NIH Expedited Reporting • Requirements for reporting vary by institute Institute NCCAM: NCI: NEI: NHLBI: NIA: NIAID: NIAMS: NICHD: NIDA: NIDCR: NIDDK: NIMH: NINDS: Data and Safety Monitoring Policies http://nccam.nih.gov/research/policies/datasafety/ http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm http://www.nci.nih.gov/clinical_trials/conducting/ http://www.nei.nih.gov/funding/policy/policy6.htm http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm http://rover2.nhlbi.nih.gov/funding/policies/dsm-12.htm http://rover2.nhlbi.nih.gov/funding/policies/dataqual.htm http://www.nhlbi.nih.gov/funding/policies/dsmb_othr.htm http://www.nia.nih.gov/funding/policy/humint.htm http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf http://www.niams.nih.gov/rtac/clinical/dsmb3.html http://www.niams.nih.gov/rtac/funding/grants/datasafe.htm http://www.nichd.nih.gov/funding/datasafety.htm http://www.nida.nih.gov/Funding/DSMBSOP.html http://www.nidcr.nih.gov/research/ctp/data_safety_monitoring_boards.pdf http://www.niddk.nih.gov/patient/patient.htm#policy http://www.nimh.nih.gov/research/safetymonitoring.cfm http://www.ninds.nih.gov/funding/ninds_patient_safety_guidelines.htm
View full slide show




Federal Regulation Agencies Consumer ConsumerProduct Product Safety Commission Safety Commission http://www.cpsc.gov http://www.cpsc.gov Department Departmentof ofLabor Labor http://www.dol.gov http://www.dol.gov Environmental EnvironmentalProtection ProtectionAgency Agency http://www.epa.gov http://www.epa.gov Equal EqualEmployment Employment Opportunity OpportunityCommission Commission Federal FederalCommunications Communications Commission Commission 3.4 http://www.eeoc.gov http://www.eeoc.gov http://www.fcc.gov http://www.fcc.gov Federal FederalReserve ReserveSystem System http://www.federalreserve.gov http://www.federalreserve.gov Federal FederalTrade TradeCommission Commission http://www.ftc.gov http://www.ftc.gov Food Foodand andDrug DrugAdministration Administration http://www.fda.gov http://www.fda.gov National NationalLabor LaborRelations RelationsBoard Board http://www. http://www.nlrb.gov nlrb.gov Occupational OccupationalSafety Safetyand and Health Administration Health Administration Securities Securitiesand andExchange Exchange Commission Commission http://www.osha.gov http://www.osha.gov http://www.sec.gov http://www.sec.gov 22
View full slide show




Resources • About the Public Access Policy: – http://publicaccess.nih.gov/ – NIH Guide Notice for Public Access (January 2008): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html – New Guide Notice for Grantee Compliance (September 2008): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html – Email Questions: [email protected] • The NIH Manuscript Submission System: – http://www.nihms.nih.gov/ – Tutorials: http://www.nihms.nih.gov/web-help/ • PubMed Central: – http://www.pubmedcentral.nih.gov/ – Educational Video: http://www.ncbi.nlm.nih.gov/Education/pmc/ – Information for Publishers: http://www.pubmedcentral.nih.gov/about/pubinfo.html 18
View full slide show




The NIH Peer Review Process Additional Information • Enhancing Peer Review Initiative http://enhancing-peer-review.nih.gov/ • Office of Extramural Research Peer Review Process http://grants.nih.gov/grants/peer_review_process.htm • Peer Review Policies & Practices http://grants.nih.gov/grants/peer/peer.htm • Center for Scientific Review http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/ 46 46
View full slide show




Extreme Questionnaire An experiment was conducted to investigate the effects of replacing the moderately worded SUS with versions with the neutral SUS Wording statements replaced by statements that were worded in an extremely positive or an extremely negative fashion. The System Usability Scale (SUS) The Extremely Positive System Usability Scale (XP-SUS) The Extremely Negative System Usability Scale (XN-SUS) 1. I think that I would like to use 1. I think that this is one of my all1. I think I never want to use the web this system frequently. time favorite web sites. site again. 2. I found the system unnecessarily 2. I found the web site was really 2. I found the web site to be horribly complex. straightforward. complex for no good reason. 3. I thought the system was easy to 3. I thought the web site was 3. I thought the web site was very use. amazingly easy to use. difficult to use. 4. I think that I would need the 4. I think that technical support 4. I think that I would need a permanent support of a technical person to services are just not required for hot-line to the help desk to be able to be able to use this system. the web site. use the web site.* 5. I found the various functions in 5. I found the various pages on the 5. I found all the pages on the web site this system were well integrated. web site worked together very to be an ugly mess. 6. I thought there was too much smoothly. 6. I thought the inconsistency in the web inconsistency in this system. 6. I thought the web site was site would kill it. 7. I would imagine that most people consistent throughout. 7. I found the web site to be completely would learn to use this system 7. I would imagine anybody could use impossible to use. very quickly. the web site like a pro from day 8. I found that this web site was 8. I found the system very one. extremely awkward to use. cumbersome to use. 8. I found the web site was a delight 9. I felt utterly confused by the web site. 9. I felt very confident using the to use. 10.Absolutely nothing about the web system. 9. I felt completely confident using the site worked 10.I needed to learn a lot of things web site. before I could get going with this 10.Everything to know about A set of volunteersI needed was asked to evaluate a website, with one-third CS 321 system. using the website was there for me. Lesson Twenty-Two Questionnaires Page 6 of the volunteers randomly assigned the traditional SUS questionnaire, one-third randomly assigned the XP-SUS questionnaire, and the final one-third randomly assigned the XN-
View full slide show




Biology Department (past participants in red) Field Biology/Ecology/Classical Genetics: Dr. Gordon Brown: Terrestrial plant ecology, ecology and evolution of interactions between plants and herbivores, Web site * Dr. Philip Chu: ornithology, systematics, Web site Dr. Larry Davis: geology, paleontology,Web site *Dr. William Lamberts: aquatic ecology, phycology, Web site (next year’s director) Dr. Jeanne Marie Lust OSB: amphibian deformities, hematology, Web site Dr. James Poff: entomology, behavioral ecology of social wasps, Web site Dr. Charles Rodell: ecological genetics, evolution of sexual reproduction, Web site Dr. Steven Saupe: plant taxonomy, secondary metabolism of plants and fungi, Web site Dr. Shawn Thomas: animal behavior and sociobiology using evolutionary theory to test hypotheses regarding mate choice and sexual selection, Web site Dr. Marcus Webster: physiological ecology, energetics of birds, Web site Cell/Molecular/Biochemistry *Dr. Barb May: immunology, microbiology, cell and molecular biology, Web site Dr. Manuel Campos: signal transduction in cells and its relation to disease, Web site Dr. Ellen Jensen: virology, biology of fungi, immunology, Web site Dr. David Mitchell: protein structure, biochemistry, Web site Dr. Michael Reagan: molecular biology, DNA repair mechanisms, Web site Dr. Elizabeth Wurdak: biology of rotifers, histology, cell biology, Web site
View full slide show




Resources • NIH RPPR Instruction Guide: http://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf • Helpful webinars and YouTube videos posted – http://grants.nih.gov/grants/rppr/ • System issues or comments – eRA Help Desk: http://grants.nih.gov/support – 1-866-504-9552 • Content questions or comments – E-mail [email protected] • SRP Annual Updates – https://tools.niehs.nih.gov/srp/resources/updates.cfm • NIH Plain Language – http://grants.nih.gov/grants/plain_language.htm • CDC Clear Communication Index – www.cdc.gov/ccindex Per Naomi Hirsch (OSU), this presentation about “Managing Compliance Using My NCBI” may be helpful to others: http://superfund.oregonstate.edu/internal 44
View full slide show




Examples from 2013 site:gov site:gov site:gov site:gov site:gov site:gov site:gov filetype:log filetype:ini filetype:conf filetype:xls filetype:xlsx filetype:doc filetype:docx filetype:rdp username 205,000 40,200 11,400 3,740,000 137,000 12,200,000 818,000 774 filetype:xls visa "12/13" filetype:xls SSN DOB 1965 site:gov site:gov site:mil site:mil filetype:mdb filetype:sql filetype:sql filetype:mdb 274 7,880 1 4 (1 in cache) site:mil filetype:ini 9 site:mil filetype:txt 696,000 site:mil noforn 95,800 inurl:allstathomehealth.com/Users filetype:rdp password inurl:https://mail.piginc.net/bidforms/LF18/115 Bldg. LF-18 NETWARCOM/Badging/ site:s3.amazonaws.com filetype:xls yourcompanyname
View full slide show




Select Resources at the NIH Grants Management Specialist on NGA - If unknown, contact Chief GMO of IC http://grants2.nih.gov/grants/stafflist_gmos.htm Program Official on NGA Division of Financial Advisory Services http://oamp.od.nih.gov/dfas/dfas.asp Office of Extramural Research http://grants.nih.gov/grants/oer.htm NIH Grants Policy Inbox (policy questions not specific to NGA) [email protected] NIH Helpdesk (technical questions) [email protected] or http://support.nih.gov/ 31
View full slide show




References: Mhealth: New Horizons for Health Through Mobile Technologies. World Health Organization. 2011 HHS.gov website on mhealth. http://www.hhs.gov/open/initiatives/mhealth/ http://www.pwc.com/us/en/health-industries/publications/the-new-gold-rush.jhtml http://www.hhs.gov/ocr/privacy/ http://www.hhs.gov/ocr/privacy/hipaa/administrative/enforcementrule/hitechenforcementifr.html http://www.jacksoncoker.com/physician-career-resources/newsletters/monthlymain/des/Apps.aspx http://www.informationweek.us/news/security/mobile/231902875 http://www.fiercemobilehealthcare.com/story/mobile-technology-implementation-now-top-mind-most-docs/2011-11-17 http://blogs.healthcareinfosecurity.com/posts.php?postID=1116 u, Y. C., Lee, J. J. K., Xiao, Y., Sears, A., Jacko, J. A., & Charters, K. (2003). Why Don’t Physicians Use Their Personal Digital Assistants? AMIA Annual Symposium Proceedings (Vol. 2003, p. 405). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1480095/?tool=pubmed Bottles, K. (2011). Physician Executives Should Not Ignore How Smartphones Will Transform Healthcare. The Health Care Blog. Retrieved April 22, 2011, from http://thehealthcareblog.com/blog/2011/01/31/physician-executives-should-not-ignore-how-smartphones-will-transform-healthcare/ Dolan, B. (2011, March 31). Survey: 27 % of US doctors have tablets. mobihealthnews. Retrieved April 21, 2011, from http://mobihealthnews.com/10627/survey-27-%-of-us-doctors-have-tablets/ Lewis, N. (2010b, September 10). Mobile Devices To Transform Healthcare. InformationWeek: Healthcare. Retrieved April 21, 2011, from http://www.informationweek.com/news/healthcare/mobile-wireless/227400122 Choudhri, A. F., & Radvany, M. G. (2010). Initial Experience with a Handheld Device Digital Imaging and Communications in Medicine Viewer: OsiriX Mobile on the iPhone. Journal of Digital Imaging, 24(2), 184-189. http://www.informationweek.com/news/healthcare/mobile-wireless/231903089 http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/breachtool.html Maki, A. (2011, April 14). Medical Breakthrough: Health Care Providers Hope iPad Can Enhance Their Services. Memphis Daily News. Retrieved from http://www.memphisdailynews.com/editorial/Article.aspx?id=57807 www.amcomsoftware.com Davis, M. (2011, April 4). For some doctors, the iPad is claiming a key spot next to the stethoscope. Boston Globe. Retrieved from http://articles.boston.com/2011-04-04/business/29380774_1_ipad-tablet-computers-ulcer Team 4-Mobile devices in Health care 21
View full slide show




RESOURCE WEB LINKS  Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm  NIH Grants Policy Statement (12/03): http://grants.nih.gov/grants/policy/nihgps_2003/index.htm  NIH Guide: http://grants.nih.gov/grants/guide/index.html  PHS 398 Application (form pgs are PDF-fillable): http://grants1.nih.gov/grants/funding/phs398/phs398.html  PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm  Handy Reference: Activity Code, Organization Codes and Definitions Used In Extramural Programs: http://grants.nih.gov/grants/funding/ac.pdf 77
View full slide show




RESOURCE WEB LINKS  Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm  NIH Grants Policy Statement (12/03): http://grants.nih.gov/grants/policy/nihgps_2003/index.htm  NIH Guide: http://grants.nih.gov/grants/guide/index.html  PHS 398 Application (form pgs are PDF-fillable): http://grants1.nih.gov/grants/funding/phs398/phs398.html  PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm  Handy Reference: Activity Code, Organization Codes and Definitions Used In Extramural Programs: http://grants.nih.gov/grants/funding/ac.pdf
View full slide show




RESOURCE WEB LINKS  Office of Extramural Research Grants Home Page: http:// grants.nih.gov/grants/oer.htm  NIH Grants Policy Statement (12/03): http://grants.nih.gov/grants/policy/nihgps_2003/index.htm  NIH Guide: http://grants.nih.gov/grants/guide/index.html  PHS 398 Application (form pgs are PDF-fillable): http://grants1.nih.gov/grants/funding/phs398/phs398.html  PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm  Handy Reference: Activity Code, Organization Codes and Definitions Used In Extramural Programs: http://grants.nih.gov/grants/funding/ac.pdf
View full slide show




Funding Opportunities Sites with important information: http://grants.nih.gov/grants/index.cfm http://grants.nih.gov/grants/welcome.htm#introduction http://deainfo.nci.nih.gov/funding.htm http://deainfo.nci.nih.gov/extra/extdocs/grantrevprocess.htm http://www.niaid.nih.gov/ncn/grants/default.htm http://www.niaid.nih.gov/ncn/grants/charts/default.htm http://www.niaid.nih.gov/ncn/glossary/default.htm
View full slide show




Resources • • • • • • NIH Public Access Page on ORD Websitehttp://www.ord.umaryland.edu/ord_research/PubAccess.html Upcoming Changes to Public Access Policy Reporting Requirements and Related NIH Efforts to Enhance Compliancehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-12160.html Changes to Public Access Policy Compliance Efforts Apply to All Awards with Anticipated Start Dates on or after July 1, 2013http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-042.html NIH Requires Use of RPPR for All SNAP and Fellowship Progress Reports, and Expands RPPR Functionalityhttp://grants.nih.gov/grants/guide/noticefiles/NOT-OD-13-035.html NLM Website - My Bibliography: Award Compliance Reports in PDF for eRA Commons Users http://www.nlm.nih.gov/pubs/techbull/nd12/nd12_myncbi_pdf.html NCBI Bookshelf – My Bibliography http://www.ncbi.nlm.nih.gov/books/NBK53595/
View full slide show




r e d n i m e R Closeout Final Reports  Failure to submit timely final reports may affect future funding to the organization – Final Financial Status Report (FSR) – Final Invention Statement and Certification – Final Progress Report  April 2, 2008, NIH Announces New Centralized Processing Center for Receipt of Grant Closeout Documents and Reminds Grantees of Required Closeout Reports for NIH Assistance Awards http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-061.html July, 27, 2007, NIH Requiring Mandatory Use of the Electronic Financial Status Report System in the eRA Commons Beginning October 1, 2007. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-078.html  June 17,2005, NIH Announces New Closeout Feature in the eRA Commons and Reminds Grantees of Required Closeout Reports for NIH Assistance Awards http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-051.html
View full slide show




Getting Help • NIH Office of Extramural Research Human Subjects Website: http://grants.nih.gov/grants/policy/hs/ • Decision Chart for Research with Data/Specimens: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102 • OHRP Website: http://www.hhs.gov/ohrp/ • 45 CFR 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm • • SF 424 (Research & Related) & Electronic Submission Page http://grants.nih.gov/grants/funding/424/index.htm • PHS 398 Instructions: http://grants1.nih.gov/grants/funding/phs398/phs398.html • NIH Human Subjects Protection Education http://phrp.nihtraining.com/users/login.php • Inclusion: http://grants.nih.gov/grants/funding/women_min/women_min.htm 47 47
View full slide show




Getting Help • NIH Office of Extramural Research Human Subjects Website: http://grants.nih.gov/grants/policy/hs/ • Decision Chart for Research with Data/Specimens: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102 • OHRP Website: http://www.hhs.gov/ohrp/ • 45 CFR 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm • • SF 424 (Research & Related) & Electronic Submission Page http://grants.nih.gov/grants/funding/424/index.htm • PHS 398 Instructions: http://grants1.nih.gov/grants/funding/phs398/phs398.html • NIH Human Subjects Protection Education http://phrp.nihtraining.com/users/login.php • Inclusion: http://grants.nih.gov/grants/funding/women_min/women_min.htm 58 58
View full slide show




Sources              "2010 Will be Changing for PepsiCo." Medill Reports Chicago. N.p., n.d. Web. 20 Apr. 2012. . "Coke vs Pepsi." Coke vs Pepsi. N.p., n.d. Web. 25 Apr. 2012. . " Google Image Result for http://41minds.files.wordpress.com/2011/04/bcggrowthsharematrix.png."Google. N.p., n.d. Web. 22 Apr. 2012. . "PEP: Summary for Pepsico, Inc. Common Stock- Yahoo! Finance." Yahoo! Finance - Business Finance, Stock Market, Quotes, News. N.p., n.d. Web. 25 Apr. 2012. . "Pepsi History." Sirpepsi. N.p., n.d. Web. 25 Apr. 2012. . "PepsiCo 2009 annual report." PepsiCo. N.p., n.d. Web. 19 Apr. 2012. . "PepsiCo Brands | PepsiCo.com." PepsiCo Home | PepsiCo.com. N.p., n.d. Web. 24 Apr. 2012. . "PepsiCo Investors | PepsiCo.com." PepsiCo Home | PepsiCo.com. N.p., n.d. Web. 25 Apr. 2012. . "PepsiCo MORE | PepsiCo.com." PepsiCo Home | PepsiCo.com. N.p., n.d. Web. 25 Apr. 2012. . Reppo, Ilya, and Michelle Yan. "PepsiCo Valuation." Leeds-faculty Colorado. N.p., n.d. Web. 14 Apr. 2012. . segment. "PepsiCo Valuation." Google. N.p., n.d. Web. 23 Apr. 2012. Steve. " Global Cola: 10 Pepsi-Cola Flavors You Can’t Get Here | WebUrbanist ." WebUrbanist | From Urban Art & 3D Graffiti to Abandoned Cities . N.p., n.d. Web. 25 Apr. 2012. .
View full slide show




Sources IPCC Fourth Assessment Report, 2007 IPCC Fourth Assessment Report, Summary for Policymakers V. Ramaswamy et.al., “Anthropogenic and Natural Influences in the Evolution of Lower Stratospheric Cooling,” Science 311 (24 February 2006), 1138-1141 National Research Council (NRC), 2006. Surface Temperature Reconstructions For the Last 2,000 Years. National Academy Press, Washington, DC. http://www.ncdc.noaa.gov/oa/climate/research/ anomalies/index.html http://www.cru.uea.ac.uk/cru/data/temperature http://data.giss.nasa.gov/gistemp http://climate.nasa.gov/ Climate Change 2001: Working Group I: The Scientific Basis, IPCC, January 2001. http://www.giss.nasa.gov/research/news/20100121/ http://science.nasa.gov/headlines/y2009/ 01apr_deepsolarminimum.htm http://www.eoearth.org/article/Climate_change_FAQs#gen0 Forster, P., V. Ramaswamy, P. Artaxo, T. Berntsen, R. Betts, D.W. Fahey, J. Haywood, J. Lean, D.C. Lowe, G. Myhre, J. Nganga, R. Prinn, G. Raga, M. Schulz and R. Van Dorland, 2007: Changes in Atmospheric Constituents and in Radiative Forcing. Understanding and Responding to Climate Change: National Academy of Sciences http://www.ncdc.noaa.gov/cmb-faq/anomalies.php#anomalies http://www.esrl.noaa.gov/gmd/ccgg/trends/ http://www.ncdc.noaa.gov/paleo/pubs/mann2008/mann2008.html Oreskes, Naomi (2007). "The Scientific Consensus on Climate Change: How Do We Know We’re Not Wrong?". In DiMento, Joseph F. C.; Doughman, Pamela M.. Climate Change: What It Means for Us, Our Children, and Our Grandchildren. The MIT Press. p. 68. http://www.bis.gov.uk/go-science/climatescience http://www.brighton73.freeserve.co.uk/gw/globalwarmingfaq.htm http://oceanservice.noaa.gov/education/literacy.html http://www.pewclimate.org/global-warming-basics/faq_s/glance_faq_science.cfm Plus many other links for the graphs and illustrations, most of which came from NASA and IPCC.
View full slide show




References and Additional Resources • Clinicaltrials.gov information https://www.clinicaltrials.gov/ct2/about-site/results • What NIH Grantees Need to Know about FDAAA https://grants.nih.gov/ClinicalTrials_fdaaa/ • Summary Table of HHS/NIH Rules/Policy Scope https:// www.nih.gov/news-events/summary-table-hhs-nih-initiatives-enhance-availability-clinical-trial-information • Questions [email protected] • FDAAA https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa • CMS – Mandatory Reporting of NCT #s on Medicare Claims Q&A https:// www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Downloads/Mandatory-Clinical-Trial-Identifier-Number-QsAs. pdf • OHSU policy for Non-cancer IIT trial registration https://bridge.ohsu.edu/community/rate/Shared%20Documents/OHSU_Policy_ClinicalTrials_InvestigatorInitiated_RegistrationReportin g_20181114.pdf • • • • OHSU Knight Clinical Trial Registration SOPs: CR007, CR013 https://bridge.ohsu.edu/research/knight/policies/SitePages/Home.aspx Knight CTRP staff [email protected] OHSU RAIN (Research Administration Information Network): https:// o2.ohsu.edu/research-administration-training-education/research-administration-information-network/index.cfm Some of the slides were adapted with permission from the work of the Clinical and Translational Science Awards (CTSA) program’s Clinical Trials Registration Workgroup of the Regulatory Knowledge Key Function Committee. Original slides available at Harvard Catalyst https://catalyst.harvard.edu/programs/regulatory/clinical-trial-reg.html The Clinical and Translational Science Awards Program (CTSA) is part of the Roadmap Initiative, Re-Engineering the Clinical Research Enterprise and is funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH).
View full slide show