National Children’s Study Co-Investigator
Each Supplemental Methodological Study (SMS) must have a designated National Children’s Study Co-Investigator. The National Children’s Study Co-Investigator is distinct from the co-investigator scientists on the team proposing the SMS. The National Children’s Study Co-Investigator may be a field contractor associated with the specific Study location, or may be a member of the National Children’s Study Program Office.
National Children’s Study Facilitator
If more than one location is involved with a given SMS, the SMS applicant must designate a National Children’s Study Facilitator from each additional location to work in accord with the National Children’s Study Co-Investigator. Responsibilities of the National Children’s Study Facilitator(s) mirror that of the National Children’s Study Co-Investigator at the respective Study locations. Both the Facilitator and Co-Investigator serve as advocates for the National Children’s Study.
The National Children’s Study Co-Investigator and National Children’s Study Facilitator(s) have the following responsibilities:
- Provide support to the SMS Principal Investigator by serving as liaison between the SMS Principal Investigator and the National Children’s Study Program Office staff.
- Facilitate communication between the SMS Principal Investigator and the National Children’s Study Program Office staff during the application and implementation phases. Issues such as data access, publication, and specimen access may require ongoing tracking and follow-up by the National Children’s Study Co-Investigator and Facilitator(s).
- Assure continued compliance with relevant National Children’s Study policies such as those pertaining to data use, disclosure review, publications, IRB approval, specimen/sample/repository use, and other agreements.
- Assure that the burden to National Children’s Study participants and Study infrastructure does not exceed that approved by the National Children’s Study Program Office.
- Assure that SMS progress is proceeding within the confines of the approved proposal; this includes but is not limited to biospecimen and environmental sample use.
- Notify the National Children’s Study Program Office if the SMS project has deviated from the agreed upon plan or has been discontinued.
- Assure that periodic (yearly or more frequently as requested) reports on SMS status are provided as requested by the National Children’s Study Program Office. Reports will drafted by the SMS Principal Investigator and emailed to SuppMethApp@mail.nih.gov.
It is to the SMS applicant’s advantage to communicate early with the National Children’s Study Co-Investigator/Facilitator(s). However, if the applicant requests assistance with selecting the National Children’s Study Co-Investigator or Facilitator, the National Children’s Study SMS Team can assist with identifying persons willing to serve in that capacity. The person(s) selected must be able to objectively oversee the SMS implementation. Inclusion of the National Children’s Study Co-Investigator and/or
Facilitator(s) in the authorship of publications pertaining to the SMS is a matter of negotiation between the parties and depends upon the significance of the contributions made by the respective parties.