Integrated Research Application System (IRAS)
Guidance on student applications
Undertaking the duties of Chief Investigator
Students below doctoral level
1.In most cases, it is expected that where projects are undertaken by a student(s) in fulfillment of educational qualifications below doctoral level, the academic supervisor will take on the role of Chief Investigator.Where acting as the Chief Investigator, the academic supervisor should sign both the Chief Investigator and supervisor declarations.
2.However, there is some flexibility in these guidelines depending on the circumstances. For studies undertaken as part of a clinical placement, although the academic supervisor should normally act as the Chief Investigator, it is accepted that it may be appropriate for the clinical supervisor to take responsibility for some or all of the duties of Chief Investigator. This may be achieved by delegation of some tasks from the academic supervisor (while remaining formally the CI) or by appointing the clinical supervisor as CI. Arrangements for delegation can be recorded on the SSI Form.
3.Exceptionally, a non-doctoral project may be undertaken by an experienced researcher working towards a further degree. In this case, it would be appropriate for the student to be named as the CI.
4.Although non-doctoral students should not be named as the CI, it is expected that the student will complete the application form on behalf of the CI as part of their training. The REC will invite the student to attend the meeting to answer questions about the study and will address all correspondence to the student (copied to the CI). (Supervisors are also encouraged to attend the meeting.) If a favourable opinion is given by the REC, it is expected that the student will actually undertake the research under supervision by the CI.
Doctoral students
5.It is normally expected that a doctoralstudent undertaking a project will be named as the Chief Investigatorrather than theacademic supervisor.
6.However, in some cases it may be more appropriatefor a clinical supervisor to take on the role of Chief Investigator for a project undertaken by a doctoral student. An NHS organisation may, for example, make such a decision in the case of a clinical trial of an investigational medicinal product or a study involving significant risk.
Student participation in other studies
7.Where the student is participating in a project that is not purely educational, the CI may be another experienced researcher such as a health professional or academic researcher.
General comments
8.The sponsor and host organisation will be responsible for agreeing the most appropriate arrangements in each case. The REC will normally follow the advice from the R&D office(s) involved.
Details of the student
9.Details of the student(s), educational course(s) and academic supervisor(s) should be provided at A2-1 in IRAS.
10.A copy of a current CV for the student(s) and academic supervisor(s) (maximum 2 pages of A4) must be submitted with applications to the REC and R&D office(s).
11.Where more than one student is involved in the project, additional students may be named by clicking the “add student” button in A2-1. Similarly where more than one academic supervisor is involved in the project additional supervisors may be named by clicking the “add academic supervisor” button in A2-1.
12.The table in A2-1 should be completed to clearly identify which supervisor(s) are responsible for which student(s)
Declaration by academic supervisor(s)
13.Under the Research Governance Framework, academic institutions sponsoring research within the NHS are responsible for ensuring that students are properly supported and supervised in the conduct of research.
14.The academic supervisor(s) should sign the declaration in Part D3 of IRAS for all projects undertaken in fulfllment of educational qualifications. The declaration provides assurance of:
The scientific and ethical quality of the research proposal and the safety and well-being of participants.
The ability of the applicant to conduct the proposed research.
The availability of time and resources to achieve the proposed research objectives.
Active and effective arrangements to monitor and assess the progress of the research (in liaison with clinical supervisors and others where appropriate).
Appropriate arrangements to disseminate the findings of the research.
15.Before the student submits the application, the academic supervisor(s) should assess the level of experience of the student(s), taking into account the scale of the research and the potential for harm to participants. A level of support should be provided reflecting this.
16.Academic supervisors are encouraged to attend the REC meeting in support of their students.
Review of student research
17.Research projects undertaken as part of a course of study must undergo the same review process as other research projects. Applications from students will be subjected to the same standard of ethical, management and/or regulatory review as all other research proposals. However, reviewers recognise that student research has an educational and training value, and that proposals will not necessarily be of the same scientific importance or quality as those submitted by professional researchers. For projects conducted by students below doctoral level the scientific review of an academic supervisor is deemed to be adequate.
18.All applications should enclose a research protocol or equivalent document. This is a self-contained document describing the objectives, design, methodology, statistical considerations (or other methods of data analysis) and organisation of a research study. In the case of student research, a copy of the project proposal or assignment may be an appropriate document. It should carry a date and version number in case it is necessary to make changes following review or during the project.
1
IRAS guidance on student applications
Version 3.0, dated December 2010