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Informed consent consistently has been a top consultation topic.
Another common consultation topic was stopping a clinical trial prior to its planned termination date.
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Consultation topics generally were consistent with those in previous reports of research ethics consultations.
Because of a need for meaningful reporting on consultation topics, the existing topics were reviewed, redundancies were eliminated, and closely related topics were combined.
From 2008 to 2012, consultation topics were entered into the database but not selected from a prespecified list, which resulted in more than 80 different topic categories.
The most frequently discussed consultation topics related to the impact of pelvic radiotherapy on both bowel and bladder function in 81% (n=56) and 70% (n=48) of consultations, respectively.
The most frequent consultation topics we encountered presumably reflect the foremost concerns of employees as they design and conduct clinical trials.
Many of our consultation topics could apply to research ethics consultations in any setting (e.g., "informed consent," "conflict of interest"), but some are more specific to a pharmaceutical drug development or corporate environment (see Table 2 note).
A pre-defined protocol was developed following consultation with topic and methods experts and is available from the PenCLAHRC website [ http://clahrc-peninsula.nihr.ac.uk/est-projects.php].
A pre-defined protocol was developed following consultation with topic and method experts and is available from the Peninsula Collaboration for Applied Research and Care (PenCLAHRC) website (http://clahrc-peninsula.nihr.ac.uk/multi-component-interventions-for-preventing-falls-and-fall-related-injuries-among-older-people--sys.php).php
The final version of the pre- and post-tests contained an equal distribution of questions pertaining to topics specific to seeing a patient during an initial consultation, and topics relevant to seeing a patient in follow-up or during continuing care.
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