International Studies carried out by University Employees
The role of a sponsor is to take overall responsibility for managing the process of setting up, running and reporting (integrity and data safety) of research studies. Additionally, the sponsor has financial oversight of studies, and provides indemnity to participants and researcher(s) as necessary. The Research Governance Team facilitates and processes sponsor responsibilities for research studies, on behalf of the University
Research studies in LMICs that UCAM will solely sponsor or co-sponsor are detailed in the guidance document on sponsorship of international studies
All UCAM health related research projects (within the clinical school, school of Biological sciences and all GCRF funded studies ) which involve humans, their tissue and/or data, must be registered with the clinical school research governance office.
The process of setting up international studies can be complex and time consuming, due to navigation of legal and regulatory frameworks for each country. The Clinical School Research Governance team and the Research Office contracts team must be fully informed and involved in the process at an early stage.
Pre Award
The guidance document details the types of studies in LMICs the university will solely sponsor and co-sponsor
If the proposed study is clinical research not involving investigational medicinal products, medical device or Clinical Trial of an Investigational Medicinal Product (CTIMP), sponsorship will need to be agreed in principle, before final submission of an application for a funding award. The MHRA’s algorithm Is it a clinical trial of a medicinal product? Is useful for determining if your study is a CTIMP. The process for agreeing sponsorship of a clinical trial in principle is as follows;
- The Chief investigator of the study should complete a sponsorship risk assessment form, in collaboration with the clinical school governance and ROO pre-award (please see SOP1 Sponsorship review of international studies).
Additionally, provisional insurance and associated costs for overseas sites will need to be agreed and costed within the funding application.
It would be prudent at this early stage to prepare for institutional due diligence particularly if this will be a new collaborator and/ or institution. It is also important to have some knowledge of the research structure and regulatory bodies in the proposed country. Early background work can identify any potential barriers, and avoid delays should the award application be successful.
Post Award sponsorship requirements for study set up
Peer Review
The University accepts peer review from funding bodies such as the Medical Research Council (MRC), Wellcome Trust, The Global Challenges Research Fund (GCRF), Biotechnology and Biology Research Council (BBRC), National Institute for Health Research (NIHR), British Academy, Cancer Research UK, British Heart Foundation and all other members of the Association of Medical Research Charities (AMRC). If a funding award falls outside those listed above, the research governance office will advise as necessary.
Overseas regulatory approvals
It is important to be aware of the regulatory bodies of the country in which the research is due to take place, and to determine if approvals are required at a national, regional/district or hospital level. For example if you are planning on undertaking any research activity in Kenya, you are required apply to the National Commission for Science, Technology, and Innovation (Nacosti) to obtain a research permit. This is in addition to applying for regional or hospital level ethical approval. Similarly, to conduct research in Uganda, an applicant must obtain approval in the form of a research permit from the Uganda National Council for Science and Technology (UNCST), or from an institution authorised by the UNCST.
The local lead site or collaborator will be responsible for applying to local regulatory bodies for approvals. The Chief Investigator needs to be able to provide relevant documentation for all ethical and additional regulatory requirements needed to commence the study in each country. A key consideration will be the language (as applicable to the host country) in which the application is made, and whether documents will require translation. This may incur an additional cost to the research project. Additionally and depending on the country, study documents may need to be translated into local dialects and submitted as part of the application. Some ethics committees may charge fees for independent review. As well as ethical approval, there may also be a requirement for additional approvals such as research permits, which could affect expected timescales for gaining approvals.
University Ethics
International research studies carried out overseas will need confirmation from the University of Cambridge research ethics that the standards for ethical review have been met. Additionally, the ethics committee maintains oversight of the related research activities taking place in the UK.
Insurance
The University arranges insurance to provide financial compensation for accidental and unforeseen loss of or damage to assets, and indemnity to pay compensation to employees and third parties for legal liability for death, injury or financial loss caused by University activities. For studies involving humans, confirmation of insurance is required for ethics approval. This is to confirm that insurance is in place to provide indemnity for compensation to participants for bodily injury, suffered as a result of participating in the study. Finalised insurance cover is confirmed only on receipt of local and university ethics approval. Additionally, the insurance office will need copies of the final protocol, participant information sheet(s) and consent form(s).
Legal agreements
The Research Operations Office’s role is to draft and negotiate all research-related contracts on behalf of the University. Agreements will be needed if data/ material is being shared, and there are collaborations with institutions to ensure appropriate Intellectual Property and financial arrangements are in place. Occasionally, input from Legal Services and external lawyers will be required. If external legal advice is required, this is a cost to the research project which the Chief Investigator must ensure can be met.
Data protection
All participant data collected and stored by Clinical School researchers must be stored and used in line with the Data Protection Act 2018, GDPR and the Common Law of Confidentiality. The Local overseas site should be compliant with their countries’ and institutional data protection policies and procedures. Researchers will need to be aware of local regulations on the storage of personal data, and specific country restrictions in the use of collected data.
DLA Piper’s Data Protection Laws of the World Handbook sets out an overview of the key privacy and data protection laws and regulations across 116 countries
UCAM Sponsorship
Research activity requiring ethical approval shall not commence at any international sites until a confirmation of sponsorship letter has been issued, following receipt of the documents below
Ethically (local and UCAM) approved protocol and study documents
Confirmation of Local ethics approval
Confirmation of university ethics clearance
Final insurance cover
Agreements including collaboration, data and material transfer as applicable
Please complete the governance check list
Monitoring
Researchers/study co-ordinators are advised to send funding milestone or progress reports to the governance team at the same time as they are being sent to funders. Additionally, study progress will be monitored through attendance to steering committees as suitable, receipt of minutes from trial steering committee meetings, and any other reports as applicable.
Amendments
If substantial amendments or changes need to be made to the protocol, the CI and local investigators should seek approval from the local ethics committee and any relevant regulatory bodies in the country research is taking place. The university ethics committee, insurance office and research governance office will also need to be informed.
