HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. V. Quality Assurance Policies, Standards, and Processes for Ensuring the Quality of Information Disseminated to the Public.


  1. Overview

    At SAMSHA, the quality assurance process begins at the inception of the information development process. Further, SAMSHA reviews the quality (including the objectivity, utility, and integrity) of information before its is disseminated and treats information quality as integral to every step of the development of information, including its creation, collection, maintenance and dissemination.

    All SAMHSA documents and audiovisuals must be prepared in accordance with professional and ethical standards, as well as generally accepted standards of good taste. They must be appropriate for dissemination by SAMHSA and must undergo appropriate review and approval prior to release. SAMHSA adheres to the laws and regulations applying to publications and audiovisual materials, including OMB Information Quality Guidelines, the HHS Printing Handbook, and relevant SAMHSA policy issuances. SAMHSA efforts to ensure and maximize information quality begin at the preparation stage and continue through the review and approval stages. When published electronically, existing SAMHSA policies developed in concert with Federal computer security laws provide appropriate security safeguards to ensure integrity of SAMHSA documents, i.e., that the information is protected from unauthorized access, revisions, corruption, or falsification. Further, SAMHSA is committed to demonstrating in its Paper Reduction Act (PRA) will be collected, maintained, and used in a way that is consistent with OMB, HHS and SAMSHA information quality guidelines.

  2. Preparation

    Each publication must be accurate, both in specific details and in general impressions, and meet accepted standards of high quality. The OMB Information Quality Guidelines define quality as including objectivity, utility, and integrity. SAMHSA documents and presentations containing text and summary data must be objective and scientifically sound. Sources should be referenced for the convenience and further information of the reader. Where appropriate, supporting data should have full, accurate, and transparent documentation. Potential error sources affecting data quality should be identified and disclosed to users. Disclaimers should be used to distinguish the status of information (e.g., based on preliminary data or partial data set).

    OMB Information Quality Guidelines hold "influential" scientific, financial, or statistical information to a higher standard of quality, requiring that the results be "substantially reproducible" by qualified third parties were the original or supporting data to be independently re-analyzed using the same methods. Making the data and methods publicly available will assist in determining whether analytical results are capable of being substantially reproduced.

  3. Plain Language

    A Government-wide directive requires Federal agencies to use plain language in all communications with the public. Plain language is writing that is geared to the target audience (i.e., a plain language document for a scientific audience may be different from a plain language document for the general public). Plain language is grammatically correct, with accurate word usage. It is clear and expresses exactly what readers need to know without unnecessary words.

  4. Layout and Design

    Each publication should be prepared in a pleasing, dignified, and finished format appropriate for its intended use and audience. Use of color and typography must be in accord with Government Printing and Binding Regulations (www.house.gov/jcp/jcpres.pdf).

  5. SAMHSA Information Review and Approval Policies and Procedures by Type of Information

    1. Overview

      The purpose of the review process is to improve the quality of SAMHSA documents and to ensure the accuracy and validity of information intended to benefit the targeted audience, such as professional associations and the general public. All materials distributed by SAMHSA must be reviewed for accuracy, propriety, completeness and quality (including objectivity, utility, and integrity). The structure of the review and the types of reviewers will depend on the nature of the information as well as the targeted audience. For scientific and technical documents, peer review provides a level of quality control that is well recognized in the scientific community. According to OMB Information Quality Guidelines, material subject to formal, independent, external peer review can be considered to be of acceptable objectivity. However, this presumption of objectivity is refutable based on a persuasive showing by a complainant in a particular instance. The single most important determinant of a review groups' excellence and credibility are its members. Reviewers must: have appropriate scientific knowledge (as demonstrated by grant and publication records, academic degrees and honors); be respected in the scientific community; have breadth of expertise; be fair and objective; and, not be influenced by inappropriate personal interests (competition, scientific bias, personal antagonisms, or similar irrelevant factors). Because utility is one measure of quality, the review group should include representatives of the targeted audience to the degree practicable.

      Statistical compendia and documents providing "influential scientific, financial, or statistical information" must be reviewed carefully. The Director of the Office of Communications must determine that these documents and the data on which they are based conform to the standards set forth here, and, if applicable, that the reported information and/or statistics reported therein be substantially reproducible.

      A document that has obtained publication clearance for paper printing is often posted on the sponsoring Center's or Office's web page for greater accessibility. Such documents should not need additional approvals. Web documents with no print counterpart require content clearance by the Office of Communications to ensure that the information observes all applicable requirements governing information for release to the public.

      Scientific papers, books, journal articles, brochures, documents, statistical compendia, newsletters, electronic documents, audio-visual productions, and similar materials.

      SAMHSA encourages dissemination of scientific research and other information by its employees. Professional and scholarly writing, lecturing, editing, and publishing are an essential part of research, are in the public interest, and bring credit and distinction to SAMHSA and to the employees themselves. In assisting employees to share information about their official and professional activities, SAMHSA seeks to advance scientific knowledge and contribute to professional education. The first report of any scientific research results or other professional findings may be made by publication in a scientific or professional journal or presentation at a meeting of a professional organization. The choice of the journal or meeting to which reports are offered is the prerogative of the author(s).

      To ensure and maximize the quality of information disseminated by SAMHSA employees, any non-extemporaneous presentation (written or electronic) by a SAMHSA employee on a subject related to his/her SAMHSA duties must be reviewed and approved through an internal SAMHSA process prior to submitting for publication consideration. With few exceptions, non-extemporaneous oral presentation on health policy or practice, or presentations with policy implications, must also be cleared in advance. Manuscripts intended for publication are customarily subjected to an external peer review process directed by the interested publisher, volume editor, or journal editor.

      Publication or oral presentation of scientific and professional information by individual employees must conform to applicable laws and regulations, including OMB Information Quality Guidelines and the HHS Standards of Conduct Regulations.

      Customary professional practices impose certain constraints on the degree to which SAMHSA employees maybe identified with the results of research and development work, including that obtained in collaboration with extra-mural grantees.2

      All SAMHSA components have a formal internal operating procedure for identifying printing requirements and tracking publications. In addition, the concept clearance process for new publications is often the vehicle to track the development of a new publication and to identify its attendant printing requirements. Each prospective publication must be cleared through the originating SAMHSA component and then be approved by the Office of Communications, SAMHSA and the Office of the Assistant Secretary for Public Affairs (OASPA), HHS.

      In brief, any official publication (including book, bibliography, chapter of a book or textbook, booklet, brochure, collection of abstracts, fact sheet, house organ, index, leaflet, manual, monograph, newsletter, pamphlet, review, periodical, proceeding, recurring report, statistical compendium, Internet document, audio-visual or the like) prepared by any SAMHSA component directly or through a contract must be sent by SAMHSA for HHS clearance. This clearance requirement does not apply to publication of articles in journals.

      All audio-visual projects and exhibits must be cleared through OASPA, whether produced in-house or under contract. To obtain clearance for audiovisual products, including exhibits, Form HHS 524A must be completed, approved by the Office of Communications, and filed and approved with the Office of the Assistant Secretary for Public Affairs before production may begin.

      Statistical compendia, including statistical analyses, aggregated information by program, Center, Office or for SAMHSA as a whole, including funding information and histories (by funding mechanism, dollars, or other criteria), require approval by the Director, Office of Communications, SAMHSA. The Director of the originating Center or Office is required to determine that the data conform to accepted scientific and quality standards and that the reported statistics are substantially reproducible.

      In general, any writing by a SAMHSA employee on a work-related subject, whether or not intended for electronic or print publication, or for oral delivery, must be prepared according to accepted SAMHSA standards of quality, reviewed for substantiative content, and administratively approved. The purpose of the clearance process is to improve the quality of information and to ensure the accuracy, objectivity, utility, and validity of information.

      Consistent with HHS Standards of Conduct (73.735-705 Writing and Editing), employees are encouraged to engage in outside writing and editing when such activity is not otherwise prohibited. If the writing or editing activity is related to the employee's official duties or other responsibilities and programs of the Federal Government, the employee must: (1) make no mention of his or her official title or affiliation with the Department, or (2) use his or her official title or affiliation with the Department, or (3) submit the material for clearance within the operating component, under procedures established by the component. When clearance is denied at any lower level, the employee shall have recourse for review up to the head of the principal operating component. This clearance will show there are no official objections to the activity, and the employee may then use his or her official title or affiliation usually without a disclaimer. Except where the requirement for disclaimer is waived as a result of official clearance, disclaimers shall be used in all writing and editing related to the employee's official duties or other responsibilities and programs of the Federal Government: (1) in which the employee identifies himself or herself by official title or affiliation with the Department, or (2) when the prominence of the employee or the employee's position might lead the public to associate him or her with the Department, even without identification other than by name. Disclaimers shall read as follows unless a different wording is approved by the Assistant General Counsel, business and Administrative Law Division, Office of the General Counsel: "This (article, book, etc.) was (written, edited) by (employee's name) in (his or her) private capacity. No official support or endorsement by (name of operating component or of Department) is intended or should be inferred."

      Oral Information including speeches, interviews, expert opinions, only if representing SAMHSA views, official position, or policies

      Any public statements, comments, or discussion of Federal policies or practices that are relevant to the employee's position or duties, draw conclusions, advocate or oppose professional practices or positions on subjects related to SAMHSA duties or that might otherwise be construed as reflecting an official position by SAMHSA, HHS, of the Federal Government, are covered by the OMB Guidelines and must be approved in the Office of Communications, SAMHSA.

      No review or approval is required for non-official and private writing, speaking, and publishing by an employee unless his/her SAMHSA employment is likely to be regarded as influencing the content.

      SAMHSA employees are responsible for the statements they make, regardless of whether or not they have been cleared. If one presents material that requires clearance but that has not been cleared prior to presentation, then the employee must inform the audience of the personal or unofficial nature of his or her views. An example of an appropriate disclaimer follows:

      "This material is presented from my own perspective and should not be taken as representing the viewpoint of the Department, SAMHSA, or the Center for...."

      SAMHSA employees shall not identify themselves as SAMHSA employees in unofficial materials prepared for dissemination to non-professional audiences, such as a letter to the editor. These materials must be reviewed prior to presentation in the Office of Communications, if the employee's identification with SAMHSA is to be shown, can be inferred, or is well known.

      SAMHSA Clearinghouse Information

      Clearinghouses often serve as a public point of contact and provide access to information about SAMHSA programs, conferences, and grant activities. These are often in electronic as well as hard copy format. Clearinghouses have been contracted to provide varying levels of service, including distribution of fact sheets, information packages, and publications; storage of materials; conducting outreach and promotion; and performing training and quality control for the clearinghouse staff. Clearinghouses may respond to inquiries about particular issues, ranging from information about available educational materials to statistical data. Clearinghouses are challenged to ensure accuracy and reliability of information, while continually striving to improve performance and response times. Clearinghouses also must determine which organizations are worthy of referral when customers need information that is not available at the clearinghouse and how to avoid implying endorsement.

    2. Procedures to Ensure the Integrity of Information.

      SAMHSA has developed World Wide Web (www) Guidance which is available on the SAMHSA Intranet to SAMHSA staff. Web page creators must periodically review material on the web page to determine whether or not it is accurate and up-to-date. Information, particularly time-sensitive information, should be posted as soon as possible. Web page creators are expected to promptly update or remove out-of-date information or to notify Division of Information Resources Management that such actions must be taken.

      Unless otherwise noted, it is safe to assume that information posted on public web sites within the "SAMHSA.gov" domain is considered to be "in the public domain." As such, others are free to establish links to SAMHSA online resources. In establishing such links, SAMHSA requests that others avoid creating the impression that SAMHSA is endorsing or promoting any particular product or service. In the same vein, any outside link to an external resource from a SAMHSA web site needs to be examined and approved on a case-by-case basis.

      Web pages containing links to external pages not located on the SAMHSA server should include a link to a statement that releases SAMHSA from responsibility for the material included in the external web page. Again, it is important to avoid giving a user the impression that SAMHSA is endorsing information or a commercial product described in an external site. Disclaimers on copyright, endorsement (general and external links), liability, and medical information are also used, as appropriate, for individual web sites.

      Each Center or Office designates a principal contact for information and approvals related to the development of web pages. SAMHSA personnel, contractors, and other authorized users must notify this contact person prior to setting up a web page on the SAMHSA server.

      The SAMHSA Division of Information Resources (DIRM) is charged with providing, coordinating, and managing information technology for SAMHSA. In terms of computer security, there are three distinct objectives: (i) confidentially -- ensuring that there is no deliberate or accidental improper disclosure of sensitive automated information; (ii) integrity -- protecting against deliberate or accidental corruption of automated information; and, (iii) availability -- protecting against deliberate or accidental actions that cause automated information resources to be unavailable to users when needed. Information is accorded protection against disclosure, alteration, loss, or destruction, based on the degree of sensitivity.

      DIRM staff use appropriate safeguards to protect data from improper disclosure by backing up critical data periodically, and, if a security incident occurs, by following proper incident response procedures. Supervisors are responsible for ensuring that employees, both Government and contractors observe all security requirements and that employees receive appropriate security training.