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 doctoral student undertaking a project will be
named as the Chief Investigator rather than the academic supervisor.
6.
However, in some cases it may be more appropriate for 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.
IRAS guidance on student applications
Version 3.0, dated December 2010
1
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.
IRAS guidance on student applications
Version 3.0, dated December 2010
2
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.
IRAS guidance on student applications
Version 3.0, dated December 2010
3