Step 1 - Complete the ethics checklist
- If the checklist determines your study to be low-risk it can be reviewed at the Departmental level.
- However, if your study is high-risk, you will need to follow additional application steps below:
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
|ICREC applications||SETREC applications|
|Application Form||Application Form|
|Protocol Template - 2a||Protocol Template - 2b|
|Participant Information Sheet - 3a||Participant Information Sheet - 3b|
|Consent Form Template||Consent Form Template|
|For primary data collection|
Be sure to prepare any other documents deemed relevant to the research; in-country ethics approval (if research is being conducted overseas) and a copy of the Sponsorship and Indemnity form (if the project is healthcare related).
Step 3 - Head of Department approval
All proposals must be submitted by the Researcher to their HoD for approval prior to ethical review. Only when the HoD has approved the proposal should it be submitted to the Joint Research Compliance Office (JRCO) for ethical consideration. The JRCO will either give ethics approval or refer the proposal to either the Imperial College Research Ethics Committee or the Science, Engineering and Technology Ethics Committee.
- Research which involves vulnerable groups; children or adults who are unable to consent, the mentally ill and individuals with learning difficulties.
- Prisoners and young offenders
- Research which is invasive
- Research where the subject matter is sensitive
- Those in an overtly dependent situation (people in care)
- Research which takes place overseas and requires local ethical approval (local approval is necessary but not sufficient on its own)
The HOD indicates their decision on the application form and signs it off. If the HOD feels that there are ethical issues that need further discussion, the application will be referred for full Committee review. The signed application must be sent to the Ethics and Research Governance Coordinator who will review the documents and may request changes before the documents are ready to submit for Committee review at the next Committee meeting. Only completed applications which are received by the closing date and have the correct approvals can be forwarded to the Committee for consideration.
If the HOD has indicated their approval but does not think the application needs to be reviewed by full Committee then the application will be sent to the Ethics and Research Governance Coordinator for JRCO review via the fast track process. The JRCO can overturn the descision of the HoD and the application may be reffered for full committee review.
In both cases the application MUST be reviewed and signed off by the HoD prior to the application being submitting to the Ethics and Research Governance Coordinator or the application will not be considered.
Step 4 - Joint Research Compliance Office (JRCO) approval
The fast-track process
After receiving an approved and signed application form, the JRCO can approve the study if there are no contentious or sensitive issues.
If the JRCO 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.
The JRCO will only be able to approve projects without full Committee review if the project has been approved by the HoD and there are no major ethical issues. The application is only valid once the HOD and PI have signed the application prior to submission to the JRCO.
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 ethical approval
The committee will give approval 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 approval
The committee will give provisional approval 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 JRCO 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 can appeal to the College Secretary.
- The College Secretary 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 participate in the discussion, but not the decision of the College Secretary
- 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.