Ethical Approval Application Process




Documentation Preparation
All documents and guidance for completion can be downloaded from the School website
Complete Ethical Approval Application form (Form 1) including the checklist on the front of
the form
Send email copy to hcmsethics@bangor.ac.uk and hard copy to Administrator
Investigator Checklist (identify risk and external ethical approval requirement).
Request expeditedAdministrator
review.
checks documents and sends to Chair
 Chair reviews if appropriate for expedited review or external review and informs
Administrator. If appropriate for external review, submitter informed.
 If not appropriate, submission goes through internal review process
 If not appropriate for expedited review or not requested then goes to next full AEC
committee meeting


Expedited review
2 reviewers from the AEC identified by ethics Administrator and forms
sent out for response within 20 working days of receipt.
Review completed independently. Form 2 returned to administrator.


Collation
Administrator collates comments and
details necessary amendments.
Send to PI/supervisor + student and
reviewers.
Amendments re-submitted to
N
Administrator within 20 working days
and checked by Chair (minor) or
Reviewers (major)

AEC Meeting
Committee considers
the proposal and gives
an opinion.
Amendments
agreed
YES
External Review
PI/ Student sends to external
ethical review.



External Opinion
External opinion received.
Amendments made as
required
Letter of Approval supplied
to the Administrator and
Chair
YES
Requires external
review



Approval Recorded
Letter of approval from Chair to show
favourable ethical opinion. NHS
Governance approvals will still be
required
School projects register updated.
AEC informed.
HCMS Ethics Application process v4 20 11 11
NO
Approval Given
1) Documentation Preparation. All documents and instructions about how to submit are on
the School websites
PI, or student with supervisor support, completes relevant documentation which includes
a) Ethical Approval Application Form (Form 1) including the checklist on the front page
b) Investigator’s checklist for ethical approval
c) All the necessary appendices such as consent forms
d) Request for expedited review (see below for details of when this would be appropriate)
If all the necessary documentation is not included or completed, the application will be returned
to you and this will delay the approval process. If you are unsure about any aspect of the
documentation or completion process you should contact the Administrator for clarification.
Expedited Review
This can be requested if the study:
i) does not involve any primary data collection – that is it only involves secondary data that has no
patient or participant identifiers.
ii) the potential risk of harm to participants and others involved in the research is minimal
NB: the decision as to whether ethical approval is necessary is determined not by what the study is
called, but by what it involves. A study called ‘evaluation’ may still involve primary data collection
and therefore will require ethical approval.
2) Documentation Sent
Forms and supplementary documentation is sent to the appropriate Ethics Administrator. A hard
copy with signatures should be sent as detailed on the website
3) Chair reviews request for expedited review if requested and if for external review, if of
appropriate quality.
If going to expedited review, the Administrator identifies 2 reviewers who are able to review the
application within the 20 day deadline (for staff) or 14 working days (for student projects) and sends
on the documentation to them.
If going to external review and of appropriate quality, the Administrator informs the PI or Student
and Supervisor who will then submit the application to the external review body. Please note:
approval for the study to go to external review is not a guarantee of automatic approval by an
external body. It is a quality review at School level only and a means of trying to minimise the
number of applications that require to be substantially amended once submitted to external
review bodies. It is expected by external bodies that applications should first have been peer
reviewed or quality assessed internally.
If the application requires more detailed review of ethical issues or overall quality, it will be
reviewed as an expedited review and follow the process for amendments where these are required
before being approved for application to the external body.
HCMS Ethics Application process v4 20 11 11
The Administrator then forwards the completed application form and project information to two
members of the Academic Ethics Committee (AEC). The reviewers consider the proposal
independently and make comments regarding amendments required to receive AEC approval or
provide an opinion on the requirement for external review. Comments are returned to the
Administrator on the Review Approval Form 2.
If no expedited review is requested or an application has been through the process but amendments
not made or agreed, then the application will go to the next full AEC meeting (2 per year only) and
be reviewed by the full committee. In these instances two reviewers will read the application in
detail and present to the full committee, but all members will participate in discussion and the
decision about granting ethical approval. The applicant can be present to answer questions.
4) Collation
The Ethics Administrator collates comments and circulates to the Chair, the reviewers and the PI/
supervisor with details of any amendments required. These should be re-submitted to the
Administrator within 20 working days to ensure that the approval process can be completed in a
timely manner.
Amendments required
Response to minor amendments will be checked by the Chair and then approval granted. Responses
to major amendments will be checked by the reviewers before being agreed by the Chair and
approval granted. The approval process operates on a ‘first pass’ principle therefore no additional
queries can be raised outside of those originally raised at this second review. It is only to ensure that
the original concerns have been address fully.
If the applicant does not agree with the amendments requested or does not make the necessary
amendments approval will not (cannot) be granted. In this instance the application will be referred
to the full AEC and considered at the next meeting.
5) Requires External review
If external review, for example from NHS Ethics or Social Care ethical bodies, is required the
appropriate application is completed by the PI, or postgraduate research student with supervisor
support, and submitted with supporting documentation. The Healthcare and Medical Sciences
documentation can be completed quickly by ‘cutting and pasting’ from the external body
documentation to prevent additional work. However, it should still be completed as a record of
having been approved through the AEC process.
The Chair will review the documentation and decide whether it is of suitable quality to go out to
external review. If so, the Administrator will convey this decision to the PI, Student and Supervisor
who will submit the documentation to the appropriate external body. Approval by the AEC does not
guarantee approval by the external body, it is a quality assurance process expected by external
review bodies prior to submission to them.
If there are quality issues or ethical concerns, the application will go through the expedited review
process and follow the same process as other applications.
6) Approval Given
Approval is given by completion of the Feedback From Reviewers (Form 2) which is returned to the
School Administrator and you will receive written approval from the Chair of the AEC.
HCMS Ethics Application process v4 20 11 11
7) External Ethical Review Approval
A copy of the approval letter from external review should be sent to the Ethics Administrator for AEC
records. Any amendments should be made by the applicant as required.
8) Approval recorded
A copy of the external approval letter is forwarded to the AEC Administrator and the School research
register updated.
Please note:
Governance approval will still be required to undertake research in the NHS and in some other
settings. In general, evidence of ethical approval will be required before this can be requested.
However, the researcher should take advice from the Research Governance department about this
at an early stage. Governance approvals in the NHS can take a considerable time so do not wait
until you have ethical approval before finding out what they require, particularly if you will not be
applying through the NHS ethics process. Interviewing staff will not now require NHS ethics
approval, but WILL still require Governance approval.
External Ethics Application Process
It is important that the submissions made to External ethical review bodies are of the highest
calibre and adequately address the ethical issues which need to be considered for a
particular study.
To ensure the quality of submissions is maintained the Schools will keep a record of staff
with experience of ethical submissions to external bodies (this will most likely be NHS Ethics
Committees). Students should be assisted by their supervisor who can take advice from a
nominated individual in the completion of the application. Requests for support with an
application should be made through the Supervisor and not directly to the nominated
individual. The application should be reviewed and approved by the supervisor or nominated
individual before it is submitted.
Staff may also request assistance from the list of experienced staff who will be assigned to
assist with the Ethics submission.
HCMS Ethics Application process v4 20 11 11