Nutrition Research

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Sylvia Rowe - One of the best experts on this subject based on the ideXlab platform.

  • scientific rigor and credibility in the Nutrition Research landscape
    The American Journal of Clinical Nutrition, 2018
    Co-Authors: Cynthia M Kroeger, Sylvia Rowe, Cutberto Garza, Christopher J Lynch, Esther Myers, Barbara O Schneeman, Arya M Sharma, David B Allison
    Abstract:

    : Scientific progress depends on the quality and credibility of Research methods. As discourse on rigor, transparency, and reproducibility joins the cacophony of Nutrition information and misinformation in mass media, buttressing the real and perceived reliability of Nutrition science is more important than ever. This broad topic was the focus of a 2016 plenary session, "Scientific Rigor and Competing Interests in the Nutrition Research Landscape." This article summarizes and expands on this session in an effort to increase understanding and dialogue with regard to factors that limit the real and perceived reliability of Nutrition science and steps that can be taken to mitigate those factors. The end goal is to both earn and merit greater trust in Nutrition science by both the scientific community and the general public. The authors offer suggestions in each of the domains of education and training, communications, Research conduct, and procedures and policies to help achieve this goal. The authors emphasize the need for adequate funding to support these efforts toward greater rigor and transparency, which will be resource demanding and may require either increased Research funding or the recognition that a greater proportion of Research funding may need to be allocated to these tasks.

  • achieving a transparent actionable framework for public private partnerships for food and Nutrition Research
    The American Journal of Clinical Nutrition, 2015
    Co-Authors: Nick Alexander, Sylvia Rowe, Eric Hentges, David M Klurfeld, Robert E Brackett, Britt Burtonfreeman, Alison Kretser, Linda D Meyers, Ratna Mukherjea, Sarah Davis Ohlhorst
    Abstract:

    : Officers and other representatives of more than a dozen food-, Nutrition-, and health-related scientific societies and organizations, food industry scientists, and staff of the USDA, the CDC, the Food and Drug Administration, and the NIH convened on 8 December 2014 in Washington, DC, to reach a consensus among individuals participating on guiding principles for the development of Research-oriented, food- and Nutrition-related public-private partnerships. During the daylong working meeting, participants discussed and revised 12 previously published guidelines to ensure integrity in the conduct of food and Nutrition Research collaborations among public, nonprofit, and private sectors. They agreed to reconvene periodically to reassess the public-private partnership principles. This article presents the guiding principles and potential benefits, outlines key discussion points, and articulates points of agreement and reservation.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    Nutrition Reviews, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Michael Lefevre
    Abstract:

    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. While 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, 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 paper, 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. The Guiding Principles are as follows. 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) prior to 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 (CRO) or act as contract Researchers, make clear statements of their affiliation; require that such Researchers publish only under the auspices of the CRO.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    The American Journal of Clinical Nutrition, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Stephanie A Atkinson, Michael Lefevre
    Abstract:

    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. Whereas 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, Nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored Research. This 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. In the conduct of public/private Research relationships, all relevant parties shall 1) conduct or sponsor Research that is factual, transparent, and designed objectively, and, 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) ensure, before the commencement of studies, 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; 8) require that academic Researchers, when they work in contract Research organizations (CRO) or act as contract Researchers, make clear statements of their affiliation; and require that such Researchers publish only under the auspices of the CRO.

Nick Alexander - One of the best experts on this subject based on the ideXlab platform.

  • achieving a transparent actionable framework for public private partnerships for food and Nutrition Research
    The American Journal of Clinical Nutrition, 2015
    Co-Authors: Nick Alexander, Sylvia Rowe, Eric Hentges, David M Klurfeld, Robert E Brackett, Britt Burtonfreeman, Alison Kretser, Linda D Meyers, Ratna Mukherjea, Sarah Davis Ohlhorst
    Abstract:

    : Officers and other representatives of more than a dozen food-, Nutrition-, and health-related scientific societies and organizations, food industry scientists, and staff of the USDA, the CDC, the Food and Drug Administration, and the NIH convened on 8 December 2014 in Washington, DC, to reach a consensus among individuals participating on guiding principles for the development of Research-oriented, food- and Nutrition-related public-private partnerships. During the daylong working meeting, participants discussed and revised 12 previously published guidelines to ensure integrity in the conduct of food and Nutrition Research collaborations among public, nonprofit, and private sectors. They agreed to reconvene periodically to reassess the public-private partnership principles. This article presents the guiding principles and potential benefits, outlines key discussion points, and articulates points of agreement and reservation.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    Nutrition Reviews, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Michael Lefevre
    Abstract:

    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. While 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, 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 paper, 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. The Guiding Principles are as follows. 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) prior to 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 (CRO) or act as contract Researchers, make clear statements of their affiliation; require that such Researchers publish only under the auspices of the CRO.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    The American Journal of Clinical Nutrition, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Stephanie A Atkinson, Michael Lefevre
    Abstract:

    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. Whereas 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, Nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored Research. This 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. In the conduct of public/private Research relationships, all relevant parties shall 1) conduct or sponsor Research that is factual, transparent, and designed objectively, and, 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) ensure, before the commencement of studies, 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; 8) require that academic Researchers, when they work in contract Research organizations (CRO) or act as contract Researchers, make clear statements of their affiliation; and require that such Researchers publish only under the auspices of the CRO.

Eric Hentges - One of the best experts on this subject based on the ideXlab platform.

  • achieving a transparent actionable framework for public private partnerships for food and Nutrition Research
    The American Journal of Clinical Nutrition, 2015
    Co-Authors: Nick Alexander, Sylvia Rowe, Eric Hentges, David M Klurfeld, Robert E Brackett, Britt Burtonfreeman, Alison Kretser, Linda D Meyers, Ratna Mukherjea, Sarah Davis Ohlhorst
    Abstract:

    : Officers and other representatives of more than a dozen food-, Nutrition-, and health-related scientific societies and organizations, food industry scientists, and staff of the USDA, the CDC, the Food and Drug Administration, and the NIH convened on 8 December 2014 in Washington, DC, to reach a consensus among individuals participating on guiding principles for the development of Research-oriented, food- and Nutrition-related public-private partnerships. During the daylong working meeting, participants discussed and revised 12 previously published guidelines to ensure integrity in the conduct of food and Nutrition Research collaborations among public, nonprofit, and private sectors. They agreed to reconvene periodically to reassess the public-private partnership principles. This article presents the guiding principles and potential benefits, outlines key discussion points, and articulates points of agreement and reservation.

  • public private partnerships the evolving role of industry funding in Nutrition Research
    Advances in Nutrition, 2013
    Co-Authors: Jeffrey Zachwieja, Richard Black, Eric Hentges, James O Hill, Maria T Vassileva
    Abstract:

    The global burdens of morbidity and mortality associated with obesity-related chronic diseases are crippling public health and are predicted to exponentially increase over the next 3 decades. Meanwhile, the resources necessary to conduct Research that may offer solutions to the obesity epidemic continue to decline and funding has become increasingly difficult to secure. Alternative models for funding Nutrition and health Research are necessary to make considerable and timely progress to improve public health. Key stakeholders include, but are not limited to, government agencies, foundations, private industry, and nongovernmental organizations.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    Nutrition Reviews, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Michael Lefevre
    Abstract:

    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. While 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, 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 paper, 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. The Guiding Principles are as follows. 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) prior to 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 (CRO) or act as contract Researchers, make clear statements of their affiliation; require that such Researchers publish only under the auspices of the CRO.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    The American Journal of Clinical Nutrition, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Stephanie A Atkinson, Michael Lefevre
    Abstract:

    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. Whereas 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, Nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored Research. This 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. In the conduct of public/private Research relationships, all relevant parties shall 1) conduct or sponsor Research that is factual, transparent, and designed objectively, and, 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) ensure, before the commencement of studies, 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; 8) require that academic Researchers, when they work in contract Research organizations (CRO) or act as contract Researchers, make clear statements of their affiliation; and require that such Researchers publish only under the auspices of the CRO.

Anthony A Fodor - One of the best experts on this subject based on the ideXlab platform.

  • highlights of the 2012 Research workshop using nutrigenomics and metabolomics in clinical Nutrition Research
    Journal of Parenteral and Enteral Nutrition, 2013
    Co-Authors: Steven H Zeisel, Deborah M Muoio, Robert A Waterland, Jose M. Ordovas, Anthony A Fodor
    Abstract:

    : The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human Nutrition who use nutrigenomic and metabolomic methods to better understand metabolic individuality and Nutrition effects on health. We are beginning to understand how genetic variation and epigenetic events alter requirements for and responses to foods in our diet (the field of nutrigenetics/nutrigenomics and epigenetics). At the same time, methods for profiling almost all of the products of metabolism in plasma, urine, and tissues (metabolomics) are being refined. The relationships between diet and nutrigenomic-metabolomic profiles, as well as between these profiles and health, are being elucidated, and this will dramatically alter clinical practice in Nutrition.

  • highlights of the 2012 Research workshop using nutrigenomics and metabolomics in clinical Nutrition Research
    Journal of Parenteral and Enteral Nutrition, 2013
    Co-Authors: Steven H Zeisel, Deborah M Muoio, Robert A Waterland, Jose M. Ordovas, Anthony A Fodor
    Abstract:

    : The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human Nutrition who use nutrigenomic and metabolomic methods to better understand metabolic individuality and Nutrition effects on health. We are beginning to understand how genetic variation and epigenetic events alter requirements for and responses to foods in our diet (the field of nutrigenetics/nutrigenomics and epigenetics). At the same time, methods for profiling almost all of the products of metabolism in plasma, urine, and tissues (metabolomics) are being refined. The relationships between diet and nutrigenomic-metabolomic profiles, as well as between these profiles and health, are being elucidated, and this will dramatically alter clinical practice in Nutrition.

Michael Lefevre - One of the best experts on this subject based on the ideXlab platform.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    Nutrition Reviews, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Michael Lefevre
    Abstract:

    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. While 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, 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 paper, 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. The Guiding Principles are as follows. 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) prior to 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 (CRO) or act as contract Researchers, make clear statements of their affiliation; require that such Researchers publish only under the auspices of the CRO.

  • funding food science and Nutrition Research financial conflicts and scientific integrity
    The American Journal of Clinical Nutrition, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, Rhona S Applebaum, Richard Black, Eric Hentges, Nancy A Higley, Fergus M. Clydesdale, Johanna T Dwyer, Stephanie A Atkinson, Michael Lefevre
    Abstract:

    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. Whereas 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 industry has played and will continue to play in the Research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, Nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored Research. This 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. In the conduct of public/private Research relationships, all relevant parties shall 1) conduct or sponsor Research that is factual, transparent, and designed objectively, and, 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) ensure, before the commencement of studies, 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; 8) require that academic Researchers, when they work in contract Research organizations (CRO) or act as contract Researchers, make clear statements of their affiliation; and require that such Researchers publish only under the auspices of the CRO.