Ongoing Consent Process
Over the course of a subject’s participation in a research study it is necessary to keep the subject informed of any changes in the research, especially, any changes to the risk/benefit ratio which may influence their continued participation.
The following questions should be addressed in consideration of the subject's feelings regarding their continuation:
1. How will you determine if the participant is willing to continue on the study?
2. What will the process be for informing a participant of the progress of the research?
3. How will new findings be communicated to the participant?
4. How will ongoing consent be documented?