The Research Ethics module aims at a risk analysis of research project in which humans are involved as object of study or volunteer. This applies to social studies in which people fill out questionnaires about their ideas, feelings and behaviours. But also in design studies where people are asked to try out new set-ups of equipment for example. In medical studies where people figure as test persons the ethics aspects are obvious too.
In all cases a number of issues has to be checked before the experiment can take place. These regard among others: privacy of personal data, the amount of physical or psychological stress the research may bring about, the protection of vulnerable participants, the informed consent of participants before the experiment starts et cetera.
The Research Ethics module consists of a webbased questionnaire with conditional questions (depending on earlier answers). The webform is routed after completion by the responsible researcher via a workflow to a Human Research Ethics Committee, which evaluates the form on-line. At the moment a decision is taken by the Committee the workflow engine informs the researcher/applicant by an alert message with a link to the details in the web module. The applicant can follow the progress of the workflow and has a back-log of prior applications available in the web module. With some modifications (w.r.t. the questionnaire) the module can be used for medical ethics applications in medical research centres and hospitals.
- Answer webbased questionnaire with conditional questions
- Follow conditional workflow to discriminate between screening and extended applications; option to send application back to applicant for revision
- Decide on-line with multi-person committee applying rules for majority, time span and resolution of ambiguity
- Track & trace the decision making process
- Register and log the decision making process