Definitions

What is meant by 'Human Participants'?

All teaching activities (with the exceptions listed in the ‘Scope of the Code of Practice’) that is carried out on University of Bolton premises and/or by University of Bolton staff or by any student under the supervision of University of Bolton staff and that involves intervention or interaction with living human participants or the collection and or study of data or material derived from living human participants, is potentially socially/politically sensitive or has potential to affect the reputation of the University and therefore requires ethics approval. You should also refer to the full ‘Code of Practice’.

For the sake of clarity, a human participant is a living individual about whom an investigator conducting research obtains (1) data or samples through intervention or interaction with individuals(s) or (2) identifiable private information.

Examples of teaching activities that that utilise “human participants” include inter alia:

• Participants in physical activities (e.g. physical exertion, ingestion of any substance, any medical procedure)
• Psychological, educational and opinion studies (e.g. surveys, questionnaires, tests)
• Studies in which the researcher is the subject of the research
• Testing of student designed invention, prototype or computer application by human participants other than student researcher
• Data/record review projects that include data that are not de- identified/anonymous (e.g. data set that includes name, birth date, phone number or other identifying variables)
• Behavioural observations that:
• involve any interaction with the observed individual(s) or where the researcher has modified the environment (e.g., post a sign, place an object).
• occur in non-public or restricted access settings (e.g., day care setting, doctor’s office)
• involve the recording of personally identifiable information.

What is meant by 'Human Tissue'?

The Human Tissue Act (2004) defines Human Tissue as ‘material, other than gametes, which consists of or includes human cells’. Relevant material does not include hair or nails from living people, embryos outside the human body or any material which contains only cells created outside the human body; for example, cell lines. The fundamental concept of relevant material is that if a sample is known to contain even a single cell that has come from a human body, then the sample should be classified as relevant material. The University does not hold an HTA licence and you should refer to the note on registration here for further guidance.