Student studies are those undertaken primarily for the purpose of obtaining an educational qualification. Studies where the main purpose is to undertake the specific research and the educational qualification is secondary do not fall into this category.
HRA Approval should be sought for any educational study led
from England that:
- requires review by an NHS Research Ethics Committee
- is taking place across more than one NHS
- is applying for support from the NIHR
Clinical Research Network.
For educational studies that are taking place at a single NHS site in England and which do not require review by an NHS REC, it is usually the case that the NHS organisation and the university sponsoring the research will have an existing partnership and understanding about how these types of studies are handled. For these studies, there are two options depending on existing local arrangements:
- Where universities and NHS organisations
currently do not require an IRAS form to be submitted to the NHS R&D
office but have alternative arrangements in place these may continue.
- Where universities and NHS organisations
currently do require an IRAS form to be submitted to the R&D
office, then an application for HRA Approval should be made. A template Statement of Activities and
template Schedule of Events will not be needed as there is not likely to be the
need to attribute funding. Such student studies will be reviewed against the
same HRA assessment standards and criteria as other studies. It is expected
that the sponsor will provide any advice and support to students using this
Please contact the R&D department of the NHS trust in which you wish to undertake your research for guidance on whether HRA Approval is required, or if local arrangements are in place. If local arrangements are in place between the NHS organisation and university, they will provide guidance on the information required.
Sponsors of student studies
Universities and colleges are expected to 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 do this. Sponsors of educational research should ensure that their supervisors can and do carry out the activities involved in fulfilling this role. It is expected that the sponsor will provide any advice and support to students using this process.
Student roles and responsibilities
The following is taken from section 9.3 of the UK Policy Framework for Health and Social Care:
Students should not normally take the role of chief investigator at any level of study, as this function should be undertaken by supervisors or course leaders. 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.
Relevant supervisors (or course leaders, where different) should be encouraged to develop and lead research projects that individual students at Masters 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.
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.
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.