TableĀ 1

Ethical issues that need considering when carrying out an observational study

Ethical issuesConsideration
Covert versus overt data collectionOvert observation occurs when participants know they are being observed and are aware of the purpose of the study.11
Covert observation means that participants are either unaware of being observed or that the observer conceals the real reason for observing them.12
Covert methods involve deception, with researchers pretending to be someone they are not. This type of observation is now considered unethical because it violates individuals' right to autonomy and their ability to decide whether they want to be observed.
Nowadays participants are normally told what the purpose of the research is. For example, in one study nurses were told that the researcher was carrying out a study which required her to spend some time observing how nurses managed pain in children.7
Obtaining consentObservational studies have unique ethical challenges in relation to consent, given the relatively unstructured nature of data collection, the extended periods of time involved and that observation often takes place in semipublic areas.13
If collecting data in a hospital setting some researchers recommend gaining informed consent from all individuals present on the ward on a regular basis.14
For individuals who are not present on a regular basis it may not be possible to obtain full informed consent, and on some occasions it may be more intrusive to introduce the researcher and the study.14
A common sense approach needs to be taken. For example, when shadowing a member of staff or collecting data about a specific patient informed consent should be obtained. For other people within the general area a simple explanation that you are collecting data for a study along with obtaining their verbal consent, may be adequate.
In reality the stance the researcher takes will be determined by the research ethics committee approving the study.
What will you do if you see poor practice?The aim of an observational study is to obtain a picture of current practices to identify where practice change is needed, to improve quality of care. Collecting observational data may, therefore, result in practice improvement.
Observation of practices that require improvement but are not dangerous or harmful (see below), without intervening, would not be considered unethical.
What will you do if you see dangerous practice?The research ethics committee approving an observational study will expect a researcher to have identified the steps they will take if they observe dangerous practice.
For example, in two studies the researcher arranged to discuss any dangerous practice she observed with the ward manager (head nurse).7 10 The ward manager would then take any necessary action.
Protecting participantsā€™ anonymity and ensuring confidentialityConfidentiality can be ensured by restricting access to the names of participants to the immediate research team.
This is easier to do if demographic data are collected prior to the start of the main data collection.
Once a participant has agreed to take part in the study, they should be given an identifying code known only to the researcher.
Anonymity can, therefore, be maintained by referring to participants using identifying codes.
Demographic details should be stored separately from other data to ensure participants cannot be identified.