This section contains information on policy and additional guidance relating to submission of traditional, solicited and unsolicited, investigator-initiated, research project grant and cooperative agreement applications to PHS. Refer to the Foreword and the Grants Information (GrantsInfo) sections for additional sources of information.
AIDS Related. Includes: (1) projects relating to the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS; (2) various sequelae specifically associated with the syndrome; and (3) preparation and screening of anti-AIDS agents as well as vaccine development, including both preclinical and clinical studies. Not all applications examining various influences on T-lymphocytes or retroviruses will be appropriate for the expedited AIDS review process. Applications only indirectly related to AIDS will be evaluated by established SRGs (study sections) appropriate to the scientific discipline during regular NIH review cycles and should not be submitted in response to the expedited AIDS receipt dates. Applicants are urged to take note of the yearly NIH Plan for HIV-Related Research, and indicate how their application addresses the NIH priorities set forth in that Plan. The Plan can be found on the NIH Office of AIDS Research Home Page.
Federal: A cabinet-level department or independent agency of the Executive Branch of the Federal Government or any component part of such a department or agency that may be assigned the responsibility for carrying out a grant-supported program.
State: Any agency or instrumentality of a State government of any of the United States or its territories.
Local: Any agency or instrumentality of a political subdivision of government below the State level.
Nonprofit: An institution, corporation, or other legal entity no part of whose net earnings may lawfully inure to the benefit of any private shareholder or individual.
For profit: An institution, corporation, or other legal entity, which is organized for the profit or benefit of its shareholders or other owners. A "for profit" organization is considered to be a small business if it is independently owned and operated, if it is not dominant in the field in which research is proposed, and if it employs no more than 500 persons. Also see definition for Small Business Concern.
Small Business Concern: A small business concern is one that, at the time of award of Phase I and Phase II, meets ALL of the following criteria:
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.3-2(a). The term "number of employees" is defined in 13 CFR 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://www.sba.gov/size/.
Socially and Economically Disadvantaged Small Business Concern: A socially and economically disadvantaged small business concern is one that is at least 51% owned by (a) an Indian tribe or a native Hawaiian organization, or (b) one or more socially and economically disadvantaged individuals; AND whose management and daily business operations are controlled by one or more socially and economically disadvantaged individuals.
Women-Owned Small Business Concern: A small business concern that is at least 51% owned by a woman or women who also control and operate it. "Control" in this context means exercising the power to make policy decisions. "Operate" in this context means being actively involved in the day-to-day management.
Child: NIH defines a child as an individual under the age of 21 years. It should be noted that the definition of child described above will pertain notwithstanding the FDA definition of a child as an individual from infancy to 16 years of age, and varying definitions employed by some states. Generally, State laws define what constitutes a "child," and such definitions dictate whether or not a person can legally consent to participate in a research study. However, State laws vary, and many do not address the age at which a child can consent to participate in research. Federal Regulations (45 CFR 46, subpart D, Sec.401-409) address DHHS protections for children who participate in research, and rely on State definitions of "child" for consent purposes. Consequently, the children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and sufficient to participate in research under State law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.
Clinical Research: NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.
Clinical Trial: For purposes of reviewing applications submitted to the NIH, a clinical trial is operationally defined as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. Clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:
Phase I clinical trials are done to test a new biomedical or behavioral intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g. determine a safe dosage range, and identify side effects).
Phase II clinical trials are done to study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Phase III studies are done to study the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.
Phase IV studies are done after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
NIH-Defined Phase III Clinical Trial: For the purpose of the Guidelines an NIH-defined Phase III "clinical trial" is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
Co-Investigator: A co-investigator (collaborator) is an individual involved with the principal investigator in the scientific development or execution of the project. These individuals would typically devote a specific percent of effort to the project and would be identified as key personnel. The individual(s) may be employed by, or affiliated with, either the grantee organization or an organization participating in the project under a consortium or contractual agreement.
Commercialization: The process of developing markets and producing and delivering products for sale (whether by the originating party or by others). As used here, commercialization includes both government and private sector markets.
Consortium or Contractual Agreement: An agreement whereby a research project is carried out by the grantee and one or more other organizations that are separate legal entities. In this arrangement, the grantee contracts for the performance of a substantial and/or a significant portion of the activities to be conducted under the grant. These agreements typically involve a specific percent of effort from the consortium organization's principal investigator and a categorical breakdown of costs, such as personnel, supplies, and other allowable expenses, including Facilities and Administrative costs.
Consultant: An individual hired to give professional advice or services for a fee, normally not as an employee of the hiring party. In unusual situations, a person may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. In order to prevent apparent or actual conflicts of interest, grantees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants may also include firms that provide paid professional advice or services.
Consulting fees: The fee paid by an institution to a salaried member of its faculty is allowable only in unusual cases and only if both of the following conditions exist: (1) the consultation crosses departmental lines or involves a separate operation; or (2) the work performed by the consultant is in addition to his or her regular workload.
In all other cases, consulting fees paid to employees of recipient or cost-type contractor organizations in addition to salary may be charged to PHS grant-supported projects only in unusual situations and when all of the following conditions exist: (1) the policies of the recipient or contractor permit such consulting fee payments to its own employees regardless of whether Federal grant funds are received; (2) the consulting services are clearly outside the scope of the individual's salaried employment; and (3) it would be inappropriate or not feasible to compensate the individual for these services through payment of additional salary.
For additional clarification on the allowance and appropriateness of consulting fees, refer to NIH Grants Policy Statement.
Cooperative Agreement: A support mechanism that will have substantial Federal scientific and/or programmatic involvement. Substantial programmatic involvement means that after award, scientific or program staff will assist, guide, coordinate, or participate in programmatic activities beyond the normal stewardship responsibility in the administration of grants. Proposed cooperative agreements will be published as policy announcements, program announcements, or requests for applications.
Essentially Equivalent Work: This term is meant to identify "scientific overlap," which occurs when (1) substantially the same research is proposed for funding in more than one proposal (contract proposal or grant application) submitted to the same Federal agency; OR (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; OR (3) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more proposals or awards, regardless of the funding source.
Feasibility: The extent to which a study or project may be done practically and successfully.
Foreign Component: (1) The use of grant funds to support any element or segment of the project which is to be performed outside the U.S., either by the grantee or by a researcher employed by a foreign institution; or (2) the use of grant funds for extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sample collection, etc. Foreign travel for consultation is not considered a foreign component.
Full-Time Appointment: May be different in terms of actual months per year or days per week at the applicant organization. The definition of a full-time appointment must be in accordance with the institutional policy and used consistently by the institution regardless of the source of support.
Gender: Refers to the classification of research subjects into either or both of two categories: women and men. In some cases, representation is unknown, because gender composition cannot be accurately determined (e.g., pooled blood samples or stored specimens without gender designation).
Grant: A financial assistance mechanism whereby money and/or direct assistance is provided to carry out approved activities.
Human Subjects: Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. The regulations governing the inclusion of human subjects in research extend to the use of human organs, tissues, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
The use of autopsy materials is governed by applicable state and local law and is not directly regulated by 45 CFR 46.
Innovation: Something new or improved, including research for (1) development of new technologies, (2) refinement of existing technologies, or (3) development of new applications for existing technologies. For the purposes of PHS programs, an example of "innovation" would be new medical or biological products, for improved value, efficiency, or costs.
Institutional Base Salary: The annual compensation that the applicant organization pays for an employee's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual may be permitted to earn outside of duties to the applicant organization. Base salary may not be increased as a result of replacing institutional salary funds with grant funds.
Some PHS grant recipients are currently subject to a legislatively imposed salary limitation. Any adjustment for salary limits will be made at time of award. Applicants are encouraged to contact their offices of sponsored programs or see the NIH Guide for Grants and Contracts for current guidance on salary requirements.
Key Personnel: Key personnel are defined as individuals who contribute to the scientific development or execution of the project in a substantive way, whether or not salaries are requested. (For a more detailed discussion, click here to view.)
Principal Investigator, Program Director, or Project Director: The one individual designated by the applicant organization to direct the project or program to be supported by the grant. The principal investigator is responsible and accountable to applicant organization officials for the proper conduct of the project or program.
Program Income: Gross income earned by the applicant organization that is directly generated by a supported activity or earned as a result of the award. The PHS Grants Policy Statement or NIH Grants Policy Statement contains a detailed explanation of program income, the ways in which it may be generated and accounted for, and the various options for its use and disposition.
Examples of program income include:
Prototype: A model of something to be further developed and includes designs, protocols, questionnaires, software and devices.
Research or Research and Development (R/R&D): Any activity that is:
Research Institution: A United States research organization that is:
(Laboratories staffed by Federal employees do not meet the definition of "research
institution" for purposes of the STTR program.)
Significant Difference: For purposes of NIH policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.
Socially and Economically Disadvantaged Individual: A member of any of the following groups: Black Americans; Hispanic Americans; Native Americans; Asian-Pacific Americans; Subcontinent Asian Americans; other groups designated from time to time by SBA to be socially disadvantaged; or any other individual found to be socially and economically disadvantaged by SBA pursuant to Section 8(a) of the Small Business Act, 15 U.S.C. 637(a).
Subcontract: Any agreement, other than one involving an employer-employee relationship, entered into by a Federal Government prime contractor calling for supplies or services required solely for the performance of the prime contract or another subcontract.
United States: The 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, and District of Columbia.
Valid Analysis: The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are:
Allocation of study participants of both sexes/genders (males and females) and from different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization; unbiased evaluation of the outcome(s) of study participants; and use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the gender and racial/ethnic groups.
Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts are not included.
Information on Other Support should NOT be submitted with the application. If other support information is included in the application, the application will be returned to the applicant organization without peer review.
This information is required for all applications that are to receive grant awards; however, NIH will request complete and up to date "Other Support" information from applicants at an appropriate time after peer review. The Institute's scientific program and grants management staff will review this information prior to award.
Information on other support assists awarding agency staff in the identification and resolution of potential overlap of support. Overlap, whether scientific, budgetary, or commitment of an individual's effort greater than 100 percent, is not permitted. The goals in identifying and eliminating overlap are to ensure that sufficient and appropriate levels of effort are committed to the project; that there is no duplication of funding for scientific aims, specific budgetary items, or an individual's level of effort; and only funds necessary to the conduct of the approved project are included in the award.
Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salary) are requested in an application but are already provided for by another source.
Commitment overlap occurs when a person's time commitment exceeds 100 percent, whether or not salary support is requested in the application. While information on other support is only requested for key personnel (excluding consultants), no individuals on the project may have commitments in excess of 100 percent.
Scientific Overlap occurs when: (1) substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration, or (2) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of the funding source. Potential scientific overlap is to be addressed by the SRG only by its identification in an Administrative Note in the summary statement.
Resolution of Overlap. Resolution of overlap occurs at the time of award in conjunction with applicant institution officials, the principal investigator, and awarding agency staff.
OTHER SUPPORT FORMAT PAGE (MS Word or PDF)
There is no "form page" for other support. Follow the sample format on the "Other Support Format Page." The sample is intended to provide guidance regarding the type and extent of information requested.
The following instructions should be followed in completing the information:
Project Number: If applicable, include a code or identifier for the project.
Source: Identify the agency, institute, foundation, or other organization that is providing the support.
Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or subcontract.
Dates of Approved/Proposed Project: Indicate the inclusive dates of the project as approved/proposed. For example, in the case of NIH support, provide the dates of the approved/proposed competitive segment.
Annual Direct Costs: In the case of an active project, provide the current year's direct cost budget. For a pending project, provide the proposed direct cost budget for the initial budget period.
Percent Effort: For an active project, provide the level of effort (even if unsalaried) as approved for the current budget period. For a pending project, indicate the level of effort as proposed for the initial budget period. In cases where an individual's appointment is divided into academic and summer segments, indicate the proportion of each devoted to the project.
Overlap: After listing all support, summarize for each individual any potential overlap with the active or pending projects and this application in terms of the science, budget, or an individual's committed effort. (See Section III B. Other Support to view definitions of the three types of overlap.)
(PERSONNEL FORM PAGE (MS Word or PDF); for Competing Continuation Applications Only)
Use only when requested by the awarding component.
List all key personnel, salaried and unsalaried, at the applicant organization or elsewhere, who participated in the project during the current budget period. Include all degrees, role on project, date of birth, annual percent of effort, and Social Security number. When requesting Social Security numbers from personnel, explain that provision of the Social Security number is voluntary, and the information will be used only for program management purposes.
Specific Program Announcements (PAs) and Requests for Applications (RFAs) are published in the Federal Register and in the NIH Guide for Grants and Contracts. The Guide also contains vital information about policies and procedures. For information on obtaining the Guide go to http://grants.nih.gov/grants/guide. Definitions regarding the use of PAs and RFAs are as follows:
Program Announcement: A formal statement about a new or ongoing extramural activity or mechanism. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or mechanism, and/or invite applications for grant support. Most applications in response to PAs may be submitted for any appropriate receipt date and are reviewed with all other applications received at that time.
Request for Applications: A formal statement that invites grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. The RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, and the application receipt date(s). Applications submitted in response to an RFA usually are reviewed by an SRG convened by the awarding component that issued the RFA.
Awarding components may not always be able to honor the requested start date of an application. Therefore, applicants should make no commitments or obligations until confirmation of the start date by the awarding component.
NIH recipient organizations must promptly report inventions to the Extramural Inventions and Technology Resources Branch of the Office of Policy for Extramural Research Administration, OER, NIH, Bethesda, MD 20892-2750, (301) 435-1986. This should be done prior to any publication or presentation of the invention at an open meeting, since failure to report at the appropriate time is a violation of 35 USC 202 and may result in loss of the rights of the applicant institution, inventor, and Federal Government in the invention. All foreign patent rights are immediately lost upon publication or other public disclosure unless a United States patent application is already on file. In addition, statutes preclude obtaining valid United States patent protection after one year from the date of a publication that discloses the invention.
Each application to the PHS requires that the following assurances and certifications be verified by the signature of the Official Signing for Applicant Organization on the Face Page of the application.
The assurances listed and explained below may or may not be applicable to your project, program, or type of applicant organization. There are a number of additional public policy requirements with which applicants and grantees must comply. Refer to your institution's research grant administrative office or the NIH Grants Policy Statement for additional information. A copy of the NIH Grants Policy Statement may be obtained from the NIH Web site (http://grants.nih.gov/grants/policy/policy.htm). In signing the application Face Page, the duly authorized representative of the applicant organization certifies that the applicant organization will comply with the following policies, assurances and/or certifications:
(SEE SECTION III. A – DEFINITIONS)
The DHHS regulations, for the protection of human subjects (see definition in Section III. A), provide a systematic means, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the DHHS. The regulations stipulate that an applicant organization, whether domestic or foreign, bears responsibility for safeguarding the rights and welfare of human subjects in DHHS-supported research activities. The regulations require that applicant organizations proposing to involve human subjects in nonexempt research, file a written Assurance of Compliance with the Office for Human Research Protections (OHRP), establishing appropriate policies and procedures for the protection of human subjects. These regulations, 45 CFR 46, Protection of Human Subjects, are available from the OHRP, National Institutes of Health, Rockville, MD 20892, (301) 496-7041.
Investigators, who conduct research involving pregnant women, human fetuses and neonates, prisoners, or children, must follow the provisions of the regulations in Subparts B, C, and D, respectively, of 45 CFR 46, which describe the additional protections required for these subjects.
No non-exempt research involving human subjects can be conducted under a DHHS award unless that organization is operating in accord with an approved Assurance of Compliance and provides certification that an appropriate Institutional Review Board (IRB) has reviewed and approved the proposed activity in accordance with the DHHS regulations. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the DHHS regulations. Foreign applicant organizations must also comply with the provisions of the regulations.
The Center of Biologics Evaluation and Research (CBER), FDA, regulates the use of biological products in humans, at the investigational and marketing phases, including somatic cell therapies and gene therapies. If your work involves these areas or preclinical research that will support later work in these areas, please see the Office of Recombinant DNA Activities Web site at http://www4.od.nih.gov/oba/.
Note: Under DHHS regulations to protect human subjects (see Section III A - D ) from research risks, certain research areas are exempt. (See Exemption Categories ). Nonetheless, studies that are exempt from the human subjects regulations must still address the inclusion of women and minorities in clinical research in the study design. Therefore, applications will be evaluated for compliance with this policy. Research involving the collection or study of existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are individually identifiable are also to be included within the term “research involving human subjects.”
In signing the application Face Page, the duly authorized representative of the applicant organization certifies that if research on the transplantation of human fetal tissue is conducted, the applicant organization will make available, for audit by the Secretary, DHHS, the physician statements and informed consents required by section 498A (b)(2) and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure DHHS access to those records, if maintained by an entity other than the applicant organization.
Research involving human subjects must comply with the “NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.” The following excerpts provide the key policy statements. Investigators should obtain full copies of the current amended Guidelines that were published in the NIH Guide at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html.
The policy of NIH is 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 in clinical research, unless a clear and compelling rationale and justification establishes inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. This policy applies to research subjects of all ages.
The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. Describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection of such subjects. Include a description of the proposed outreach programs for recruiting women and minorities as participants.
Funding: Awards will not be made if the research project does not comply with this policy. In addition, awardees must report annually on enrollment of women and men, and on the race and ethnicity of research participants in the “5/01 Inclusion Enrollment Report Format Page (MS Word or PDF).”
(See Section III-A, "DEFINITIONS;")
Research involving children must comply with the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects," issued March 6, 1998. The following excerpts provide the key policy statements. Investigators should obtain full copies of the Policy and Guidelines from NIH staff, or from the NIH grants Web site under the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/notice-files/not98-024.html).
NIH policy requires that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling reasons not to include them. This policy applies to all NIH conducted or supported research involving human subjects, including research that is otherwise "exempt" in accord with Section 401 (b) of 45 CFR 46 Subpart A - Federal Policy for the Protection of Human Subjects. The inclusion of children as subjects in research must be in compliance with all applicable subparts of 45 CFR 46 as well as with other pertinent federal laws and regulations. Therefore, proposals for research involving human subjects must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.
Additionally, IRBs have special review requirements to protect the well-being of children who participate in research. These requirements relate to risk, benefit, parental/guardian consent, and assent by children, and to research involving children who are wards of the State or of another institution. The local IRB approves research that satisfies the conditions set forth in the regulations.
http://stemcells.nih.gov/index.asp
In signing the application Face Page, the duly authorized representative of the applicant organization certifies that if research using human embryonic stem cells is proposed, the applicant organization will be in compliance with the “Notice of Extended Receipt Date and Supplemental Information Guidance for Applications Requesting Funding that Proposes Research with Human Embryonic Stem Cells” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html).
The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS. The PHS policy stipulates that an applicant organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS-supported research activities. This policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an institutional animal care and use program. This policy does not affect applicable State or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 USC 2131 et sec.) and other Federal statutes and regulations relating to animals. These documents are available from the Office for Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163.
The PHS policy defines "animal" as "any live, vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes."
No PHS award for research involving vertebrate animals will be made to an applicant organization unless that organization is operating in accordance with an approved Animal Welfare Assurance and provides certification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed activity in accordance with the PHS policy. Applications may be referred by the PHS back to the IACUC for further review in the case of apparent or potential violations of the PHS policy. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the PHS policy. Foreign applicant organizations applying for PHS awards for activities involving vertebrate animals are required to comply with PHS policy or provide evidence that acceptable standards for the humane care and use of animals will be met.
Executive Order 12549, "Debarment and Suspension," mandated development of a Government-wide debarment and suspension system for nonprocurement transactions with Federal agencies. Executive Order 12689 and Section 2455 of the Federal Acquisition Streamlining Act of 1994 further required Federal agencies to establish regulations for reciprocal Government-wide effect across procurement and nonprocurement debarment and suspension actions. This reciprocity rule is effective for any debarment, suspension or other Government-wide exclusion initiated on or after August 25, 1995. DHHS regulations implementing Executive Orders 12549 and 12689, and Section 2455 of the Federal Acquisition Regulation, are Provided in 45 CFR 76, "Government-wide Debarment and Suspension (Nonprocurement) and Government-wide Requirements for Drug-Free Workplace (Grants)." Accordingly, before a grant award can be made, the applicant organization must make the following certification (Appendix A of the DHHS regulations):
Grantees are required to obtain a similar certification from most subawardees, called "lower tier participants." (See 45 CFR 76, Appendices A and B.)
The Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle D) requires that all grantees receiving grants from any Federal agency certify to that agency that they will maintain a drug-free workplace. DHHS regulations implementing the Act are provided in 45 CFR 76, "Government-wide Debarment and Suspension (Nonprocurement) and Government-wide Requirements for Drug-Free Workplace (Grants)." Accordingly, before a grant award can be made, the applicant organization must make the certification set forth below (Appendix C of the DHHS regulations). The certification is a material representation of fact upon which reliance will be placed by the PHS awarding component. False certification or violation of the certification shall be grounds for suspension of payments, suspension or termination of grants, or Government-wide suspension or debarment.
The applicant organization certifies, "that it will continue to provide a drug-free workplace by:
"(a) Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the grantee's workplace and specifying the actions that will be taken against employees for violation of such prohibition;
"(b) Establishing an ongoing drug-free awareness program to inform employees about:
The dangers of drug abuse in the workplace;
The grantee's policy of maintaining a drug-free workplace;
Any available drug counseling, rehabilitation, and employee assistance programs, and
The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;
"(c) Making it a requirement that each employee to be engaged in the performance of the grant be given a copy of the statement required by paragraph (a);
"(d) Notifying the employee in the statement required by paragraph (a) that, as a condition of employment under the grant, the employee will:
Abide by the terms of the statement; and notify the employer in writing of his or her conviction for a violation of a criminal drug statute occurring in the workplace no later than 5 calendar days after such conviction;
"(e) Notifying the agency in writing within 10 calendar days after receiving notice under subparagraph (d)(2) from an employee or otherwise receiving actual notice of such conviction. Employers of convicted employees must provide notice, including position title, to every grant officer or other designee on whose grant activity the convicted employee was working, unless the Federal agency has designated a central point for the receipt of such notices. Notice shall include the identification number(s) of each affected grant;
"(f) Taking one of the following actions, within 30 calendar days of receiving notice under subparagraph (d)(2), with respect to any employee who is so convicted:
Taking appropriate personnel action against such an employee, up to and including termination, consistent with the requirements of the Rehabilitation Act of 1973, as amended; or
Requiring such employee to participate satisfactorily in a drug abuse assistance or rehabilitation program approved for such purposes by a Federal, State, or local health, law enforcement, or other appropriate agency;
"(g) Making a good faith effort to continue to maintain a drug-free workplace through implementation of paragraphs (a), (b), (c), (d), (e), and (f)" For purposes of paragraph (e), regarding agency notification of criminal drug convictions, the DHHS has designated the following central point for receipt of such notices:
Division of Grants Management and Oversight
Office of Management and Acquisition
Department of Health and Human Services
Room 517-D
200 Independence Avenue, S.W.
Washington, DC 20201
Title 31, United States Code, Section 1352, entitled "Limitation on Use of Appropriated Funds to Influence Certain Federal Contracting and Financial Transactions," generally prohibits recipients of Federal grants and cooperative agreements from using Federal (appropriated) funds for lobbying the Executive or Legislative Branches of the Federal Government in connection with a specific grant or cooperative agreement. Section 1352 also requires that each person who requests or receives a Federal grant or cooperative agreement must disclose lobbying undertaken with non-Federal (nonappropriated) funds. These requirements apply to grants and cooperative agreements exceeding $100,000 in total costs. DHHS regulations implementing Section 1352 are provided in 45 CFR Part 93, "New Restrictions on Lobbying."
The complete Certification Regarding Lobbying is provided below.
"The undersigned (authorized official signing for the applicant organization) certifies, to the best of his or her knowledge and belief that:
"(1) No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement.
"(2) If any funds other than Federally appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form LLL, "Disclosure of Lobbying Activities," in accordance with its instructions.
"(3) The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans and cooperative agreements) and that all subrecipients shall certify and disclose accordingly.
"This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure."
Standard Form LLL, "Disclosure of Lobbying Activities," its instructions, and continuation sheet are available from GrantsInfo, National Institutes of Health, e-mail: GrantsInfo@nih.gov, (301) 435-0714.
The Federal Debt Collection Procedure Act, 28 U.S.C. 3201 (e), provides that an organization or individual that is indebted to the United States, and has a judgment lien filed against it, is ineligible to receive a Federal grant. NIH cannot award a grant unless the authorized organizational official of the applicant organization (or individual in the case of an individual National Research Service Award) certifies, by means of his/her signature on the application, that the organization is not delinquent in repaying any Federal debt. If the applicant discloses delinquency on a debt owed to the Federal Government, NIH may not award the grant until the debt is satisfied or satisfactory arrangements are made with the agency to which the debt is owed.
Each institution that receives or applies for a research, research training, or research-related grant or cooperative agreement under the Public Health Service Act must certify that the institution has established administrative policies as required by (1) 42 CFR Part 50, Subpart A, "Responsibilities for PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science" and (2) 42 CFR 94, "Public Health Service Standards for the Protection of Research Misconduct Whistleblowers" (effective on the date set forth in the final rule.)
The signature of the official signing for the applicant organization on the Face Page of the application serves as certification that:
"Misconduct in Science" and "Research Misconduct" are defined by the Public Health Service as "fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest error or honest differences in interpretation or judgments of data."
For further information, please contact:
Office of Research Integrity
Division of Education and Integrity
Rockwall II, Suite 700
5515 Security Lane
Rockville, MD 20852,
Phone: (301) 443-5300
Fax: (301) 594-0042 or (301) 445-5351.
Before a grant award can be made, a domestic applicant organization must certify that it has filed with the
DHHS Office for Civil Rights: an Assurance of Compliance (Form HHS 690) with Title VI of the Civil Rights
Act of 1964 (P.L. 88352, as amended), which prohibits discrimination on the basis of race, color, or national
origin; Section 504 of the Rehabilitation Act of 1973 (P.L. 93-112, as amended), which prohibits
discrimination on the basis of handicaps; Title IX of the Education Amendments of 1972 (P.L. 92-318, as
amended), which prohibits discrimination on the basis of sex; and the Age Discrimination Act of 1975 (P.L. 94-135), which prohibits discrimination on the basis of age.
The Assurance of Compliance Form HHS 690 is available from GrantsInfo, e-mail: GrantsInfo@nih.gov, (301) 435-0714.
Note: Assurance of Compliance Form HHS 690 is now used in lieu of individual assurances: Form HHS 441,
Civil Rights; Form HHS 641, Handicapped Individuals; Form HHS 639-A, Sex Discrimination; and Form
HHS 680, Age Discrimination.
NIH requires grantees and investigators (except Phase I SBIR/STTR applicants) to comply with the requirements of 42 CFR Part 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought." These requirements promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an investigator.
The signature of the authorized organizational official on the face page of the application serves as certification of compliance with the requirements of 42 CFR Part 50, Subpart F, including that:
Consistent with Government-wide implementing regulations, 15 CFR Part 19, Subpart B and/or any other Government-wide requirements, PHS policy is to support Federal transition to the metric system and to use the metric system of measurement in all grants, cooperative agreements, and all other financial assistance awards. Likewise, measurement values in reports, publications, and other communications regarding grants will be in metric.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Organizations described in section 501(c)4 of the Internal Revenue Code of 1968 that engage in lobbying are not eligible to receive grant/cooperative agreement awards. This is not to be confused with 45 CFR Part 93, Section 1352, "New Restrictions on Lobbying" See Section IIIG, Item 9, "Lobbying."
The Privacy Act of 1974 (5 U.S.C. 552a) is a records management statute and regulates the collection, maintenance, use, and dissemination of personal information by Federal agencies. In accordance with the Act, the PHS is required to provide the following notification to each individual whom it asks to supply information.
The PHS maintains applications and grant records pursuant to its statutory authority for awarding grants. The purpose of the information collection is to aid in the review, award, and administration of PHS programs. Provision of information is voluntary; however, a lack of sufficient information may hinder PHS' ability to review applications, monitor grantee performance, or perform overall management of grant programs.
The Privacy Act authorizes discretionary disclosure of this information within the Department of Health and Human Services and outside the agency to the public, as required by the Freedom of Information Act and the associated DHHS regulations (45 CFR 5), including the Congress acting within its legislative authority, the National Archives, the General Accounting Office, the Bureau of Census, law enforcement agencies, and pursuant to a court order. Information may also be disclosed outside the Department, if necessary, for the following purposes:
Under the provisions of the Privacy Act, principal investigators may request copies of records pertaining to their grant applications from the PHS component responsible for funding decisions. Principal Investigators are given the opportunity under established procedures to request that the records be amended if they believe they are inaccurate, untimely, incomplete, or irrelevant. If the PHS concurs, the records will be amended.
The PHS makes information about awarded grants available to the public, including the title of the project, the grantee institution, the principal investigator, and the amount of the award. The description, on Form Page 2 of a funded research grant application is sent to the National Technical Information Service (NTIS), U.S. Department of Commerce, where the information is used for the dissemination of scientific information and for
scientific classification and program analysis purposes. These descriptions are available to the public from the
NTIS.
The Freedom of Information Act and implementing DHHS regulations (45 CFR Part 5) require the release of certain information about grants, upon request, irrespective of the intended use of the information. Trade secrets and commercial, financial, or otherwise intrinsically valuable information that is obtained from a person or organization and that is privileged or confidential information may be withheld from disclosure. Information, which, if disclosed, would be a clearly unwarranted invasion of personal privacy, may also be withheld from disclosure. Although the grantee institution and the principal investigator will be consulted about any such release, the PHS will make the final determination. Generally available for release, upon request, except as noted above, are: all funded grant applications including their derivative funded noncompeting supplemental grant applications; pending and funded noncompeting continuation applications; progress reports of grantees; and final reports of any review or evaluation of grantee performance conducted or caused to be conducted by the DHHS. Generally, not available for release to the public are: competing grant applications (initial, competing continuation, and supplemental) for which awards have not been made; evaluative portions of site visit reports; and summary statements of findings and recommendations of review groups.
By regulation (45 CFR 74.36), grantees that are institutions of higher education, hospitals, or non-profit organizations are required to release research data first produced in a project supported in whole or in part with Federal funds that are cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (e.g., regulations and administrative orders). "Research data" is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings. It does not include preliminary analyses; drafts of scientific papers; plans for future research; peer reviews; communications with colleagues; physical objects (e.g., laboratory samples, audio or video tapes); trade secrets; commercial information; materials necessary to be held confidential to a researcher until publication in a peer-reviewed journal; information that is protected under the law (e.g. intellectual property); personnel and medical files and similar files, the disclosure of which would constitute an unwarranted invasion of personal privacy or information that could be used to identify a particular person in a research study.
These requirements do not apply to commercial organizations or to research data produced by State or local governments. However, if a state or local governmental grantee contracts with an educational institution, hospital or non-profit organization, and the contract results in covered research data, those data are subject to these disclosure requirements.
The National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) apply to NIH-funded and non-NIH-funded gene transfer projects that are conducted at or sponsored by an institution that receives NIH support for recombinant DNA research. As defined by the NIH Guidelines, recombinant DNA molecules are either: (1) molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (2) DNA molecules that result from the replication of those described in (1). The NIH Guidelines set forth principles and standards for safe and ethical conduct of recombinant DNA research and apply to both basic and clinical research studies. Specific guidance for the conduct of human gene transfer studies appears in the appendix of the document (Appendix M.) The NIH Guidelines should be carefully reviewed to ensure compliance with all other requirements for the conduct of projects involving recombinant DNA research and human gene transfer. Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of NIH funds for recombinant DNA research at the organization or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization. A copy of the NIH Guidelines is posted at the following URL: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html and may be obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838.
A list of the NIH program guidelines and other publications is available on the NIH Web site http://www.nih.gov/index.html and from http://grants.nih.gov/grants/index.cfm. A partial list of the most frequently requested program guidelines is provided below. Applicants may contact GrantsInfo, by e-mail: GrantsInfo@nih.gov, or by telephone (301) 435-0714.
These fellowships are awarded to qualified individuals holding the doctoral or equivalent degree to support full-time research training in designated biomedical science areas. (Applicants should use the F32 guidelines and PHS 416-1 to apply for support.) See http://grants.nih.gov/training/nrsa.htm.
Investigators who hold a doctorate or equivalent degree and have had at least 7 subsequent years of relevant research or professional experience may apply for senior fellowships. The award is designed to provide
opportunities for experienced scientists to make major changes in the direction of their research careers, to acquire new research capabilities, to broaden their scientific background, to enlarge their command of an allied
research field, or to take time from regular professional responsibilities to increase their capabilities for engaging in health-related research. (Applicants should use the F33 guidelines and Form PHS 416-1 to apply for
support.) See http://grants.nih.gov/training/nrsa.htm.
These awards are made to domestic institutions that have the facilities and faculty to provide for research training programs in scientific specialties. Grant funds may be used for personnel, equipment, supplies, trainee stipends (both pre and postdoctoral), and related costs. (Applicants should use the T32 guidelines with the PHS 398 application to apply for support.) See http://grants.nih.gov/training/nrsa.htm.
The goal of these institutional training awards is to provide predoctoral students in health professional schools with research experience during off-quarters or summer periods, so as to encourage them into a research career. (Applicants should use the T35 guidelines and the PHS 398 application.) See http://grants.nih.gov/training/nrsa.htm.
See http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#awardsforeign.
Among NIH components, several types of career awards are available to research and academic institutions on behalf of scientists with clear research potential, but requiring additional experience in a productive scientific environment in preparation for careers in independent biomedical research. (Applicants should use the PHS 398.) See http://grants.nih.gov/training/careerdevelopmentawards.htm.
Support is provided to scientists at eligible domestic institutions for small-scale health-related research projects, such as pilot research projects and feasibility studies; development, testing, and refinement of research
techniques; and similar discrete research projects that demonstrate research capability. This award is directed toward those smaller public and private colleges and universities that provide undergraduate training for a
significant number of the U.S. research scientists. (Applicants should use the PHS 398 with the AREA guidelines.) See
http://grants.nih.gov/grants/funding/area.htm.
International Research Fellowship Award
Application (NIH 1541-1)
Available from:
Fogarty International Center
(301) 496-1653Nonresearch Training Grant Application (PHS 6025)
Available from:
Health Resources and Services Administration
(301) 443-6960Health Services Project Application (5161-1)
Available from:
Substance Abuse and Mental Health Services Administration (SAMHSA)
(301) 436-8451
If You Want to Obtain.....
If You Want to Know More About....
[ Table of Contents] [Section I ] [Section II ] [ Section IV ] [ Section V ] [ Section VI ]