NOT-OD-15-032: Update: New Biographical Sketch Format
Transcription
NOT-OD-15-032: Update: New Biographical Sketch Format
NOT-OD-15-032: Update: New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After May 25, 2015 Update: New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After May 25, 2015 Notice Number: NOT-OD-15-032 Key Dates Release Date: December 5, 2014 Related Announcements NOT-OD-15-085 NOT-OD-15-024 Issued by National Institutes of Health (NIH) Agency for Healthcare Research and Quality (AHRQ) Purpose This Notice supersedes NOT-OD-15-024 about the NIH and AHRQ requirement for use of a new biosketch format and provides some latitude in the transition for those who have already been compiling biosketches for their large grant applications with deadlines in early in 2015. NIH and AHRQ encourages applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015. Applicants may submit using the new biosketch format for due dates before January 25, 2015, if they wish. New Format The revised forms and instructions are now available on the SF 424 (R&R) Forms and Applications page and adjustments have been made to improve their usability. Individual fellowships, R36 dissertation grants, and diversity supplements should use the Fellowship Application Biographical Sketch Format Page and related pre-doc and post-doc instructions and samples, while research grant applications, career development, training grant, and all other application types should use the general Biographical Sketch Format Page and instructions and sample. The new format extends the page limit for the biosketch from four to five pages, and allows researchers to describe up to five of their most significant contributions to science, along with the historical background that framed their research. Investigators can outline the central findings of prior work and the influence of those findings on the http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-032.html[5/4/2015 2:59:40 PM] NOT-OD-15-032: Update: New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After May 25, 2015 investigator’s field. Investigators involved in Team Science are provided the opportunity to describe their specific role(s) in the work. Each description can be accompanied by a listing of up to four relevant peer-reviewed publications or other non-publication research products, including audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware that are relevant to the described contribution. In addition to the descriptions of specific contributions and documentation, researchers will be allowed to include a link to a full list of their published work as found in a publicly available digital database such as MyBibliography or SciENcv. Tool to Help Build the New Biosketch The Science Experts Network Curriculum Vitae (SciENcv), which serves as an interagency system designed to create biosketches for multiple federal agencies, will be updated by the end of December to support the new biosketch format and to address some issues found in testing. SciENcv pulls information from available resources making it easy to develop a repository of information that can be readily updated and modified to prepare future biosketches. A YouTube video provides instructions for using SciENcv. Additional Information Note that having a different biosketch format than other applications being reviewed in the same panel is not grounds for appeal. See FAQs for additional information. Inquiries Please direct all inquiries to: Grants Information Office of Extramural Research (OER) National Institutes of Health (NIH) Phone: 301-435-0714 Email: GrantsInfo@nih.gov Weekly TOC for this Announcement NIH Funding Opportunities and Notices Department of Health and Human Services (HHS) NIH... Turning Discovery Into Health® Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-032.html[5/4/2015 2:59:40 PM] NOT-OD-15-085: Reminder: NIH and AHRQ Biosketch Requirements for Due Dates On or After May 25, 2015 Reminder: NIH and AHRQ Biosketch Requirements for Due Dates On or After May 25, 2015 Notice Number: NOT-OD-15-085 Key Dates Release Date: March 24, 2015 Related Announcements NOT-OD-15-032 Issued by National Institutes of Health (NIH) Purpose The National Institutes of Health (NIH) and the Agency for Health Research and Quality (AHRQ) require the new biosketch format (NOT-OD-15-032) for all competing and non-competing applications submitted for due dates on or after May 25, 2015. Biosketch format pages, instructions, samples and FAQs are available on the SF 424 (R&R) Forms and Applications page (http://grants.nih.gov/grants/funding/424/index.htm#format). Applicants can use Science Experts Network Curriculum Vitae (SciENcv) to generate their biosketches faster and in the right format. A YouTube video provides instructions for using SciENcv. Inquiries Please direct all inquiries to: Grants Information Office of Extramural Research (OER) National Institutes of Health (NIH) Email: grantsinfo@od.nih.gov (preferred method of contact) Phone: 301-435-0714 Weekly TOC for this Announcement NIH Funding Opportunities and Notices Department of Health and Human Services (HHS) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-085.html[5/5/2015 2:47:28 PM] OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) Completion Date MM/YYYY FIELD OF STUDY Please refer to the Biographical Sketch sample in order to complete sections A, B, C, and D of the Biographical Sketch. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) Completion Date MM/YYYY FIELD OF STUDY NOTE: The Biographical Sketch may not exceed five pages. Follow the formats and instructions below. A. Personal Statement Briefly describe why you are well-suited for your role in the project described in this application. The relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C). Also, you may identify up to four peer reviewed publications that specifically highlight your experience and qualifications for this project. If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and active duty military service. B. Positions and Honors List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee. C. Contribution to Science Briefly describe up to five of your most significant contributions to science. For each contribution, indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work. For each of these contributions, reference up to four peer-reviewed publications or other non-publication research products (can include audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware) that are relevant to the described contribution. The description of each contribution should be no longer than one half page including figures and citations. Also provide a URL to a full list of your published work as found in a publicly available digital database such as SciENcv or My Bibliography, which are maintained by the US National Library of Medicine. D. Research Support List both selected ongoing and completed research projects for the past three years (Federal or non-Federallysupported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Hunt, Morgan Casey eRA COMMONS USER NAME (credential, e.g., agency login): huntmc POSITION TITLE: Associate Professor of Psychology EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION University of California, Berkeley University of Vermont University of California, Berkeley DEGREE (if applicable) Completion Date MM/YYYY B.S 05/1990 Psychology Ph.D. 05/1996 Postdoctoral 08/1998 Experimental Psychology Public Health and Epidemiology FIELD OF STUDY A. Personal Statement I have the expertise, leadership, training, expertise and motivation necessary to successfully carry out the proposed research project. I have a broad background in psychology, with specific training and expertise in ethnographic and survey research and secondary data analysis on psychological aspects of drug addiction. My research includes neuropsychological changes associated with addiction. As PI or co-Investigator on several university- and NIH-funded grants, I laid the groundwork for the proposed research by developing effective measures of disability, depression, and other psychosocial factors relevant to the aging substance abuser, and by establishing strong ties with community providers that will make it possible to recruit and track participants over time as documented in the following publications. In addition, I successfully administered the projects (e.g. staffing, research protections, budget), collaborated with other researchers, and produced several peer-reviewed publications from each project. As a result of these previous experiences, I am aware of the importance of frequent communication among project members and of constructing a realistic research plan, timeline, and budget. The current application builds logically on my prior work. During 2005-2006 my career was disrupted due to family obligations. However, upon returning to the field I immediately resumed my research projects and collaborations and successfully competed for NIH support. 1. Merryle, R.J. & Hunt, M.C. (2004). Independent living, physical disability and substance abuse among the elderly. Psychology and Aging, 23(4), 10-22. 2. Hunt, M.C., Jensen, J.L. & Crenshaw, W. (2007). Substance abuse and mental health among communitydwelling elderly. International Journal of Geriatric Psychiatry, 24(9), 1124-1135. 3. Hunt, M.C., Wiechelt, S.A. & Merryle, R. (2008). Predicting the substance-abuse treatment needs of an aging population. American Journal of Public Health, 45(2), 236-245. PMCID: PMC9162292 Hunt, M.C., Newlin, D.B. & Fishbein, D. (2009). Brain imaging in methamphetamine abusers across the life-span. Gerontology, 46(3), 122-145. B. Positions and Honors Positions and Employment 1998-2000 Fellow, Division of Intramural Research, National Institute of Drug Abuse, Bethesda, MD 2000-2002 Lecturer, Department of Psychology, Middlebury College, Middlebury, VT 2001Consultant, Coastal Psychological Services, San Francisco, CA 2002-2005 Assistant Professor, Department of Psychology, Washington University, St. Louis, MO 2007Associate Professor, Department of Psychology, Washington University, St. Louis, MO Other Experience and Professional Memberships 1995Member, American Psychological Association 1998Member, Gerontological Society of America 1998Member, American Geriatrics Society 2000Associate Editor, Psychology and Aging 2003Board of Advisors, Senior Services of Eastern Missouri 2003-05 NIH Peer Review Committee: Psychobiology of Aging, ad hoc reviewer 2007-11 NIH Risk, Adult Addictions Study Section, members Honors 2003 2004 2009 Outstanding Young Faculty Award, Washington University, St. Louis, MO Excellence in Teaching, Washington University, St. Louis, MO Award for Best in Interdisciplinary Ethnography, International Ethnographic Society C. Contribution to Science 1. My early publications directly addressed the fact that substance abuse is often overlooked in older adults. However, because many older adults were raised during an era of increased drug and alcohol use, there are reasons to believe that this will become an increasing issue as the population ages. These publications found that older adults appear in a variety of primary care settings or seek mental health providers to deal with emerging addiction problems. These publications document this emerging problem but guide primary care providers and geriatric mental health providers to recognize symptoms, assess the nature of the problem and apply the necessary interventions. By providing evidence and simple clinical approaches, this body of work has changed the standards of care for addicted older adults and will continue to provide assistance in relevant medical settings well into the future. I served as the primary investigator or co-investigator in all of these studies. a. Gryczynski, J., Shaft, B.M., Merryle, R., & Hunt, M.C. (2002). Community based participatory research with late-life addicts. American Journal of Alcohol and Drug Abuse, 15(3), 222-238. b. Shaft, B.M., Hunt, M.C., Merryle, R., & Venturi, R. (2003). Policy implications of genetic transmission of alcohol and drug abuse in female nonusers. International Journal of Drug Policy, 30(5), 46-58. c. Hunt, M.C., Marks, A.E., Shaft, B.M., Merryle, R., & Jensen, J.L. (2004). Early-life family and community characteristics and late-life substance abuse. Journal of Applied Gerontology, 28(2),2637. d. Hunt, M.C., Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A. (2007). Community-based intervention strategies for reducing alcohol and drug abuse in the elderly. Addiction, 104(9), 14361606. PMCID: PMC9000292 2. In addition to the contributions described above, with a team of collaborators, I directly documented the effectiveness of various intervention models for older substance abusers and demonstrated the importance of social support networks. These studies emphasized contextual factors in the etiology and maintenance of addictive disorders and the disruptive potential of networks in substance abuse treatment. This body of work also discusses the prevalence of alcohol, amphetamine, and opioid abuse in older adults and how networking approaches can be used to mitigate the effects of these disorders. a. Hunt, M.C., Merryle, R. & Jensen, J.L. (2005). The effect of social support networks on morbidity among elderly substance abusers. Journal of the American Geriatrics Society, 57(4), 15-23. b. Hunt, M.C., Pour, B., Marks, A.E., Merryle, R. & Jensen, J.L. (2005). Aging out of methadone treatment. American Journal of Alcohol and Drug Abuse, 15(6), 134-149. c. Merryle, R. & Hunt, M.C. (2007). Randomized clinical trial of cotinine in older nicotine addicts. Age and Ageing, 38(2), 9-23. PMCID: PMC9002364 3. Methadone maintenance has been used to treat narcotics addicts for many years but I led research that has shown that over the long-term, those in methadone treatment view themselves negatively and they gradually begin to view treatment as an intrusion into normal life. Elderly narcotics users were shown in carefully constructed ethnographic studies to be especially responsive to tailored social support networks that allow them to eventually reduce their maintenance doses and move into other forms of therapy. These studies also demonstrate the policy and commercial implications associated with these findings. a. Hunt, M.C. & Jensen, J.L. (2003). Morbidity among elderly substance abusers. Journal of the Geriatrics, 60(4), 45-61. b. Hunt, M.C. & Pour, B. (2004). Methadone treatment and personal assessment. Journal Drug Abuse, 45(5), 15-26. c. Merryle, R. & Hunt, M.C. (2005). The use of various nicotine delivery systems by older nicotine addicts. Journal of Ageing, 54(1), 24-41. PMCID: PMC9112304 d. Hunt, M.C., Jensen, J.L. & Merryle, R. (2008). The aging addict: ethnographic profiles of the elderly drug user. NY, NY: W. W. Norton & Company. Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/collections/public/1PgT7IEFIAJBtGMRDdWFmjWAO/?sort=d ate&direction=ascending D. Research Support Ongoing Research Support R01 DA942367 Hunt (PI) 09/01/08-08/31/16 Health trajectories and behavioral interventions among older substance abusers The goal of this study is to compare the effects of two substance abuse interventions on health outcomes in an urban population of older opiate addicts. Role: PI R01 MH922731 Merryle (PI) 12/15/07-11/30/15 Physical disability, depression and substance abuse in the elderly The goal of this study is to identify disability and depression trajectories and demographic factors associated with substance abuse in an independently-living elderly population. Role: Co-Investigator Faculty Resources Grant, Washington University 08/15/09-08/14/15 Opiate Addiction Database The goal of this project is to create an integrated database of demographic, social and biomedical information for homeless opiate abusers in two urban Missouri locations, using a number of state and local data sources. Role: PI Completed Research Support R21 AA998075 Hunt (PI) 01/01/11-12/31/13 Community-based intervention for alcohol abuse The goal of this project was to assess a community-based strategy for reducing alcohol abuse among older individuals. Role: PI OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Richard E. Harris POSITION TITLE: Associate Professor eRA COMMONS USER NAME (credential, e.g., agency login): reharris EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) Completion Date MM/YYYY FIELD OF STUDY Purdue University, West Lafayette IN BSc 05/1992 Biology University of California at Berkeley, Berkeley CA PhD 05/1997 Mol. and Cell Biology National Institutes of Health (NINDS) Postdoc 08/2000 Neuroscience Maryland Institute of Traditional Chinese Medicine Dipl. Acu. 08/2002 Acupuncture University of Michigan MS 05/2005 Clinical Research A. PERSONAL STATEMENT I currently serve as Associate Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan, as an acupuncturist, and an internationally recognized pain researcher. I am also a faculty member of the Chronic Pain and Fatigue Research Center (CPFRC) at the University of Michigan. Over the past 15 years, my work in this group has contributed in showing the prominent central nervous system contributions to pain and other somatic symptoms in individuals with conditions such as fibromyalgia. I attended Purdue University as an undergraduate and the University of California at Berkeley for graduate school. My graduate work was heavily focused on the biophysics of nerve cells as I examined the effects of pore blockers on cloned potassium channels in vitro. Although I chose not to pursue this line of research for my academic career, it provided me the necessary foundation for understanding the nervous system at a molecular and cellular level with which I have applied to my current field (see below). Following my graduate work, I decided to switch to clinical research and explore the mechanisms of action of alternative medical treatments, specifically acupuncture. I joined the CPFRC at Georgetown and performed one of the first acupuncture clinical trials in fibromyalgia funded through NIH. During this time I also gained training in acupuncture at the Maryland Institute of Traditional Chinese Medicine and then relocated to the University of Michigan (UM) to continue my work in the field of pain neurobiology and integrative medicine. Since moving to UM in 2002, I have continued my research in chronic pain and during my K-award, I became trained extensively in the methods of functional, structural, and chemical neuroimaging. This training, in combination with my graduate work in molecular neuroscience, has allowed me to explore the neurobiological correlates of various chronic pain conditions including: fibromyalgia, interstitial cystitis, vulvodynia, and pelvic pain. During this time I also served as Treasurer and Co-President for the Society for Acupuncture Research (SAR), an internationally based organization whose main focus is to promote and disseminate the rigorous exploration of acupuncture in the research setting. In the proposed studies of pain in sickle cell disease, I will coordinate and assist in the acquisition and analysis of brain neuroimaging data. I bring broad expertise in performing such studies in other chronic pain conditions wherein I have identified aberrant neurochemical, structural, and functional connectivity. The below four publications specifically highlight my experience and qualifications for this proposal. a. Harris RE, Sundgren PC, Craig AD (Bud), Kirshenbaum E, Sen A, Napadow V, and Clauw DJ. Elevated Insular Glutamate (Glu) in Fibromyalgia (FM) is Associated with Experimental Pain. Arthritis Rheum Sep 29;60(10):3146-3152, 2009. PMCID:PMC2827610 b. Napadow V, Kim J, Clauw DJ, Harris RE. Decreased Intrinsic Brian Connectivity is Associated with Reduced Clinical Pain in Fibromyalgia. Arthritis Rheum Jul;64(7):2398-403, 2012. PMCID:PMC3349799 c. Napadow V and Harris RE. What has functional connectivity and chemical neuroimaging in fibromyalgia taught us about the mechanisms and management of “centralized” pain? Arthritis Research and Therapy. 16:425, 2014. PMCID:PMC4289059 d. Ichesco E, Schmidt-Wilcke T, Bhavsar R, Clauw DJ, Peltier S, Kim J, Napadow V, Hampson J, Kairys AE, Williams DA, Harris RE. Altered Resting State Connectivity of the Insular Cortex in Individuals with Fibromyalgia. J Pain May 9 S1526-5900(14)00700-7, 2014. PMCID:PMC4127388 [Available 2015-08-01] B. POSITIONS AND HONORS Positions and Employment 1998 – 2000 Postdoctoral Researcher in Synapse Formation and Unit at NIH, NINDS 2000 – 2002 Instructor, Dept. Rheumatology, Georgetown University 2002 – 2007 Research Investigator, Dept. Internal Med. Div. Rheumatology, Univ. of Michigan 2007 – 2010 Research Assistant Professor, Dept. Internal Med. Div. Rheumatology Univ. of Michigan 2008 – 2010 Research Assistant Professor, Dept. Anesthesiology University of Michigan 2010 – 2014 Assistant Professor, Dept. Anesthesiology University of Michigan 2010 – 2014 Assistant Professor, Dept. Internal Medicine Div. Rheumatology Univ. of Michigan 2013 – Faculty Neuroscience Graduate Program, University of Michigan 2014 – Associate Professor, Dept. Anesthesiology University of Michigan 2014 – Associate Professor, Dept. Internal Med. Div. Rheumatology, Univ. of Michigan Other Experience and Professional Memberships 2003 – Member American Pain Society 2003 – Member Society for Acupuncture Research 2006 – 2008 Peer review NIH/NCCAM Training and Education 2006 – Board Member, Society for Acupuncture Research 2006 – 2007 Treasurer, Society for Acupuncture Research 2007 – 2014 Co-President, Society for Acupuncture Research 2008 – Member International Association for Study of Pain 2009 – Member Society for Neuroscience 2008 Peer review NIH Somatosensory and Chemosensory Study Section 2009 Peer review Medical Research Council, United Kingdom 2014 – Peer review American Pain Society 2014 Peer review NIH/NCCAM Center Grants 2015 Peer review Department of Defense, Congressional Medical Research Program Honors 1992 1991 -1992 1988 -1992 1991 -1992 1991 -1992 1995 1999 2003 Singleton Award – Best Honors Thesis Howard Hughes Med. Inst. undergraduate fellowship Gannette Foundation scholarship Phi Beta Kappa Golden Key National Honor Society Outstanding graduate student instructor award (MCB 160) National Research Service Award (Intramural Competition) Traditional Chinese Medicine World Foundation Research Award C. CONTRIBUTIONS TO SCIENCE C.1 Identifying central neurobiological correlates of chronic widespread pain (fibromyalgia: FM). During my faculty career at UM, I have published multiple studies examining the central neurobiological factors that may be involved in the pathophysiology of centralized pain, of which FM is an exemplar. I have become familiar and have gained training in multiple brain neuroimaging methods: positron emission tomography (PET: specifically opioid receptor PET), functional magnetic resonance imaging (fMRI, including resting state functional connectivity as proposed in this application), and proton magnetic resonance spectroscopy (1H-MRS). In the beginning of my training, there was very little known about the pathogenesis of FM and associated chronic pain conditions; however, I believed that this was a very real problem and that the brain may be the area wherein some of the pathology may lie. Between the period of 2005 and 2015, I wrote several articles identifying aberrant nerurochemical (opioid receptor binding, glutamate, and GABA), structural, and functional connectivity patterns associated with chronic widespread pain. This work has contributed to the recognition and validation of this condition which heretofore has been largely ignored or marginalized by the scientific and medical communities. This work is relevant to the larger pain field as it is becoming increasingly apparent the pathophysiology of FM is related to other conditions with overlapping symptoms. These brain markers, and potentially pathologies, are present to a lesser or greater degree in other chronic pain conditions. a. Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, and Zubieta J-K. Decreased Central µ-Opioid Receptor (MOR) Availability in Fibromyalgia (FM). Journal of Neuroscience Sept:27(37):10000-10006, 2007. b. Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim S-H, McLean SA, Gracely RH, and Clauw DJ. Dynamic Levels of Glutamate within the Insula are Associated with Improvements in Multiple Pain Domains in Fibromyalgia (FM). Arthritis Rheum Mar;58(3):903-7, 2008. c. Foerster BR, Petrou M, Edden RA, Clauw DJ, Sundgren PC, Schmidt-Wilcke T, Lowe SE, Harte SE, Harris RE. Reduced Insular Gamma-aminobutyric acid in Fibromyalgia. Arthritis and Rheumatism Feb;64(2):579-83, 2012. PMCID:PMC3374930 d. Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, and Harris RE. Intrinsic Brain Connectivity in Fibromyalgia is Associated with Chronic Pain Intensity. Arthritis Rheum 62(8):2545-55, 2010. PMCID:PMC2921024 C.2 Understanding the mechanism(s) of action of acupuncture/acupressure for the treatment of chronic pain and fatigue. Although I had gained training in Traditional Chinese Medicine, it quickly became clear to me that there was an enormous gap in the field about how these methods of healing (acupuncture/acupressure) work, specifically from a Western scientific perspective. In 2000, I played a key role in a clinical trial of acupuncture in fibromyalgia that was funded by the NIH and Daniel Clauw was the study principal investigator. (My collaboration with Dr. Clauw has persisted throughout the past 15 years and I have risen to the ranks of an NIH R01 funded independent investigator over this time.) Surprisingly to me, this clinical trial did not show that there was any specificity behind acupuncture needle placement or stimulation. However the response rate of the FM patients to acupuncture (and sham) was larger than other published placebo rates for this condition. Given the paradoxical findings that it didn’t seem to matter whether or not needles were used in the “right” way, but that many patients benefited from treatment, I chose to test whether or not acupuncture was different from a placebo by examining the brain patterns resulting from these two interventions. In this work I found, to my surprise, that although both sham and real acupuncture reduce pain in FM, they do it via differing mechanisms: sham increases the release of endogenous opioids while real acupuncture increases the opioid receptor binding. From this work, I have gone on to explore self-administered acupressure as a treatment for fatigue in cancer survivors. These studies were some of the first to show that acupuncture/acupressure “work” for pain and fatigue, and they have contributed to the more global recognition of the usefulness and effectiveness of these long standing safe and effective healing arts. a. Harris RE, Tian XM, Cupps TR, Williams DA, Tian T, Cupps TR, Petzke F, Groner KH, Gracely RH, and Clauw DJ. Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency. J Altern Complement Med Aug,11(4):663-71, 2005. b. Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, and Clauw DJ. Traditional Chinese Acupuncture and Placebo (Sham) Acupuncture Are Differentiated by Their Effects on µ-Opioid Receptors (MORs). Neuroimage Sept 47(3):1077-85, 2009 PMCID: PMC2757074. c. Harris RE, Jeter J, Chan P, Higgins P, Kong F-M, Fazel R, Bramson C, Gillespie B, and Cohort 11 of the University of Michigan Clinical Research Design and Statistical Analysis Program. Using acupressure to modify alertness in the classroom: A single-blind, randomized, crossover trial. J Altern Complement Med Aug,11(4):673-9, 2005. d. Zick SM, Alrawi S, Merel G, Burris B, Sen A,Litzinger A, and Harris RE. Relaxation Acupressure Reduces Persistent Cancer Related Fatigue. Evidenced-Based Complementary and Alternative Medicine 2011. pii: 142913. Epub 2010 Sep 2. PMCID:PMC2949582 C.3 I have used neuroimaging and quantitative sensory testing (QST) to demonstrate that within FM patients, there are sub-groups or endo-phenotypes that have a differing response to effective treatments. A better understanding of the underlying mechanisms responsible for pain could in turn promote more effective ways to treat specific patients. I have used multiple neuroimaging techniques (resting state connectivity, 1H-MRS, and fMRI) as well as QST outcomes, to show that within the spectrum of patients diagnosed with FM, various subsets exist which in turn respond differentially to treatment. In my most recent studies, I have used neuroimaging and QST findings, indicative of centralized pain, to differentially predict increased responsiveness to either: pregabalin, milnacipran, or acupuncture. This type of data could be instrumental in “tailoring” individualized treatment strategies for specific patients. While this type of individualized medicine has been discussed in the literature for some time, the current state of medicine is to treat all chronic pain patients with a given diagnosis with the same intervention. The field is beginning to accept that there may be multiple underlying pathways to develop a certain chronic pain state, and each individual patient may respond better (or worse) to a given strategy. This type of finding has clear clinical implications for treatment of pain patients. a. Harris RE, Napadow V, Huggins JP, Pauer L, Kim J, Hampson J, Sundgren PC, Foerster B, Petrou M, Schmidt-Wilcke T, and Clauw DJ. Pregabalin Rectifies Aberrant Brain Chemistry, Connectivity, and Functional Response in Chronic Pain Patients. Anesthesiology Dec;119(6):1453-64. 2013. [Not NIH funded] b. Schmidt-Wilcke T, Ichesco E, Hampson J, Kairys A, Peltier S, Harte S, Clauw D, Harris RE. Resting State Connectivity Correlates with Drug and Placebo Response in Fibromyalgia Patients. Neuroimage Clinical 2014 Sep 16;6:252-61. doi: 10.1016/j.nicl.2014.09.007. eCollection, 2014 PMCID:PMC4215460 c. Harte SE, Clauw DJ, Napadow V, and Harris RE. Pressure Pain Sensitivity and Insular Combined Glutamate and Glutamine (Glx) are Associated with Subsequent Clinical Response to Sham but not Traditional Acupuncture in Chronic Pain Patients. Medical Acupuncture. 2013 Apr;25(2):154-60. PMCID:PMC3616440 A URL of my complete published work is: http://www.ncbi.nlm.nih.gov/sites/myncbi/richard.harris.1/bibliography/40651090/public/?sort=date&direction=a scending D. RESEARCH SUPPORT Ongoing U01 DK082345 (Clauw, DJ – Contact / Clemens, JQ) 09/15/14 – 06/30/19 NIH/NIDDK University of Michigan MAPP Research Network Discovery Site In Phase II of the MAPP, in addition to the performance of the UCPPS Symptom Pattern Study, we propose three additional aims we believe bring innovative research methods and expertise to the broader trans-MAPP efforts. Role: Co-Investigator R01 CA151445 (Zick, S – Contact / Harris, RE) 09/03/10 – 07/31/15 NIH/NCI Acupressure for Persistent Cancer Related Fatigue The goal of this project is to conduct a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. Role: Principal Investigator (MPI) 1I01CX000458-01A1 (Foerster, B) 10/01/12 – 09/30/15 VA Merit Award MR Imaging of the Excitatory and Inhibitory Neurotransmitters in Chronic Pain The goal of this study is to improve targeted treatments for chronic pain conditions such as knee pain and osteoarthritis of the knee (KOA). Role: Co-Investigator R01 AT007550 (Harris, RE – Contact / Napadow, V) 05/01/13 – 04/30/18 NIH/NCCAM Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain Our overall goal is to evaluate the impact of acupuncture-induced somatosensory afference on altered neurobiology and analgesia in FM. Role: Contact Principal Investigator (MPI) NPT-201 UM (Clauw, DJ) 06/04/13 – 09/30/15 Cerephex Corporation A Single-Blinded, Proof of Concept, Phase 2(a) Study with a Placebo Run-in Exploring the Safety and Efficacy of RINCE Technology for the Treatment of Patients with Fibromyalgia The primary objective of this study is to evaluate the safety and efficacy of up to 24 treatments with a noninvasive cortical electrostimulation therapy (Reduced Impedance Noninvasive Cortical Electrostimulation [RINCE®] therapy) delivered by the NeuroPoint® device. Role: Co-Investigator Completed in the Past Three Years (Harris, RE) 03/01/09 – 03/01/12 Dana Foundation Grant: Program in Brain and Immuno-Imaging Distinct Roles of Anterior and Posterior Insula Glutamate in Chronic Pain The goal of this investigation is to assess the role of insular glutamate with respect to co-morbid pain and anxiety in fibromyalgia patients treated with acupuncture. Role: Principal Investigator 53-10 (Henry, NL) 07/01/10 – 06/30/13 Damon Runyon Cancer Research Foundation Pain processing pathway analysis in aromatase inhibitor-associated musculoskeletal syndrome The goal of this study is to investigate the impact of estrogen deprivation with aromatase inhibitors on pain perception and the development of aromatase inhibitor-associated arthralgias. Role: Co-Investigator U01 DK082345 (Clauw, DJ-Contact PI/ Clemens, JQ-MPI) 09/15/08 – 06/30/14 NIH/NIDDK Multi-disciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Discovery Site This discovery site application proposes to conduct three projects in support of the hypothesis that a sizable subset of individuals with interstitial cystitis (IC) have aberrant central pain processing rather than a peripheral pathology. This study has an epidemiologic, a phenotyping (including psychphysiological), and a pharmacological treatment as part of the trial, all of which target specific purported dysfunctional mechanisms. Role: Co-Investigator Innovative Research Grant (IRG) (Li, Lydia) 02/01/13 – 01/31/15 Arthritis Foundation Acupressure for Older Adults with Symptomatic Knee Osteoarthritis The primary objective of this project is to determine whether self-administered acupressure is an effective and feasible self-management strategy for older adults with symptomatic knee osteoarthritis (KOA). Role: Co-Investigator