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Durham University

Research and Innovation Services

Ethical Review Guidelines for Sub-Committees

1. The ethical review process
2. The decision-making process
3. The approval process
4. Expedited review procedures
5. Register and retention of applications for ethical review

1. The ethical review process

In undertaking ethical review, the Ethics Sub-Committee shall consider:

a) The interests, needs, health and safety of applicants who are applying to undertake projects of good quality. However, the goals of the project, and of project applicants, while important, should always be secondary to the dignity, rights, health, safety and well-being of the project participants and concerned communities.

b) The following documentation, with the signed application form/proposal, which may include:

    • Recruitment poster
    • Letter of invitation to participate
    • Information sheet/ fair processing notice for all relevant parties, written in accessible, layperson’s language which the recipients will understand
    • Consent form for all relevant parties, including parents/ guardians where children are involved, to ensure full, informed consent is given. Supplement with assent form for children where appropriate
    • Access agreement with e.g. the school or agency where recruitment will take place
    • Interview schedule/ survey/ questionnaire for participants

c) A justification of the proposal, in which foreseeable risks and inconveniences, including those for both applicants and participants, are weighed against the anticipated benefits of the project.

d) The research approach (for example Community-based Participatory Research) and the target cohort (e.g. minors, prisoners, adults lacking capacity to consent).

e) The appropriateness of the study design in relation to: the objectives of the study; the statistical methodology; and the potential for reaching sound conclusions with the proposed number of participants (where applicable).

f) The requirements of regulatory agencies and of applicable laws where known. It is not for the Sub-Committee to provide specific interpretation of regulations or laws, but it may indicate in its ethical advice to the project applicant and interested parties where it believes further consideration needs to be given to such matters.

g) The ethical requirements of the professional code of conduct/practice/ethics applicable to the work of the applicant’s Faculty/Department/School.

h) Where applicable: the applicant’s assurance that he/she has consulted as early as possible with the University’s Insurance Officer where, for example:

    • an application requires referral to an external committee or organisation, including an NHS Research Ethics Committee;
    • a project is likely to fall outside or require an extension to the University existing insurance cover;
    • there is some significant risk involved;
    • a funder/sponsor requires a particular insurance policy to be in place.

2. The decision-making process

In making advisory decisions on the ethics of applications for ethical review, whether by correspondence or at a meeting, the Sub-Committee should adopt the following procedures:

2.1 Conflicts of interest

Members should be alert to potential conflicts of interest (including personal or financial interests) regarding applicants and applications, and should withdraw from the discussion of any application in which they have such an interest. The conflict of interest should be declared to the Chair prior to the review of the application where possible, and recorded in the minutes/record of correspondence on each project.

2.2 Independent expert advice

The Chair may invite non-voting independent experts or others to advise on, or to take part in, the discussion of any relevant ethical aspects of a specific proposal that lie beyond the expertise of the members, or on which members request additional input. Advice from the independent experts should be recorded.

2.3 Pre-requisites for decision

A final advisory ethical decision may only be taken when:

a) [at a meeting]: sufficient time has been allowed for review and discussion of an application in the absence of non-members (e.g. the investigator, independent experts)

b) the documents required for a full ethical review of the application are complete and the relevant elements have been considered

c) a quorum of the committee, or the minimum number of reviewers required for the application (as defined by departmental procedures), is present/has been consulted

3. The approval process

It is recommended that ethical decisions taken at a meeting are reached by consensus where possible. Where a consensus is not achievable, the Sub-Committee should take a two-thirds majority vote, or may choose to give the Chair the final decision.

3.1 Possible decisions

The following decisions may be taken on the ethical review of an application:

a) approve – the application is granted ethical approval without amendment

b) provisionally approve subject to amendment – the application is granted ethical approval subject to specific, relatively minor amendments and authority is delegated to the Chair to confirm that the response received from the project applicant conforms to the Sub-Committee’s requirements

c) defer – consideration of the application is deferred to a future meeting pending receipt of specified, substantial amendments, clarification or future information

d) reject – the application is refused ethical approval as it is intrinsically unethical and not capable of reasonable amendment

e) refer – the application, or particular related ethical issues arising, cannot be determined by the Sub-Committee and is/are referred to the Faculty Ethics Sub-Committee or the Ethics Committee [in exceptional cases only]

Any decision by the Sub-Committee or Chair not to give ethical approval to an application should be accompanied by clearly stated, recorded reasons and explained in full to the applicant/s.

3.2 Conditions of approval

The Sub-Committee will offer ethical approval subject to the following general conditions:

a) No substantial changes are made to the original application without first applying for ethical review of the changes to the Sub-Committee.

b) Regular progress and / or completionreports are received where required by the department or faculty – in light of which the Sub-Committee may review the favourable ethical opinion originally given.

c) Project work will start within one year of the date approval is given and will be completed within five years of the award date. If this is not the case an extensions or re-approval should be sought.

d) Adverse events are notified to the Sub-Committee [and any Sponsor]

3.3 Chair’s action

Chair’s action may be used:

a) To determine an application considered by circulation among members

b) To confirm minor amendments in applications approved subject to amendment where the project leader has fulfilled the Sub-Committee’s original requirements

c) To determine whether amendments to applications already approved are sufficiently substantive to require consideration by the full Sub-Committee, by a group of the Sub-Committee, in oral or written consultation with the Chair, or whether they are sufficiently minor to be approved by Chair’s action alone

Decisions under Chair’s action should be reported to the Sub-Committee as appropriate.

4. Expedited review procedures

The Sub-Committee is encouraged to consider establishing procedures necessary for the expedited review of applications for projects to help staff or students, their funders/sponsors when in urgent need of swift ethical review. These procedures should include:

a) The nature of the applications, amendments, and other considerations that would be eligible for expedited review. (For example: applications submitted to fulfil an application for or condition of, funding and/or to commence a project at an early date).

b) The quorum requirements for expedited review (whether Chair’s action alone would be sufficient for routine/urgent applications; the number of members who would need to see the application, whether such a number could be determined by the Chair on a case by case basis; whether applications for expedited review should be considered at a full meeting or only by correspondence).

c) The status of decisions (whether requiring prior/subsequent confirmation by the full Sub-Committee at a meeting/by correspondence - or not).

5. Register and retention of applications for ethical review

The Sub-Committee should keep a register of all the proposals that come before it and of applications ethically determined by external ethics Committees/organisations. The register should include:

a) the name of each application and applicant;

b) the funder/sponsor (where applicable);

c) the documents reviewed;

d) a list of members who considered each application to the Sub-Committee;

e) any interests declared by Sub-Committee members;

f) specific ethical issues which arose.

Appropriate sections should be shared where appropriate and in confidence with interested parties and regulatory authorities, including members of University Ethics Committees, the research/project sponsor and relevant University officers.

The Secretary of the Sub-Committee will retain copies of all applications received for a period of six years beyond the conclusion of the project.