Undergraduate

Once the Worktribe application is complete and submitted, this is routed automatically to the researcher's Head of Department for approval prior to ethics review. If the Head of Department requires further amendments to be made to the application for their approval, this will be returned back to the researcher to update.

In addition, if the Head of Department feels that there are ethical issues that need further discussion, the application will be referred for full Committee review.

Worktribe Guidance HoD [Word]. Also applicable to Supervisors of students.

The fast-track process

After receiving an ethics application, the RGI team can approve the study if there are no contentious or sensitive issues.

If the RGI team feels that the study needs further discussion, the PI will be contacted to discuss the issues further and the application may be submitted for review at the next Committee meeting.

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.

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.