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 Supplemental Methodological Studies

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Supplemental Methodological Studies Overview
Application and Review Process for Supplemental Methodological Study Proposals
Selection of Site(s)
Composition of SMS Team: NCS Co-Investigator and Facilitator(s)
Guidance for Obtaining Institutional Review Board (IRB) Review
Office of Management and Budget Guidance
Funding
Contracted Services
Supporting Documentation Required for Final Approval
Data Use Agreements and Data Security (as per NCS Data Access Team Policy)
Material Transfer Agreements (MTA)
Data Sharing (as per NCS Data Access Team Policy)
Progress Reports
Publications and Presentations:  Disclosure Review (as per NCS Data Access Team Policy)
Publications and Presentations: General Requirements
SMS Application 

Supplemental Methodological Studies (SMS) Overview

Supplemental Methodological Studies (SMS) are focused studies that occur during the Vanguard (pilot) phase of the National Children's Study (NCS). SMS are designed to inform the Main Study by addressing feasibility, acceptability, and cost of activities pertaining to methodological, logistical and operational elements of the Study, such as assessment of Study visit instruments.

SMS are initiated and developed from outside the study protocol planning process. They are funded externally (unlike Formative Research which is generally initiated from within the NCS and funded by the NCS appropriation). SMS involve interaction with Vanguard phase participants and/or requests for Vanguard phase biospecimens or environmental samples (in addition to requests for data). An SMS application form is provided below (under the Research tab on the NCS Public Website). Requests for just data (no participant interface nor laboratory materials) are not considered SMS and should be submitted directly to the NCS Data Access Team. Data Use Agreements are required for any access to restricted data and are under the purview of the Data Access Team.

Application and Review Process for SMS Proposals

Applicants proposing an SMS should submit an application (including a biosketch of the Principal Investigator and of any additional key personnel).

The NCS Research Partnerships Program Director leads the formal process of review and approval of SMS. Iterative discussion with the SMS Team is recommended during development of the application to facilitate the application process and the likelihood of approval. Review of SMS applications is conducted by NCS Program Office scientists and, if indicated, additional subject matter experts. The review is to assure the quality and integrity of the proposed SMS including support of Vanguard Study goals (feasibility, acceptability, and cost of methodological aspects of the Study) to inform the Main Study; and to assess impact and burden on the Vanguard Study infrastructure and participants; scientific value; relevance and "fit" with the Vanguard Study; appropriate use of limited biospecimens and environmental samples; etc. For these studies to effectively inform the planning of the Main Study, timely completion of the SMS is pertinent. Data derived from an SMS must be shared with the NCS so that it can be made available for further research. (See section on Data Sharing.)

Initial review of an acceptable application will generally result in 'provisional approval pending additional specified documentation.'  A letter of provisional approval is sufficient as a basis for requesting funding from outside sources.  Applicants are then instructed to obtain various supporting documents (detailed below and on the application) in order to receive final approval to implement an SMS. Applications that are not approved may be offered an opportunity for revision and resubmission in an effort to obtain approval. This is generally an iterative process to facilitate development of an acceptable revision.

Selection of Site(s)

If the SMS requires selection of locations (e.g. if participant interaction is required), and if the applicant does not know which locations may be appropriate for the specific SMS, the NCS Program Office SMS Team will assist with facilitating an appropriate selection. It is not required that location(s) be selected prior to submitting the application. The location(s) must however be confirmed prior to final approval of an SMS application.

Composition of SMS Team: NCS Co-Investigator and Facilitator(s)

NCS Co-Investigator

Each SMS must have a designated NCS Co-Investigator. The NCS Co-Investigator is distinct from the co-investigator scientists on the team proposing the SMS. The NCS Co-Investigator may be a Program Office member, a Regional Operations Center Principal Investigator or designee, or other NCS contractor. The main role of the NCS Co-Investigator is to oversee the SMS so that its implementation is consistent with its approval, thus serving as the advocate of the NCS and its participants. If an SMS involves ONLY the use of NCS biospecimens or environmental samples, and not interface with participants, the NCS Laboratory Officer will function as the NCS Co-Investigator. The NCS Co-Investigator, if sufficiently involved with the SMS, can potentially achieve authorship on any resulting manuscript, based upon agreement with the SMS PI.

NCS Facilitator(s)

If interaction with participants at more than one geographically distinct location is required for a given SMS, an NCS Facilitator must be designated from each additional location to work in conjunction with the NCS Co-Investigator. Responsibilities of the NCS Facilitator(s) mirror those of the NCS Co-Investigator at their respective locations.  Both the Facilitator and Co-Investigator serve as advocates for the NCS and the participants. If an SMS involves no participant interaction but only biospecimens and/or environmental samples then there will generally be no need for NCS Facilitators at the various locations (and the NCS Laboratory Officer will function as the NCS Co-Investigator).

The NCS Co-Investigator and NCS Facilitator(s) have the following responsibilities:

  • Serve as liaison between the SMS Principal Investigator (PI) and the NCS Program Office staff, as necessary, to facilitate communication during the application process and during the post-award implementation phases, and to facilitate and ensure compliance with relevant NCS policies such as pertaining to data access and use, specimen/sample/repository use, IRB approval, disclosure review, publications, and other agreements.  The NCS Co-Investigator provides support to the NCS Facilitators. The NCS SMS Team will provide guidance regarding relevant SMS policies and procedures.
  • Ensure that SMS progress is proceeding within the confines of the approved proposal, particularly ensuring that the SMS burden to participants and to study infrastructure does not exceed that approved by the NCS, thus serving as an advocate for the Study and the participants. They must notify the NCS Program Office, within 2 weeks of their becoming informed, if the SMS project has deviated from the agreed upon plan or has been discontinued.
  • The Program Office SMS Team will facilitate selection of NCS Co-Investigator and Facilitators, either by selecting a Program Office staff member or by working with the relevant NCS Regional Operations Center or other contractor to identify persons willing to serve in those capacities. The person(s) selected must be able to objectively oversee the SMS implementation. Their inclusion in the authorship of SMS publications is a matter of negotiation between the parties and depends upon the significance of the contributions made by the respective parties.

Guidance for Obtaining Institutional Review Board (IRB) Review

SMS research activities are not considered as part of the Vanguard Study protocol and therefore are not covered by the approval of the Vanguard protocol.  Appropriate Institutional Review Board (IRB) approval will be required for (final approval of) SMSs that interact directly with NCS participants and/or use participants' identifiable data, biospecimens, and/or environmental samples.

IRB of Record for the SMS:

Applicants are responsible for assuring that that their SMS receives the required local IRB approval(s) or waiver(s). The IRB associated with the Federal Wide Assurance (FWA) holding institution conducting the SMS is responsible for determining whether the institution's activities are exempt from or require IRB review. The reviewing IRB will determine, for example, whether samples are identifiable and whether a proposed SMS should be considered human subjects research. Final approval to implement the SMS is contingent upon receipt of documentation of either local IRB approval or a waiver reflecting that the study is not considered human subjects research. Note that IRB approval is not required prior to provisional approval, but is required prior to final approval to implement the SMS.

Regional Operations Center IRB

ROC IRBs are responsible for determining whether the ROC staff is engaged in research in accordance with federal regulations and OHRP guidance. For example, if ROC personnel participate in activities such as administering informed consent or collecting identifiable data, then the ROC would be considered to be engaged in research and the ROC IRB would need to review and approve the ROC SMS activities.

NICHD IRB

Generally, NICHD IRB approval is not necessary for providing a de-identified data set for an SMS that has local IRB approval for participation in an SMS (in accordance with the NCS Data Access policies which stipulate that the Program Office determines what level of data access is granted). The NCS 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 must be obtained prior to final approval to implement the SMS.

Office of Management and Budget Guidance

The NCS Program Office staff will determine whether referral to the Office of Management and Budget (OMB) is required for a given Supplemental Methodological Study proposal. In general, if the funding for the SMS is from other than a government contract, then OMB is not involved.  If OMB referral is necessary, NCS Program Office staff will facilitate the process.  

Funding

Applicants must indicate the proposed source of funding. Funding details such as a Letter of Award specifying amount, timeline etc. will be required for final approval to implement the SMS. Provisional approval from the NCS Program Office SMS Team should be sufficient for submitting funding requests.

Contracted Services

Services from field contractors who are contracted by the NCS may be necessary to implement a given SMS. SMS applicants may need to provide the required funding for certain contracted services. Guidance will be provided by the Program Office if such funding is required.

Supporting Documentation Required for Final Approval

Upon submission of an SMS application, the NCS 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, in order to achieve final approval to implement the SMS:

  • A signed National Children's Study Co-Investigator/Facilitator Agreement Form (PDF 35 KB) for each NCS Co-Investigator and Facilitator.
  • Informed Consent Materials: Applicants are responsible for developing all informed consent materials required for conducting their SMS. Applicants should review NCS consent forms in collaboration with their local IRB(s), and determine whether the research proposed in the SMS is covered by the NCS consent materials or if it requires additional consent or a waiver of informed consent. The NCS consent forms can be obtained upon request from the NCS Program Office at NCSIRBs@mail.nih.gov.  If additional consent for the SMS is required, the SMS consent materials should include language stating that the SMS is separate from the NCS and that participation in the SMS is not required for continued participation in the NCS.
  • Applicable local/institutional and ROC IRB determinations (approvals, waivers, etc.): Documentation of applicable IRB review and approval (or waiver) must be provided as well as the IRB-approved protocol and informed consent forms with a cover letter highlighting any interim changes from what was reviewed and provisionally approved by the NCS. Submit to SuppMethApp@mail.nih.gov  
  • Proof of Funding: Applicants must provide proof of funding, such as a Letter of Award specifying timeline, dollar amount, etc.

Data Use Agreements and Data Security (as per NCS Data Access Team Policy)

Once final approval of the SMS is issued, SMS investigators must secure Data Use Agreements (DUA)s for the SMS Principal Investigator (PI) and for all personnel who will require access to non-public use NCS data. In addition, the PI must submit Material Transfer Agreements (MTA) if the proposed study requires biospecimens or environmental samples. Neither electronic data nor biospecimens or environmental samples will be transmitted to the SMS PI or key personnel until the relevant DUAs (and MTAs as applicable) have been submitted and approved.

There are two kinds of DUAs, Affiliated and Non-Affiliated. Persons under contract with the NCS are considered 'affiliated.' Others are considered 'non-affiliated' with the NCS for the purpose of the DUA. 

The following steps outline how to submit a request for an Affiliated or Non-Affiliated DUA:  

  • IF YOU DO NOT HAVE A PORTAL ACCOUNT:External Web Site Policy
    • Complete an NCS Data Center Access Request Form by contacting the NCS Help Desk (helpdesk-ncs@norc.org) in order to access the NCS Portal OR send an e-mail to SuppMethApp@mail.nih.gov
    • Send the completed form to SuppMethApp@mail.nih.gov to approve the request.
    • All Portal requests must be emailed to the NCS Help Desk, helpdesk-ncs@norc.org, directly from the SMS team.
  • IF YOU DO HAVE A PORTAL ACCOUNT:
    • Submit an Affiliated or Non-Affiliated DUA request 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).  
    • Go to the Portal
    • Go to "Applications" and hover over that tab
    • Go to "Data Access Compliance Suite (DACS)"External Web Site Policyand click
    • Click (in the left hand side bar under TOOLS) "Submit New DUA for Non-Affiliated (or Affiliated) User"External Web Site Policy
    • Fill out the form and submit.  

For questions regarding data access and confidentiality matters, contact the NCS 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.

Material Transfer Agreements (MTA)

If the proposed SMS will utilize NCS laboratory/repository materials (biospecimens and/or environmental samples) a Material Transfer Agreement between the NCS and the requesting institution 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 222 KB) for more information about MTAs.

Data Sharing (as per NCS Data Access Team Policy)

The NCS Data Access policy requires that data collected from NCS participants or generated from analysis of NCS biological or environmental samples should be made available to the NCS in order to maximize the benefit of the materials.

At the conclusion of the project, investigators shall:

  • Provide all data including metadata collected from NCS participants or generated from analysis of NCS biological or environmental samples or through use of assessment instruments.
  • Provide a summary description of the project and any electronic file(s) containing raw data together with quality control data if applicable. Include a data dictionary that identifies the file format and defines all the variables in the electronic file. Investigators should contact the NCS Data Access Team at NCSDataAccess@mail.nih.gov for further direction.
  • Complete the Data Disposition Form External Web Site Policy and email it to the Data Access Team at NCSDataAccess@mail.nih.gov.

Progress Reports

The Program Office will request periodic (twice yearly or more frequently as requested) reports on SMS status. Reports will be drafted by the SMS PI and emailed to SuppMethApp@mail.nih.gov with a copy to the NCS Co-Investigator (and Facilitators). The reports shall address the SMS progress and status regarding burden to participants and infrastructure as well as any negative effects of the SMS on retention in the NCS.

Publications and Presentations:  Disclosure Review (as per NCS Data Access Team Policy)

Prior to publishing or presenting interim or final results of an SMS, the manuscript or presentation must undergo NCS disclosure review.

To initiate disclosure review:

  • Submit material (presentation or draft manuscript) to NCSDataAccess@mail.nih.gov, copy SuppMethApp@mail.nih.gov
    • Use a subject line heading "FOR DISCLOSURE REVIEW: [Title of Submission]"
  • The material must be encrypted in Federal Information Processing Standards (FIPS) 140-2 (PDF 1.4 MB) compliant fashion, which includes use of secure e-mail services approved by the NCS Mission Assurance Team,  or the use of either WinZip (9.0 or later) or TrueCrypt (2.0 or later) with the following requirements:
    • Use AES-256 or AES-128 encryption
    • Encryption keys passwords should have a length of at least 8 characters and should contain at least one uppercase letter, at least one lowercase letter, and at least one number or other printable symbol or punctuation
    • Make sure the encrypted archive has the file extension .zip (WinZip) or .tc (Truecrypt)
    • A second individual should test the encrypted file to ensure the encrypted file and encryption key password are functional
    • File titles should be descriptive and unique such that other submissions would be unlikely to have the same name (for example, do not simply use 'File for Disclosure Review')
    • After disclosure review, the file can be shared unencrypted.
  • Researchers must submit the encryption password through the National Children's Study Portal: Submit Password.External Web Site Policy
    • When you click on the link, it will take you to the portal log-in. Enter your user name and password. For assistance, contact the Helpdesk at helpdesk-ncs@norc.org
    • The following are important considerations for manuscript and presentation development in order to avoid inappropriate disclosure and to facilitate the disclosure review process:
      • All presented count data must be N ≥ 10 (this refers to both data presented and data derivable from a presented table.) If an N < 10 is presented or derivable, aggregation of cells or the presentation of percentages (without an N) are acceptable fixes, and should be incorporated by the authors prior to submitting the manuscript or presentation for approval. Derived counts refer to tables where multiple rows and columns are presented, potentially allowing a careful reader to infer a smaller count.
      • Names of geographic areas smaller than the Primary Sampling Unit (PSU) are not mentioned.
      • Maps of geographic areas do not depict Secondary Sampling Units (or smaller).
      • Images of faces have clear documentation that informed consent has been given for use of facial image or that the image is a stock photo.
      • Employers, hospitals, providers, or industries are not named as residing in sampled areas.
      • Potential or enrolled participant demographics or health status are not described at the individual level.

For detailed information regarding disclosure review, contact the NCS Data Access Team at NCSDataAccess@mail.nih.gov. Once the document has passed disclosure review, it no longer requires encryption.

Publications and Presentations: General Requirements

All SMS publications and presentations (such as manuscripts, abstracts, posters, etc.) must present the NCS appropriately and must comply with relevant NCS policies and procedures including but not limited to disclosure review, NICHD clearance (only if there is an author from NICHD/NCS), and inclusion of applicable acknowledgements and disclaimers. For further guidance, send a request to the SMS Team at SuppMethApp@mail.nih.gov or review NCS Publications Policies and Procedures on the Portal.

Additionally, the SMS PI shall notify the NCS Program Office Publications Team of all peer reviewed accepted publications, presentations, and published abstracts regarding the SMS, in the standardized PubMed format. For questions regarding publications, contact NCSPubs@mail.nih.gov.

SMS Application:

  4/3/2014
  4/3/2014