Audience

This page is intended for use by students and researchers in the University of Cambridge Schools of Technology and Physical Sciences whose research involves observational studies of people using products or technologies.

Many projects require so-called "user-trials" (note - is it still called a "user-trial", if you are just observing the use of existing products?) of software or observations of people using products or technologies. Very often these are inclusive and do not involve children, vulnerable, or unusual participants and do not involve experimental manipulations of the situation and hence do not easily sit within the remit of the psychology or biological ethical panels. Instead, they may often be characterised as "normal" people using everyday things in conventional environments. Despite this, a number of ethical and governance concerns are still appropriate and explicit consideration of them necessary. This page does not deal with research governance issues that will be covered in a separate area.

Ethical review guidance

Areas of Applicability

It is important to note that many methods and techniques are potentially useful for this purpose. The main areas will be:

• Software or Hardware trials;
• experiments - in which case, relevant advice is given in the section on controlled experiments;
• surveys - relevant advice is given in the section on survey methods and data research;
• observations and protocol analysis.

Is the following specifically related to observational studies, or should it be placed on another page?

It is also important to note what the roles are of the stakeholders. There are many terms used. For example:

• experimenter (only really used in the case of an experiment) /observer/student;
• supervisor/senior researcher/Principal investigator;
• participant/product or computer user/subject/respondent;
• expert/consultant/designer/co-designer;
• client, commissioner, authority.

Roles

On this basis it should be possible to identify the roles of all involved, whether participant, researcher or supervisor.

Identify and clarify the rights and responsibilities of all stakeholders:

• Design the method and procedure for the study
• Examine the costs and benefits of the design for the stakeholders. For example, the researcher may benefit from a 4 hour trial but the requirement on the participant is onerous and therefore to their cost.
• Decide on a design of study that does not compromise the participants rights or subject them to unintended coercion or control by the experimenters.

Issues to be Addressed

The following issues (loosely based on British Psychological Society Guidelines) should be addressed during self-assessment:

• RECORDS - The participants have a right to control and privacy with respect to all data collected about them. This means that records of trials etc should be accurately and carefully made and stored in a secure way and that the anonymity of the participants is preserved.
• CONSENT - explicit informed consent should be obtained prior to the study. This usually involves asking them to sign a consent form which explains clearly and concisely what the study involves and what the participants' rights are during the procedure.
• RECORDINGS - participants should be asked permission for recordings of any sort to be made of their actions and given explicit right to decline or stop recording and to delete any record made.
• DISCLOSURE - It should be assumed that disclosure of data and results should be anonymous and restricted to specific situations e.g. academic publications or presentations.
• DECEPTION - No deception should be carried out in the study. If deception is required the study should be referred to others in an Ethical panel for review. Restricting information about the study may be necessary in the Briefing stage to avoid confounding the experimental purpose but this should be clearly revealed and explained at the debriefing stage before the participant leaves.
• ASSESSMENT - avoid creating implicit or explicit comparisons of participants' performance with others. Do not rate their performance as good or bad or give them a score that implies comparison. Do not make qualitative assessments of their capabilities.
• REWARD - the use of incentives such as payment or tokens is common. However, it should be clear that this creates a power relationship between the participant and the researcher that should be monitored.
• FATIGUE - Be wary of making extended demands or requirements of your participants. Offer rest, refreshment, and the right to stop. 

Procedure

Essentially there will be four stages to a participants involvement:

• Recruitment - this is the point at which you sample the population at large and effectively select your participants. Avoid unnecessary exclusion and try to maintain a fair sample of the population to whom you intend to generalise the results.
• Briefing - the reason for and exact nature of the study should be explained in advance to the satisfaction of the participant. Any recording equipment or other apparatus should be pointed out. Consent should be obtained at this point.
• Participation - If the participant fails to understand what is required of them or acts in a way that is incompatible with your expectations, do not force, coerce or comply them to participate differently.
• Debriefing - The participant should leave fully informed as to what the purpose of the study was and how the manipulations were carried out. They should not have been assessed, measured or rated in any way that may concern them and should feel that data regarding them will be used responsibly, for specific stated putposes that will preserve their anonymity. (Note: If an observational study, there won't have been any manipulations, so this is really a comment about experiments)

Some General Points of relevance to observational studies 

• Be aware of your ethical and legal responsibilities (these may already exist whether you are aware of them or not).
• Have a written justification of your studies design decisions
• Consult others if your knowledge is inadequate
• Inclusive experimentation requires that you recognise potential impairments, disabilities and handicaps in your participants and how this may impact on their ability to participate. Do not exclude people from participation without reference to the rationale for the study.
• Health and Safety - be aware of health and safety regulations and possible risks that may arise during your study to participants and researchers.

The initial version of this page was developed by Pat Langdon

Please send any feedback to ethics@tech.cam.ac.uk