• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Science & Research

  • Print
  • Share
  • E-mail

Volume III - 6.6 Scientific Conduct When Performing Research

DFS Pyramid Logo

Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-06

VERSION NO.:2.7

Section 6 ORA Method Development and Validation Program

EFFECTIVE DATE:
04-02-04
REVISED: 01-09-14

ORA analysts are responsible for adhering to the highest standards of intellectual honesty and ethical standards when formulating (MDVP proposals), conducting or presenting method development/validation, studies or research. ORA scientists are expected to follow the guidelines below. The guidelines promote uniform application of the highest ethical standards when conducting research. Violation of these guidelines can undermine the supervisor’s trust in the employee as well as the reader’s trust of the author’s work which in turn undermines the public’s trust in the Agency.

 6.6.1 Data Management 1

Data from analysis, studies, instrument data, and statistical data is recorded with integrity and is inseparable from the acquisition.

All data generated is documented and recorded directly, promptly and, if not computer generated, legibly.

All data is retained by the analyst to allow analysis and repetition by others. The schedule for retention is included in the local laboratory’s procedure or in the SMG 3291.2, Field Office Filing System.

 6.6.2 Publication Practices

Publication is an integral and essential component of method development/validation, studies or research. In addition to submission of LIB manuscripts to the ORS for approval and publication on the FDA network, each author is also responsible for attaching a copy of the approved LIB to their completed CARTS Project Record.

LIBs attached to CARTS project records are searchable for keywords or phrases. Detailed instructions explaining how to access CARTS project information can be found on the ‘CARTS Guides and Templates’ webpage: http://inside.fda.gov:9003/it/Applications/ORAApplications/ucm289485.htm

Authors are responsible for the delivery of an official publication that is accurate, well written, reflect the Agency’s position, and does not disclose trade secrets, confidential commercial information, or other non-public information.

Timely publication of new significant results is important for the progress of science, but fragmentary publication of the results of a scientific investigation or multiple publications of the same or similar data are inappropriate.

All information that would be necessary for scientific peers of the author(s) to repeat the study should be in each paper or made available from the author/s.

Check the referenced sources - It is the Analyst’s responsibility to ensure that the scientific article is accurate, carefully researched and referenced.

Plagiarism of any kind will not be tolerated. In general terms, plagiarism2 is the act of representing someone else’s words or ideas as one’s own without crediting the true source or origin.

 6.6.3 Review and Clearance Policy

All ORA laboratory managers, supervisors, and analysts follow current FDA and local policy and procedures for review and clearance of scientific articles. Scientific articles are defined as the following: publications, articles, speeches, presentations and Laboratory Information Bulletins (LIB).

FDA has a policy2 stating that scientific articles are reviewed for the following: scientific and technical accuracy; agreement with current Agency policy or future regulatory programs; and not adversely affecting the requirements of policies on other FDA centers or offices.

All scientific articles should be peer reviewed prior to submitting for review and clearance.

It is the responsibility of the author’s to make revisions and corrections deemed necessary by their supervisors during the clearance process.

If appropriate, add a disclaimer to the scientific article. The FDA policy2 defines when a disclaimer is necessary.

 6.6.4 Authorship

Authorship refers to the listing of participating scientists’ names in all communications, oral and written, experimental results and their interpretation to scientific colleagues.

Authorship is based on significant contributions to the conceptualization, design, execution or interpretation of a research study.

For those individuals who have limited contributions to a study, e.g. providing certain advice, reagents, analyses and support, these individuals may more appropriately acknowledged but not listed as authors.

References:

  1. U.S. Department of Health and Human Services, PHS, Guidelines for the Conduct of Research within the Public Health Service, January 1, 1992
  2. FDA Policy on the Review and Clearance of Articles to be Published in Scientific or Professional Journals (available at http://intranet.nctr.fda.gov/documents/FDAPublicationPolicy.pdf)