CDC's policies and procedures are designed to ensure and maximize the quality of its information products with regard to their utility, objectivity, and integrity. The agency's quality assurance process begins at the inception of the information development process. CDC has guidelines to address the general principles concerning the responsibilities of the CDC staff in the collection and recording of data, publication practices, authorship determination, peer review, confidentiality of information, collaborations, and human subjects research. Authorship issues and review and clearance procedures are set forth in the "Authorship of CDC Publications and the Clearance Procedures for Scientific and Technical Documents" (www.cdc.gov/od/foia/policies/clearance.htm).
CDC reviews the quality (including the objectivity, utility, and integrity) of information before it is disseminated and treats information quality as integral to every step of the development of information, including its creation, collection, maintenance and dissemination. Further, CDC is committed to demonstrating in its Paperwork Reduction Act clearance packages that each draft information collection will result in information that will be collected, maintained, and used in a way that is consistent with OMB, HHS and CDC information quality guidelines. The individual CIO Associate Directors for Science (ADS) or designee are responsible for assuring the quality of information disseminated by CDC and that the quality assurance methods and procedures described in Overview of Quality Assurance Policies and Practices in HHS are met. To meet the standards for external merit review of research and scientific studies and intramural research programs, CDC policy is to peer review extramural research and intramural research studies and programs.
The CIO ADS or designee are responsible for clearance of documents originating in that CIO before dissemination and for ensuring that the necessary clearances are obtained and that written material distributed is appropriate and consistent with HHS policy. While each CIO can determine preparation, review and approval procedures, all must meet standards provided by the ADS, CDC and those provided in the HHS Part I Overview D.4.d.
- Utility CDC addresses utility, a measure of the usefulness of information products to its intended users, by staying informed of user needs through information product research and user needs assessment, user feedback, consultation with advisory committees, and conference participation.
- Objectivity CDC provides assurance that information is accurate, reliable, and unbiased. Objectivity is achieved through existing review and clearance procedures and, in many cases, the peer review of disseminated information.
- Integrity CDC assures the integrity of its data and information products through the enforcement of rigorous controls that protect against unauthorized access, revision, or corruption. Some of the controls used at CDC include access control, user authentication, encryption, access monitoring, provision of unalterable electronic content, and audit trails.
CDC Information Review and Approval Policies and Procedures by Type of Information
- Health and Public Health Information
- Scientific research studies
CDC encourages professional dissemination of scientific research and other information by its employees. Publications or presentations by CDC employees are expected to meet high standards of quality, make a substantial contribution to the field, and contain sufficient information for the informed audience to assess its validity. Publication of scientific information by individual employees must undergo a formal review and clearance process by the CIO ADS or designee before dissemination. This review includes the evaluation of data collection measures for completeness, accuracy and timeliness, data management and analysis, clarity and accuracy of presentation, and validity of interpretation of findings.
Oral presentations undergo appropriate supervisory review. Laboratory data are reviewed to assure that good laboratory data practice was followed for sampling, methodology, instrumentation and analysis.
Intramural research programs will be subject to review and monitoring by external, objective peer review through an advisory committee or board of scientific counselors. Scientific research studies submitted to journals are subject to peer review of methods and findings by the journal prior to publication. ATSDR has a mandated policy for external peer review of all intramural and extramural research study protocols and findings prior to public dissemination.
- Authoritative health, medical and human services information aimed at consumers and health and human services professionals
CDC disseminates authoritative health and medical information routinely as part of its mission. As an example, articles or reports for publication in the MMWR are subject to routine CDC review and approval procedures in the originating CIO. Because information disseminated in the MMWR often has impact on the practice of public health, the CDC ADS must also review and approve it. Health Alerts related to bioterrorism that are disseminated by CDC are also reviewed and approved at the CDC ADS level prior to release.
- Public heath surveillance and epidemiology information
CDC often obtains surveillance information from third parties, such as States, grantees, or community-based organizations. Reliance on third parties places limits on CDC's quality assurance, although the accuracy, completeness and timeliness of the information are subject to sample audits, site visits, and an evaluation for completeness and consistency with trends and external controls. The MMWR Summary of Notifiable Diseases, for example, depends on data reported from States. CDC conducts audits and checks for consistency for trends before reporting these data. ATSDR produces Toxicological Profiles for hazardous substances found at National Priorities List sites as well as other documents that undergo public comment periods before being finalized and distributed. The Toxicological Profiles and other ATSDR documents are first produced as drafts and are then subject to public comments following announcement in the Federal Register and using other means. Only after considering the comments, the profiles and documents are finalized and then distributed to the public.
ATSDR has a government to government policy on Tribal Nations that specifies how the agency works with and respects Tribal rights, sovereignty, and culture. Data or information collected from American Indian/Alaska Native communities requires approval from the Tribal government and direct involvement in the research or study from concept to completion. The Tribe reserves the right to review and critique the design and findings. Issues of release and ownership of data, information or other products must be agreed to by the Tribal government. Close collaboration and involvement of the Tribe is essential to ensure quality, utility, objectivity and integrity of information prior to being disseminated.
- Scientific research studies
- Statistical products
CDC routinely employs a number of widely accepted methods and procedures for ensuring quality, including independent assessments of statistical methodologies, peer reviews, and observance of professional standards. To insure the utility of CDC statistical and analytic information products, CDC conducts independent research and consults experts in areas such as data collection, data analysis and a variety of substantive topics and areas. Additionally, CDC maintains ongoing contact with users, and participates in conferences, and workshops in order to objectively assess and identify the current and future data needs of CDC's constituents. Further, CDC employs a wide variety of dissemination mechanisms to make its statistical and analytic information products widely available and broadly accessible.
To assure that statistical and analytic information products are accurate, reliable, and unbiased, CDC obtains these data through generally accepted statistical theory and practice. Dissemination of data also follows generally recognized guidelines in terms of defining acceptable standards regarding minimum response rates, maximum standard errors, cell size suppression, quality of coding and other processing operations. CDC also maintains staff expertise in areas such as concept development, survey planning and design, data collection, data processing and editing, data analysis, evaluation procedures, and methods of data dissemination.
All CDC statistical and analytic information products undergo a formal clearance process before dissemination. Publications and reports, whether in electronic or paper form, are reviewed by a CIO ADS or designee. These reviews cover the clarity of descriptive text, the appropriateness of the methodology, the soundness of the analysis, the adherence to confidentiality and disclosure avoidance restrictions, the readability of tabular and graphic presentations of data. Finally, all products undergo editorial review, (e.g., formatting, proofreading, spell checks, proper punctuation). Oral presentations undergo appropriate supervisory review. The CIO ADS or designee may also review for programmatic and policy implications on behalf of and in consultation with other division or senior staff. In addition, all public-use tapes are reviewed by the CIO ADS or designee for accuracy and appropriate confidentiality protections.
CDC statistical and analytic information products are derived using generally acceptable statistical practices and methodologies which are clearly documented and available to the public. These procedures enable responsible statisticians and analysts outside of CDC to replicate CDC's statistical methods and obtain results consistent with those obtained by CDC.
- Health and Public Health Information