R&D Ethical Guidelines: Clinical Human Subject Research
Introduction
As part of the activities of Bezalel’s academic departments, products and services are being researched and developed that directly affect people’s condition, both physically and mentally. This includes a range of academic learning, research and experiential activities that involve physical contact between the researcher/designer and research participants, including observations, instrument experimentation and data collection. These activities often occur in the gray area between “R&D” and “clinical human experiments”.
The scientific community has determined clear ethical standards that seek to ensure the appropriateness of experiments involving humans, and these are carefully and systematically enforced. With the expansion of Bezalel’s R&D activities, it seeks to impose these standards and thereby ensure the health and safety of students and experimenters taking part in its academic activities. The present document defines right and wrong in academic activities in Bezalel, rules that are applicable to both course and students’ final projects.
Definition: Human Subject Research
Human subject research is scientific research on humans, where the scientist compares two conditions, one of which involves a significant change in the immediate environment of lives of human participants. This change enables the researcher to examine a hypothesis regarding a causal relationship between the factor changed and other factors in the research context. This change is essential in order for the study to be considered an experiment. In terms of scientific ethics, even studies that do not involve a deliberate and significant change in the system under examination, which includes humans, and therefore constitute scientific observation of humans, are defined as human subject research.
A common type of human subject experiments is conducted in medical studies to examine the effectiveness and safety of medical treatments. Experiments of this type are called “clinical”. Paramedical and psychotherapeutic disciplines conduct experiment that approach clinical standards to the best of their ability. Other human subject experiments do not examine human treatments at all. Non-clinical human subject experiments are conducted in psychology, education and other social sciences, as well as various technological disciplines such as human engineering.
Guidelines
As a rule, R&D activities in Bezalel will not include clinical human experiments, including intrusive procedures or the collection of physiological data.
Activities in Bezalel will be divided into the development and experimental (validation) stage. The development stage includes formulating the idea, constructing a model and refining it in an iterative process. This stage does not require any approval and may proceed unrestrictedly.
The experimental stage involves actual testing on humans, with or without the collection of physical data. Such activity will not be allowed in Bezalel at all, apart for exceptional situation where the experiment is specifically approved by the Research Authority Ethics Committee.
If a clinical human experiment is deemed necessary to develop a certain product, this will be done in coordination with the Research Authority, at research@bezalel.ac.il.
Forms:
