Investigators who are interested in conducting clinical studies will be asked to provide the following information at the same time they submit a full proposal (i.e., not at the letter-of-intent stage) in response to the annual Pilot and Research Award request for applications:
- How many participants will be recruited? What is the maximum and minimum number of participants required for the project?
- What is the source of participants? (e.g., local clinic)
- Recruitment milestones
- Criteria that will be used to determine eligibility for participation in the study. For example:
a. Intelligence quotient
d. Who will be involved (proband/mom/dad/siblings)
e. Other score or test criteria (e.g., Vineland Adaptive Behavior Scales
f. Medical history concerns (e.g., febrile seizures, handedness,
history of psychosis, etc.)
g. Location of participants (e.g., site)
h. Genetic diagnosis
- Will participants be genetically characterized (if yes, how?) or will biospecimens be collected for possible later genetic characterization?
- A brief list of participation benefits, if any (e.g., a no-cost health examination)
- Potential risks to participants
- The time or other commitment required of the participants
- What is the status of the institutional review board approval?