Ethics approval overview
For Imperial College London, ethics reviews mean ensuring that a research project is conducted in such a way that any potential adverse impact is in proportion to its expected benefit. Adverse impacts are those that may affect the environment and/or the health, well-being, safety, threats to privacy and in rare cases liberty of individuals and/or the reputation of the College.
We must ensure that a research project is conducted in such a way that any adverse impact is in proportion to its expected benefit.
Adverse impacts may consist of acknowledged potential direct risks (such as rare or adverse reaction to researcher intervention), unintended consequences (such as stigmatisation of an individual through involvement in research).
The expected benefits must not only be desirable but also in sufficient degree likely to actually occur. The benefits of the research are a material consideration in deciding whether a proposal is ethical as presented since they must be in satisfactory proportion to the potential adverse impacts.
Research ethics forms an integral part of proper scientific conduct, and we expect all staff and students to adhere to Imperial Expectations.
Do I need to apply?
If your work includes human data, raises ethical issues or risks, then yes, you need to apply.
Being ‘ethical’ means acting in accordance with a set of core values and principles, in particular, integrity, compliance with the law, respect for human rights and avoiding unnecessary risk to people’s safety and well-being. Imperial College London seeks to ensure that any potential ethical risks arising from research are limited strictly in proportion to the importance of the intended benefits.
A researcher must, therefore, consider the ethical implications of any work that:
- has the potential to damage the mental or physical health of human participants, (e.g. volunteers, College staff and students, or patients,) or others who may be affected
- has the potential to jeopardise the safety and liberty of people affected by the research (e.g. volunteers working in sensitive situations or abroad)
- has the potential to compromise the privacy of individuals whose data is involved in the work
- involves methods (e.g. genetic research, interviews, questionnaires, randomised control trial) or subject matter (e.g. recreational and controlled drugs, human impact on the environment) that are sensitive and therefore need to be managed consistently with the College's high public reputation
- has the potential for environmental impact
- carries a risk of an actual or perceived conflict of interest on the part of researchers and/or the College
If yes, then why must I apply?
Ethics approval is needed for any research that involves human participants; their tissue and /or data to ensure that the dignity, rights, safety and well-being of all participants are the primary consideration of the research project.
Full approval is a mandatory requirement of the College for all research it sponsors and must be sought before the start of the research project. Conducting research without such approval constitutes misconduct. The College takes no responsibility, financial or otherwise for this.
- The JRCO and the committees (ICREC and SETREC) cannot grant approval retrospectively. Only data collected after ethics approval has been given can be used. Any data collected before this must not be used.
- Analysis of secondary data requires ethics approval; whether the data is sensitive or anonymised (this does not include publically avaiable data).
- Unless you can demonstrate that your project is not research you should apply for ethical approval.
When don't I need to apply?
If your study falls under the following criteria then you do not need to apply:
Service evaluation is undertaken to benefit those who use a particular service and is designed and conducted solely to define or judge current service. The participants will normally be those who use the service or deliver it. It involves an intervention where there is no change to the standard service being delivered (e.g. no randomisation of service users into different groups).
Audit is defined as assessing the level of service being provided against a set of pre-determined standards. This generally involves analysing existing data with results usually being used/distributed locally in order to effect change to improve/change the level of service currently being provided.
The Committees and the jrco do not review the following:
- Research which involves animals -this should be reviewed by AWERB (Animal Welfare and Ethical Review Body)
- Projects which involve the NHS (NHS patients, data) - these should be considered by the HRA Research Ethics Committees.
- If the project is educational research or an educational review/evaluation that you may want to publish - this should be reviewed by (EERP) Education Ethics Review Process.
ICREC and SETREC do not give ethics reviews for research in which a College researcher is a Co-Investigator unless procedures such as those above will be taking place at Imperial. However, the Co-Investigator must ensure that the Principal Investigator gains ethical approval from his/her own institution before the research begins.
Please see the flow chart of Routes to ethics review.