If the Supplemental Methodological Study (SMS) requires selection of locations (for example, if participant interface is required), and if the applicant does not know which locations may be appropriate for the specific SMS, the National Children’s Study Program Office SMS Team will assist by facilitating an appropriate selection. Identifying and obtaining concurrence at specific locations is not absolutely required prior to submitting the application, though it is to the applicant’s advantage to do so. However, the location(s) must be confirmed prior to final approval of an SMS application.
Composition of Supplemental Methodological Study Team: National Children’s Study Co-Investigator and Facilitator(s)
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.
Institutional Review Board (IRB) Guidance
Institutional Review Board (IRB) approval will be required for (final approval of) Supplemental Methodological Studies (SMS) that interact directly with National Children’s Study participants and/or use participants’ identifiable data, biospecimens, and/or environmental samples. The reviewing IRB will determine whether samples are identifiable and whether a proposed SMS should be considered human subjects research. SMS will require local (and perhaps NICHD) IRB review and approval or a determination by the relevant IRB that the study is not considered human subjects research. Note: IRB approval is not required prior to provisional approval, but is required prior to final approval to implement the SMS.
NICHD IRB: The National Children’s Study Program Office staff (Human Subject Protections/IRB Team) will determine whether a given application requires NICHD IRB review. If it does, the IRB Team will initiate the process at NICHD. If NICHD IRB approval is required, this approval should, whenever possible, precede local IRB approval and must be obtained prior to final approval to implement the SMS.
Local IRBs: Applicants are responsible to assure that SMS receive the required local IRB approval(s) or waiver(s). Final approval to implement the SMS is contingent upon receipt of documentation of local IRB approval. See Supporting Documentation Required for Final Approval to Implement a Supplemental Methodological Study for details regarding obtaining the required IRB documentation.
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Office of Management and Budget Guidance
The National Children’s Study Program Office staff will determine whether referral to the Office of Management and Budget (OMB) is required for a given Supplemental Methodological Study (SMS) proposal. In general, if the funding for the SMS is from other than a contract, then OMB is not involved. If OMB referral is necessary, National Children’s Study Program Office staff will facilitate the process.
Funding and Contracted Services
Applicants must indicate the proposed source of funding. Funding details will be required for final approval to implement the Supplemental Methodological Study (SMS). Provisional approval should be sufficient for submitting funding requests.
Contracted services may be necessary to plan or implement an SMS. SMS applicants need to provide funding for such contracted services. Functions that may be carried out by National Children’s Study contracted services to assist with SMS planning and implementation for which the applicant may need to provide funding, may include, but are not limited to:
- Identification/selection and tracking of participants
- Conducting impact analyses, such as potential additional burden on Study infrastructure and participants
- Developing “pick-lists” for obtaining laboratory samples
- Allocating, handling, and shipping laboratory/repository materials.
Guidance will be provided by the National Children’s Study Program Office regarding logistics and costs for such services as required of the National Children’s Study or its contractors to support the SMS.
Supporting Documentation Required for Final Approval
Upon submission of a Supplemental Methodological Study (SMS) application, the National Children’s Study Program Office will review the proposal. 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 Materials: 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).
- 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.
Implementing a Supplemental Methodological Study
Once final approval is issued, the Supplemental Methodological Study (SMS) investigators must secure Data Use Agreements (DUAs) for the PI and all key personnel in order to access non-public use data. The following steps outline how SMS investigators can submit DUAs:
- Complete a National Children’s Study Data Center Access Request Form by contacting the NCS HelpDesk (email@example.com) in order to access the NCS Portal.
- Complete and submit an E-Sign Agreement (located on the NCS Portal) for each data user.
- 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 (firstname.lastname@example.org). 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 DUA authorization and are required to ensure compliance with OMB, FISMA, and HHS guidance on the management of personally identifiable information.
- Submit a non-affiliated (for individuals not under contract to the NCS) 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.
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Publishing Supplemental Methodological Study Results
Supplemental Methodological Study (SMS) publications and presentations do not fall under the purview of the National Children’s Study Publications Committee. However, they must present the National Children’s Study appropriately and must comply with National Children’s Study policies and procedures regarding disclosure review, NICHD clearance, and applicable acknowledgements and disclaimers. For detailed information regarding disclosure review, contact the National Children’s Study Data Access Team at NCSDataAccess@mail.nih.gov.
Additionally, the SMS Principal Investigator shall notify the National Children’s Study Program Office of all peer reviewed accepted publications, presentations, and published abstracts regarding the SMS: provide title of publication, name(s) of authors, name of journal or other venue, date, volume, and page numbers. For questions regarding publications, contact NCSPubs@mail.nih.gov.
SMS Application (PDF 856 KB)
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