Grant Processes and Guidelines
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Grant Processes
Grant Processes and Applications
Global Action uses three primary processes for identifying potential grants. These are: (i) requests for proposals and funding announcements; (ii) solicited applications; and (iii) unsolicited applications.
Grant proposals undergo several rounds of review by program staff, independent third parties, and the Board of Directors. Assessment is based on relevance of the project objective, rigor of the approach, ethical considerations, and experience of the project team.
All grant applications are submitted through the organization’s online grants submission system, which provides explicit and clear guidelines to grant applicants.
All proposed grant funded research must be designed and implemented in a manner that is consistent with research best practices and research ethical principles. In particular, all research involving human participants must be designed and implemented in a manner that is consistent with human subjects research best practices and ethical principles. These requirements may include seeking and receiving Institutional Review Board (IRB) approval, fair recruitment, and participant informed consent. Research proposals involving human participants receive an additional level of review to assess that these criteria will be met.
Below are some websites that provide general information regarding research involving human subjects. This list is not intended to be exhaustive. All investigators who intend to conduct grant funded research involving human subjects must comply with their host institution policies relating to human subjects research and are encouraged to obtain detailed information and training on this topic from their host institution.
- The European Code of Conduct for Research Integrity – ALLEA
- Ethical Codes & Research Standards | HHS.gov
- Guiding Principles for Ethical Research | National Institutes of Health (NIH)
- Research Ethics and Integrity Awareness.pdf (ed.ac.uk)
Open Science Principles
All grant funded research must be conducted in a manner that is consistent with Open Science principles. Open Science is the principle and practice of making research products and processes available to all, while respecting diverse cultures, maintaining security and privacy, and fostering collaborations, reproducibility, and equity. In line with this practice, grantees are required to publish in open access journals, disseminate their findings, and, where appropriate, share published materials, code, and data for research purposes. Grantees are encouraged, but not required, to consider depositing articles on a publicly accessible preprint server.
Scientific Review Criteria
The following review criteria will be applied in the review of all research grant proposals:
Criteria 1: Importance of the Research (25%)
a) Significance
b) Actionability
c) Alignment with Global Action research priorities
Criteria 2: Research Factors (50%)
a) Methodological Approach
b) Feasibility
c) Approach to Human Subjects Protection/Data Confidentiality (as appropriate)
Criteria 3: Expertise and Resource (25%)
a) Qualifications of Principle Investigators and Named Staff
b) Research Environment
Criteria Assessed but Not Scored
a) Budget
b) Communication and Dissemination Plan (if relevant)
All grant applicants will be advised of the outcome of their applications via email after funding decisions are finalized.
Cessation Education and Dissemination Project Review Criteria
Global Action also funds grants for cessation education projects. The following review criteria will be applied in the review of these types of grant proposals:
Criteria 1: Importance of the Project (25%)
a) Significance
b) Actionability
c) Alignment with Global Action research priorities
Criteria 2: Project Factors (50%)
a) Implementation Approach
b) Feasibility
Criteria 3: Expertise and Resource (25%)
a) Qualifications of Project Leads and Named Staff
b) Organizational Resources and Project Environment
Criteria Assessed but Not Scored
a) Budget
b) Communication and Dissemination Plan (if relevant)
All grant applicants will be advised of the outcome of their applications via email after funding decisions are finalized.
Grant Guidelines
Disclosure of Potential Conflicts of Interest
The Organization maintains a Conflict of Interest Policy, which can be found here. Article VIII of Global Action’s Bylaws.
As part of the grant application process, all key study personnel are required to disclose in writing, among other potential conflicts, any direct or indirect ownership or investment interest in, or any past or present financial relationship, including, but not limited to, salary or wages, remuneration, consulting fees, honoraria, expert testimony fees or speaking engagement fees received from, a tobacco company or any commercial entity involved in the development and/or commercialization of nicotine-containing products or the tobacco reduction or smoking cessation field or that otherwise may be affected by the scientific research conducted or funded by the Organization.
All key study personnel are also required to report other potential conflicts as required by the Policy.
Expenditure Responsibility and Equivalency Determinations
The Organization, as a private foundation under U.S. tax laws, exercises “expenditure responsibility” in accordance with Section 4945(h) of the Internal Revenue Code of 1986, as amended (the “Code”), with respect to grants to organizations, domestic or foreign, that are not public charities recognized as tax exempt under Section 501(c)(3) of the Code. Alternatively, with respect to the making of a grant to a foreign organization that is the equivalent of a public charity under U.S. law, in lieu of exercising expenditure responsibility, the Organization may make an “equivalency determination.” A grant applicant’s organizational status will not affect the consideration of its application. However, successful grant applicants may be asked to provide the Organization with additional information about the grantee organization prior to execution of a grant award to ensure that the Organization can meet its tax law obligations.
Expenditure responsibility requires a private foundation to exert all reasonable efforts and establish adequate procedures to see that a grant is spent solely for the purpose for which it was made, obtain full and complete reports from the grantee on how funds were spent and make full and detailed reports with respect to such expenditures on an annual basis on the private foundation’s Form 990-PF filed with the U.S. Internal Revenue Service.
The general requirements for expenditure responsibility are: (i) a pre-grant inquiry regarding the grantee: (ii) a written agreement specifying the charitable purposes the grantee intends to accomplish and containing certain limitations (such as prohibiting the use of grant funds for lobbying) and (iii) providing that the grantee establish a separate account for the grant funds; (iv) regular reports from the grantee; and (iv) annual reporting by the Organization to the IRS on its Form 990-PF indicating that expenditure responsibility payments were made, including a brief description of each grant. The grant-making procedures the Organization has established, including the application process, the terms of the grant agreement, and the required reporting and recordkeeping by the grantee, are designed to ensure compliance with the requirements of “expenditure responsibility.”
To fulfil the requirements of equivalency determination, the Organization must make a good faith determination based on an affidavit and analysis of financial, programmatic, governance, and other documents from the potential grantee or an opinion of legal counsel that the grantee is the equivalent to a U.S. public charity.
Grant Funding
Global Action to End Smoking, Inc. awards grants for charitable, scientific, and educational purposes within the meaning of section 501(c)(3) of the Internal Revenue Code (IRC), to support its mission to improve public health by ending the smoking epidemic.
While Global Action appreciates that all grant applications are the result of considerable effort, it makes no representations that any grant application will be funded. All decisions to fund grants remain in the sole discretion of Global Action. Grant proposals and related documentation will be disclosed to employees, consultants, legal counsel, and others. Grant proposals and related documentation will not be treated as confidential and Global Action does not maintain the confidentiality of any such materials. Grant applicants should carefully consider the content of grant proposals and related documentation and not include any proprietary or confidential information if there is any concern about the impact of disclosure of these materials.
Grants that Global Action does not fund include those that are prohibited by applicable laws and regulations including grants in support of lobbying or political campaign activities. These include grants relating to attempts to influence legislation, either by communicating with government personnel who are involved in the legislative process or urging the public to do so. These prohibited grants include both domestic and international activities. Similarly, Global Action grant monies are not used to influence the outcome of any political campaigns or to conduct voter registration drives, either within the United States or abroad. Global Action generally may fund grant activity that properly qualifies as an exception to lobbying, such as grants for nonpartisan analysis, study, or research, and grant work being performed in response to a written request for technical assistance.
In addition, grants will not be made to any organization that is not authorized in its country of origin to receive grant funds from Global Action and/or whom Global Action is prohibited or restricted by law or regulation from funding. Global Action’s rigorous procedures for making and monitoring grants ensure that its grant funds are used for the intended charitable purposes and not to support terrorist or other illegal activities.
Grant Solicitation and Application
Global Action to End Smoking (“Foundation”) directly solicits early-phase concept memos and proposals from organizations identified and known to be well suited to advance its mission and programs.
The Foundation also coordinates grant solicitations by issuing periodic calls for:
- Letters of Intent to provide short-term detailed scoping grants to inform, guide, and advance the Foundation’s research initiatives and priorities
- Proposals for multi-year research projects on topics related to smoking cessation and harm reduction
- Proposals for strengthening capacity of researchers and other stakeholders to conduct activities related to the Mission of Foundation
Requests for proposals and Letters of Intent (“grant applications”) are submitted through the Foundation’s online grants submission system, which provides explicit and clear guidelines to grant applicants.
Grant applicants are required to provide the following information on prescribed templates:
- Applicant information (including organization name, address, telephone number, website, organization mission, geographic focus, contact name for organization, contact email and mailing addresses, and contact telephone number)
- Tax-exempt status of the Applicant (including copy of exemption ruling)
- Detailed proposal, including the background or Curriculum Vitae of the key personnel who will participate in and be directly responsible for the research supported by the grant
- Detailed Budget, and Work Plan
- All research must be conducted in line with Open Science principles. These principles include (1) making all data available for re-analysis, (2) publishing all results whether positive or negative, and (3) making data available for publishing in peer-reviewed journals that offer open access.
Applicants must have the internal capacity for sex- and gender-based analysis where appropriate and the Foundation encourages a gender balance in team leadership and team composition.
The Foundation maintains separate files for each grant applicant in which all correspondence and other information is retained.
Grant Application Review and Approval
All grant applications are evaluated by experts both internally and externally and, if recommended for progression, are subject to review and oversight at various levels of leadership within Foundation’s structure, including its Science Oversight Committee, Board of Directors, and legal team. Included in the evaluation is a review of the Applicant’s ability to appropriately administer the grant.
All grant applicants are advised of the outcome of their applications in accordance with the dates and timelines announced within the call for proposals.
Grant applicants selected for further consideration will be contacted to develop the parameters of the proposal.
The terms and conditions of all grants awarded under this process are memorialized in a formal grant agreement.
Disclosure of Potential Conflicts of Interest
Foundation maintains a Conflict of Interest Policy which can be found in Article VIII of Foundation’s Bylaws.
As part of the grant application process, each Applicant is required to disclose in writing any direct or indirect ownership or investment interest in, or any past or present financial relationship, including, but not limited to, salary or wages, remuneration, consulting fees, honoraria, expert testimony fees or speaking engagement fees received from, a tobacco company or any commercial entity involved in the development and/or commercialization of nicotine-containing products or the tobacco reduction or smoking cessation field or that otherwise may be affected by the scientific research conducted or funded by Foundation.
Ethical Guidelines and Standards
Introduction
Bioethics is a broad field that connects biological sciences with ethical concerns. Research ethics is a subfield of bioethics that focuses on issues related to basic and clinical research. In this Grant Policies and Procedures, the term “research” refers to any systematic investigation designed to develop or contribute to generalizable knowledge. This includes, but is not limited to, medical experiments, surveys and observational studies, neuroimaging, and genetic studies. (These ethical guidelines do not apply to marketing research which involves insight survey, polls, or focus group.)
Background
At the request of the United States Congress in 1974, experts in medicine, law and ethics came together to form the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (i.e., the “National Commission”). As part of its findings, the National Commission stated that research involving humans should be guided by three (3) ethical principles: beneficence, respect for persons, and justice.
Beneficence
Beneficence provides that all research must be done for the good of both the participants and the broader community. Implied in the term beneficence is another principle, called nonmaleficence, which holds that research should not result in harm.
Respect for Persons
Respect for persons, sometimes called “respect for autonomy,” emphasizes the importance of informed consent from competent individuals, and special protection for vulnerable populations (described below).
Justice
‘Justice in human subjects’ research means that the goods or benefits derived from research must be distributed fairly.
The order of these principles does not indicate the importance of one over another; they are understood to conflict at times and must be balanced and weighted accordingly.
Ethical Standards
The ethical standards governing the research on human beings can be divided into three subfields: (1) standards relating to research protocol; (2) standards relating to the selection and treatment of research subjects; and (3) standards regarding the relationships with the communities in which the research is conducted.
Standards Relating to Research Protocols
Scientific validity
A precondition of exposing human subjects even to minimal risk in research is that the research design can be scientifically valid. This requires attention to the basic scientific structure of the research and the competence of the research team, and a realistic appraisal of the research team’s ability to enroll a sufficient number of subjects, in reasonable time, to complete a study with statistical power; and of the feasibility of carrying the study to completion within the political or cultural contexts in which the research is to be.
Risk – Benefit Ratio
Researchers need to assess the risks and benefits of their research to their study population. A research study poses only “minimal risk” to human subjects when the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Minimal-risk studies may be justified by relatively small benefits to the study population, but as risk and inconvenience increase, studies need to be justified by greater benefits to study subjects or to their…
Social Value – Aims of Study
Researchers must assess the social value of their research separately from their assessment of the risk benefit balance faced by potential human subjects. Who will benefit from the research, and in what way?
Social Value – Publication
The social value of research is enhanced by its broad related to publication, the World Health Organization (“WHO”) has called for a minimal set of information on all clinical trials to be registered in a public database. Foundation accepts the WHO’s mandate, and therefore requires that, for each trial on human subjects undertaken by its grantees, before the enrollment of any subjects begins, all elements of the WHO’s Trial Registration Data Set must be registered.
Conflicts of Interest
A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. The Institute of Medicine defines a conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary. ” Primary interests of concern include promoting and protecting the integrity of research and the welfare of subjects. Secondary interests “may include not only financial gain but also the desire for professional advancement, recognition for personal achievement, and favors to friends and family or to students and colleagues.”
Standards Relating to Human Participants
Respect for Study Subjects
- Study designers and researchers must respect research subjects. This includes not only respect for the decisional autonomy of subjects or their surrogates, but also respect for their role in and centrality to the research enterprise, and sensitivity to their cultural norms.
Fair Selection of Subjects
- The study population must be recruited and selected not only in a way that ensures the scientific validity of the research, but also in a way that ensures the just distribution of the benefits and burdens of Care should be taken to ensure that particular sub-populations (whether or not they are identified as “vulnerable,” see below) are neither excessively recruited into research nor excluded from it.
Informed Consent
- Grantees must obtain the voluntary informed consent of all subjects, or, in the case of subjects who are not capable of giving informed consent, the permission of a legally authorized surrogate decision-maker. Informed consent should normally be documented in
For these purposes, vulnerable human beings are persons who are incapable of protecting their own interests because they lack sufficient power, intelligence, education, resources, or other attributes needed to protect their own interests. Vulnerable subjects include (among others) children, pregnant women and their developing fetuses, persons from impoverished communities, persons who lack capacity, prisoners, severely ill persons, and subordinate members of hierarchical groups.
Standards Relating to the Community
All research on human subjects must be approved in advance by one or more scientific and ethical review committees or Institutional Review Boards (“IRB”). Review committees must be independent of the grantee’s research team, and no benefit they may derive from the research should be contingent on the outcome of their review. Review committees should conduct periodic reviews of all research they have approved, including monitoring study progress.
When research is conducted outside the U.S., and especially when research is conducted on vulnerable populations, it is preferable that a national or local ethical review should be conducted by a committee that has established ties to the community where the research will be conducted, and to the subject population. Advice from local authorities can help avoid unnecessary problems and expense. All research must be approved by a locally approved IRB or equivalent AND approved through a corporate review process.
Expenditure Responsibility and Equivalency Determinations
The Foundation, as a private foundation, exercises “expenditure responsibility” in accordance with Section 4945(h) of the Internal Revenue Code of 1986, as amended, with respect to the making of a grant to an organization, domestic or foreign, that is not a public charity. Expenditure responsibility requires a private foundation to exert all reasonable efforts and establish adequate procedures to see that a grant is spent solely for the purpose for which it was made, obtain full and complete reports from the grantee on how funds were spent and make full and detailed reports with respect to such expenditures on an annual basis on the private foundation’s Form 990-PF filed with the U.S. Internal Revenue Service.
The general requirements for expenditure responsibility are a pre-grant inquiry regarding the grantee, a written agreement, and annual reports from the grantee. The grant-making procedures the Foundation has established, as outlined above, including the application process, the terms of the grant agreement and the required reporting and recordkeeping by the grantee, shall comply with the requirements of “expenditure responsibility.”
Alternatively, with respect to the making of a grant to a foreign organization that is the equivalent of a public charity under U.S. law, in lieu of exercising expenditure responsibility, the Foundation may make an “equivalency determination.” An equivalency determination involves a determination that a foreign charity is the equivalent of a public charity under U.S. law based on a legal opinion analyzing the foreign organization’s ability to qualify as such, which involves an analysis of financial information, governing documents, programs and activities and other relevant information.
Grant Funding
Global Action to End Smoking, Inc. awards grants for charitable, scientific, and educational purposes within the meaning of section 501(c)(3) of the Internal Revenue Code (IRC), to support its mission to improve public health by ending the smoking epidemic.
While Global Action appreciates that all grant applications are the result of considerable effort, it makes no representations that any grant application will be funded. All decisions to fund grants remain in the sole discretion of Global Action. Grant proposals and related documentation will be disclosed to employees, consultants, legal counsel, and others. Grant proposals and related documentation will not be treated as confidential and Global Action does not maintain the confidentiality of any such materials. Grant applicants should carefully consider the content of grant proposals and related documentation and not include any proprietary or confidential information if there is any concern about the impact of disclosure of these materials.
Grants that Global Action does not fund include those that are prohibited by applicable laws and regulations including grants in support of lobbying or political campaign activities. These include grants relating to attempts to influence legislation, either by communicating with government personnel who are involved in the legislative process or urging the public to do so. These prohibited grants include both domestic and international activities. Similarly, Global Action grant monies are not used to influence the outcome of any political campaigns or to conduct voter registration drives, either within the United States or abroad. Global Action generally may fund grant activity that properly qualifies as an exception to lobbying, such as grants for nonpartisan analysis, study, or research, and grant work being performed in response to a written request for technical assistance.
In addition, grants will not be made to any organization that is not authorized in its country of origin to receive grant funds from Global Action and/or whom Global Action is prohibited or restricted by law or regulation from funding. Global Action’s rigorous procedures for making and monitoring grants ensure that its grant funds are used for the intended charitable purposes and not to support terrorist or other illegal activities.