The National Advisory Council for Complementary and Alternative Medicine (NACCAM) is charged with the responsibility of advising, consulting with, and making recommendations to the Director, NCCAM, on matters relating to the research activities and functions of the Center.
Past Meetings and Workshops
Conferences and Workshops
Advisory Council 52nd Meeting
Date: Friday, June 6, 2014Location:
NIH Campus, Building 31/6C
Conference Room 10
31 Center Drive
Bethesda, Maryland 20892
NIH Office of Dietary Supplements Research Practicum
Date: Tuesday, June 3, 2014 - 7:30am to Friday, June 6, 2014 - 12:00pmLocation:
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) is offering a 4-day educational opportunity to provide fundamental knowledge of dietary supplements to faculty, students, and practitioners with a serious interest in this subject. This intensive practicum will provide a thorough overview and grounding about issues, concepts, unknowns, and controversies about dietary supplements and supplement ingredients. It will also emphasize the importance of scientific investigations to evaluate the efficacy, safety, and value of these products for health promotion and disease prevention as well as how to carry out this type of research.
Topics to be addressed include:
- supplement use in the United States and reasons for use;
- the regulatory framework governing supplements;
- differences in bringing foods, drugs, and supplements to market;
- supplement quality;
- assessing the health effects of foods and supplements; and
- developing policies and advice about supplement use based on science.
Participants will also meet with various stakeholders—the dietary supplement industry, consumer advocacy groups, and media—who study, advocate, regulate, or educate about dietary supplements. Participants will also have the option to take a guided tour of the NIH.
The International Research Congress on Integrative Medicine and Health (IRCIMH)
Date: Tuesday, May 13, 2014 to Friday, May 16, 2014Location:
National Center for Complementary and Alternative Medicine (NCCAM) staff are presenting in the following workshops at the International Research Congress on Integrative Medicine and Health. The congress is convened by the Consortium of Academic Health Centers for Integrative Medicine.
NCCAM staff names are in bold below.
Tuesday, May 13 (Pre-Congress Workshops)
Writing a Grant: Challenges in Clinical Trial Design and Important Statistical Considerations
Cynthia Long, Ph.D., Statisticians Working on Complementary and Alternative Medicine and Integrative Medicine Studies; Laura Lee Johnson, Ph.D., NCCAM
9 a.m.–12 noon
This workshop is intended to help participants in their grant writing efforts, with an emphasis on addressing important issues pertaining to clinical trial design, statistical considerations, and how to present a study proposal to grant, protocol, and manuscript reviewers. The introduction will discuss how CAM and integrative medicine trials are and are not different from other medical trials and the obstacles that these trials face. Though alternative study designs will be discussed, the focus will be on randomized, controlled clinical trials and the elements in designing such studies. We will identify those elements of the study design that grant reviewers focus on and expect to be in a grant proposal. We will also discuss statistical considerations such as sample size and identifying an appropriate statistical consultant for grant proposals. A practicum conducted in small groups will focus on refining clinical trial designs submitted by former participants and/or proposed by workshop teachers. This workshop will help researchers, in particular research trainees, fellows, and junior faculty, in their grant writing efforts—with an emphasis on important issues pertaining to a statistician's role on collaborating in grant writing, how to find and effectively collaborate with a statistician and data manager, critical issues that need to be addressed, and what reviewers look for in the research strategy section.
From Idea to Project: Career Development Strategies
Alberto Rivera-Rentas, Ph.D., Emmeline Edwards, Ph.D., Catherine Bushnell, Ph.D., Wendy Weber, N.D., Ph.D., M.P.H., Peter Kozel, Ph.D., NCCAM
9 a.m.–5 p.m.
The proposed workshop reaffirms NCCAM’s long-standing commitment to research training and the development of a well-prepared diverse biomedical workforce and its alignment with its strategic objective four: Improve the Capacity of the Field To Carry Out Rigorous Research. The workshop theme is the development of an independent investigator and the presentations will focus on successful career development strategies. Activities will provide an overview of the process of conceptualizing a project that: (1) meets NCCAM guidelines, (2) fits the Center’s research priorities, (3) is aligned with NCCAM’s strategic plan, and (4) supports the Center’s mission. Speakers at different career stages will share their experiences and paths to become independent research investigators. This day-long workshop will also include a working lunch session for participants to meet with NCCAM's staff and program officials representing different scientific areas, which will allow time for exchange of ideas and onsite guidance.
Wednesday, May 14
NCCAM's Strategic Priorities for Funding Clinical Trials
Wendy Weber, N.D., Ph.D., M.P.H., Emmeline Edwards, Ph.D., Kristen Huntley, Ph.D., Dale Birkle Dreer, Ph.D., Robyn Bent, R.N., B.S.N., NCCAM
A significant proportion of NCCAM’s extramural research portfolio includes clinical research projects and, specifically, clinical trials. Similar to other National Institutes of Health (NIH) institutes and centers, NCCAM wants our clinical research portfolio to reflect the Center’s current strategic priorities in allocating funding resources where they can be most impactful with rigorous clinical designs. In the last year, NCCAM has critically examined the clinical research portfolio and developed a strategy to encourage clinical trials that align with NCCAM’s priorities. This symposium will provide an overview of the challenges NIH and NCCAM have encountered with funded clinical trials, including participant recruitment and retention, costs, inadequate timeframe, and failure to publish. Presenters will describe the range of clinical trials that investigators can pursue from intervention refinement, to efficacy studies, to dissemination and implementation of effective treatments. NCCAM’s priorities for clinical trials will be highlighted. NCCAM program officials will describe the available funding opportunities for clinical trials and the process for submitting large clinical trials. The NCCAM review officer will provide an overview of the review criteria that are applied to clinical trials. The presentation will help the audience determine which funding opportunity is the best fit for the stage of research (and the level of evidence) they are proposing. A representative from the Office of Clinical and Regulatory Affairs will discuss available resources for planning and implementing clinical trials, including NCCAM’s Clinical Research Toolbox and the NCCAM onsite clinical monitoring program. Ample time will be reserved for a panel discussion to answer questions about the overall NCCAM strategy for clinical trials.
NIH Pain Consortium—Standards for Research on Chronic Low-Back Pain
Partap Khalsa, D.C., Ph.D., NCCAM; Anthony Delitto, Ph.D., P.T., FAPTA, University of Pittsburgh
A critical issue for advancing research on chronic low-back pain (cLBP) is the challenge of comparing results from the many classes of interventions. NIH Pain Consortium workshops on cLBP noted that prior clinical studies have often used variable criteria for determining inclusion/exclusion, varying case definitions for low-back pain, and inconsistent baseline assessments, stratification criteria, and outcome measures. Hence, it has been challenging to compare studies of similar or competing interventions, replicate findings, pool data from multiple studies, resolve conflicting conclusions, develop multidisciplinary consensus, or even achieve consensus within a single discipline regarding interpretation of findings. A key recommendation from the NIH workshops on how to advance cLBP research was to establish research standards on cLBP. The NIH Pain Consortium convened a Research Task Force that, through a series of meetings, has crafted a set of research standards that includes the following: 1) definition of cLBP; 2) classification of cLBP by level of impact; 3) minimum dataset for NIH-supported cLBP research comprising assessment of: medical history, physical examination, diagnostic testing, self-report of functional status, psychosocial factors, and mood disturbance; 4) supplemental data for specific situations; 5) outcome recommendations; and 6) recommendations for research on the proposed standards. These research standards will be required by NIH for future research grant applications submitted on cLBP.
Thursday, May 15
Conducting Pragmatic Trials With Complementary and Integrative Interventions: Lessons Learned
Wendy Weber, N.D., Ph.D., M.P.H., Partap Khalsa, D.C., Ph.D., Laura Lee Johnson, Ph.D., NCCAM; Jeffery Dusek, Ph.D., Penny George Institute for Health and Healing, Allina Health; Lynn DeBar, Ph.D., Kaiser Permanente Center for Health Research; Jason Gerson, Ph.D., Patient-Centered Outcomes Research Institute (PCORI)
10:30 a.m.–12 noon
In the last few years there has been a growing interest by the public and the scientific community in clinical trials that will test research hypotheses, which will directly inform the health care system. This interest has been driven by a number of factors including the high cost of traditional efficacy studies and the exclusion of many individuals from efficacy trials, resulting in results that do not generalize to many patients. This symposium includes presentations that will provide definitions of pragmatic and comparative effectiveness research (CER) studies, and describe circumstances when these study designs are appropriate. NCCAM and PCORI representatives will highlight an overview of funding opportunities and priorities for pragmatic and CER studies. Two investigators will present an overview of ongoing pragmatic research studies. One is designed as a prospective observational study design conducted within a hospital care system utilizing electronic health records to gather outcome data. The second study is a cluster randomized pragmatic trial examining treatments for chronic pain in multiple health care systems. Presenters will discuss an overview of the challenges encountered in conducting these studies and how they have overcome these challenges. The final presenter will be a statistician who will provide a summary of the statistical and data quality concerns that need to be addressed in pragmatic studies including: sites needed for cluster randomization, data quality in electronic health records, and confounding and bias in observational designs. The session will close with a panel discussion with all presenters to answer questions from the audience.
Peer Review, or How To Prepare Competitive Applications
Peter Kozel, Ph.D., Dale Birkle Dreer, Ph.D., Martina Schmidt, Ph.D., Hungyi Shau, Ph.D., NCCAM
The peer review process is an essential step in the path NIH and other funding sources follow to identify and select grant applications for funding. The evaluative meetings at which the scientific merit of applications is assessed are usually closed to the public. However, understanding the peer review process, its outcomes, and how to respond to those outcomes are key skills for investigators to master if they wish to become successful applicants. This workshop will use the NIH peer review process as a model to provide participants with an inside perspective on the review process and guidance on preparing competitive grant applications to NIH and other funding sources in a highly challenging funding climate. Aspects addressed include: a description of the review process; differences in review criteria between different mechanisms; timelines for preparing and submitting applications; common applicant mistakes and how to avoid them; and guidance on how respond to previous reviewers’ comments in your revised application. Recent changes and updates to the NIH application and review processes will also be discussed. Participants will leave this workshop being better prepared to develop and submit competitive grant applications to NIH and other funding sources. This workshop is relevant to scientists and clinicians at all career stages, from graduate students submitting individual fellowship applications, to full professors and deans submitting multicomponent center grants.
Friday, May 16
Practical Considerations in Planning and Implementing Individual and Group Intervention Studies: Strategies That Can Help (or Hurt) Scientific Rigor
Qian Li, Sc.D., Laura Lee Johnson, Ph.D., Robyn Bent, R.N., B.S.N., Wendy Weber, N.D., Ph.D., M.P.H., Christine Wishnoff, NCCAM
10:30 a.m.–12 noon
Study teams strive for rigorous study designs to address research questions despite numerous challenges. While it may appear simple to plan a randomized, controlled, double-blind study, implementation can be challenging. Based on implementation challenges commonly noted in trials of yoga, tai chi, meditation, and whole systems studies, this workshop will guide attendees through the study design and implementation process, and assist in the recognition of common pitfalls. It starts by proposing a series of research questions and discussing several study design options such as group, cluster, or individual level randomization; interactions between the study team, participants, and intervention delivery; and basic statistical considerations including intent-to-treat or per protocol analysis populations and missing data. Attendees will work in groups to define a study question, hypotheses to test, and study design strategies. Choices made by the groups will determine the potential study planning and implementation problems that the groups will encounter on their path to successful study completion. The small groups will then be challenged with an implementation hurdle such as difficulties recruiting, retaining, blinding, or randomizing participants; differential participant retention and followup; or other issues with study conduct. These challenges will be shared with all the workshop attendees to get feedback and additional perspectives through guided discussion. At the end of the workshop, choices for final study design and determination of which questions can be answered based on that design will be shared with workshop attendees. This will be a highly interactive and engaging session sharing creative and best practices in addition to lessons learned across communities. Upon completion of the workshop, participants and presenters should have an expanded perspective on potential study implementation and interpretation issues and potential solutions that can be used in designing their own studies, reviewing study proposals, evaluating the literature, and developing new research recommendations.
Spotlight on Rigorous Study Design, Reproducibility, and Transparent Reporting
Emmeline Edwards, Ph.D., David Shurtleff, Ph.D., Carol Pontzer, Ph.D., NCCAM
Developing effective complementary and integrative interventions for symptom management is central to the mission of NCCAM. To accomplish its mission, NCCAM relies on and supports a diverse preclinical and clinical research grant portfolio. The reproducibility of such research, however, has been questioned and, most recently, the spotlight has been on the irreproducibility of preclinical research. This session will highlight these concerns and the likely causes. It will provide possible solutions for improving the design, execution, and reporting of preclinical studies, basic human mechanistic studies, and Phase I clinical studies that serve as the foundation for translating basic research discoveries into improved clinical practice and health. Dr. David Shurtleff will summarize recent concerns and possible causes for preclinical research irreproducibility. He will describe steps NIH and other organizations, such as scientific journal publishers, are taking to address this problem. Dr. Emmeline Edwards will discuss the need for a core set of reporting standards for basic human mechanistic studies with a special emphasis on data handling. She will highlight practices related to data handling that can lead to false positives, such as interim data analysis, ad hoc exclusion of data, retrospective primary end-point selection, sample size determination, and adequacy of control conditions. Dr. Carol Pontzer will describe some negative and inconclusive NCCAM-sponsored natural products intervention trials to exemplify the importance of rigorous foundational research, evaluation of scientific premise, and analysis and interpretation of clinical trials data. She will also comment on efforts by scientific journals and reviewers to ensure quality of publications through the enhancement of review guidelines.
Probiotic Nutritional Pharmabiotic Interventions of the Brain-Gut-Microbiota Axis: A Systems Biology View
Linda Duffy, Ph.D., NCCAM; John Bienenstock C.M., M.D. (Hon), FRCP, FRCPC, FRSC, McMaster University; Kristen Tillisch, M.D., UCLA Medical Center
Gut microbiota are increasingly recognized as influencing many aspects of human health. Emerging evidence suggests that the gut microbiota also influences brain function and may have a role in anxiety, mood, and cognitive behaviors, neurophysiology, and neurochemistry. The abundance and complexity of symbiotic host-microbial interactions contributes to the fitness of human well-being under varying ecologic conditions. Whether this translates to microbial-based central nervous system nutritional and biotherapeutic interventions remains an intriguing possibility and one that is worthy of much further investigation. For example, commensal strains of bacteria in animals has been shown to reduce anxiety and change the presence and activity of receptors in certain brain regions that are associated with anxious and depressive-like behaviors. A unique view of the symposium is the emerging ecologic and systems biology perspective available with novel cellular- and molecular-based technologies. Preliminary evidence suggests that administration of selected keystone eco-stabilizers as probiotic interventions can also modulate various aspects of brain function, some of which are vagus dependent. Ingestion of lactic acid bacteria (LAB) selected strains can decrease anxiety and reduce stress-induced increases of plasma corticosterone levels in mice. LAB strains also have been shown to alter the mRNA expression of GABA and GABA receptors in several brain regions. These preliminary findings suggest that parasympathetic innervation is necessary for probiotic effects to functionally alter select microbiota-brain interactions. However, the strains with the most translational impact need to be carried out longitudinally in randomized, controlled safety studies under tight regulatory INDs to examine if there are systematic changes that correlate with anxiety, stress, and other brain behavior conditions.
Advancing the Use of Population-Based National Survey Datasets Including Data on CAM Use in Children
Christina Bethell, Ph.D., M.P.H., M.B.A., Child and Adolescent Health Measurement Initiative/Oregon Health and Science University; Barbara Stussman, NCCAM
This workshop provides resources, technical tips, and applied examples to expedite and enhance the valid and meaningful use of the Complementary and Alternative Medicine (CAM) Supplement of the National Health Interview Survey. Qualitative and quantitative approaches to the survey’s development, design, and data collection will be discussed, and the content and methodological features of the survey dataset will be described. To provide a platform to translate these data into knowledge and action, free user-friendly online tools for accessing data, datasets, and resources will be demonstrated. An interactive group activity will draw upon real world examples to show potential research uses of the dataset and online tool. The workshop will promote use of the national survey among CAM researchers and advocates by describing the depth, breadth, methods, and features of the survey, as well as the functionality of data access and technical assistance resources.
Pre-Application Webinar on Center for Advancing Natural Products Innovation and Technology (CANPIT) FOA
Date: Tuesday, April 1, 2014 - 2:00p.m. ET to 3:00p.m. ET
On Tuesday, April 1, 2014 from 2:00 – 3:00 EST. the National Center for Complementary and Alternative Medicine (NCCAM), and the Office of Dietary Supplements (ODS), components of the National Institutes of Health (NIH), will hold a pre-application webinar to discuss the Center for Advancing Natural Products Innovation and Technology (CANPIT), a new and exciting funding opportunity announcement (FOA). This FOA is released in conjunction with a companion FOA (RFA OD-14-001): Botanical Dietary Supplement Research Centers (P50).
A teleconference was previously held on January 27, 2014 to provide an overview; however, the April 1 webinar will provide additional technical assistance and amplify more details to prospective grant applicants, including an overview of the research grant submission process, an in-depth discussion of the funding opportunity, and explain the peer-review process. The webinar will also address participant questions.
Please register for the CANPIT webinar. After registering, you will receive a confirmation email with your unique link to connect to the webinar.
Pre-Application Teleconference on Plasticity and Mechanisms of Cognitive Remediation in Older Adults (R01)
Date: Thursday, February 6, 2014 - 2:00p.m. ET to 3:00p.m. ET
Plasticity and Mechanisms of Cognitive Remediation in Older Adults (R01)—NCCAM and NIA will hold a pre-application teleconference on Thursday, February 6, 2014 from 2:00–3:00 p.m. (EST). The purpose of this teleconference is to provide technical assistance to prospective applicants, including an overview of the research program and a discussion of the grant mechanism used. The teleconference will also provide information on preparing an application, highlight the peer review process, and address participant questions. If you would like to participate in this teleconference, please contact Anita McRae-Williams at email@example.com to RSVP your attendance. After you RSVP, you will be provided the conference call dial-in information.
NCCAM Pre-Application Teleconference to Discuss the Center for Advancing Natural Products Innovation and Technology (CANPIT) (U41)
Date: Monday, January 27, 2014 - 2:00p.m. ET to 3:00p.m. ET
NCCAM Funding Opportunity Announcement: RFA-AT-14-006
Companion Funding Opportunity Announcement: RFA-OD-14-001, P50 Botanical Dietary Supplement Research Centers (BDSRC) (P50)
Purpose of Teleconference:
On January 27, 2014, the National Center for Complementary and Alternative Medicine (NCCAM) convened a pre-application teleconference to provide technical assistance to prospective grant applicants. The teleconference provided an overview of the research grant submission process, including an indepth discussion of the funding opportunity, and explained the peer-review process. The teleconference also addressed participant questions received via telephone and e-mail.
Application Receipt Dates: Friday, June 27, 2014, by 5 p.m. local time of applicant organization
D. Craig Hopp, Ph.D., NCCAM, Program Director
Peter Kozel, Ph.D., NCCAM, Scientific Review Officer
Barbara Sorkin, Ph.D., Director, Botanical Research Centers Program, Office of Dietary Supplement (ODS)
Anita McRae-Williams, M.A., NCCAM, Outreach Program Manager (Moderator)
Important information provided about this funding opportunity announcement (FOA) by NCCAM and specific questions and answers asked during the teleconference appear below:
Important Information About the Program Announcement
- The purpose of this award is to establish a cooperative agreement between experts in relevant technologies and natural product researchers, both within the Center for Advancing Natural Products Innovation and Technology (CANPIT), and in collaboration with other leading investigators. The goal is to improve and strengthen technologies and methods used in natural products research and to overcome methodological and technological hurdles that hinder advances in natural products research. The CANPIT is expected to overcome existing research limitations by developing and/or adapting cutting- edge, innovative approaches and technologies that will have significant impact on the chemical and biological investigation of natural products.
- A letter of intent (LOI) is not required, but encouraged, and is due by May 27, 2014.
- The first submission receipt date is June 27, 2014.
- The award amount is $750,000 in direct costs per year. The maximum award period is 5 years.
- Foreign applicants or foreign components are not eligible to apply for this initiative.
- The principal investigator (PI) should have substantial knowledge of natural products; however, project leaders might have expertise in technology primarily. The PI does not have to be a project leader.
- This FOA is released in conjunction with a companion FOA (RFA OD-14-001): Botanical Dietary Supplement Research Centers (P50).
- The PI is expected to be the leader of the administrative component.
- The PI can be the applicant for both the P50 and U41 mechanisms.
Information About the Use of the U41 Mechanism
U41 Applications General Information
- The U portion of the mechanism designates this is a cooperative agreement, which is different than a regular R grant or a P, Program Project Grant. The U mechanism is a cooperative agreement between the grantee and the National Institutes of Health (NIH) where NIH has substantially more input and oversight responsibilities than for other types of funding mechanisms.
- The 41 part of the grant mechanism indicates this is a Biotechnology Resource Center and the “Resource Center” of that indicates that the grantee is expected to produce something that can be useful to other researchers.
Additional Administrative Points:
The administrative core component helps oversee the general management of the projects as well as manages the U41 collaborations with the P50 grantees. The PI is required to be the leader of the administrative core component of this Center.
Coordination and Dissemination
The coordination and dissemination component establishes best practices and disseminates the best practices that have been compiled, promoting use and adaptation or adoption of the technologies developed within the U41, and requires development of a robust Web presence that is readily accessible.
Technology, Research, and Development (TRD) Projects
- A minimum of three and a maximum of four projects are allowed.
- Projects should be focused on highly innovative methodology.
Technology Demonstration Projects
- At least one Technology Demonstration project (TDP) is required for each technology demonstration project per Technology Research and Development (TR&D) project. However, overlap is allowed. One of the TDPs can collaborate with more than one TR&D project. A maximum of 10 demonstration projects are allowed; 5–7 are more likely.
- Technology developed within the U41 can be funded by the U41 and is meant to be used by an entity outside of the U41.
- Funds cannot be transferred from the U41 directly to External Technology Demonstration project collaborators through a sub-award.
Areas of Research Interest
- Innovative approaches for better characterization of network-level pharmacological interactions between complex mixtures and complex biological systems
- Novel chemo-informatics technology for fingerprinting of complex mixtures
- Methodologies that can identify active components with reduced reliance on bioactivity guided fractionation; tools to quickly identify biological targets for natural products
- Novel approaches for rapid de-replication of active components in complex mixtures
- Innovative methodologies to detect contaminants or adulterants in complex mixtures
- Development of high-content phenotypic assays capable of capturing multiple mechanisms of action
- Tools that can qualitatively and/or quantitatively establish presence of multiple active constituents (i.e., synergism) in a complex mixture
Excluded Research Topics
- Tools that are too limited in their application; either to a particular structure, a particular target, disease or condition, or a particular natural product source, etc.
- Projects focused on methodologies to improve production of individual natural products or their derivatives
- Projects focused on tools to modify natural products for the purpose of improving potency, novelty, etc.
- Development of tools and technologies that do not address existing bottlenecks or challenges
Information on Review of Grant Applications
- Letters of intent are not required and are not binding. However, staff in both Program and Review find it extremely helpful to have information about forthcoming applications prior to the submission of actual applications. Therefore, letters of intent are appreciated by both Program and Review staff. Letters of intent are due to Dr. D. Craig Hopp by May 27, 2014.
- Applicant organizations must complete essential registrations prior to submitting an application: (1) the System for Award Management (SAM), (2) the U.S. Small Business Administration (SBA) Company Registry, (3) Grants.gov, (4) Electronic Research Administration (eRA Commons), and (5) Dun & Bradstreet Universal Numerical System (DUNS). Grants.gov will not accept applications from organizations that do not have these registrations.
- All applications in response to this FOA must be submitted electronically through Grants.gov or through a peer-to-peer system that some universities and third party providers have developed.
- Due to the complexity of the U41 Centers, applications are prepared through NIH’s Application Submissions System & Interface for Submission Tracking (ASSIST). ASSIST is a tool that helps applicants assemble all documents required for a complex, multi-component application (like the U41) into a form that Grants.gov will accept. Training webinars for ASSIST: grants.nih.gov/grants/webinar_docs/webinar_20130813.htm. FAQs on electronic application submissions: grants.nih.gov/grants/electronicreceipt/faq_full.htm.
ASSIST itself can be found at: public.era.nih.gov/assist.
- The review process begins by administratively reviewing each application to ensure that it is responsive to the funding opportunity, is complete, and does not contain any inappropriate material. Applications that lack required components identified during the administrative review or contain material not permitted in the FOA or the SF424 instructions will be returned unreviewed to the applicant.
- Members of advisory committees: The RFA requires funded centers to establish and maintain an external advisory committee (EAC). For this U41, applicants should not name or identify members of their outside advisory committee. The RFA clearly states that applicants may not have even recruited potential members of their EAC at the time of application. Applicants may only describe the scientific disciplines that might be included on the EAC.
- The FOA has several specific page limits that must be followed. The overall and administrative core components are each limited to six pages. Each TR&D project is limited to 12 pages. The coordination and dissemination component is limited to 12 pages. Common grant writing tips are located at: nccam.nih.gov/grants/resources/grantwrite-advice.htm.
- All key personnel should provide an up-to-date bio sketch using the appropriate form. The form includes a personal statement, which should address the roles and contributions the individual will make to the proposed U41 program. Each bio sketch may not exceed four pages.
- The FOA uses standard formatting guidelines common to all NIH grant applications. Specifically, margins should be no less than half an inch. Applicants may use only Arial, Helvetica, Palatino Linotype, or Georgia typefaces that are black font color with a font size of no less than 11 points. No more than 15 characters per inch horizontally and less than 6 lines per inch vertically are allowed. Detailed grant-writing tips can be found at grants.nih.gov/grants/writing_application.htm.
- The FOA also states that appendix documents should be kept to a minimum. Reviewers may or may not look at the appendix materials; therefore, nothing that is critical to the review of your application should appear in the appendix. Tables are not allowed in the appendix. NIH guidance clearly states that applicants who present information in tabular form will be considered as having circumvented NIH rules on page limits.
- Only specific sorts of documents may be included in the appendix. Not more than three of the following documents are permitted in the appendix: manuscripts and/or abstracts accepted for publication but not yet published; published manuscripts and/or abstracts only when a free, online, publicly available journal link is not available; and patent materials directly relevant to the project. Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents may be submitted in the appendix as necessary.
Process of Reviewing Grant Applications
- Applications should address the review criteria in the FOA; should be easy to read; and should be organized so that it is easy for reviewers to find information.
- The composition of the review panel will be a reflection of the science proposed in the applications NCCAM receives. Consequently, the experience of the panel may be broad. All reviewers will provide scores for all applications with which they are not in conflict. This means that an application should be written so that it can be understood by someone who is not an expert in your field(s).
- Overall Center: Review criteria are based on the standard five review criteria for research grant applications, namely: significance; investigators; innovation; approach; and environment. Note that under each of these overarching criteria are additional criteria specific for this RFA.
- Technology Research and Development Projects: The review criteria are based on the standard five review criteria for research grant applications, namely: significance; investigators; innovation; approach; and environment. Note that under each of these overarching criteria are additional criteria specific for this RFA. Be sure to look these criteria over carefully.
- Coordination and Dissemination, and Administration: For the coordination and dissemination, the criteria are: coordination; best practices; and dissemination. The criteria for the administration portion do not have subject headings. Be sure to look these criteria over carefully.
- Applicants are urged to carefully read, understand, and address all of the review criteria in their applications.
Teleconference Participants’ Questions and Answers
- Question: What are the relationships between this new Natural Products Center and the Office of Dietary Supplements Botanical Centers?
- Answer: These were issued as companion funding opportunities and they are expected to work together. Ideally, the Botanical Dietary Supplements Research Centers are exploring different biological activities of botanicals and it is envisioned that this U41 group is going to be developing some very innovative technologies that will be very useful to the Botanical Centers. The Botanical Centers represent a substantial investment by NCCAM as well as ODS and we would want to leverage these investments synergistically. In addition, the Botanical Research Centers have a strong focus on looking at multi-component botanicals and trying to elucidate how multiple components of those botanicals exert biological activity in combination. One of the challenges in the field is doing this in an effective way, and perhaps this is one of the contributions the U41 can make. The Botanical Dietary Supplements Research Centers are expected to meet together annually to exchange research findings. We would certainly hope to include the U41 researchers in that meeting once the new awards are made and that the investigators on the Botanical Dietary Supplements Research Centers might be excellent sources of information and resources. So, those are a couple of the ways we see these interacting with each other.
- Question: We are looking at submitting a dual proposal to both initiatives. Could you please explain more about the PI requirements for the P50 versus the U41?
- Answer: The PI for the P50 is expected to be a leader in this field with the ability to coordinate and manage a large project such as this, but specifically for these initiatives. For the P50, the PI has to be the leader of the administrative core and must also be a leader of one of the research projects. For the U41, the PI has to be the leader of the administrative core but is not required to be a leader of one of the research projects. Aside from that, expectations for the PIs are the same as we expect for any large multi-component project.
- Question: In the two applications for the P50 and the U41, is it okay to indicate that we plan to submit applications for both and plan for them to work together, and justify the PI’s lower time commitment in the U41 based on the fact that we have submitted a P50, or would you advise against that?
- Answer: I would advise against cross-referencing your applications in the other application just because these are going to be reviewed by different review panels, at different times, and they should be able to stand on their own merits. In addition, keep in mind that each review panel is evaluating the applications before them. One of the things they will be considering is the strength of the investigator’s team. For instance, is there adequate commitment from the PI to do what the application indicates and keep the research coordinated, productive, and on track?
Therefore, if you have a PI who has other commitments and cannot provide sufficient commitment to each of the applications, to make a strong one, then perhaps you need to do some more thinking about how to make that work.
- Question: Do you want us to have a P50 question for a Technology Demonstration project (TDP); the question is what happens if the center isn't funded? Does it matter?
- Answer: The TDPs are expected to be an ever-changing, evolving body of external collaborators and if you have proposed something and the funding does not go through, then you need to have a process in place to recruit new TDPs. It is part of the expectation in the application that applicants will lay out a process whereby the TDPs are recruited, terminated, renewed, and replaced. If applicants propose something and it does not work out, then they have to just move on to plan B. Note that plans to recruit, evaluate, select, manage, and end TDPs are reviewable.
- Question: A followup question for the exact opposite scenario. If I'm a part of an existing P50 center, should we propose some method development within the existing P50? If there is overlap, if supposedly we were to submit a U41 or we were to do a TDP with some other group putting in a U41, if there was overlap in the proposed methodology, what would happen? That is, if we got lucky, the P50 was funded and the U41 was funded, ours or somebody else's, and there's overlap, what happens then?
- Answer: NIH and NCCAM do not want to duplicate funding. However, if you were in such a situation, we would work with you to eliminate any overlap in funding and have you redirect either those dollars or that effort into new or different areas.
- Question: I am familiar with the U54. Is this U41 funding mechanism similar to a U54, and could you give us some examples of existing U41s that might help us in organizing and thinking about this?
- Answer: A U41 is basically the cooperative agreement version of a P41. U41s are very rare and there are very few of them at the NIH. However, there is a robust community of P41 grantees who are now funded largely by the National Institute of General Medical Sciences (NIGMS) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB). This list is included in the FOA, which links to those NIH resources. There are 40 or 50 ongoing current P41 grantees at NIH through NIGMS and NIBIB that you can locate in the FOA links provided, which from there will take you to a list of all the current grantees. This will give you a sense of what these U41 grantees are doing and what we have in mind in terms of modeling our approach after this existing program structure.
- Question: Does the principal investigator for this new center need to have previously received NIH support?
- Answer: No is the short answer. The PI does not have to have previous or NIH funding but it is expected that the PI will have a well-established track record of research documented through publications and a documented history of being a very productive researcher and collaborator.
- Question: Could you please explain the dissemination piece of this for us?
- Answer: The dissemination piece is a very important component. We have talked a lot about technology and how we expect this to break through some barriers and advance the field forward, but technology is only good if somebody else uses it. The dissemination part is very important too and there is a training aspect within the dissemination. For instance, you have to make these technologies available to as many people as possible, so allowing for the possibility of different training mechanisms and outreach methods to disseminate information through various channels such as publications, workshops, and scientific meetings. The critical aspect of various technologies being disseminated is so they can be adopted to achieve our objective of really changing the field substantially.
- Question: Do you envision single or multiple institutions involved?
- Answer: Like any other large projects you are going to need to have a team of people involved and often times, especially nowadays with the way collaborative research works, it is not always the case that all the team members are within the same institution or within a very tight geographical area. Certainly there is going to be an expectation that many applicants are going to have people involved who are somewhat remote. As long as they mention the eligibility criteria, they are not foreign components. It is not unexpected at all that you are going to have to some distant external collaborators, especially when you start to incorporate the universe of the technology demonstration projects. So this is fine and expected as long as you can demonstrate the plan and the history of managing this type of environment.
- Question: In the funding opportunity announcement, it says that you can have up to 10 Technology Demonstration projects. Is that over the total up-to-5-year time span of the U41 or is that per year?
- Answer: This is meant that at any one point in time, at the time of application you are limited to a maximum of 10. We are not necessarily expecting these brand new collaborations to have 10 of these Technology Demonstration projects initially. However, 10 is the maximum that we would expect any one group to have ongoing at one point in time.
- Question: Can TDPs come from foreign researchers?
- Answer: Yes, because no funds would be expended through the TDP. Although these would be foreign components, in one sense, they would not be in the sense that no dollars from this award would be sent to the foreign collaborator. So if you have a foreign researcher who you want to work in developing this technology, as a TDP, they would be allowed to be part of the U41 team. This is a good reminder that Technology Demonstration projects have to be funded elsewhere, may not be funded through the U41; and presumably a TDP project that is funded outside of the United States could be part of this because no funds would be coming from this U41 to support that Technology Demonstration project. It is expected that all the Technology Demonstration projects will have external funding.
- Question: For budgeting purposes, should we think of the U41 as sort of a super-core that they need to take on all questions that come in from or uses for their expertise that would come in from, say, other P50s?
- Answer: Actually this is a required component that will be reviewed. How are you going to select, how are you going to bring in new ones, and how are you going to select them? This required component will be evaluated in the review process–for example, the applicant's plans for gathering, assessing, prioritizing, supporting, and ultimately closing out TDPs. Within your budget for the U41, you should state how you plan on managing up to a maximum of 10 TDPs, making sure you have not overextended yourself.
For programmatic questions, contact:D. Craig Hopp, Ph.D.
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892 (Courier Service - 20817)
For review questions, contact:Dale Birkle Dreer, Ph.D.
Chief Office of Scientific Review
Division of Extramural Activities
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892 (Courier Service - 20817)