Question and Answers: Student Eligibility Criteria

Doctoral (or equivalent level on UK qualification frameworks) students can be Chief Investigators. The UK Policy Framework for Health and Social Care Research states that the supervisor should normally be the Chief Investigator. Exceptions are allowed for students undertaking doctoral level research. They should have the relevant expertise in the area they are undertaking their research.

The sponsor is responsible for liabilities arising from the design or management of the study. It is expected that the university or college is the sponsor for research being undertaken for educational qualifications. The university or college would need to check if its insurance policy excludes students being a Chief Investigator. It is the sponsor's role to assess the suitability of the Chief Investigator for a research project.

It is the responsibility of universities, colleges, and course leaders to provide training, support, and guidance to their students.

Undertaking research in the NHS/HSC can take significantly more time than students might expect. Universities and course leaders need to manage expectations with students so they do not attempt to undertake projects that are unrealistic.

The student guidance offers alternatives to making applications to undertake research in the NHS/HSC. Supervisors need to advise students who are eligible and wish to undertake individual research projects of the level of commitment needed to successfully deliver a research project within the NHS.

The criteria apply to all projects requiring an NHS REC or Social Care REC review, or otherwise intended to take place in the NHS.

The sponsor and supervisor are responsible for ensuring they have read and understood the guidance to avoid any student unnecessarily completing IRAS where they would not be eligible. Sponsor representatives should not authorise any study that falls outside the eligibility criteria. The HRA or Devolved Administration equivalent will have final decision on whether a project is accepted for review and consideration by NHS organisations.

The expectation across the UK is that the Chief Investigator leads the study, not the student. The student may be doing various aspects of the study including the data collection, analysis and write up. In the criteria, stand-alone research means research where the student designs the study, submits for approval, and conducts the project on their own with supervision.

The expectation is that individuals wishing to undertake research in the NHS should have experience in working in the NHS. This is to ensure they understand how the NHS works and would not place undue burden on the NHS, maximising the likelihood that the research would be successfully delivered.

Yes, an NVQ-qualified healthcare worker would meet the definition, but we would expect them to complete research consistent with their role as a healthcare assistant. A health care professional would include all NHS/HSC employed clinical staff and non-clinical NHS/HSC professionals (for example health informatics and support workers) or those with recent NHS/HSC experience.

A student on a health care course would include a student undertaking an academic course providing skills for provision of health care or health research in the NHS/HSC. For example, pharmacy, psychology, speech and language therapy, pathology, and other professional courses.

A health care professional would include all NHS/HSC employed clinical staff and non-clinical NHS/HSC professionals (for example health informatics and support workers) or those with recent NHS/HSC experience.

Trainees are individuals who are employed within the NHS/HSC but have not yet attained the level of qualification required for their vocation. Applicants must demonstrate current or recent experience in the NHS/HSC to ensure they understand how to undertake the research without creating undue burden on the NHS/HSC. There is an expectation the research is in the scope of their discipline.

For medical students, a research project will be assessed against the eligibility criteria for the degree being undertaken. For medical students intercalating, the level of the intercalated course the research project is being undertaken at is the determining factor.

A student (up to Master's level) undertaking a business degree (or other non-health and care course) is not eligible to carry out health and care research in the NHS/HSC or apply for NHS ethics approval of any type. However, it is worth the student considering if their planned activity is genuinely research or whether it is service evaluation. The decision tool Is my study research? can help to determine this.

Applications that include a group of students are acceptable for review. The student eligibility criteria table applies to standalone or projects for individual students.

The HR Good Practice Resource Pack, which sets out the research passport processes, should be useful here.

Non-REC is defined as a study that does not require NHS REC review. It may however still require HRA and HCRW Approval or Devolved Administrations equivalent. For example, studies that include research with NHS staff do not usually require NHS REC approval, but do require HRA and HCRW Approval or the equivalent in Northern Ireland or Scotland. Where the table states ‘yes’, for non-REC studies, students meeting the criteria can apply for research requiring HRA & HCRW Approval or Devolved Administrations equivalent. The scope of HRA and HCRW Approval or Devolved Administrations equivalent, will be defined in the student decision toolkit currently in development.

As a minimum, the department or academic supervisor should have submitted an IRAS application within the past two years.

Before March 2020, there were no restrictions on standalone or individual research projects – all were eligible for submission for an NHS ethics review and HRA and HCRW Approval or equivalent in Northern Ireland or Scotland.

The student research eligibility criteria apply to all applications to the Social Care RECs and Health and Social Care in Northern Ireland. The types of research that require review by the Social Care RECs are published on the HRA website https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/social-care-research/.

HRA and HCRW Approval, for England and Wales, and NHS Permission in Scotland is not required for research to be carried out in social care setting, as social care is not part of the NHS. Research that does not require review by the Social Care RECs and does not involve the NHS is therefore exempt from these criteria.

If there is a legal requirement to obtain NHS or social care ethical approval or other approvals, for example when involving adults lacking capacity, then only those students who meet the eligibility criteria for a full REC review can undertake the research.

If a student is unsure who they should contact within a Trust for service evaluation or audit, they can ask the NHS R&D/I office. The expectation is that a student would only be conducting a service evaluation or audit within a Trust where they are employed.

NHS/HSC processes for clinical audit and service evaluations are organisation specific. Before undertaking a service evaluation or audit, the individual should check the local review process with the NHS/HSC organisation. If you are unsure who to contact, ask your R&D/I Office for guidance. Clinical audits and service evaluations are not research and therefore do not require an IRAS submission to obtain approval.

Yes, service evaluations can be published in academic journals. Each journal will have its own requirements. The output from the decision tree Is my project research? can be used as evidence that a service evaluation is not classified as research.

Service evaluations that do not meet the definition of research in the NHS do not require NHS ethics favourable opinion or to complete an IRAS form. They may require university ethics review. NHS/HSC processes for clinical audit and service evaluations are organisation-specific.

A service evaluation may involve interviews with ‘clients’ or other service users. See our defining research table.

The UK four nations joint position with the Medicines and Healthcare products Regulatory Agency on Good Clinical Practice training is available on the HRA website. The same principles apply to students undertaking research. Members of the research team are expected to be qualified by education, training and experience.

Training needs to be appropriate to the activities being undertaken. Appropriate training should be incorporated into the course modules.

This is outside the scope of the HRA and Devolved Administrations, but has been noted for further discussion. ARMA and UKRIO have a guide for setting up a REC: New guidance: Research Ethics Support and Review in Research Organisations

IRAS project filter question nine should be answered ‘yes’. It should be made clear in the free text box that appears once yes is selected that this is a group project. Students can be listed in section A2-1 of the IRAS form, but they do not have to be listed.

Retrospective data that is routinely collected must be anonymised by the direct care team before the data is provided to the researcher for it to be deemed anonymous data. Where the researcher is within the direct care team, the data should be fully anonymised in any data collection tools, prior to any analysis.

This scenario is covered in a new student decision toolkit, which is under development. We will provide a link to this soon. In the meantime if you have any queries you can contact queries@hra.nhs.uk.

A student decision toolkit is in development, which will assist with this. The toolkit will signpost existing resource. We will provide a link to this soon. In the meantime if you have any queries you can contact queries@hra.nhs.uk.

NHS REC is a legal requirement for research involving the use of ionising radiation. The guidelines in Table 1 apply to all student research projects requiring review. A Master's (or equivalent) level student would only be able to apply for NHS REC for a study exposing human participants to ionising radiation, if the student was a health and care professional or trainee on a course in health and care run by a research-active university department.

Course leaders need to consider the course they are providing and the students undertaking the qualification. Where courses contain a mix of health professional or trainees and non-health professionals, they have a choice to tailor things individually, (where some students, who are eligible, undertake an individual research project and other student undertake alternative activities), or design the course so all students look for alternatives to individual research studies (for example, provision of a group research project that takes advantage of the mix of experience). This is a decision for course leaders, based on the educational objectives of the course.

This eligibility policy has been designed to focus students on doing activities that have value for the NHS and supporting educational learning of research, rather than individual publication. It is important to note that it is possible to publish non-research projects, such as service evaluations and clinical audits.

The decision tool is likely to be published in August.

We have expanded the scope of the decision tool, and included links to the other tools taking students through their research planning in a logical way to determine eligibility.

The supplementary declaration form is a simple declaration completed in MS Word and submitted as an attachment with the IRAS application. It will be published on the website before the criteria take effect in September.

Students can undertake delegated activities within an existing, approved research project without notification to regulatory bodies. The sponsor is responsible for determining whether the student's role is appropriate, and the Principal Investigator is responsible for the suitability of their research team members for the activity delegated to them.

The HRA is committed to supporting any evolving community of practice led by the Association of Research Managers and Administrators and NHS Research and Development Forum.
If you would like to share your examples of good practice as a case study on the HRA website, please email communications@hra.nhs.uk.

The guidance directs students to ensure they contact their sponsor regarding any local sponsorship review, which may include a university ethics review.

The guidance and toolkit direct students to the required approvals, and direct them to contact their sponsor about any local sponsorship review, which may include a university ethics review.

The HRA is working closely with ARMA and RD Forum to answer any questions and take onboard feedback.

We recently attended a workshop organised by ARMA and RD Forum about the new eligibility criteria to help us to understand where further clarity and guidance might be required.

Attendees at the workshop saw a presentation about the decision tool and we are now updating this and will be publishing it soon. It will be circulated for comment and feedback from a small selection of attendees due to timescales.

The HRA and the Devolved Administrations will work together with ARMA and RD Forum to disseminate information as widely as possible. The latest information is on the HRA website. Universities and colleges should also use their communication channels to ensure the message is spread widely.