EXPLORATORY GRANTS FOR ALTERNATIVE MEDICINE

NIH Guide, Volume 22, Number 12, March 26, 1993



RFA:  OD-93-002



P.T.





Keywords:



National Institutes of Health



Letter of Intent Receipt Date:  April 30, 1993

Application Receipt Date:  June 8, 1993



PURPOSE



The Office of Alternative Medicine (OAM) was initiated within the

Office of the Director (OD), National Institutes of Health (NIH), in

response to Congressional language that accompanied the Fiscal Year

1992 Labor, HHS, and Education and Related Agencies Appropriation

Bill in October 1991 [Senate Report 102-104, Page 147].  The mandate

of the OAM is to evaluate what was then termed "unconventional

medical practices," and was renamed more recently "Alternative

Medicine."  The purpose of the OAM is to encourage the investigation

of alternative medical practices, with the ultimate goal of

integrating validated alternative medical practices with current

conventional medical procedures.



The purpose of this Request for Applications (RFA) is to solicit

applications for support of:  (1) developing collaborations between

practitioners of alternative medicine and conventional researchers;

and (2) small scale studies designed to obtain preliminary data

relevant to the evaluation of alternative medicine which, for the

purpose of this RFA, is understood as a new and unique activity, not

currently supported by NIH.



It is anticipated that activities supported by these exploratory

grants will form the basis for competitive applications that could be

submitted in response to future RFAs, including a Cooperative

Agreement RFA, from the Office of Alternative Medicine.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This RFA,

Exploratory Grants for Alternative Medicine, is related to the

priority area of alternative medical practices.  Potential applicants

may obtain a copy of "Healthy People 2000"  (Full Report:  Stock No.

017-001-00474-0) or "Healthy People 2000"  (Summary Report:  Stock

No. 017-001-00473-1) through the Superintendent of Documents,

Government Printing Office, Washington, DC 20402-9325 (telephone 202-

783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic, foreign, for-profit and

non-profit organizations, public and private such as universities,

colleges, hospitals, laboratories, units of State and local

governments, federally recognized Indian Tribal governments, and

eligible agencies of the Federal government.  Applications from

minority individuals and women are encouraged.  The OAM encourages

non-institution-affiliated individual alternative health care

providers/scientists to apply.



MECHANISM OF SUPPORT



Support of projects will be through the NIH Exploratory/Development

Grant (R21).  Applicants will be responsible for the planning,

direction, and execution of the proposed project.  The total project

period for applications submitted in response to the present RFA may

not exceed one year.  The anticipated award date is September 30,

1993.



Because the nature and scope of the research proposed in response to

this RFA may vary, it is anticipated that the size of an award will

vary also.



Except as otherwise stated in this RFA, awards will be administered

under PHS grants policy as stated in the PHS Grants Policy Statement.



FUNDS AVAILABLE



The present RFA is a one-time solicitation, and approximately

$600,000 total costs is committed to fund applications.

Approximately 20 awards, not to exceed $30,000 total costs each, will

be made for a period of funding not to exceed 12 months.  This

funding level is dependent on the receipt of applications of high

scientific merit and the availability of funds for this purpose.



RESEARCH OBJECTIVES



Background



In a recent article, the demographics, prevalence, and patterns of

use of unconventional medicine in the United States were described

(Eisenberg D. et al, New England J. Med. 328:246-252, 1993).  The

most relevant findings were:  (a) most people used unconventional

therapies for chronic rather than life-threatening medical

conditions; (b) 72 percent of the respondents who used unconventional

therapy did not inform their medical doctor; extrapolation to the

United States population suggested that in 1990, Americans made

approximately 425 million visits to providers of unconventional

therapy; and (c) expenditures associated with this type of therapy

appeared to be similar to non-reimbursed expenses incurred for all

hospitalizations in the United States.  These findings clearly

demonstrated that unconventional medicine plays a significant role in

the health care system within the United States.



Despite the large number of people using alternative medicine

treatments, relatively little scientific data are available to

demonstrate convincingly whether or not a particular treatment is

safe, efficacious, beneficial, helpful, or leads to a positive

outcome (e.g., produces a regression in the size of a tumor, prolongs

or improves quality of life, reduces or eliminates adverse symptoms

of a toxic treatment).  This, in essence, was also the conclusion

reached in 1990, in a report published by the Office of Technology

Assessment concerning unconventional cancer treatments: "For none of

the treatments reviewed in this report did the evidence support a

finding of obvious, dramatic benefit that would obviate the need for

formal evaluation to determine effectiveness" (U.S. Congress, Office

of Technology Assessment, OTA-H-405, 1990, p. 225).  The report went

on to urge a more systematic analysis of unconventional treatments on

major diseases and effect on wellness.  These exploratory grants will

provide funds to initiate the first stages of systematic evaluation

of alternative treatments.



Goals and Scope of the present RFA



This RFA will create a research opportunity for alternative health

care practitioners, otherwise unlikely to participate in NIH

programs, to contribute to the nation's biomedical effort.  These

grants will provide funds for initiating short-term studies that are

preliminary in nature.



Alternative health care providers and scientists are invited to

respond to this RFA to:  (1) develop collaborative arrangements

(alternative health care providers with experienced scientists, and

conversely); and (2) obtain/refine preliminary data that could form

the basis for future applications for larger studies that will

investigate and evaluate alternative treatments, utilizing a

rigorous, scientific methodological approach.  Although it is

anticipated that pilot clinical studies of alternative medicine will

be the focus of this RFA, laboratory proposals clearly relevant to

alternative medicine will also be considered.



Types of interventions to be investigated could include, but are not

limited to:



o  Diet, nutrition, and lifestyle changes

For example, macrobiotics, megavitamins, diets, and changes in

lifestyle



o  Mind/body control

Examples include art therapy/relaxation, biofeedback, counseling,

guided imagery, hypnotherapy, and sound/music therapy



o  Traditional and ethnomedicine

For example, acupuncture, Ayur Veda, herbal medicine, homeopathic

medicine, Native American medicine, natural products, and Traditional

Oriental Medicine



o  Structural manipulations and energetic therapies

Examples are acupressure, chiropractic medicine, massage,

reflexology, rolfing, therapeutic touch, Qi Gong



o  Pharmacological and biological treatments

Examples include anti-oxidants, cell treatment, chelation therapy,

metabolic therapy, and oxidizing agents



o  Bioelectromagnetic applications

Examples include diagnostic and therapeutic applications of

electromagnetic fields (e.g., transcranial electrostimulation,

neuromagnetic stimulation, electroacupuncture)



NIH currently supports research projects falling under some of the

above headings.  Thus, in applications dealing with such topics, the

applicants should carefully justify why they consider their proposals

to be "alternative" (see PURPOSE)



It is anticipated that the proposed studies will be designed to

contribute to the evaluation of the potential for any of these

procedures to affect the clinical course and outcome of an illness,

and/or to increase wellness.  The study of effects of alternative

treatment on any major health condition (e.g., cancer, AIDS,

hypertension) is encouraged, although any health issue or disease

could be the subject of research, if a sound rationale is provided.



For funded applications, the first part of the project will be to

develop/finalize the terms of collaboration and, when applicable, to

obtain proper approval for the use of human subjects.  This part of

the project should be completed within approximately three months.

To facilitate this important aspect of the grant activity, the OAM

may convene two meetings of all grantees; the first shortly after

funding and a second meeting approximately three months later.  These

meetings, likely to take place in Bethesda, MD, will be designed to

provide a setting conducive to furthering collaborations and to

provide information regarding the NIH grant process.



The acquisition of preliminary data should begin as soon as

appropriate collaborations are in place.  In instances where

collaborations are already in place at the time of funding, the

acquisition of data should begin immediately after funding.



Special Requirements



As indicated above, one of the major purposes of this RFA is to

foster collaborations between practitioners of alternative medicine

and individuals familiar with conventional research methodologies.

The requirement for collaboration between alternative medical

practitioners and conventional investigators is three-fold:  (1) to

ensure that experience in research design and statistics, access to

patient populations of special interest, and methods of documentation

are included in each funded proposal; (2) conversely, to ensure that

appropriate expertise in alternative medicine will be available so

that research protocols are compatible with the paradigm to be tested

(e.g., appropriate choice of treatment or controls, in the context of

homeopathy, acupuncture); and (3) to provide a basis for scientific

collaboration and better understanding of issues involved in the

practice of alternative medicine, as well as conventional biomedical

research.



Alternative medical practitioners must provide credible preliminary

evidence (e.g., proof of prior collaboration or detailed letter of

intent to collaborate) from experienced investigators indicating

their willingness to participate in the preliminary studies.



Conversely, institution-based (e.g., university) investigators must

provide similar evidence of collaborations with non-university-based

alternative health care providers/scientists with training and

experience relevant to aspects of the research proposal.  It is

expected that such arrangements will not merely be pro forma, but

rather will be genuine collaborations in which alternative medical

practitioners will have significant roles in the development of the

protocols, the conduct of the studies, and will be given the

opportunity for receiving significant exposure to, and experience in,

sound research methodologies.



A research project grant may be made to a non-affiliated individual

in the United States rather than to an institution or organization.

In such cases, special administrative features pertain (see APPENDIX

I below).



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder, or condition under

study; special emphasis must be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear compelling

rationale must be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues must be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information must be included in the form PHS 398

(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in

Section 5, Human Subjects.  Applicants are urged to assess carefully

the feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all research projects to include representation of

the full array of United States racial/ethnic minority populations

(i.e., Native Americans [including American Indians or Alaskan

Natives], Asian/Pacific Islanders, Blacks, Hispanics).  The rationale

for studies on single minority population groups should be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and prevention strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to,

clinical trials.



The usual NIH policies concerning research on human subjects also

apply,  Basic research or clinical studies in which human tissue

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the Unites States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in as study design is inadequate to answer the

scientific question (s) addressed and the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and reflected

in assigning the priority score to the application.



All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these

policies.



LETTERS OF INTENT



Prospective applicants are asked to submit, by April 30, 1993, a

letter of intent that includes the name, address, and telephone

number of the Principal Investigator, the identities of other key

personnel and participating institutions if any, a brief descriptive

title of the proposed research, and the number and title of the RFA

in response to which the application may be submitted.



Although a letter of intent is not required, is not binding, and does

not enter into the review of subsequent applications, the information

that it contains will be extremely helpful in planning for the review

of applications.  It allows OAM and review staff to estimate the

potential review workload and to avoid conflict of interest in the

review.



The letter of intent is to be sent to:



Dr. Daniel Eskinazi

Office of Alternative Medicine

National Institutes of Health

Building 31, Room B1-C35

Bethesda, MD  20892

Telephone:  (301) 402-2466

FAX:  (301) 402-4741



APPLICATION PROCEDURES



The research grant application form PHS 398 (rev. 9/91) is to be used

in applying for these grants.  These forms are available at most

institutional offices of sponsored research; from the Office of

Grants Inquiries, Division of Research Grants, National Institutes of

Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone

301/496-7441; and from the NIH program administrator named below.



Prior to writing the application, please carefully read the

instructions provided with the form PHS 398 and this RFA.



In developing the application, clearly explain how the project was

chosen and how it will provide convincing preliminary data to form

the basis of a competitive application for a larger scale study.  For

example, if a future clinical trial is envisioned, describe

explicitly how the proposed pilot activities in the application will

assess the impact of the alternative medical procedure on the

clinical course of a given disease and/or the quality of life and the

cost effectiveness of the treatment or other.  Similarly, how will

short-term and longer term adverse effects be evaluated?  Justify the

alternative intervention, disease model, and patient population

(e.g., children, menopausal women, elderly, minorities) proposed,

based on existing literature, personal experience, and, if possible,

already documented preliminary data.  Explain how the conduct of the

proposed pilot study may benefit a larger target population.

Finally, applicants should explain how this exploratory grant would

help them to complement their expertise, become more effective

participants in the area of alternative medicine research, and how

this fits in their long-term career plans.



Transportation expenses for the Principal Investigator and/or

collaborators must be for well justified travel that is essential to

the conduct of the project (travel to attend national scientific/

professional meetings will not be allowed).  In addition, budgets

should allow for the Principal Investigator(s) to attend at least one

two-day meeting in Bethesda, Maryland.



Applicants should describe resources for support of the research

other than the proposed grant.  A project might seem too ambitious,

if the only funds available would be those afforded by the

anticipated grant.



The RFA label available in the PHS 398 application form must be

affixed to the bottom of the face page of the application.  Failure

to use this label could result in delayed processing of the

application such that it may not reach the review committee in time

for review.  In addition, the RFA title and number must be typed on

line 2a of the face page of the application form and the YES box must

be marked.



Submit a signed, typewritten original of the application, including

the Checklist, the letter of intent to collaborate and four signed

photocopies in one package to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



At the time of submission, mail one additional complete copy of the

application to Dr. Daniel Eskinazi at the address noted below.



Applications must be received by June 8, 1993.  If an application is

received after that date, it will be returned to the applicant.  The

Division of Research Grants (DRG) will not accept any application in

response to this announcement that is essentially the same as one

currently pending initial review, unless the applicant withdraws the

pending application.  Submission of identical applications will not

be allowed, nor will essentially identical applications be reviewed

by different committees.  Therefore, an application cannot be

submitted in response to this RFA that is essentially identical to

one that has already been reviewed.  This does not preclude the

submission of substantial revisions of applications already reviewed,

but such applications must include an introduction addressing the

previous critique.



REVIEW CONSIDERATIONS



Upon receipt, applications will be reviewed by NIH staff for

completeness and responsiveness.  Incomplete applications will be

returned to the applicant without further consideration.  If the

application is not responsive to the RFA, OAM staff will contact the

applicant to determine whether to return the application to the

applicant or submit it for review in competition with unsolicited

applications at the next review cycle.  Applications that lack the

intent to collaborate letter will be considered incomplete.



Applications may be triaged by a DRG peer review group on the basis

of relative competitiveness.  In this instance, the NIH would

withdraw from further competition those applications judged to be

non-competitive for award and notify the applicant Principal

Investigator and institutional official.  Those applications judged

to be competitive will undergo further scientific merit review in

accordance with the criteria stated below for scientific/technical

merit by an appropriate peer review group especially convened by the

DRG.  The final level of review will be provided by the National

Advisory Research Resources Council.



Review Criteria for this RFA will be:



o  relevance to alternative medicine;



o  scientific and technical merit:  proper justification of

endpoints; appropriateness of the experimental approach and

methodology to test the paradigm to be evaluated (e.g.,

individualization of treatment, statistical methods allowing for

potentially inherent experimental variability);



o  medical significance and originality of proposed research;



o  qualifications and clinical/research experience of the Principal

Investigator and staff, particularly, but not exclusively, in the

area of the proposed research;



o  documented intent to develop collaboration(s) that will provide

the range of expertise needed for a successful study (proof of

collaboration or detailed letter of intent to collaborate);



o  availability of sound literature documentation or the availability

of preliminary data justifying the proposed model to be studied;



o  availability of the resources necessary to perform the research;



o  appropriateness of the proposed budget;



AWARD CRITERIA



The anticipated date of award is September 30, 1993.  Funding

decisions will be based on scientific merit as determined by peer

review and relevance to the OAM program.  Among projects of

essentially equivalent merit and program relevance, preference will

be given to those applicants who have not received previous research

funding from the NIH.  Only highly-rated applications that represent

new and unique activities not currently supported by the NIH will be

funded.  Awards will be made by the National Center for Research

Resources (NCRR), with post-award administration jointly by staff of

the OAM and the NCRR.



INQUIRIES



Written and telephone inquiries concerning this RFA are encouraged.

The opportunity to clarify any issues or questions from potential

applicants is welcome.



Direct inquiries regarding programmatic issues to:



Daniel Eskinazi, DDS, Ph.D.

Office of Alternative Medicine

National Institutes of Health

Building 31, Room B1C35

Bethesda, MD  20892

Telephone:  (301) 402-2466



Direct inquiries regarding fiscal matters to:



Ms. Lacey J. Durham

Office of Grants and Contracts Management

National Center for Research Resources

Westwood Building, Room 849

Bethesda, MD  20892

Telephone:  (301) 496-9840



AUTHORITY AND REGULATIONS



Awards will be made under authorization of the Public Health Service

Act, Titles III and IV (Public Law 78-410, as amended by Public Law

99-158, 42 USC 241 and 285) and administered under PHS grants

policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.

This program is not subject to the intergovernmental review

requirements of Executive Order 12372 or Health Systems Agency

review.



APPENDIX I - SPECIAL POLICIES REGARDING RESEARCH GRANTS AWARDED TO

NON-AFFILIATED INDIVIDUALS



Allowances and Expenditures



No indirect cost allowance will be provided to individuals as

grantees, nor may they use grant funds for alterations or

renovations, or for the purchase of fixed equipment.  Otherwise, the

expenditures policies applicable to research grants made to grantee

institutions and organizations are applicable to grants made to

individuals.



Equipment



Title to moveable equipment will vest upon acquisition in the Federal

Government, with final disposition of the equipment to be determined

by the awarding unit when the project is terminated.



Human Subjects



With respect to human and animal subject research, please read

carefully the relevant instructions in the PHS 398 application kit.

Note that no assurance to comply with 45 CFR 46 is required as a

condition for applying.  However, no awardee may receive NIH grant

funds for non-exempt human subjects research or animal research,

unless the awardee provides the Office for Protection from Research

Risks (OPRR) with written Assurance to comply with 45 CFR 46.  For

additional information concerning human subjects and/or animal

assurances and related arrangements, contact OPRR Building 31, Room

5B59, telephone (301) 496-7041 for human subjects issues and 496-7163

for animal issues.



Responsibility



Although the individual is entirely responsible for the grant,

personal indemnity bonds are not required.



.

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