1.3.2 Sources of pressure and bias-producing communication of pressure
A. Background & Definitions
EQIPD Quality System relies on and should become part of the overall organizational quality culture.
An essential element of the organizational quality culture is awareness and control over pressure that may lead to unacceptable practices and/or that may bias the planning, conduct and reporting of research.
4.1.1 Risk assessment is one of the central elements of the EQIPD Quality System that emphasizes the importance of collecting all information contributing to a decision to accept a risk.
The probability of unwanted practices or biased research results is often directly connected with the pressure that the scientists are exposed to.
B. Guidance & Expectations
EQIPD does not expect any formal documents or analyses to be conducted. However, it is highly desirable that the Process Owner reviews potential sources of bias-generating pressure and evaluates whether there are sufficient protective measures (e.g. training, study design rigor):
financial (e.g. if financial rewards are directly or indirectly linked to performance) business (e.g. if research unit's success depends on performance of a single method or technique) personal (e.g. if individual members of a research unit are not treated equally) Process Owner is also expected to make every effort to avoid transmitting unnecessary pressure to the team members that may result in unwanted practices (e.g. communication of attractive perspectives that would open with a certain pattern of research results).
PLEASE DO NOT FORGET
To discuss potential sources of pressure and protective measures with the team members
C. Resources
- Competitive pressure in biomedical research [1]
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