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Home  >  Research  >  Research ethics  > 

Indicators of risk

On this page:

High Risk Research
Low Risk Research
Minimal Risk Research

 High Risk Research
These types of research are considered to present significant risks or have important ethical implications for either or both Research participants and Researcher that need to be assessed and reviewed by the QMUL REC or NHS REC committees

• Research that involves any NHS patients, staff, records, data or premises. This may include, for example, simply interviewing nurses about their working conditions at the London Hospital. Any such research has to be reviewed directly by a centralised NHS REC committee. This is a very lengthy and complicated process. The web portal for preparing such applications is: http://www.nres.npsa.nhs.uk/ however, if your research falls into this category you are strongly advised to arrange a meeting with your school ethics advisor (Dr. Bronwyn Parry) asap.
• Research involving vulnerable groups (mental patients, the cognitively impaired, prisoners, and children under 16 years of age amongst others).
• Research involving sensitive topics (e.g sexual behaviour or orientation, illegal or political behaviour, experience of violence etc).
• Research that involves subjecting the participants to higher risks than they would experience in everyday life (such as higher levels of psychological stress, anxiety, humiliation or more than minimal pain).
• Research involving deception or that conducted without the participants full and informed consent.
• Research involving use of personal, confidential or identifying information including genetic or biological information.
• Research involving tissue or blood samples (including cell lines)
• Research involving groups where permission of a gatekeeper is required to secure access to vulnerable communities including potentially some ethnic, cultural, indigenous or native groups.
• Research involving intrusive interventions – e.g administration of drugs, substances, vigorous physical exercise, hypnotherapy etc.
• Research that is likely to invoke legal action against the researcher or QMUL.
• Research that involves offering participants incentives to take part that exceed reimbursement of basic costs of participation such as bus fares; payment in lieu of work etc.
  

 Low Risk Research
The risks of this research are considered to be low and may be effectively assessed and addressed by School Ethics Committees

• Research that does not involve NHS sites, staff, patients, premises, medical records, tissue or blood samples (excluding cell lines).
• Research that does not involve vulnerable groups (mental patients, the cognitively impaired, prisoners, and children under 16 years of age amongst others).
• Research that does not address sensitive topics (e.g sexual behaviour or orientation, illegal or political behaviour, experience of violence etc). And additionally, research in which:
• Participants are not exposed to risks considerably greater than those encountered in their normal lives.
• Participants are fully briefed about the aims of the study and given the opportunity to ask questions both before and after participation.
• Participants give explicit consent before taking part in the study.
• No information about the study is deliberately withheld from the participants.
• No incentive is offered to participants beyond compensation of costs of participation
• No participant is under the age of 16.
• No participant has an impairment that might limit their understanding or communication.
• The researcher does not occupy a position of authority or influence over any of the participants
• Participants are informed that they can withdraw from the study at any time without penalty.
• Participants are informed of the researchers’ contact details
• Data collected from participants is stored EITHER in an anonymous form OR stored and used in an attributable form only with their informed and written consent.
• Participants have no cause for legal action as a result of participating in the study.
  

 Very minimal risk
This research is generally considered to be exempt from Ethical Review though check with your tutor and complete the ERA as instructed.

• Research involving the collection or study of EXISTING data, documents or records that are publicly available. For example, published biographies, newspaper accounts of individual's activities and published minutes of a meeting would not be considered 'personal data'.
• Research involving anonymised records and data sets that exist in the public domain, for example, datasets available through the office for National Statistics where appropriate permissions have already been obtained and where it is not possible to identify individuals from the information provided.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), large scale surveillance or observation of public behaviour UNLESS information obtained is recorded in such a manner that human participants can be identified AND where disclosure of their responses outside the research could reasonably place the participants greater at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.
• Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, OR if a food is consumed that contains a food ingredient at or below the level and for use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the appropriate government regulators.