Grant Solicitation, Application, Review, and Approval Process - Foundation for a Smoke-Free World

Grant Solicitation, Application, Review, and Approval Process

Grant Solicitation and Application

Foundation for a Smoke-free World (“Foundation”) directly solicits early-phase concept memos and proposals from organizations identified and known to be well suited to advance its Mission and programs.

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 Foundation’s research initiatives and priorities
  • Proposals for multi-year research projects on topics related to smoking cessation and harm reduction, and
  • Proposals for strengthening capacity of researchers and other stakeholders to conduct activities related to the Mission of Foundation.

Foundation does not accept unsolicited proposals. However, Foundation does invite interested parties to contact support@smokefreeworld.org to discuss ideas that may stimulate its Purpose.

Requests for Proposals and Letters of Intent (“grant applications”) are submitted through 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
  • Detailed 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.

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.

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.

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.

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 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, 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.

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