What is ‘human research’?
Human research is defined as an activity designed to test a hypothesis (theory). The testing of this hypothesis lets an investigator draw conclusions as to whether the hypothesis is true, false or null (neither true or false). The results of hypothetical investigations ultimately contribute to generalizable knowledge; that is to say these investigations, although tested in relatively small numbers, may be applied to larger numbers. Human research begins when an investigator develops a study protocol to test a hypothesis. A study protocol is a uniform set of directions the investigator follows during a research project. The study protocol defines the objective, or goal, of the research project; for example, does substance B work better than substance A? The protocol defines what sort of activities or tests will be carried out in order to answer the hypothetical question. Once the investigator has developed a protocol to test the hypothesis, the investigator sends this information to the
According to the National Statement on Ethical Conduct in Human Research 2007, human research is conducted with or about people, their data or tissue.Human participation in research is therefore to be understood broadly, to include involvement of human beings through: • Taking part in surveys, interviews or focus groups. • Undergoing psychological, physiological or medical testing or treatment. • Being observed by researchers. • Researchers having access to their personal documents or other materials. • The collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair bones, tumor and other biopsy specimens) or their exhaled breath. • Access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.
