UB Breakthroughs Summer 2016

The UB Breakthroughs newsletter for summer of 2016. This issue contains articles discussing Dr. Faezipour's research into a smartphone app for skin cancer detection, Dr. Katsifis' research into the mutagenic and carcinogenic effects of heavy metals, Dr. Oberleitner’s research into the link between social isolation and exclusion and physical and emotional pain, Dr. Lee’s classes and camps teaching college and high school students big data analytics, professor Good’s study into teaching chiropractic warm-up with resistance bands, professor Brett’s research into the safety and efficacy of electro-acupuncture, Dr. Picardi’s research into employee and employer perceptions and how to create better matches in employment, Dr. Richmond’s new book examining African-American student activism in the northeast from the 1960s through 2015, Dr. Xiong’s new MEMS-based sensor for detecting miniscule air pollutants, UB’s 3-D Printing and Advanced Manufacturing Center, Dr. Wei’s study of China and international relations regarding the South China Sea, and Dr. Pallis’ support of the UB CanSat Competition team

Innovation in Regulatory Science: Metrics for Evaluation of Regulatory Science Claims Based on Best Available Regulatory Science

This paper describes the historical evolution of the Best Available Science concept leading to Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC). The paper identified five BARS Principles consisting of Open-mindedness, Skepticism, Scientific Rules, Ethical Rules, and Reproducibility. These Principles lead to three pillars. The pillar of Standardization consists of Proven Science (scientific laws and their applications); Evolving Science, consisting of Reproducible, Partially Reproducible, Association Based, Hypothesized Evolving Science; Borderline Science (Judgement and Speculation); and Fallacious Information. The pillar of Reliability includes Personal Opinions, Gray Literature, Peer-reviewed, and Consensus-processed Science. The final pillar describes areas Outside the Purview of Science, implying that societal objectives, ideology, or any other non-scientific issue are not science but policies. The separation of science from non-scientific issues and processes is a key element of regulatory science.https://doi.org/10.21423/jrs-v05n01p050 (DOI assigned 4/17/2019

Regulating Ionizing Radiation Based on Metrics for Evaluation of Regulatory Science Claims

This article attempts to reconcile differences within the relevant scientific community on the effect of exposure to low levels of ionizing radiation notably the applicability of linear nonthreshold (LNT) process at exposures below a certain limit. This article applies an updated version of Metrics for Evaluation of Regulatory Science Claims (MERSC) derived form Best Available Regulatory Science (BARS) to the arguments provided by the proponents and opponents of LNT. Based on BARS/MERSC, 3 categories of effects of exposure to ionizing radiation are identified. One category (designated as S) consists of reproducible and undisputed adverse effects. A second category (designated as U) consists of areas where the scientific evidence for potential adverse effects includes uncertainties. The scientific evidence in the U category leads to a threshold. In contrast, the scientific foundation of the third category (designated as P) is questionable, as the scientific evidence indicates that adverse effects of the exposure at this level are not only questionable but may be helpful. This article claims that the third area is the domain of policy makers including regulators. This article describes Jeffersonian Principle that categorizes the affected community into specialists, knowledgeable nonspecialists, and the general public. Based on Jeffersonian Principle, the relevant scientific information, particularly the U and P areas, must be translated into a language that at a minimum is understandable to the knowledgeable group. Once this process is completed, the policy makers including regulators may select exposure limits based on their judgment

Regulatory Science: The Maturation of an Evolving Scientific Discipline

Regulatory science encompasses the participation of a large array of scientific disciplines involved in the regulatory process. Although each discipline addresses different phenomenology and exploits different methodologies, the common scientific core is the same:  objective pursuit of verifiable and useful knowledge.  This paper updates the definition and scope of the practice of regulatory science, starting with a concise historical overview. It then examines the different phases of regulatory science applications: initial, exploratory, and standard operating. The paper also reviews the definitions of regulatory science used by various agencies and provides abbreviated scientific definitions. The paper summarizes Best Available Regulatory Science (BARS) and Metrics for Evaluation of Scientific Claims (MERSC), along with key elements and tools of regulatory science: peer review; regulatory science ethics, including the so-called Jeffersonian principle; mathematical models; cost benefit analysis; and stakeholder participation. The paper concludes with a brief description of these key tools and elements, highlighting their importance in the field of regulatory science

Regulatory Science Education: The Need for Generalization

Ever since the beginning of regulatory science, the need for relevant education has been recognized. However, after the Food and Drug Administration (FDA) officially recognized regulatory science, several universities have developed educational programs. This paper provides the results of a study to evaluate the existing education programs on regulatory science. The study identifies the generic definition of regulatory science, consisting of applied version of various scientific disciplines used in the regulatory process. The study found that the educational programs in regulatory science largely dealt with compliance with FDA regulations. In many cases, the programs used the term "regulatory affairs" to describe the regulations and how to comply with them. Based on the experience at Georgetown University, the study provides an outline for regulatory science education. The proposed educational program consists of: 1) approximately 10 topics that are relevant to most, if not all, regulatory science disciplines; 2) a summary of various regulatory science disciplines; and 3) education in specific regulatory science disciplines. https://doi.org/10.21423/jrs-v08moghiss

Regulatory Science Transparency: Assessment Of Environmental Protection Agency’s Proposed Rule on Strengthening Transparency in Regulatory Science

In its proposed rule, Strengthening Transparency in Regulatory Science, the Environmental Protection Agency (EPA) requires transparency in certain areas of regulatory science. The proposed rule mandates public access to the details of studies that address dose response and models. This paper is the result of a study conducted by graduate students at Georgetown University. The study relied upon a specific process for selecting a small number from an exceptionally large number of responses to study the subject. The evaluation of the responses was largely based on Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims derived from BARS. The results of the study indicate that opposition to the EPA's proposed rule is largely based on the claim that its implementation would eliminate key studies that contain confidential data from consideration during the regulatory process. Although the proposed rule would allow exemptions from the public access requirements, there is opposition to making exemptions available at the discretion of the EPA Administrator. The study concluded that a regulatory science process called "controlled transparency" would be a reasonable solution to compliance with transparency requirements while protecting confidential information.https://doi.org/10.21423/jrs-v07moghiss