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Undergraduate

2 students

Step 1 - Complete the ethics checklist

Complete the Undergraduate Study Proposal Ethics Checklist [Word]. Once completed, send the study proposal ethics checklist to the Ethics and Research Governance Coordinator‌ who will confirm the below.

If the checklist determines your study to be low-risk it can be reviewed and approved at the departmental level.
However, if your study is of a higher-risk, you will need to follow additional application steps by accessing Worktribe and creating an ethics application which will need to be approved by your Supervisor and the Head of Department. Please note, this system has an inbuilt application form, the documents listed below must completed and attached to the “documents” tab.

The research ethics risk checklist [Word] can provide further guidance on determining whether your research is considered low or high risk.

Students will need to be set up on the Worktribe system to create ethics applications. Please email the Worktribe Admin mailbox to request the ability to create ethics applications. If you are funded by a research grant, please ask your supervisor for the research grant P number, and provide the P number in your email.

Please refer to the guidance documents: Worktribe Guidance Applicant [Word] and the Applicant Worktribe Quick Guide [Word].

Worktribe Guidance HoD [Word] also applicable to Supervisors of student ethics application.

Step 2 - Prepare appropriate documents

Prepare the appropriate documents for your application according to your research type:

Health-related studies need to complete the ICREC documentation
Non-health-related studies need to complete the SETREC documentation

Forprimarydata coll Summary of the table's contents
ICREC applications	SETREC applications
For primary data collection
ICREC Primary Data Protocol Template [Word]	SETREC Primary Data Research Methods-Protocol Template [Word]
ICREC Participant Information Sheet (word)	SETREC Participant Information Sheet (word)
Consent Form ICREC (word)	Consent Form SETREC (word)

FoSummary of the table's contents
For secondary data collection
ICREC Secondary Data Protocol Template [Word]	SETREC Secondary Data Protocol Template [Word]

Please also submit any other participant facing documentation. This includes surveys, semi-structure interview guides and focus group topic guides. In addition, any recruitment materials (e.g. posters, invitation e-mails, social media adverts) need to be submitted. All documents need a version/date added.

The Committee guidance is useful to refer to for completing an ethical application.

Step 3 - Head of Department approval

Step 4 - Research Governance and Integrity Team (RGIT) approval

Step 5 - Committee approval

If the application warrants discussion at a Committee meeting, the PI will be notified by the Ethics and Research Governance Coordinator. The coordinator will invite the PI to attend the meeting to answer any questions that might arise. For student projects, the person attending the meeting will be the student's supervisor and the student.

The PI will normally be notified in writing, within 5 working days after the meeting with the committee decision.

There are three possible ethical decisions:

1. ICREC/SETREC gives a favourable opinion

The committee will give a favorable opinion to a study if they feel that:

Potential harm is in proportion to potential benefit;
Sufficient procedures are in place to protect those involved in the research;
The ethical issues are adequately dealt with;
All the relevant documentation and information has been provided.

If the proposal is approved, the Researcher is free to continue with preparations for the start of the research.

2. ICREC/SETREC gives provisional ethical opinion

The committee will give provisional opinion if they feel that:

An amendment to the proposal needs to be made
Further information on one or a number of aspects to the proposal is needed

The Researcher will be notified of the issues that need resolution.

Depending upon the extent of the amendments, or the importance of the additional information, the proposal can subsequently be approved by one of the following methods:

The RGI team can review and approve the amended documents on behalf of Committee
Chair's Action or an extraordinary subcommittee
Sent to the next Committee meeting for further discussion and decision

3. ICREC/SETREC rejects the proposal

The Committee will reject the proposal if they feel that:

The proposal is too ethically controversial
The potential harm to participants outweighs potential benefits
The researchers are not adequately qualified
The risks are too great

If a proposal is rejected, but the researcher feels that the decision is unjustified, they have the right to a single appeal to the Director of the Research Office who will convene a panel with the College Secretary to decide on the appeal.

The panel will discuss the proposal, the reasons given by Committee for their rejection and any counter-evidence provided by the researcher
The researcher and a member of Committee will be invited to attend the appeal meeting
The decision of the College Secretary is final

NB - An appeal can only be lodged by a PI if Committee has rejected the proposal completely, and not if Committee has asked for amendments/further information.

Tips for making a successful application

We encourage researchers to use the document templates which will ensure your documents are formatted correctly to gain approval.

For applications to be processed without the need for revisions the Researcher must demonstrate that they have considered what the risks are in relation to their research and show what they will do to mitigate those risks. How will confidentiality be maintained, where and how is the data being stored, who will have access, are they entitled to do so and do these provisions meet College regulations, GCP and in country (overseas/local) guidelines.

For research involving children, researchers must ensure adequate consideration has been given to the parental consent/ child assent process and that the consent forms appropriate for the age of the child. Has the Researcher considered any potential coercion to consent and what steps will be put in place to address it? Information sheets must be informative, using lay language and easily understandable by the audience.

Researchers must make the aims and objectives of their project clear and ensure the inclusion, exclusion and withdrawal criteria is clearly outlined in the application and made clear to the participants. Are the recruitment and advertising processes outlined in sufficient detail? If your project involves participants, are there contingencies in place for unexpected situations and emergencies.

For research that is taking place overseas, researchers need to show in their application that consideration has been given to:

The wider relevant (e.g. social and legal) environment in which they will work, in particular, local sensitivities and politically contentious factors.
What contingency planning the researcher has made to ensure that where local difficulties arise that may pose ethical problems the researcher will be able to take appropriate and defensible action in a timely manner .e.g. in balancing the duty to respect individual confidentiality on the one hand with a wider public interest such as the reporting of malpractice to a competent authority on the other.
The researcher must show that the proposal's benefits are in satisfactory proportion to the potential adverse impacts. In order to do this, they must show that the proposal is scientifically credible.

Please note: after being approved, there are a number of responsibilities that you will need to maintain - find out more about these on the post-approval responsibilities page.

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