Research Ethics Policy Note no. 1: Defining Human Research Participants, Personal Data and Human Tissue

In order for the University Research Ethics Policy to work effectively, some basic definitions are necessary with respect to the scope of its application. The Research Ethics Policy applies to research involving human participants, personal data, or human tissue.

1. Human Participants

In the first instance, research involving human participants can be broadly defined as research that:

  • directly involves people in research activities through their actual participation as research subjects: ‘actual participation’ may involve invasive research processes (e.g. surgery) and/or non-invasive research processes (e.g. interviews, questionnaires, surveys or observational research carried out face-to-face, or via telephone, email or the internet), and may mean the active or passive involvement of a person;
  • indirectly involves people in research activities as research subjects, through their provision of, or access to their, personal data and/or tissue; or
  • involves people in research activities while they are acting on behalf of others who are research subjects (e.g. as parents or legal guardians of children or mentally incapacitated people, or as supervisors of people in controlled environments, such as prisoners, pupils, asylum seekers, sectioned psychiatric patients, etc.).

The nature of participation in research and the degree of commitment and intensity of effort that may be requested from participants, subject to their consent, will vary from one research project to another. Regardless of such variations, however, all research that involves human participation in any of three senses outlined above must be reviewed via one of the routes outlined in the Research Ethics Approval Procedure section of this Policy.

Research Ethics Approval Procedure

These three categories of participation do not, however, exhaust the possibilities for human participation in research. Other people - such as academics, research workers, students, technicians, administrators, secretarial staff and maintenance staff - participate in research, inasmuch as they take part in, and contribute to, whatever processes are necessary to produce and collect data. Thus even natural science laboratory research, for example, necessarily involves human participation.

There may also be indirect participation by people other than research subjects per se. Any research may take place in proximity to passers by and bystanders, if not attracting an actual audience; this is particularly true for field research, which takes place outside laboratories, classrooms or other environments dedicated to research. These people are indirect participants in that they are, potentially at least, open to effects, whether positive or negative, deriving from the research in progress in their vicinity. Their safety and well-being should always be considered.

Indirect participation is particularly an issue in auto-ethnographic research, in which the researcher uses her/his own life experience as a primary source of data. However, no life is lived in a social vacuum and information about other people can never be excluded from auto-ethnography. These other people are, therefore, indirect participants, which raises questions about their anonymity and opportunity to exercise informed consent. For further discussion of auto-ethnography, see Research Ethics Policy Note no. 2, on `Consent´, and the Specialist Research Ethics Guidance Paper entitled ‘Ethical considerations in autoethnographic research’.

Research Ethics Policy Note no. 2: 'Principles of Consent'

Specialist Research Ethics Guidance Papers

The safety and well-being of human research participants in the very broad senses outlined in the two paragraphs immediately above should be taken into account when planning research. These aspects of research do not, however, require formal ethics review within the University´s procedures. They are, however, like all formally University-sponsored activities, subject to health and safety at work legislation and similar regulations, and governed by a duty of care and other common law considerations.

Forward to section 2 of this Policy Note: Personal Data