Response to PIA questions

Due to the limitation of the Privacy Impact Assessment (PIA) form, please find below the full response to
Question #37:

At the end of SEED Teen, the PII will be retained, as per the consent agreement, to enable future contact with
the participants. At the conclusion of the overall SEED program, all PII will be retained by CDC for one year as per
the CDC Scientific and Research Project Records Control Schedule. After one year, all identifiable information
must be destroyed in accordance with the Certificate of Confidentiality approved application. The study periods
for SEED and SEED Teen are defined to include data analysis and publication. The end of the study period will be
considered to be 1 year after the final manuscript from a SEED data analysis is submitted for publication. No
identifiable information will be retained or transferred to the National Archives.
a. Retention Time Information Will Be Kept in Identifiable Form
Identifying information will be collected during the data collection period and will be kept private in a
separate file from the other data collection elements. Only the research staff will have access to a list
linking a participant’s study ID to his/her study data. Each SEED Teen site‘s data will be stored separately
from all others and no site will have the means to access the personally identifiable data stored by
another site unless granted permission to do so for specific study purposes.
Study participants will be asked in the written consent form for permission for study personnel at the
site to retain access to this study link after the study period, in order to allow for potential re-contact for
follow-up studies, and for genetic data sharing. Participants can give consent to all, any one, or none of
these individual permission requests. For participants who agree, this study link will remain indefinitely.
For participants who do not allow the link to be kept, this information will be destroyed at the end of
the study period. The Data Coordinating Center will maintain the central database with all the study
data.

Scientific and Research Project Records Control Schedule (Additional
Information)
Scientific and Research Project Records
1. Precedent-Setting Scientific and Research
Records represent scientific data and all aspects of research including project development, demonstration,
distribution, assessment, testing, and related tasks. Systems that document the planning, history, results, and
outcome of a scientific and or research project conducted as part of CDC/ATSDR’s mission or under the
supervision of CDC/ATSDR employee(s).
These records include but are not limited to planning documents, and/or documents that evaluate or appraise a
project or other research during its course. Records include but not limited to original observations, laboratory
notebooks, databases that contain scientific observations, modeling and sampling methodologies, and any other
research-related documentation.
Master file, system or database that is precedent-setting, received remarkable interest from the public health
community and garnered extreme interest by the public, media, and health researchers; these records have
long-term evidentiary and informational value.
a.

Long-Term ongoing Studies that contain cumulative research data

Authorized Disposition: PERMANENT: Transfer “snapshot” copy of data to NARA in 1 year intervals (or
other time period established with NARA); the first transfer to occur within the first year after the
approval of Records Control Schedule. Electronic media will be transferred to NARA formatted in
accordance with current applicable regulations regarding transfer of electronic records.
b.

Completed Studies
Authorized Disposition: PERMANENT: Transfer to NARA a copy of the completed database no longer
than one year after the end of the project. Electronic media will be transferred to NARA formatted in
accordance with current applicable regulations regarding transfer of electronic records.

Selection Criteria for Permanently valuable data: Includes, but not limited to, research records meeting one or
more of the following criteria:
 Records of scientific investigations that are deemed to be Influential Scientific Information or Highly
Influential Scientific Assessments (per Office of Management and Budget (OMB) Bulletin for Peer
Review, December 15, 2004):
 Scientific information that CDC reasonably determines will have or does have a clear and substantial
impact on important public policies or private sector decisions.
 An evaluation of a body of scientific or technical knowledge, which typically synthesizes multiple factual
inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in
the available information.
 A scientific assessment is a subset of "influential scientific information" and is considered "highly
influential" by the agency or the OIRA Administrator [Office of Information and Regulatory Affairs in
OMB] determines the dissemination could have a potential impact of more than $500 million in any one
year on either the public or private sector or that the dissemination is novel, controversial, or precedent
setting, or has significant interagency interest.
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Long-term data collections and monitoring efforts of national or international interest.
Datasets that is irreplaceable, critical to the CDC mission, and in a condition which allows future use.
Scientific investigations that receive national or international awards of distinction.
Works of prominent CDC investigators of widely recognized professional stature, or who have received
national or international recognition outside their professional discipline.
Activities that result in a significant improvement in public health, safety, or other vital public interest.
Significant contributions to new national or international health policies, or had a significant impact on
the development of new national or international scientific, political, economic, or social priorities.
Subjects of widespread national or international media attention.
Materials related to significant social, political, or scientific controversy.
Activities subject to extensive Congressional, Department of the Interior, or other government agency
scrutiny or investigation.
Precedents that significantly change CDC scientific investigations.
All projects published and unpublished publications.