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HHS and NIH Request Public Comments on Steps to Enhance Transparency of Clinical Trial Results

The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) are releasing for public comment two proposals to increase the transparency of clinical trials via information submitted to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine. The first is a Notice of Proposed Rulemaking (NPRM) that describes proposed regulations for registering and submitting summary results of certain clinical trials to ClinicalTrials.gov in compliance with Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products. The second proposal is a draft NIH policy that would extend the similar registration and reporting requirements to all clinical trials funded by NIH, regardless of whether they are subject to FDAAA. Both proposals aim to improve public access to information about specified clinical trials, information that is not necessarily available from other public sources. The proposals are not intended to affect the design or conduct of clinical trials or define what type of data should be collected during a clinical trial. Rather, they aim to ensure that information about clinical trials and their results are made publicly available via ClinicalTrials.gov. A summary of the proposed changes is available from the NIH.

The public may comment on any aspect of the NPRM or proposed NIH Policy. Written comments on the NPRM should be submitted to docket number NIH-2011-0003. Commenters are asked to indicate the specific section of the NPRM to which each comment refers. Written comments on the proposed NIH Policy should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email; mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; or by fax at 301-496-9839, by February 19, 2015. All comments will be considered in preparing the final rule and final NIH Policy.

OCLC Announces Community Health Engagement Opportunity for Public Libraries!

As part of its IMLS-funded Health Happens in Libraries program, OCLC is seeking up to five public libraries wishing to collaborate with a local partner to develop and implement community health activities. These activities, to be conducted with the Health Happens in Libraries team from January through July 2015, will support the goals of each participating library and their partner(s), and enhance public library capacity to advance health and wellness priorities in the communities they serve. Activities may include a range of services, such as a workshop on healthy family meal planning, or training to patrons seeking reliable online health information. In addition to stipend support for any related travel, participating libraries will also be eligible to receive $500 for supplies, materials, or other necessary expenses to meet their goals. Actual time commitment will ultimately be proportional to the engagement goals of each library community

The Participant Overview provides a full description of this opportunity, including how to submit a statement of interest for your library to be considered for this exciting work. If interested in participating in this 7-month project, please submit a statement of interest by 5:00 PM PST Tuesday, December 9, 2014. Selected libraries will be notified by December 31, 2014. A panel will review all statements in an effort to select a variety of libraries, representing diverse perspectives and communities. Questions about the program may be directed to the Project Coordinator, Liz Morris.

New NN/LM PSR Resource Library Director: Mary Shultz

Mary Shultz

In June, the University of Nevada School of Medicine welcomed Mary Shultz as the new director of the Savitt Medical Library in Reno. She will also oversee the medical library operations and programs at the Las Vegas campus of the School of Medicine. Mary was previously at the University of Illinois at Chicago (Urbana regional site), where she was regional head librarian and worked extensively with learners, faculty and community partners. She received her master’s degree in library and information science from the University of Illinois at Urbana-Champaign in 1997 before first working as a resident librarian at the University of Illinois Library of the Health Sciences in Chicago from 1997 to 1999, and then as the assistant health sciences librarian at the Library of the Health Sciences-Urbana from 1999-2007. In the assistant role, Mary was responsible for all instruction and reference services, and in collaboration with faculty from the Colleges of Medicine and Nursing, built a program of course-integrated library instruction across the curricula. For the last seven years, she was the regional head and was responsible for all operational aspects of the site library.

Mary has a strong history of collaborating with faculty from Medicine and Nursing, the local hospital libraries, and her colleagues across the University of Illinois library system. Her research interests include the accuracy of mapping mechanisms of search terms to the Medical Subject Headings and the relationship to information loss. She has published on this and other topics in peer-reviewed journals and has regularly presented at the Medical Library Association’s annual meetings.

Please join us in welcoming Mary to the region!

Turn the Pages of a Rare Book on Mongolian Astrology from the NLM Collections

The National Library of Medicine announces the release of a new Turning the Pages virtual book on its Web site, via iPad App, and in kiosks onsite at the NLM. The new project features selections from a colorfully illustrated 19th-century manuscript from Mongolia on astrology and divination following Mongolian and Tibetan Buddhist traditions.

Basics of Mongolian AstrologyThis Turning the Pages project includes a selection of 15 images from the over 40 pages in the Mongolian Book of Astrology and Divination, along with a curator’s descriptive text, putting many divine figures and astronomical charts into context for a modern Western audience. For instance, many of the astrological factors calculable among the charts corresponded to different organs of the body or life events such as birth, old age, illness, and death. The ultimate goal was keeping one’s life in balance with the cosmos, using the calculations in this manuscript to choose an auspicious time to begin a new project, conceive a child, receive a treatment, or even remove the corpse of a loved one from one’s home.

Launched at the NLM in 2001, Turning the Pages represents an ongoing collaboration between research engineers at the Lister Hill National Center for Biomedical Communications and curators and historians at the NLM’s History of Medicine Division, to help make the NLM’s rare and unique history of medicine collections widely available to the public. To date, Turning the Pages has offered the public access to a wide range of early printed books and manuscripts that span centuries, cover topics from surgery and anatomy to botany and horse veterinary medicine, and originate from places as diverse as Iran, Japan, Egypt, Italy, and now Mongolia. The NLM’s copy of Mongolian Book of Astrology and Divination is just one item from its Buddhist Mongolian and Tibetan materials relating to health and disease. The Library holds one of the world’s largest collections of early books relating to East Asian health and medicine.

Chemical Hazards Emergency Medical Management (CHEMM) Updates

CHEMM WebsiteThe National Library of Medicine (NLM) has released a new version of Chemical Hazards Emergency Medical Management (CHEMM). CHEMM is a Web-based resource that can be downloaded in advance to Windows and Mac computers to ensure availability during an event if the Internet is not accessible. CHEMM’s content is also integrated into the NLM Wireless Information System for Emergency Responders (WISER), which is Web-based and downloadable to Windows computers. CHEMM’s content is also available in WISER’s iOS and Android apps. The new CHEMM content will be incorporated into the next release of WISER.

New or updated content in CHEMM includes:

  • Updated and enhanced content on Decontamination Procedures, Discovering the Event, and Training and Education
  • An NIH CounterACT program funded database with information on twenty-two medical countermeasures (including efficacy, relevant publications, research in progress, FDA and other global regulatory status information)
  • Content for how emergency responders can recognize and handle events dealing with toxic gases generated by the combinations of consumer products or common household chemicals
  • A workshop report describing toxic chemical syndromes, or toxidromes, that lays the foundation for a consistent lexicon for use in CHEMM and for other uses that, if adopted widely, will improve response to chemical mass exposure incidents
  • A toxidromes outreach plan whose goal is to raise widespread awareness and encourage use of the toxidromes throughout the stakeholder community, and
  • An evaluation and validation plan for CHEMM’s Intelligent Syndromes Tool (CHEMM-IST) that, once completed, will move CHEMM-IST from its current state as a prototype to a product ready for use in an operational response environment.

For more information see the “What’s New on CHEMM?” section of CHEMM.

November 2014 Issue of NIH News in Health Now Available!

Composite illustration of a couple dancing, a woman swimming, a scale, diary, and vegetables.Check out the November issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research. In this issue:

  • Preventing Type 2 Diabetes: Steps Toward a Healthier Life
    People with diabetes have a problem with blood sugar. Their blood sugar, or blood glucose, can climb too high. Having high levels of sugar in your blood can cause a lot of trouble. Diabetes raises your risk for heart disease, blindness, amputations, and other serious issues. But the most common type of diabetes, called type 2 diabetes, can be prevented or delayed if you know what steps to take.
  • Parkinson’s Disease: Understanding a Complicated Condition
    We rely on our brains for every movement we make, whether writing, walking, talking, or even sleeping. But a serious brain disorder like Parkinson’s disease can rob a person of the ability to do everyday tasks that many of us take for granted. There’s no cure, but treatment can help. And researchers continue to seek new understanding to improve medical care.
  • Progress Toward a Bird Flu Vaccine
    An experimental bird flu vaccine triggered a powerful immune response in more than half of the volunteers who received it. The approach might lead to better vaccines against a variety of flu viruses.
  • Participating in Alzheimer’s Research
    Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills. Eventually, affected people can’t perform even simple tasks. There’s no cure, but researchers are now testing new ways to diagnose, treat, or even prevent Alzheimer’s disease.
  • Featured Website: Safe to Sleep
    Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1 month and 1 year of age. Find out how you can reduce your baby’s risk of SIDS and other sleep-related causes of infant death.

NIH News in Health is available online in both HTML and PDF formats. Print copies are available free of charge for offices, clinics, community centers, and libraries within the U.S. Visit the NIH News in Health Facebook page to suggest topics you’d like to see covered, or share what you find helpful about the newsletter!

NIH Request for Information on Data Management and Data Science

The NIH has issued a Request for Information (RFI) on the NIH Big Data to Knowledge (BD2K) Initiative Resources for Teaching and Learning Biomedical Big Data Management and Data Science, with a submission deadline of December 31, 2014. As part of its Big Data to Knowledge (BD2K) Initiative, NIH wishes to help the broader scientific community update knowledge and skills in the important areas of the science, storage, management and sharing of biomedical big data, and wants to identify the array of timely, high quality courses and online learning materials already available on data science and data management topics for biomedical big data. With this RFI Notice, the NIH invites interested and knowledgeable persons to inform NIH about existing learning resources covering Biomedical Big Data management and data science topics. All responses must be submitted electronically by December 31, 2014, in the form of an email, using the subject “data management.” PPT files or other curriculum materials should not be attached to responses. Responses are welcome from associations and professional organizations as well as individual stakeholders.

NLM Resource Update: Environmental Health Student Resources

The National Library of Medicine (NLM) provides online environmental health student resources for students in grades 1-12. The information and data in the following resources are free and vetted by science professionals. The resources can be used by science educators in their classrooms, in after school programs, in home school programs, and by students for their academic research assignments.

  • Environmental Health Student Portal (Grades 6-8): Provides middle school students and educators with information on common environmental health topics such as water pollution, climate change, air pollution, and chemicals.
  • Toxicology Tutorials (Grades 9-12+): Teach basic toxicology principles; written at the introductory college student level.
  • Household Products Database (Grades 6-12+): Learn about the potential health effects of chemicals in common household products ranging from personal hygiene products to landscape care products.
  • ToxTown (Grades 6-12+): Interactive guide to commonly encountered toxic substances. Includes classroom materials. Also available in Spanish.
  • TOXMAP (Grades 9-12+): Uses maps of the United States to visually explore Superfund and Toxic Release Inventory (TRI) sites and data from the EPA. Includes classroom materials.
  • Native Voices Exhibition Lesson Plans & Activities (Grades 6-12): Familiarize students with Native American, Alaska Native and Native Hawaiian healthcare by using the NLM Native Voices exhibition Web site content materials.
  • ToxMystery (Grades 1-5): Teaches elementary school students about toxic substances in the home. Game format; includes lesson plans and activities. Also available in Spanish.

NLM’s Refugee Health Information Network (RHIN) Rebranded as HealthReach

The National Library of Medicine’s Refugee Health Information Network (RHIN) resource was a national collaborative partnership with the principal focus of creating and making available a database of quality multilingual/multicultural, public health resources to professionals providing care to resettled refugees and asylees. In October, 2014, NLM’s Specialized Information Services (SIS) broadened the scope of RHIN by rebranding it HealthReach. This was done to better meet the needs of the diverse non-English and English as a second language speaking audiences. HealthReach continues to recognize the importance of providing refugee and asylee specific information while expanding the information provided to meet the needs of most immigrant populations. Over the next several months new resources will be added to the web site. There is also a new Twitter feed, @NLM_HealthReach. There isn’t much change between the old RHIN and the new HealthReach; this was intentional to help with the continuity of service through the transition.

Padlet: A Free Virtual Bulletin Board and Brainstorming Tool

A recent AEA365 Evaluation Tip-a-Day featured a review and several hot tips for Padlet, a freely available web-based bulletin board system. The hot tips include the use of Padlet as an anonymous brainstorming activity in response to a question or idea, and as a backchannel for students or conference attendees to share resources and raise questions for future discussion. Padlet’s bulletin board configuration settings are intuitive and easy to use with various backgrounds and freeform, tabular, or grid note arrangement display on the bulletin board. Free Padlet accounts can be created by either signing up directly or by linking to an existing Google or Facebook account. Padlet includes many privacy options that are clearly explained, including “Private” mode, requiring the use of a password for you and those you invite to participate to access the Padlet, and “Public” mode to view, write or moderate. A new update feature includes a variety of ways to share Padlet data, ranging from choosing the icon for six different social media channels to downloading data as a PDF or Excel/CSV file for analysis. For a trial run of this resource, visit the NN/LM Outreach Evaluation Resource Center’s Padlet about the OERC Evaluation Series booklets and leave your input! Posts will be moderated on the Padlet before they display publicly.