Imperial has adopted a risk-based application process ensuring that research is submitted to a suitable level of review based on the level of risk posed. The research ethics risk checklist [Word] can help determine whether your research is considered low or high risk.
Step 1 - Prepare Worktribe application
You will need to follow the application steps by accessing Worktribe and creating an ethics application which will need to be approved by your Supervisor (if you are a student) 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.
Staff and 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.
If your application concerns pedagogic research study please follow the Educational Ethics Review Process (EERP).
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
To ensure you are submitting the correct documents, you can consult the Research Ethics application checklist [Word].
| 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) |
| 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.
Additional steps
- Step 3 - Head of Department approval
- Step 4 - Research Governance and Integrity Team (RGIT) approval
- Step 5 - Committee approval
- Tips for making a successful application
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.
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.
