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 Supporting Documentation Required for Final Approval to Implement a Supplemental Methodological Study

Upon submission of a Supplemental Methodological Study (SMS) application, the National Children’s Study Program Office SMS Team will have the proposal reviewed. If the application is acceptable, provisional approval will be provided and the applicant will be instructed to obtain the following supporting documentation as indicated for the SMS: 
  • A Signed National Children’s Study SMS Co-Investigator/Facilitator Agreement Form (PDF 35 KB) for each National Children’s Study Co-Investigator and Facilitator.
  • Informed Consent: Applicants are responsible for developing all informed consent materials required for the conduct of their SMS. Applicants should review the National Children’s Study general consent form in collaboration with their local IRB(s), and determine whether the research proposed in the SMS is covered by the National Children’s Study general consent or if it requires additional consent forms, waivers of informed consent, or documentation of informed consent. The general consent form can be obtained upon request from the National Children’s Study Program Office at NCSIRBs@mail.nih.gov .
  • Applicable Local IRB Determinations (Approvals, Waivers, etc.): Documentation must be provided as well as the IRB-approved protocol with a cover letter highlighting any interim changes from what was reviewed and provisionally approved. Submit to SuppMethApp@mail.nih.gov with a copy to the project’s National Children’s Study Co-Investigator.
  • Proof of Funding: Applicants must provide proof of funding (a grant number or screen shot is sufficient). 
  • Data Access and Confidentiality*: Prior to receiving any non-public use data, SMS investigators will need to:
    1. Complete a National Children’s Study Data Center Access Request Form by contacting the NCS HelpDesk (helpdesk-ncs@norc.org) in order to access the NCS Portal.
    2. Complete and submit an E-Sign Agreement (located on the NCS Portal) for each data user. 
    3. Ensure your location has an approved Security Plan covering all IT and physical environments by working with the National Children’s Study Mission Assurance Team (ncs_mission_assurance@bah.com). Check with your institution to determine if there is already an approved security plan. Security Plans approved by the NICHD Chief Information Officer are a prerequisite for Data Use Agreement (DUA) authorization and are required to ensure compliance with OMB, FISMA, and HHS guidance on the management of personally identifiable information.
    4. Submit a non-affiliated Data Use Agreement (DUA) using the Data Access Compliance Suite (DACS) located on the NCS Portal. Data Use Agreements are user, data, and access location specific, based on the approved Security Plan above.
For questions regarding Data Access and Confidentiality, contact the National Children’s Study Data Access Team at NCSDataAccess@mail.nih.gov. 
*Federal regulations regarding data access, confidentiality, and use will be enforced. Failure to comply could result in revocation of data privileges, termination of data agreements, fines, legal action, and contractual repercussions as appropriate. If National Children’s Study data are needed to develop the SMS proposal, then a request for data should be submitted separate from and prior to submitting the SMS proposal. However, if National Children’s Study data are not required for the purpose of developing the proposal, then the Data Use Agreement can be submitted after provisional SMS approval.
  • Material Transfer Agreement (MTA): If the proposed SMS will be utilizing National Children’s Study laboratory materials (biospecimens and/or environmental samples), a Material Transfer Agreement between NICHD and the institution requesting such materials is required. Separate Material Transfer Agreement templates are required to request use of:

Refer to An Overview of Material Transfer Agreements in NICHD Clinical Research (PDF 221 KB) for more information about MTAs.
  4/30/2012
  4/30/2012