This communication is divided into three parts:

Part I: A discussion of the priorities and general design considerations of research investigations funded by FCER;

Part II: Guidelines for developing, strengthening, and troubleshooting a research plan;

Part III: Evaluation of budgetary items in the FCER grant application and general administrative guidelines of the funded research grant.

It is hoped that this document will help the prospective researcher gain a clearer understanding of the requirements and expectations underlying FCER's Awards and Grants Program. In particular, the intended outcome is to facilitate the preparation and submission of grant applications to the Foundation.

Further inquiries may be made at any time to FCER at 380 Wright Road, P.O. Box 400, Norwalk, Iowa 50211 USA.

At precisely the time that chiropractic has gained public and governmental recognition as one of the leading modalities of intervention for the treatment of low-back pain, FCER recognizes that the research that it seeks to support is at a major crossroads. The research regarding low back pain that has appeared in peer reviewed journals over the past twenty years has been invaluable in documenting the effectiveness of chiropractic intervention to the extent that it has recently gained both governmental and public recognition as one of the leading modalities of intervention for the treatment of low-back conditions. While further documentation of low back-care is to be sought, it is essential that the clinicians' reports of the effectiveness of chiropractic care in the management of upper back, muscular, and somatovisceral conditions be verified as well if the scope of chiropractic care is to be anything broader than for low-back conditions in the future.

Hopefully, it will become apparent why the following seven areas represent FCER's current funding priorities:

A. The Disease Model:

Often labeled as specialists, chiropractors have commonly faced the responsibility of treating patients with specific conditions. Numerous anecdotal and case reports, in addition to a handful of clinical trials, have recently emerged to support the effectiveness of chiropractic care in the management of conditions beyond low-back pain. These include:

1. Upper cervical conditions;

2. Headache;

3. Carpal tunnel syndrome;

4. Fibromyalgia, arthritis and other muscular conditions;

5. Pulmonary and cardiac disorders [asthma, hypertension, and angina];

6. Neurological problems [Bell's palsy, cerebral palsy, epilepsy];

7. Gastrointestinal syndromes [irritable bowel syndrome, ulcers];

8. Chronic fatigue and chronic fatigue syndrome.

To gain credibility, chiropractic interventions regarding any of the above conditions or others in addition to back problems depend upon appropriate research, the design of which is to be discussed below.

At the same time, the identification of new groups of patients is a high priority for future chiropractic research. This would involve women [obstetric and gynecological disorders, such as premenstrual syndrome, chronic pelvic pain and dysmenorrhea], children and infants [otitis media, colic, enuresis, scoliosis, hyperactivity and attention deficit disorders], and elderly populations.

B. The Wellness Model:

A basic tenet of chiropractic theory envisions chiropractors being able to forestall or prevent specific conditions from emerging through the treatment of subluxations through the application of chiropractic adjustments. A broader school of clinicians has engaged in nutrition/diet and lifestyle/ergonomic counseling in the effort to treat or prevent diseases. With the problems of effective health care reform, cost control, and effective primary care becoming national priorities within the past year, FCER seeks research efforts involving chiropractic care that are addressed to diet and nutrition as well as ergonomic issues, maintenance and prevention.

A major outcome of documenting both an expanded list of conditions treated by chiropractic intervention and establishing chiropractic as a means for preventative health care is the establishment of the chiropractor as a primary health care physician. Given the recent growth of managed health care systems, having the chiropractor function as the first point of contact as well as a referral service is a matter of great priority. It should thus be readily apparent why publishing the research to document both parts (A) and (B) of this discussion is of major importance.

C. Basic Research:

Within the past decade, chiropractic research has attracted the interests of basic scientists as well as clinicians. Thus, one finds biochemists, clinical chemists, biostatisticians, epidemiologists, and more and more M.D.s taking an active interest and role in chiropractic research. This is not unlike the advent of molecular biology in the early 1950s, when the interests of chemists, mathematicians, and physicists converged with those of the biologists to propose a working model of DNA that in turn led to an explosion of discoveries in cellular biology and medicine.

If chiropractic researchers are to be truly conversant with research interests that stand to add as much to chiropractic theory as the Watson-Crick model of nucleic acids added to our understanding of cell biology, we must look to relevant basic research interests as well as the applied. This would include more thorough understanding of such areas as:

1. The biomechanics of the spine, loading, adjustments, and repetitive stress;

2. The physiological and molecular basis of receptors, nerve transmission [including signal transduction], and neuroplasticity;

3. The chemical and molecular basis of immunological functions in relation to chiropractic intervention;

4. The chemical and molecular basis of nutrition;

5. Healthy and unhealthy states and alterations of analytes in the blood, urine, and lymph systems.

D. Verification of Instruments, Design, and Data Processing Techniques:

While chiropractic intervention undoubtedly has gained virtually mainstream status in the management of low-back pain by dint of well-crafted clinical trials which have been published in the indexed journals within the past two decades, it has also had to endure studies of questionable execution and/or interpretation which have appeared within the past year in The New England Journal of Medicine and Pain. This raises the need to add new and better-executed clinical trials to the chiropractic research literature, in addition to new case and cohort studies which, after all, represent the observational efforts from which all clinical trials are ultimately designed.

E. Economic and Practice Patterns of Chiropractic Care:

As managed health care comes to the forefront of the health care reform debate, cost-benefit data concerning alternative health therapies will undoubtedly become increasingly important to third-party providers as they consider and approve covered services. Thus it is to the benefit of the profession to provide data addressed to the comparative costs of traditionally covered [allopathic] and chiropractic modalities. FCER's research interests extend to topics involving both the economic and practice patterns of chiropractic care. This concern includes cost-effectiveness and patient satisfaction as additional indices with which to assess chiropractic care in relation to other health care modalities.

F. Educational Research:

Given the increasing importance of proper accreditation and the inevitable comparisons that are made between the chiropractic education process and that of other healthcare professions, a major priority has been to focus many of our research capabilities upon the actual chiropractic program of instruction itself. In particular, we need to ask:

1. What models of clinical training are appropriate for achieving either a successful specialist or generalist role?

2. What models of research training may be incorporated into the education program?

3. How can we integrate the named techniques into the formal educational program based on evidence?

4. What are the best means available for training and enhancing the effectiveness of preceptors?

5. How may competencies in delivering patient-centered care be developed and monitored?

G. Psychosocial Aspects:

Especially within the past two decades, all healthcare professions have become increasingly aware of the importance of the psychological status of the patient in both resisting and overcoming disease. Extremely high patient satisfaction has always been a hallmark of chiropractic health care, and this has now been recognized to the point at which the better-designed clinical trials must now assess patient attitudes and expectations in addition to what are usually considered to be the more "objective" outcomes. Chronic pain, on the other hand, is now understood to have a major psychosocial component which takes into account the patient's own perception of well-being or its opposite. In terms of the necessary research which must document these phenomena, we need to know, for example:

1. In what ways does the satisfaction and expectation of the patient affect the quantity and quality of visits to the practitioner?

2. In what ways is patient affected by nontherapeutic [placebo] effects?

3. What is the role in choosing a provider in producing a therapeutic effects?

4. What are the elements of therapist-patient interaction leading to more effective patient responses?

5. How are patient beliefs formed with regards to therapists, treatments, and health in general?

To summarize, seven lines of investigation are woven together in the chiropractic research efforts to be supported by FCER: somatovisceral and musculoskeletal outcomes research; basic research [including biomechanics]; wellness and prevention; the verification of instruments, design and data processing techniques; economic and practice patterns of chiropractic care; educational research; and psychosocial issues. These areas, therefore, form the nucleus of the research objectives and scope of interest at FCER.

Concise summaries of the actual research which has brought chiropractic to its current level of recognition are available in three previous publications.^1-3

1Rosner AL. Musculoskeletal disorders research. In Redwood D [ed]. Contemporary Chiropractic, New York, NY: Churchill Livingstone, 1997, pp. 163-187.

It has to be understood that the entire spectrum of clinical research methodology must be embraced to build the future knowledge base of chiropractic or any health profession. In order to assure a balanced program of clinical investigations, FCER encourages not only randomized clinical trials, but prospective, retrospective, and single case studies to be included in the mix of research efforts.

The most elaborate and publicized multisite, blinded, crossover and placebo-controlled randomized clinical trials all had their beginnings with "lowly" case studies--and so the research objectives of the profession within the next few years are necessarily predicated upon the observations gleaned from every clinician's office. It is part of FCER's mission to reach out to these locales and encourage the research development of practitioners whose work is deemed promising and within scientific guidelines. We would only expect that sound rationales and complete literature reviews be included in the research proposals submitted to us.

The rules for designing effective basic and instrumentation research do not follow all the guidelines for clinical investigations that were just discussed; rather, they require concise statements of the hypotheses, a consideration of possible complications that may be anticipated in the research, and, above all, a clear discussion as to how the problem to considered relates to chiropractic health care.

The FCER Grant Application contains a section entitled "Research Plan." A research plan, in many respects, represents the heart of a grant application. A research plan conveys both the conceptualization of a research problem area and the methodology to investigate the problem. A well-conceptualized plan and a plan which reflects a complete and valid methodology are essential to the funding of a grant application.

A complete research plan should be comprised of the following components:

1. Background and Statement of the Research Problem, Question, and Hypotheses.

2. Operational Definitions of All Major Variables.

3. Important Assumptions and Limitations of the Study Design.

4. The Theoretical and/or Clinical Significance of the Proposed Study.

5. A Review of Relevant Literature and Critical Research Investigations.

6. A Complete Description of the Proposed Methodology: target population and sampling plan; planned instrumentation and measurement techniques for data collection; overall research design; and identification of appropriate statistical techniques for data analyses.

7. Stated Timelines for the Implementation and Completion of the Proposed Study.

In order to assist the researcher in the preparation of a proposal’s research plan, ten common problems in the development of a research plan are identified.

Problem #1: A researcher fails to provide a meaningful and valid context for a research study.

A research plan should present the theoretical and clinical background of a study. This provides the basis for the research topic. It is very difficult to evaluate the appropriateness of a proposal’s research questions without an adequate presentation of the background. The background statement can draw on relevant theory, past research, and clinical experience. The general information concerning a study’s background should not be confused with the more comprehensive "review of literature." Rather, the researcher should depict the factors or influences that have led to the selection of a particular research topic. The clinical significance of a proposed study should be particularly emphasized.

Problem #2: A complete and precise purpose statement is missing in the introduction to a research plan.

A well-constructed purpose statement is critical to a proposal and identifies the essential research activities of a study (e.g., "evaluate," "compare," "develop," "analyze," etc.), the major variables of interest, and the study population.

Consequently the purpose statement reflects what phenomena are being investigated, how these factors are being examined, and on whom the study is being conducted.

The purpose statement should be placed near the beginning of a research plan to orient the reader/evaluator.

An example of a complete purpose statement follows:

"The purpose of the proposed study is to evaluate the efficacy of spinal manipulative therapy in the treatment of low-back pain, compared to a therapy of bed-rest and analgesics, for a sample of patients with acute, localized low-back pain who are between the ages of 20 to 60 years."

Problem #3: A research plan does not include a complete and correctly stated set of research questions or research hypotheses.

Questions and hypotheses represent the specific focus of a study. It is possible that a general purpose statement can be linked to a number of specific questions and related hypotheses. Research questions concern relationships among variables; hypotheses offer speculations about the nature of these relationships. Hypotheses are informed conjectures based on theory or previous research, not merely wild guesses. Most studies that are exploratory in nature, however, may only contain research questions.

To be useful and meaningful, a hypothesis should reflect the following major characteristics: (a) a hypothesis should express an expected relationship between two or more variables or predict a difference between groups on a measured variable; (b) a hypothesis should be supported by documented references or a clear and logical rationale; (c) a hypothesis should be empirically testable, i.e., the relationship or differences that are stated in the hypothesis should permit measurement of the variables as well as the necessary statistical comparisons.

Problem #4: Research questions and hypotheses are not grounded in clear and acceptable operational definitions.

An operational definition explicitly sates the manner in which a factor, variable, or characteristic is being measured or manipulated. It may be possible to operationally define a variable in a number of ways. Operational definitions possess critical implications for how a study’s findings will be interpreted. Illustrations of defining terms are selecting operational procedures for the treatment variable of "spinal manipulative therapy" or specifying the defining elements of "chronic low-back pain."

Problem #5: A researcher does not recognize inherent assumptions and limitations of a research plan which will affect a study’s validity and generalizability.

A proposal should recognize any important assumptions underlying the research problem and research design. Assumptions represent "givens" that will not be tested or investigated. An example of an assumption might be: "A maximum of six treatments lasting no longer than 15 minutes each are considered a potentially effective treatment regimen." A rationale should be provided to support any assumption that is likely to be challenged.

Any limitations of a study which may have a serious effect on the interpretation of the findings or on the generalizability of the results should also be recognized. Limitations primarily occur because of design constraints. Design constraints usually involve some aspect of sampling, measurement or control. Examples of limitations are samples consisting only of volunteers, measurement instruments with inadequate or unknown validity, or failure to include important control variables in the design. Often, limitations do not become apparent until a study is completed, but any important limitations imposed on a study in the planning stage should be mentioned in the proposal.

Problem #6: Research questions and hypotheses and research methodology are not supported by a review of current and relevant literature.

A consistent area of weakness of many research plans is a proposal’s inability to present a concise but comprehensive analysis and synthesis of past relevant research literature. A review of the literature should be a well integrated discussion of the theory and previous research which have bearing upon a study’s questions, hypotheses, or methodology. A good review of literature is much more than an annotated bibliography. Rather, it demonstrates how previous studies are related to each other and to the proposed study. An integration of past findings and a recognition of the implications of completed investigations for new research are key attributes of the effective literature review.

A literature review in a research plan need not be all inclusive but should be accurately representative of the knowledge which is germane to a research study. Particular note should be made of the gaps or deficiencies in past research literature since this often serves as a rationale for a proposed study. The logic that exists between prior scientific study and proposed research must be obvious from the review of the literature.

Problem #7: A sampling plan for subject selection is not presented, a target population is not specified, and issues related to the representativeness of a sample are not considered.

The generalizability of a study’s findings (i.e., the degree to which the findings can be applied to individuals not participating in the study) depends upon the limitations of a study’s sampling procedures. A proposal must, therefore, identify: (a) the general group to which findings are intended to apply (target population); (b) the segment of this group accessible for study (available population); (c) the manner in which subjects will be selected for study (sampling plan); and, (d) the resulting group of subjects who will participate in the study, as well as any obvious biases in the method used to select individuals for the sample (data producing sample).

In clinically oriented research, it must also be apparent what inclusion and exclusion criteria have been developed and applied to the sample selection process. These criteria affect the homogeneity of treatment groups and also define the types of patient populations to which a study’s findings can be generalized.

Additionally, in specific types of clinical research designs, it must be clear what procedures, such as random assignment, are used to place subjects in alternative treatment groups. These procedures should be adequately defined and should be replicable.

Finally, a basis for the proposed sample size or individual treatment group sizes should be presented which is substantiated by the intended power of the statistical procedures.

Problem #8: The planned instrumentation and measurement techniques to collect data are not justified or supported by validity and reliability documentation.

The success in answering questions and testing hypotheses directly depends on the quality of the collected data. Thus, the techniques used to generate data must be appropriate to the purpose of a study (validity) and must yield consistent, dependable information (reliability). The burden of proof for both validity and reliability of measurement rests on the researcher and documentation of this proof must be clearly evident in a research plan. The development of valid and evident in a research plan. The development of valid and reliable data collection techniques has been of particular concern to researchers in chiropractic. In clinical research which focuses on the efficacy of alternative treatment plans, it must also be shown that measurement procedures are adequately sensitive to change in treatment outcomes. The empirical approach to answering questions and building new knowledge directly depends on the accuracy and consistency of observation and measurement systems. Inexperienced researchers should review the methodological and statistical procedures which have been developed to improve or to assess the validity and reliability of a measurement technique.

Some research proposals consider the development of a new method of measurement as an aspect of the investigation. Although this is an acceptable and important purpose for doing research, it is critical that validity and reliability assessments be built into a research plan.

Problem #9: An appropriate, overall research design is not selected or identified by researcher.

A research plan must identify and detail a specific research design that will be used to address a study’s objectives, answer research questions, and test hypotheses. A research design represents the strategy that guides all of the activities of the research investigation. Some researchers confuse a study’s research design with its statistical design. Although the two are related, the research design is a more global definition of the overall plan for selecting and assigning subjects, manipulating and measuring variables, and collecting and analyzing data.

Research methodologists have developed and refined a number of alternative designs; each of these has an appropriate use which is dependent upon the basic purpose of the study. A design cannot be rationally and correctly selected until the purpose statement of a study has been developed. For example, a design can be descriptive in focus and involve a variety of population survey design methodologies. On the other hand, research can be relational in nature and utilize correlational, causal-comparative, quasi-experimental, or experimental design options. The use of the relationship design rests upon the objective of analyzing and documenting relationships between or among variables.

Within the broad area of clinically oriented experimental research there exists a variety of specific design option. These options relate to the selection, manipulation, and assessment of "treatment" and "control" groups of patients/subjects. Valid "single subject" designs have also been developed for use in experimental clinical research. A major priority for clinical research in chiropractic is the use of prospective, controlled designs which permit valid comparisons of treatment conditions. A research plan cannot be adequately evaluated unless a research design is identified and is shown to be appropriate for the purpose of a study. Furthermore, the researcher must recognize and discuss the strengths and weaknesses of the selected design. The design of a study represents the basic "blueprint" that is to be followed throughout an investigation; this blueprint must successfully integrate all of the discrete activities of a research study.

Problem #10: Statistical techniques necessary to answer questions or to test hypotheses are either not identified or are not shown to be applicable to the type of collected data or to the research design.

The presentation of statistical procedures in a research plan should include the name or description of each procedure, the variables and related data that are to be analyzed by a procedure, and the question or hypothesis that is addressed by a procedure.

General references to statistical procedures are not acceptable (ex: "correlation coefficient" or "test of group differences"); rather, a research plan must identify the specific statistical tests that will be employed. If a statistical procedure is commonly employed by other researchers in the field, its name is sufficient. A reference and, perhaps, a formula should be supplied for established procedures which are not commonly employed by other researchers.

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Although most chiropractic researchers are comparatively expert in their respective fields of study, common weaknesses surface in the research proposals of many prospective researchers. These weaknesses relate to the content and scope of the research plan and interfere with a valid and complete evaluation of the proposal. Fortunately, these weaknesses can be remediated by consulting the large body of knowledge in the area of research methodology. Chiropractic researchers who develop a more precise and complete research plan in a proposal can expect more accurate consideration of their requests for funding. As a recent publication from the Division of Research grants of the National Institutes of health notes: "Don’t assume that reviewers will know what you mean. Discuss in detail the experimental design and procedures to be used to accomplish the specific aims of your project. While you may safely assume that the reviewers are experts in the field and familiar with current methodology, they will not make the same assumptions about you. The burden of proof is on you to show, through a clear, succinct, yet detailed explication, that you understand and are capable of handling the research methodology.

The FCER grant application process and application form represent procedures common to most external funding agencies. However, several elements of these procedures require clarification in order to facilitate FCER’s grant application process as it applies to the colleges of chiropractic.

Several points of clarification relate to the application form itself and, specifically, pages 4 and 5 [download sample budget illustration PDF file]. The detailed budget for the first 12 months (page 4) should be complete in an accurate and highly specific manner:

1. All personnel costs should reflect an accurate estimate of the time each individual will be actively involved in grant activities. For professionals, this estimate should be in the form of a percent of time per week. For nonprofessionals, this estimate should be expressed as hours per week. All personnel costs should be explained and justified as specifically as possible on page 5 in regard to the weekly duties or responsibilities each individual will fulfill.

2. Only equipment and supplies which are essential to the conduct of the project should be requested. The cost effectiveness of rental compared to purchase of equipment should be evaluated prior to submission of the application and this information should also be provided on page 5 under the budget explanation and justification section.

3. Travel expenses should include only those expenses which are essential to the conduct of the project. Expenses related to attendance at conferences and meetings will not be supported.

4. As an applicant institution, a college of chiropractic may request a maximum of 10% indirect costs associated with the management and sponsoring of a proposed research project. Indirect costs should be computed on the basis of total direct costs (i.e., sections B, C, D, E, F, and G on page 4 of the grant application form). The applicant institution should provide a brief rationale for the percentage of indirect costs requested.

5. FCER encourages an applicant to locate additional sources of grant support including resources within the sponsoring chiropractic college. These sources of support should be incorporated in the detailed budget on page 4 of the application form. A funding decision will take into account the degree to which an applicant has been able to locate or negotiate support from sources in addition to FCER.

6. Care must be taken to complete either the "protection of human subjects" or "humane treatment of vertebrate animals" section of the application as appropriate. An application will not be processed for funding unless these sections are completed.

In addition to the completion of the grant application form, several points require clarification related to the evaluation, funding, and conduct of an FCER-supported project:

1. Upon receipt of a grant application, submitted for funding at the October 1 or March 1 deadline, FCER will conduct a preliminary evaluation of the application. This evaluation will cover an application’s responsiveness to the funding priorities established by FCER, the scientific design of the research plan and the completeness and precision of the grant application. Applications judged deficient in any of these areas will be returned to the principal investigator. An investigator can elect to resubmit the application at the next application deadline.

2. At any time during the year, an investigator can request a non-prejudicial, preliminary scientific review of a potential application. The application will be reviewed only by the FCER Research Committee. The application will be reviewed primarily for its scientific merit. No evaluation will be made relative to funding. The purpose of this type of evaluation is to provide a prospective applicant with constructive feedback. This feedback can suggest refinements for a grant application which is to be submitted at the next October 1 or March 1 deadline. Approximately two months will be required to conduct a preliminary review.

3. Normally, the monies for an approved project will be dispersed by FCER at three-month intervals (September, December, March, and June) over the projected duration of the project. A principal investigator will be required to file interim progress reports prior to each disbursement. Failure to file a progress report which reflects satisfactory progress in a project will result in the interruption of disbursements.

4. It is the responsibility of a principal investigator to immediately inform FCER of any condition which interrupts the conduct of a funded project. At that point funding for the project may be temporarily suspended or terminated. Any unused monies which have been dispersed for a terminated project must be returned to FCER. A principal investigator and sponsoring chiropractic college assume joint responsibility for maintaining accurate and up to date financial records of an FCER-funded project.

5. Modifications in the original budget of a funded project (i.e., transfer of monies from one budget item to another) require prior approval from FCER.

Borg, W.R., and Gall, M.D. Educational Research (4^th ed.), New York: Longman, Inc., 1983.

Buerger, A.A., and Greenman, P.E. (Ed). Empirical Approaches to the Validation of Spinal Manipulation. Springfield, Illinois: 1985.

Deyo, R.A., and Tsui-Wu, Y. Descriptive epidemiology of low-back pain and its related medical care in the United States. Spine, 1987; 12(3):264-268

Diggett, D.M. The chiropractic wars (Commentary). Journal of Manipulative and Physiological Therapeutics, 1987; 10(2):71-77.

Feinstein, A.R. Clinical Epidemiology – The Architecture of Clinical Research. Philadelphia: W.B. Saunders Co., 1985

Gitelman, R. Chiropractic and research (Outlook). ACA Journal of Chiropractic, 1985; 22(12):5,8,16.

Haldeman, S. Basic principals in establishing a chiropractic clinical trial. ACA Journal of Chiropractic, 1978; 12(s):33-37.

Hildebrandt, R.W. Science, medicine, and chiropractic theory (Editorial). Journal of Manipulative and Physiological Therapeutics, 1986; 9(3): 181-182

Keating, J.C., and Mootz, R.D. Five contributions to a philosophy of the science of chiropractic (Commentary). Journal of Manipulative and Physiological Therapeutics, 1987; 10(1): 25-29.

Keating, J.C. Quitoreano, L.A., Seville, J., and Christensen, L. How to hunt the unicorn: an approach to clinical research. Articulations, March, 1984: 10-16.

Long, T.J., Convey, J.J., and Chivalek, A.R. Completing Dissertations in the Behavioral Sciences and Education. San Francisco: Jossey-Bass, 1985.

Meinert, C.L. Clinical Trials – Design, Conduct and Analysis. New York: Oxford University Press, 1986

Office of grants Inquiries, Division of Research Grants, National Institutes of Health. Helpful hints on preparing a research grant application to the National Institutes of Health. (February, 1980). Bethesda, MD: Author.

Phillips, R.B. Where do we go from here? The future of chiropractic research. ACA Journal of Chiropractic, 1983; 20(2): 26-28.

Reports of The Commission of Inquiry Into Chiropractic. Chiropractic In New Zealand. (P.D. Hasselber, Government Printer). Wellington, New Zealand, 1979.

The Foundation for Chiropractic Education and Research [FCER] is a nonprofit philanthropic organization with a charitable tax-exempt status under section 501 c (3) of the Internal Revenue Code. FCER seeks to stimulate and support scientific research which will enhance the knowledge and practice of chiropractic as a conservative, non-invasive approach to the restoration and preservation of health. The Foundation is currently the primary source of funding for chiropractic research.

FCER will consider applications for support of research that scientifically relates to chiropractic and the principles upon which it is founded. The Foundation is interested in developing research capabilities within the chiropractic profession but is not restricted to considering proposals submitted exclusively by chiropractors or chiropractic institutions. All proposals submitted by qualified persons which fulfill the following instructions will receive equal consideration.

The following outlines the types of research FCER is interested in supporting. Proposals outside of these areas will also be considered but will receive lower priority:

Basic Science Research:

The purpose of this program is to stimulate research within the basic sciences which will further the understanding of the principles upon which chiropractic is founded, including: biomechanical studies of the spine and related soft tissue structures, small animal studies pertaining to the relationship between the spine and body functions, and objective laboratory evaluation of the effects of manipulation upon various physiological processes.

Clinical Science Research:

The purpose of this program is to support research which attempts to evaluate the role of chiropractic in health care, including: controlled clinical trials of spinal manipulation, evaluation of the effectiveness of manipulation for various conditions, reliability studies on various chiropractic analytical and diagnostic procedures, validation studies on various instrumentations used in chiropractic, surveys of utilization of chiropractic treatment and epidemiological and sociological studies.

Requests for Proposals and Contracts:

From time to time, FCER publishes and distributes Requests for Proposals [RFPs] to conduct specific types of research. These RFPs are distributed to the chiropractic colleges and other academic and professional institutions, as well as to individuals with expertise relevant to the topic of interest. Any organization or individual may request to be included in the RFP distribution list from FCER.

The Foundation may also entertain bids from qualified personnel and/or institutions for contracts to perform specific projects.

Dates of Submission and Board Consideration:

Application deadlines for research grant proposals are March 1 and October 1 of each year. Funding considerations for each submission cycle are completed by the FCER Board of Trustees at their semiannual meetings, held within 4 months of the submission deadlines. Announcement of awards is made within two weeks of the funding decision.

Application Review:

Upon receipt by FCER, research grant applications are first reviewed for completeness by FCER, who may either return applications or recommend modifications before forwarding them for further review. Proposals are then submitted to an external panel of reviewers whose fields overlap those expressed in the application; their scientific critiques are returned to applicants within 10 weeks of submission. The next stage of review is provided by the FCER Research Committee, who evaluate the scientific reviews just completed as well as providing their own. At this time proposals are also ranked in order of merit as well as in their relevance to FCER's funding priorities.

All recommendations and synopses of grant content and evaluations are submitted to the FCER Board of Trustees for final action at their semiannual meetings. Final funding decisions are based upon merit, overall funding priorities, and monies available.

Project Duration:

The project duration for which support is requested should be consistent with the nature and complexity of the proposed research. The expiration date may include a nonfunded "flexibility" period for up to 9 months in which no funds are provided. A final project report shall be due within 90 days of the expiration date.

Changes in the Project:

In cases in which the date of the award, amount of the grant or modifications in the scope or methods of the proposal necessitate a change in the project period as stated in the proposal, the Principal Investigator must request such a change in writing before any actions are taken. Changes exceeding greater than 10% of any of the budget allocations originally specified in the application must be requested in writing with written approval received from FCER prior to their implementation.

Reporting Requirements:

PROGRESS REPORT: FCER requires written progress reports for its grants, routinely submitted on a quarterly basis. Forms for both the technical and financial aspects of the project are furnished with notification of the award. Copies of reprints of publications or manuscripts submitted for publication should accompany the report.

FINAL REPORT: In addition to the form provided, the report should include:

*An executive summary/abstract of the completed project for public dissemination;

*A technical description of the project and its results, including a discussion of the significance of the results, their application, and their implications for further research; and

*A complete bibliography of publications resulting from this project including manuscripts in preparation with their intended destinations; and

*A detailed report of all expenditures.

General Policies:

Any qualified individual and/or institution may apply. The training and experience of a project's investigative team should be appropriate and the resources of the institution or organization at which the proposed research is to take place should be appropriate.

Funding:

Funding levels from $500 to $300,000 are normally eligible. Amounts exceeding $2,000 are normally disbursed in multiple payments geared to the progress of the research.

Inventions, Patents, and Software:

Each FCER grant in support of research is subject to a patent and invention clause governing the disposition of inventions made or conceived under the grant in a manner calculated to protect the Foundation's interests and the equities of the grantee. In general, it provides that whenever an invention is conceived or first actually reduced to practice by the grantee or its employees in the course of a research grant, the grantee must furnish FCER with complete information about the invention. The Foundation will determine whether or not a patent application should be filed, as well as the disposition of the invention and rights in any resulting application or patent.

Grants for support of databanks or the creation of computer software of wide usefulness are subject to conditions reserving certain rights of access to these data by FCER.

Publications:

Research projects funded in part or totally by FCER should give acknowledgment for this support in any publication pertaining to the research. Authors are expected to report their results in refereed scientific publications.

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Download Application Form Word Document

Read and follow these instructions carefully to avoid delays and misunderstandings. Use English only and avoid scientific jargon and unexplained abbreviations. Type the application, single spaced and staying within reasonable margins. The Principal Investigator's name [last name first] and project title should be entered in the upper right-hand corner of each page of the application, with the exception of the cover sheet.

Do not submit an incomplete application. An application will be deemed incomplete and returned if it fails to follow the instructions below or it the material presented is insufficient to permit an adequate review. Do not submit additional material pertinent to an application after its due date unless it is specifically agreed upon by prior discussion with the FCER Research Committee. Occasionally, IRB reviews require the delayed submission of an IRB form, but not later than 60 days after the due date of the application.

Mail or deliver 9 copies of the completed application plus an acknowledgment postcard to:

Foundation for Chiropractic Education and Research

380 Wright Road, P.O. Box 400

Norwalk, IA 50211 USA

515-981-9888

Item 1. Title of Proposal: Choose a title that is descriptive and specifically appropriate rather than general.

Item 2. Applicant Institution [or Organization]: Name the institution which will be legally and financially accountable for the use and disposition of any funds awarded on the basis of this application. When two or more institutions join in the submission of an application, each institution must be listed.

Item 3a. Name of Principal Investigator: Name the one person responsible to the applicant institution for the scientific and technical direction of the project.

Item 3b. Title at Institution: Self-explanatory.

Item 3c. Department: Self-explanatory.

Item 3d. Mailing address: Self-explanatory.

Item 3e. Telephone: Self-explanatory.

Item 4. Project Duration: Select a beginning date which occurs at least 4 months after the original application deadline. For more information, see "Project Duration" in the General Information section of these guidelines.

Item 5. Application Category: Delete [This item is now defunct.].

Item 6. Total amount requested from FCER for first 12-month budget period: Self-explanatory, must include any indirect costs. Specify amount in U.S. currency.

Item 7. Total amount requested from FCER for entire proposed project period: Self-explanatory, must include any indirect costs and be fully justified on continuation pages representing each year other than Year 1. Specify amount in U.S. currency.

Item 8. Human subjects involved. If yes, complete page 10 of the application ["Projection of Human Subjects"].

Item 9. Vertebrate animals involved. If yes, complete page 11 of the application ["Humane Treatment of Vertebrate Animals"].

Item 10. Performance Site[s]. Indicate where the work described in the Research Plan will be conducted. If there is more than one site, list all the sites [Use attached sheets if necessary] and provide an explanation on page 8 of the application ["Resources and Environment"].

Item 11. Official authorized to sign for applicant institution: Self-explanatory.

Item 12. Official in business office to be notified if grant is made: Self-explanatory.

Item 13: Signature of person named in item 11: Self-explanatory.

Item 14. Principal Investigator Assurance: Self-explanatory.

Self-explanatory.

Self-explanatory, making sure that language employed is accessible to the average layperson.

Download a sample budget PDF document

Include all budget items necessary for project whether or not funding for particular items is requested from FCER. Include amounts provided by other sources in last column.

Include any indirect costs [up to a limit of 10% of total costs] in Section H at bottom of page.

Item A. Personnel: List all participants, professional and nonprofessional by name and project time or by title if not yet employed. Give the best estimate of per cent of time or effort for each professional [use % symbol] and hours per week for each nonprofessional. Fringe benefits may be requested as direct costs if this is a standard grant procedure for the applicant institution.

Item B. Subtotals: Provide subtotals for the amounts requested from FCER and amounts provided by other sources for personnel.

Item C. Equipment: List all items of equipment requested and include the cost of each.

Item D. Supplies: Itemize supplies such as glassware, chemicals, and animals in separate categories. If animals are involved, indicate the number to be used, the unit purchase costs and the unit care cost.

Item E. Computer Services: Computer services requested should be specified. The purchase of computers or associated hardware should be listed under items of equipment.

Item F. Travel: Itemize by cost and destination, including living expenses where appropriate.

Item G. Other Expenses: Self-explanatory.

Item H. Total Expenses: Self-explanatory.

Justifications must be provided on a separate page for all expenses exceeding $200.

Download a sample budget PDF document

Item A. Budget for Entire Proposed Project Period: Self-explanatory.

Item B. Budget Explanation/Justification: Following is an outline of budget documentation requirements:

Personnel: Describe specific functions of all personnel. List individually those personnel grouped under item A.6 ["Others"], specifying title, function, hours, salary and fringe benefits and indicating amounts requested from FCER and provided by other sources.

Equipment: If funds are requested to purchase equipment that appears to duplicate or be equivalent to items on the "Resources and Environment" page [page 8] or items used in preliminary studies, justify the reasons for duplication.

Computer Services: A justification of cost based on established computer service rates at the applicant institution should be included.

Travel: Itemize costs. Address the nature and extent of travel and its relationship to the project.

For items such as leases and rentals, explanations/justifications must be provided. Details of contractual arrangements for materials or services must also be provided. Justify also any other major budget items.

For all years, justify any costs that do not have an obvious need. For any additional years of support requested, justify any significant increases [5% or more] over the first 12-month budget period or current level of support.

Self-explanatory.

Self-explanatory.

Self-explanatory.

The research plan should include complete information to permit the scientific review of each application without reference to previous applications. Be specific and avoid redundancy, using a style that is accessible to the enlightened layperson. Eschew verbosity and grandiosity; i.e., be direct.

Reviewing groups are assisted materially in their evaluation of applications when the research is arranged in a uniform pattern of captions. The reviewing groups will consider the information provided as the key example of the Principle Investigator's approach to a research objective and as an indication of his or her ability to conduct research in this area.

The suggested format for the Research Plan is as follows:

A. Specific Aims: State concisely and realistically what the research described in this application is intended to accomplish and/or what hypothesis is to be tested.

 

B. Objective: State the overall objective or long-term goal of the proposed research.

 

C. Background: Briefly give the background of the present proposal, critically evaluate existing knowledge and specifically identify existing gaps which the project is intended to fill.

 

D. Significance: What is the potential importance of the proposed work? Discuss any novel ideas or contributions which the proposal offers. Make clear the health-related implications of the research to the overall objective.

 

E. Progress Report/Preliminary Studies: Provide an account of the Principal Investigator's preliminary studies pertinent to the application and/or any other information which will help to establish the experience and competency of the investigator to pursue the proposed project.

The titles and complete references to appropriate publications and completed manuscripts may be listed. Copies of these papers may be submitted as an Appendix.

 

F. Supplementary Graphs, Diagrams, Tables, Charts: These may be included either in the text of the narrative or as separate Appendices. If such material is essential to the evaluation of the research plan, incorporate it within the main body of the application.

 

G. Experimental Design and Methods: Discuss in detail the experimental design and procedures to be used to accomplish the specific aims of he project. Describe the protocols to be used. Include the means by which the data will be analyzed and interpreted, including power analyses to justify the number of subjects proposed in clinical research. Describe any new methodology to be used and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches used to achieve the aims. Include, if appropriate, a discussion of pitfalls that may be encountered. Point out any procedures, situations or materials that may be hazardous to personnel and the precautions to be exercised.

 

H. Human Subjects: If the proposed research involves human subjects:

1. Describe the characteristics of the subject population, such as their anticipated number, age ranges, sex, ethnic background and health status. Identify the criteria for inclusion or exclusion. Explain the rationale for the use of special classes of subjects who are likely to be vulnerable; e.g., young children or the elderly.

2. Identify the sources of research material obtained from individual subjects in the form of specimens, records or data, indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records, or data.

3. Describe plans for the recruitment of subjects and the consent procedures to be followed, including the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to the prospective subjects and the method of documenting their consent. State if the institutional review board has authorized a modification or waiver of the elements of consent or the requirement for the documentation of consent.

4. Describe any potential risks--physical, psychological, social, legal, or other--and assess the likelihood and seriousness of these. Where appropriate, describe alternative treatments and the procedures that might be advantageous to the subject.

5. Describe the procedures for protecting against or minimizing any potential risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for insuring necessary medical or professional intervention in the event of adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the data collection to insure safety of subjects.

6. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the scientific knowledge that may reasonably be expected to result.

 

I. Vertebrate Animals: If vertebrate animals are involved, justify their use and state the species, strains, ages and number of the animals involved. If the animals are in short supply, costly or to be used in large numbers, provide a specific rationale for their selection as well as for their numbers. Describe the procedures for adequate maintenance and veterinary care of any animals involved. Describe the procedures to be used to avoid unnecessary discomfort, pain or injury to the animals, such as surgical anesthesia, post-trauma analgesia, tranquilizing drugs and comfortable restraining devices.

 

J. Consultants: If consultant arrangements have been confirmed in writing, attach appropriate letters from each individual as Appendices, confirming his or her role in the project.

 

K. Consortium Arrangements: Provide a detailed explanation of the programmatic, fiscal and administrative arrangements made between the applicant institution and the collaborating organization[s]. Provide a statement that the applicant institution and the collaborating organization[s] have established or are prepared to establish in writing the required institutional agreements. Letters of confirmation or copies of written agreements may be attached as Appendices.

 

L. Timetable: Provide a tentative sequence or timetable of the investigation.

 

M. Literature Cited: Do not scatter complete literature citations throughout the text, but rather in a separate Bibliography at the end of the Research Plan. Each complete literature citation must include the names of all authors, the title of the article or chapter, the name of the book or journal, volume number, issue number, page numbers, year of publication, and [for books] the name of the publisher together with its resident city and state.

 

N. Appendices: Include as many sets as applications [9] with your submission; do not mail this material separately. Identify each with the project title and name of the Principal Investigator. When specific sections of the Appendices are cited in the body of the Research Plan, label them clearly in both the Appendix and the Research Plan.

Applicants must complete the Declaration of Assurance on page 10 regarding the protection of human subjects if research involves human subjects in activities non-exempt from the DHHS Regulation 45 CFR-46 [Exempt activities are discussed below.].

The DHHS Regulations for the Protection of Human Subjects, 45 CRF-46, are available from the Office for Protection from Research Risks, National Institutes of Health, Bethesda, MD 20205. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities.

The regulations define "human subject" as a "living individual about whom an investigator [whether professional or student] conducting research contains [1] data through intervention or interaction with the individual, or [2] identifiable private information." The regulations extend to the use of human organs, tissues, and body fluids as well as to graphic, written or recorded information derived from individually identifiable human subjects.

The use of autopsy materials is governed by applicable state and local law and is not directly regulated by 45 CFR-46. The regulations also specify additional protection for certain classes of human research involving fetuses, pregnant women, in vitro fertilization, or prisoners. The regulations require that all non-exempt research activities involving human subjects be reviewed and approved by an institutional review board.

Exemption from coverage by the regulations are activities in which the only involvement of human subjects will be in one or more of the following categories:

1. Research conducted in established or commonly accepted educational settings;

2. Research involving use of educational tests if the responses of individual subjects cannot be identified;

3. Research involving survey or interview procedures or observations of public behavior except where: a] responses are recorded in a manner by which subjects can be identified; b] subjects' responses could place them at risk of criminal or civil liability or be damaging to their financial standing or employability or c] research deals with sensitive aspects of subjects' behavior such as illegal conduct, drug or alcohol use or sexual behavior;

4. Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens if these resources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified.

If the grant is to be used in whole or part for research involving human subjects in non-exempt activities, the applicant must certify that an institutional review board, which applies the ethical standards and the criteria for approval of grants set forth in the Department of Health and Human Services policy for the protection of human subjects [45 CFR-46, as amended from time to time], has determined that the human subjects involved in this grant will not experience risk over and above that involved in the normal process of care and are likely to benefit from the proposed research program.

Investigations must also obtain the legal, informed consent of each subject or of the legal guardian before involving the subject in the research, where required by and in accordance with 45 CFR-46, or as required by applicable state or local law.

FCER requires that the use of all vertebrate animals in research be governed by the DHHS Principles for Use of Animals and also, in the case of warm-blooded vertebrates, Guide for the Care and Use of Laboratory Animals. The current versions of the guidelines are available from the DHHS Office for Protection from Research Risks, National Institutes of Health, Bethesda, MD, 20205. Institutions are required to comply with the Laboratory Animal Welfare Act of 1966 and subsequent amendments.

The Principles for Use of Animals provides for humane treatment and care of animal research subjects. Animals are not to suffer unnecessary discomfort, pain or injury and are to receive proper care and treatment. As part of a Declaration of Assurance, the applicant institution must confirm that it has established a review committee to assist in meeting the commitment to humane care and treatment of animals in compliance with existing regulations.

Committee [or administrative] review of individual projects using animals is encouraged, and proposals may be referred by FCER to the review committee in the case of apparent or potential violations of the Principles or other requirements.

Photocopy and use continuation pages as needed, entering the name of the Principal Investigator and the project title in the upper right-hand corner. Number continuation pages for a particular item consecutively, using alphabetical subscripts; e.g., for page 9 in the Research Plan, continuation pages would be numbered page 9a, page 9b, page 9c, etc.

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