1. The International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles
  2. Rowe, Sylvia MAT
  3. Alexander, Nick BA, PhD
  4. Clydesdale, Fergus M. PhD
  5. Applebaum, Rhona S. PhD
  6. Atkinson, Stephanie PhD
  7. Black, Richard M. PhD
  8. Dwyer, Johanna T. DSc, RD
  9. Hentges, Eric PhD
  10. Higley, Nancy A. PhD
  11. Lefevre, Michael PhD
  12. Lupton, Joanne R. PhD
  13. Miller, Sanford A. PhD
  14. Tancredi, Doris L. PhD
  15. Weaver, Connie M. PhD
  16. Woteki, Catherine E. PhD
  17. Wedral, Elaine PhD


There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. Although biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that the industry has played and will continue to play in the research process, the International Life Sciences Institute North America Working Group on Guiding Principles has, in this article, set out proposed conflict-of-interest guidelines regarding industry funding for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The article, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement


Article Content

Guiding Principles

In the conduct of public/private research relationships, all relevant parties shall:


1. conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome;


2. require control of both study design and research itself to remain with scientific investigators;


3. not offer or accept remuneration geared to the outcome of a research project;


4. before the commencement of studies, ensure that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time frame;


5. require, in publications and conference presentations, full signed disclosure of all financial interests;


6. not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations;


7. guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and


8. require that academic researchers, when they work in contract research organizations or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the contract research organization.



Swine Flu Recommendations

The human swine flu outbreak continues to grow in the United States and internationally. In response to the intensifying outbreak, the World Health Organization raised the worldwide pandemic alert level to Phase 4. A Phase 4 alert is characterized by confirmed person-to-person spread of a new influenza virus able to cause "community-level outbreaks." The increase in the pandemic alert phase indicates that the likelihood of a pandemic has increased.


The Center for Disease Control (CDC) has activated its emergency operations center to coordinate the agency's emergency response. The CDC's goals are to reduce transmission and illness severity and provide information to help healthcare providers, public health officials, and the public address the challenges posed by this swine influenza virus. Yesterday, CDC issued a travel warning recommending that people avoid nonessential travel to Mexico. The CDC continues to issue interim guidance daily on the Web site and through health alert network notices. The CDC's Division of the Strategic National Stockpile is releasing one-quarter of its antiviral drugs, personal protective equipment, and respiratory protection devices to help states respond to the outbreak. The swine influenza A (H1N1) virus is susceptible to the prescription antiviral drugs oseltamivir and zanamivir.


This is a rapidly evolving situation, and CDC will provide updated guidance and new information as it becomes available.


Everyday actions that people can take to stay healthy:


a. Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.


b. Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective.


c. Avoid touching your eyes, nose, or mouth. Germs spread that way.


d. Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.


e. If you get sick, CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.



Source: Center for Disease Control and Prevention