Applying for ethical approval
RISK-BASED ASSESSMENT CHECKLIST
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. This streamlined process will rely on the researcher to think through and explain the ethical risks associated with their project, allowing them to make the initial judgement on the risk level and complete the appropriate sections of the new application form.
The JRCO will then preform a light touch review to ensure the correct risk level was selected.
UNDERGRADUATE RESEARCH ETHICS
Undergraduate students should complete the Undergraduate Study Proposal Ethics Checklist. If the checklist determines your study to be low risk, it can be reviewed at the Departmental level. If your study is high risk, follow the application process outlined below.
POSTGRADUATE STUDENTS AND STAFF RESEARCH ETHICSThe Researcher completes an application form. The Researcher should then submit the application form and all supporting documentation such as the protocol, participant info sheet and consent form to their Head of Department.
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 the Research 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 which takes place overseas and requires local ethical approval (local approval is necessary but not sufficient on its own)
- Research where the subject matter is sensitive
- Those in an overtly dependent situation (people in care)
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 submit it for Committees' 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 go 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.
In both cases the application MUST be reviewed and signed off by the HoD prior to the application being submitting to the JRCO Administrator or the application will not be considered.
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.
If the application warrants discussion at a Committee meeting, the PI will be notified by the JRCO Co-ordinator. The coordinator will allocate the PI a reference number and 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.
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.
Re-applying for approval
Once a proposal has been approved, the Researcher has responsibility to ensure that the ensuing research stays in line with the original proposal.
A Researcher must re-apply for ethical approval if any of the following occur:
- A change in named personnel
- A change in the protocol that affects any of the ethical issues
- A change in the external ethical environment that affects the ethical issues of the proposal
- The project lasts longer than 5 years
ICREC has the power to demand a review of any proposal which has been granted ethical approval, either by the Committee or by a Head of Department or his/her nominee, at any point in the lifetime of a project. The Researcher has a responsibility to assist with any such review.
Submitting an Amendment
The Notice of study amendment should be used if you want to change the study design, study team or request a time extension. Once completed, this form should be submitted to the JRCO Co-ordinator.
Your ethical approval is based on the ethics form and supporting documents you originally submitted. If a change is made to your original ethics submission and you do not notify the Committee, then your ethical approval may become invalid.