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Based on a comprehensive analysis of the scientific evidence, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA has determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the FD&C Act. The salmon are safe to eat, the introduced DNA is safe for the fish itself, and the salmon meet the sponsor's claim about faster growth. Because the sponsor has met these requirements, the FDA must approve the application. The FDA has also analyzed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the quality of the human environment in the United States and has issued its final Environmental Assessment and Finding of No Significant Impact.

More than 400 scientists, bioethicists, and historians from 20 countries on 6 continents have gathered this week in Washington, DC, for the Human Gene Editing Summit. The attendees are a veritable who's who of genome editing: Jennifer Doudna of the University of California, Berkeley, Emmanuelle Charpentier of Max Planck Institute for Infection Biology, and Feng Zhang of the Broad Institute of MIT and Harvard-the three discoverers of the CRISPR-Cas9 system's utility in gene editing-plus dozens of other big names in genome science. Cal Tech's David Baltimore along with the heads of the four national societies hosting the meeting (US National Academy of Sciences, US National Academy of Medicine, Chinese Academy of Sciences, and the U.K.'s Royal Society) provided opening remarks on Tuesday (December 1). And as I sat stage right in the NAS auditorium, I noticed the unmistakable rear profile of Harvard Medical School's George Church three rows in front of me. Church was scheduled to speak at a session later that afternoon about the application of CRISPR and other new precision gene editing techniques to the human germline-a hot-button topic since April, when a Chinese group published it had successfully modified the genomes of human embryos, and the National Institutes of Health (NIH) said it would not fund such research. Then in September, the U.S./U.K.-based Hinxton Group, an international consortium of scientists, policy experts, and bioethicists, said it supported the use of genetic editing in human embryos for limited applications in research and medicine.  

This directed case study was developed to introduce students to the CRISPR-Cas9 system for genome editing. CRISPR-Cas9 has made numerous headlines in both the scientific and popular press, and thus serves as an excellent model for learning current biotechnology and applying concepts from biology courses. After providing a general overview of CRISPR-Cas9, the majority of the case focuses on the clinical applications of the system as experienced by a carrier for the X-linked recessive allele underlying Duchenne Muscular Dystrophy. The case is structured so that students use a variety of popular and scientific sources (some of which may require a subscription to access-check with your institution), increasing in difficulty as they move through each part of the case. The goals are for students to learn the molecular mechanisms of CRISPR-Cas9, the benefits and limitations of the system, and the clinical applications of the technology. Open-ended questions are included to spark discussion of ethical considerations, societal impacts, and the overall implications of the technology.

Dubilier is hardly alone in her plight. A heaping teaspoon of soil or a shot of ocean water may contain as many as one million bacterial species. Many of them are potential gold mines of chemicals and metabolites with medicinal, engineering, and energy applications. But when researchers have tried to culture these microbes in the lab, only a minority of cells form colonies. Clearly, nutrients, a carbon source, and time are usually not enough to coax bacteria isolated from the wild to grow in a laboratory setting. So what's the missing ingredient?

This interrupted case is based on a genome wide association study (GWAS) that identified the genetic variation causing some inhabitants of the Solomon Islands to have blond hair. The case illustrates the connection between genotype and phenotype, and an application of Hardy-Weinberg equilibrium. The narrative focusses on John and his new roommate, Peter, from the Solomon Islands who happens to have dark skin and blond hair. Using thought-provoking questions students learn about the genetics and the biochemistry of the hair color trait and how a single genetic variation can influence phenotype. Is migration or mutation involved?  Upon completion of the activity students will know the source of the genetic variation that causes the blond hair phenomenon in the Solomon Islands and if it has any European origins. The case was written for an upper-level genetics course, but could also be adapted for introductory biology or for a genetics course for non-majors. An optional PowerPoint presentation with clicker questions is available for download from within the Answer Key.

This set of mini cases on the ecology of eastern cottontail rabbits is designed to give students practical experience using statistics in a scientific context. Given a dataset and experimental design, groups of students are asked to play the part of a wildlife management researcher to determine the results for each study. Students practice the scientific process and gain experience making hypotheses and predictions, choosing an appropriate statistical test, interpreting and displaying results, and presenting data to others. Students choose between four basic, commonly used, statistical tests (t-test, one-way ANOVA, linear regression, and Chi-square test), and justify their choices. This activity was developed for undergraduate level students and is applicable to biology courses, particularly those dealing with ecology or management. The case is designed for student groups, but could be modified into clicker questions or individual assignments.

Loss of species richness is often due to anthropogenic activity. The global decline of amphibians is one such example. This case study examines the impact of road deicing agents on amphibians living near bridges and roads treated heavily with salt during the winter months. Concepts explored in this case include changes to the aquatic environment as a result of road deicing applications, bioaccumulation, osmoregulation in amphibians living in clean freshwater, and the impact of increased aquatic salinity levels on the ability of amphibians to adequately osmoregulate in an environment for which they are not adapted. Three short videos created by the author can be shown in class or assigned for viewing in advance for a "flipped" classroom approach. Originally developed for a general education/introductory biology course, the case could also be used with introductory level animal anatomy and physiology courses as part of a deeper exploration of the renal system.

Nanotechnology Center for Learning and Teaching (NCLT) is conceived to train a nano science and technology literate workforce that can solve global problems by implementing a three-pronged strategy: 1. Publish integrated STEM instructional modules with nano-based applications; 2. Offer professional training through workshops, lectures and seminars; 3. Develop a network of multi-sector nano education communities.

Promotes accurate understanding and comprehensive teaching of evolutionary theory for a wide audience Explores the practical applications of evolutionary principles in daily life and the impact of evolutionary theory on culture and society throughout history Offers teaching tools such as unit and lesson plans and classroom activities, as well as additional online content such as podcasts and powerpoint presentations

Session description: The session will provide an introduction to the ethics of research involving human participants. It will ad-dress the history of research ethics, present a contemporary eth-ical framework, and discuss its application to differing kinds of research studies. The ethical framework consists of four principles: respect for persons, beneficence, justice, and respect for communities. Each principle provides the foundation for ethical rules, including requirements for informed consent and confidentiality of health information. Taken together these ethical principles and rules provide a comprehensive framework for the analysis of ethical challenges in health research.

Many biology courses are designed to develop student understanding and application of the scientific method, but few seriously examine the various ethical questions associated with scientific research. This interdisciplinary case study presents three experiments and asks not only if they are scientifically valid but whether they were ethically performed.  The experiments examine the psychology of love, a cause of breast cancer, and how the immune system functions in the presence of cancer. Based on their opinions of the validity and ethics of each experiment, students are asked to conclude which of the experiments were actually conducted by scientists and which are fictional. Students should already be familiar with the scientific method, but information on the Georgetown Mantra and Nuremberg Code.is included. The case could be modified for use in non-majors and majors classes.  The format of the case challenges students of any background to use information from both science and ethics to see how the differing approaches of scientist and ethicist can complement and strengthen each other.

This case study presents the story of "Nick," a student who has been assigned the task of writing a research paper describing the fundamentals of chemical bonds and how they relate to human life. When Nick experiences difficulty remembering information about the different types of chemical bonds, he turns to his tutor, Josh, for help. Josh explains orbitals and valence electrons to Nick, and then they together review nonpolar and polar covalent bonds, ionic bonds, and hydrogen bonds. A final practical application exercise requires that students write about how different types of chemical bonds may relate to the development of Alzheimer's disease and to the mechanism of action of potential drug treatments.  The case is presented with PowerPoint slides and is designed to be used with a personal response system ("clickers"), but students can instead record their answers on paper or share them verbally.  The content is appropriate for use in high school and undergraduate introductory chemistry and biology courses.

As the leader of a project called Finding of Rare Disease Genes (FORGE) in Canada, Kym Boycott is one of the top experts in the world in the application of exome sequencing to solve rare disorders. The Canadian project involves a network of doctors and scientists all across the country looking to identify patients with rare childhood conditions and refer them when appropriate for sequencing and analysis.

The mouse is the leading organism for disease research. A rich resource of genetic variation occurs naturally in inbred and special strains owing to spontaneous mutations. However, one can also obtain desired gene mutations by using the following processes: targeted mutations that eliminate function in the whole organism or in a specific tissue; forward genetic screens using chemicals or transposons; or the introduction of exogenous transgenes as DNAs, bacterial artificial chromosomes (BACs) or reporter constructs. The mouse is the only mammal that provides such a rich resource of genetic diversity coupled with the potential for extensive genome manipulation, and is therefore a powerful application for modeling human disease.

Vector control is a fundamental element of the existing global strategy to fight malaria. Vector control interventions have a proven track record of successfully reducing or interrupting disease transmission, particularly in areas that are highly prone to malaria. Indoor residual spraying (IRS) and long-lasting insecticidal nets (LLINs) are the two core, broadly applicable malaria vector control measures. This section covers both core and supplementary vector control methods and discusses the action that is required to prevent and manage the increasing challenge of malaria vector resistance to insecticides.

Problem-based learning (PBL) is an exciting way to learn biology and is readily incorporated into large classes in a lecture hall environment. PBL engages students in solving authentic biological case problems, stimulating discussion among students and reinforcing learning. A problem-based learning environment emulates the workplace and develops self-directed learners. This is preferable to a mimetic learning environment in which students only watch, memorize, and repeat what they have been told. The examples given here are suitable for use in a first year college biology lecture theater, but the method is applicable to any class size and educational level. [A more detailed explanation of PBL in Biology may be found in Chapter Four of INSPIRING STUDENTS, published in 1999 by Kogan Page.]

Avida-ED is an award-winning educational application developed at Michigan State University for undergraduate biology courses to help students learn about evolution and scientific method by allowing them to design and perform experiments to test hypotheses about evolutionary mechanisms using evolving digital organisms.

Officials in Panama have ruled that AquaBounty Technologies' has been operating in violation of environmental regulations as it experiments with genetically engineered (GE) salmon in that country. In a decision that could challenge the U.S. Food and Drug Administration's (FDA) ongoing safety assessment of AquaBounty's GE salmon, Panamanian officials fined the company $9500. Food & Water Watch, Center for Food Safety and Friends of the Earth called on the FDA today to terminate its regulatory review and deny AquaBounty's pending regulatory application to sell the company's GE fish in the United States.

Tweaking the human genome with current and future gene-editing tools could lead to sophisticated treatments and prevention strategies for disease. The promise of those applications is reason enough to move forward with such work in the lab and clinic, albeit cautiously, the dozen scientists and bioethicists who organized the International Summit on Human Gene Editing said today after three days of deliberation and presentations in Washington, D.C.

This animation depicts the CRISPR-Cas9 method for genome editing - a powerful new technology with many applications in biomedical research, including the potential to treat human genetic disease. Feng Zhang, a leader in the development of this technology, is a faculty member at MIT, an investigator at the McGovern Institute for Brain Research, and a core member of the Broad Institute. Further information can be found on Prof. Zhang's website at http://zlab.mit.edu .