Full Text PA-95-033 RESEARCH ON THE EFFECTS OF POWER FREQUENCY ELECTRIC AND MAGNETIC FIELDS NIH GUIDE, Volume 24, Number 6, February 17, 1995 PA NUMBER: PA-95-033 P.T. 34 Keywords: Health, Radiation Effects Environmental Effects National Institute of Environmental Health Sciences PURPOSE The National Institute of Environmental Health Sciences (NIEHS), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Child Health and Human Development (NICHD) invite grant applications through a joint Program Announcement (PA) for basic studies on the effects of electric and magnetic fields. This solicitation is issued to encourage investigator-initiated research projects in areas of special programmatic interest to the National Institutes of Health (NIH). 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 Program Announcement, Research on the Effects of Power Frequency Electric and Magnetic Fields, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017- 001-00474-0 or 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 foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This program announcement will use the NIH research project grant (R01) and FIRST (R29) award. RESEARCH OBJECTIVES This program announcement is issued to encourage and foster investigator-initiated basic and applied research on the possible health effects of electromagnetic fields (EMF). Because of the limited data on EMF biological effects it is anticipated that some projects may be more focused on identification of EMF effects than on the possible mechanisms of EMF actions. Such applications should state the means by which the information generated will be useful in risk assessment and/or developing mechanistic hypotheses. Collaborative research efforts among toxicologists, physicists, engineers, and scientists in closely related disciplines are encouraged to ensure quality in all aspects of the proposed study. Research interests include, but are not limited to, studies designed to: a. Determine the effects/mechanisms of action of EMF on cellular responses such as DNA synthesis, modulation of ion binding, and interaction with hormones and growth factors. b. Determine the effects on cancer processes in vivo and in vitro. c. Determine the effects of EMF on reproductive/developmental and nervous systems in vivo and in vitro. d. Development of well-characterized EMF exposure systems for assessing biological effects. Background The NIEHS is the principal NIH component for support of basic research on environmental factors that contribute to human health problems and disease. Major emphasis by NIEHS is placed upon research examining those physical and chemical substances to which humans are exposed in their general environment as a result of human activities such as modern technologies and industrial and commercial processes. In addition to the NIEHS, the NINDS also supports research on those factors that impinge on the nervous or sensory systems. The NICHD is interested in factors such as EMF that may affect reproduction and development. As a result of electrification of our homes and work places, people from all walks of life and of all ages are now exposed to power frequency (60 Hz) electric and magnetic fields. Increasingly, scientists, regulators and lay people are asking whether human exposure to theses fields involves risks to human health. EMF causes biological effects in human beings, in laboratory animals, and in cells and tissues from humans and animals. However, the extant literature does not provide a basis for assessing the risks, if any, from exposure to these fields. Thus there is a need for additional research on the biological effects of EMF exposure particularly at the frequencies of power lines and electrically powered devices. The results of studies on the biological effects of EMF are controversial. One reason for controversy is the finding of positive and negative effects in some similar studies. Also, there are scientists who believe that power frequency fields cannot cause biological effects other than the well known hazards of electrical shock and burn. This position is based on two points. (1) the energy of a 60 Hz electromagnetic wave is too weak to break chemical bonds; (2) natural electric fields in the body are orders of magnitude greater than those that can be induced by common EMF exposure. On the other hand, there are reports of biological effects of EMF at many levels of biological organization. These studies have examined a wide range of endpoints but, for the most part, have been phenomenological rather than hypothesis based. For example, in vitro studies report effects on the cell membrane, DNA synthesis, RNA transcription, ornithine decarboxylase activity, calcium-ion efflux, cellular response to hormones and cancer cells. These responses to EMF at the cellular level display a considerable complexity including resonant responses in frequency and field strength, complex time dependencies, and dependence on the ambient DC magnetic field created by the earth. Animal systems have been used for studies under a range of electric and magnetic field intensities for varied exposure conditions and durations. A few examples are studies of animal behavior with and without drugs, melatonin synthesis in the pineal gland, and circadian rhythms. In general, research is needed to determine if in vivo EMF exposure has a deleterious effect on animals and to define exposure conditions that may be effective. The results of epidemiological studies are controversial because some studies report no association between residential EMF exposure and cancer while other work suggests a possible association. For example, a study published in 1979 reported increased incidence of leukemia and brain tumors in children exposed to EMF. Criticisms of the report led to a second study, which addressed many of the study design problems. This work also found a weak association between EMF exposure and leukemia and brain tumors. However, another epidemiological study in 1980 failed to demonstrate an association between residential EMF exposure and childhood leukemia. In addition, some but not all studies of occupational exposure of electrical workers have suggested an increased incidence of leukemia and brain cancer; however, the causative agent for this pattern remains unknown. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of the program announcement must be types in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (express mail) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the Program Announcement. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o appropriateness of the proposed budget and duration in relation to the proposed research; The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Michael J. Galvin, Jr. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 Email: GALVIN@NIEHS.NIH.GOV Dr. Eugene Streicher Division of Fundamental Neurosciences National Institute of Neurological Disorders and Stroke Federal Building, Room 916 Bethesda, MD 20892 Telephone: (301) 496-5745 Dr. Felix de la Cruz Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development Executive Plaza North, Room 631 Bethesda, MD 20892 Telephone: (301) 496-1383 Email: CRUZF@HDOL.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 Email: MINEO@NIEHS.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (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 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. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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