Promoting and Safeguarding Public Trust in Promoting and Safeguarding Public Trust in Nutrition Science Cutberto Garza, MD, PhD, Boston College, Chair, ASN Advisory Committee on Ensuring Trust in Nutrition Science

Advisory Committee Charge Develop recommendations for the ASN Board of Directors that identify best practices to ensure transparency, objectivity, and comprehensiveness in ASN’s internally and externally sponsored deliberations and activities with the aim of assuring Civil Society’s trust and access to the best science.

Desired Outcomes Recommended practices to support the best science attainable with the highest levels of rigor and transparency. A high-profile, supporting publication available to all interested parties for reference purposes. Adoption of best practices by ASN and other professional societies and organizations. Creation by ASN of a guide to assist the public in objectively evaluating the scientific rigor and transparency of nutrition research and its findings with confidence.

Committee Roster Vinita Bali: Chair of Global Alliance for Improved Nutrition, GAIN Catherine Bertini: Syracuse University Eric Campbell: Harvard University, School of Medicine Edward Cooney: Retired, Former Exe Dir Congressional Hunger Center Cutberto Garza (Chair): Boston College Michael McGinnis: National Academy of Medicine Sylvia Rowe: SR Strategy Robert Steinbrook: Yale University Carol Tucker-Foreman: Consumer Fed of America, Food Policy Institute Catherine Woteki: Retired, USDA John Courtney (ex-officio member): ASN Patrick Stover (ex-officio member): Cornell University Judith Alonzo (Graduate Student): Cornell University Marth Field (Senior Research Associate): Cornell University Sarah Ohlhorst (Research Associate): ASN

Framework: Domains of Interest DHHS Office of Research Integrity  Data acquisition, management, sharing, and ownership; Mentor/trainee responsibilities; Publication practices and responsible authorship; Peer review Collaborative science Human subjects; Research involving animals; Research misconduct; Conflict of interest and commitment ASN Advisory Committee Public Benefit Public Trust Scientific Rigor COI & Objectivity Transparency, Equity Communications Accountability

Public Benefit e.g., clear identification of the (a) benefits, (b) beneficiaries, (c) framework for the realization of anticipated benefits, (d) support necessary for their attainment and (e) losers, if any.

Public Trust e.g., to be useful the term must be supported by the identification of the specific public(s) of interest and the public’s expectations must be clearly delineated, as must be the importance of meeting those expectations. It is similarly helpful to also consider the consequences of success or failure in meeting expectations in considering the term “public trust.”

Scientific Rigor e.g., actively ensure that research designs, methods, and analytical approaches that are used enable appropriate levels of accuracy and precision of findings and that conclusions are supported by evidence.

Transparency, COI & Objectivity, and Equity e.g., protect the integrity of the research process and its results, manage potential and actual biases due to financial and other forms of conflict of interest, and insure the inclusivity, and generalizability of research findings, actively minimizing the actual or potential for fraud and other forms of misrepresentation.

Communications e.g., support/enable effective and accurate communication with all sectors of society of new knowledge by scientists, journalists, advocates, stakeholders, and government officials. Have a voice in the scientific literacy agenda

Accountability e.g. monitor, support, and take remedial actions when necessary to instill confidence in the adherence to best practices in each of the foregoing domains of trust and in those identified by the DHHS’ Office of Research Integrity.

Process Initial “Face-to-face” mtg Follow-up monthly calls as needed Survey reviews Systematic literature search Review of relevant publications Stakeholder outreach Drafting

Search Strategy Six libraries were generated: 1-Public Benefit, 2-Scientific Rigor, 3-Conflict of Interest, 4-Communications, 5-Accountability, 6-Public Trust

Search Strategy Relevant publications in each of the interest domains will be identified by searching three different information sources: (1) surveys, (2) peer-reviewed literature, and (3) grey literature.

Surveys Multiple databases were queried for data relevant to the committee’s charge and expected outcomes: GSS data explorer from NORC at the University of Chicago (https://gssdataexplorer.norc.org/) 2.   Public Agenda (https://www.publicagenda.org/) 3.   iPoll/the Roper Center at Cornell University (https://ropercenter.cornell.edu/) 4.   IFIC (http://www.foodinsight.org/research) 5.   The Harman Group (http://www.hartman group. com/).

Surveys Search parameters were adjusted to identify any broadly defined “science-related” surveys. Search parameters were adjusted to include, but not limited to, the following terms: GMO, vaccines, food, and science. Two members independently screened all survey databases.

Peer-reviewed Literature Multiple databases were queried for publications relevant to the previously identified interest domains: 1. Web of Science-Core Collection, 2. PubMed, 3. PAIS Index, and CABI: CAB Abstracts and Global Health

Literature Review The search identified approximately 8150 potentially relevant reports. Evaluation of these publications occurred in three stages. Stage 1: Publications were scanned initially using the following criteria, applied broadly: Clear statement of goal/hypothesis or equivalent relevant to committee’s charge A literature review/background with an identifiable underlying rationale/strategy Clear description of methodologies, design, and analyses

Literature Review Stage 2: Publications meeting those criteria were screened for two additional criteria by two committee members : Is the manuscript grounded in research or opinion? If opinion-based, are opinions from authoritative sources? Are they relevant to the group’s charge and expected outcomes? If research based, is the research relevant to any of the interest domains identified in the search strategy? Stage 3 In depth reviews were conducted of all publications assessed to be relevant in Stage 2. A list of publications reviewed in depth was posted in the Stakeholder Outreach website to assist identifying key publications that may have eluded the search “net” cast by the literature search.

Grey Literature Two databases were consulted: OpenGrey, and the NY Academy of Medicine Grey Literature Report.

Grey Literature Review Not yet examined. If carried through, the screening process is projected to be adapted from the process used for the peer reviewed literature.

Stakeholder Outreach Initiated in January, ’17 Closed at the end of February, ‘17. Who: ASN membership (5000+) and > 20 stakeholder organizations. Eight questions/requests were posed and literature search results were shared: 1. What are the 3 most important issues to address? 2. Views re use by ASN of funds with potential conflicts of interest? 3. If such funding is acceptable, its basis and essential safeguards.  4. If not, reasons for expressed views. 5. Key publications for inclusion in the committee’s literature review? 6. Are all relevant domains/concerns being addressed? 7. If not, what is missing? 8. What additional information do you wish to share?

Survey Search Results Information directly relevant to food and nutrition identified in the survey databases was very limited. And in the view of the reviewing group consistent with publications in the peer reviewed literature.

Search Results: Peer Reviewed Databases Number of Peer-Reviewed Articles for each Library   Peer-reviewed articles Nutrition+trust Nutrition+trust >2010 Public Benefit 101 N/A Scientific Rigor 731 Conflict of Interest 21,142 9,733 40 Communication 146,331 64,420 136 Accountability 131,969 48,440 105 Public Trust 647

Search Results: Grey Literature Number of Grey Literature Articles for each Library   Grey Literature Public Benefit 1 Scientific Rigor 2 Conflict of Interest 478 Communication 8,338 Accountability 2,509 Public Trust 4

Chair’s Initial Impressions Plethora of opinions re best practices Paucity of reasonably documented evidence of best practices related to scientific societies Even greater paucity of evidence gathered primarily to address food and nutrition interests

Remaining Tasks and Timeframe Iterative committee process: Drafting Finalizing Recommended “Best Practices” Reporting to ASN board of directors ASN process takes over: adoption and ongoing monitoring, and assessing