The alternatives section is perhaps the most important part of the consent discussion for studies involving treatment or a delay to treatment. The purpose of this section is to inform potential subjects about alternatives to participation in the treatments or assessments provided during a research study. It is also an important opportunity to clarify for subjects whether the study will be clinically useful by providing treatment or information such as the results of medical tests or other assessments.
All patients (those identified as having a diagnosis), especially those patients looking for treatment ,are making a dififerent decision when considering research than others who are not patients. The wording of the section must be tailored to the specifics of the study.
For example, treatment studies must describe other standard approaches to treatment. Assessment and non-treatment protocols which include patients must clarify if the assessments will provide clinically valuable information for the subject, and if the assessment is available in the non-research context.