice a trial has ended

Part 4 - Good Clinical Practice and conduct:

• Put and keep in place arrangements to adhere to GCP (if no other person is specified)
• Ensure Investigational Medicinal Products available to subjects free of charge
• Take appropriate urgent safety measures (with investigator)

Part 5 - Pharmacovigilance:

• Keep records of all adverse events reported by investigators
• Ensure recording and prompt reporting of suspected unexpected serious adverse reactions (SUSARs)
• Ensure investigators are informed of SUSARs
• Ensure all SUSARs including those in third countries entered into European database
• Provide annual list of suspected serious adverse reactions and a safety report Please refer to the Clinical Trials Regulations for further details.