The main federal policy and administrative instruments for public health are:

3.4 The Public Health Service Policy on Humane Care and Use of Laboratory Animals

Just as the AWAR provides many of the operational details for implementing the AWA, the PHS policy provides many the operational details for the National Institutes of Health’s Office of Laboratory Animal Welfare (NIH/OLAW) to oversee the implementation of the Health Research Extension Act of 1985. All institutions that use animals under the authority of the Health Research Extension Act must comply with the PHS policy. The PHS policy regulates the use of vertebrate animals (i.e., fish, amphibians, reptiles, birds, and mammals) used or intended for use in research, research training, biological testing, and similar purposes, such as teaching (PHS Policy III,A), when PHS funds are used for those purposes.

The PHS policy has three components:

The published PHS policy itself [17], which is about 12 pages in length and provides the basic information needed to comply with the pertinent sections of the Health Research Extension Act of 1985. It includes information on the animal welfare Assurance (described below), the IACUC and its functions, review of proposed research projects, reporting and record-keeping requirements, and similar items. Some of the wording of the PHS policy parallels the wording of the AWARs.

Section IV, A of the PHS policy requires institutions that receive (or will be receiving) financial support from the PHS to provide NIH/OLAW with a written animal welfare Assurance. The Assurance is evaluated by NIH/OLAW “to determine the adequacy of the institution’s proposed program for the care and use of animals in PHS-conducted or supported activities.” Without an approved Assurance, no PHS-conducted or supported activity involving animals is permitted. The Assurance is based on the Guide for the Care and Use of Laboratory Animals [24], which is discussed below. Institutions having PHS funding submit a new Assurance to NIH/OLAW every 4 years.

The US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training [25]. This part of the PHS policy consists of a list of nine brief, overarching concepts for the proper use of animals. They include commentaries on animal transportation and care, the relevance of a planned study to human or animal health, the species used and animal numbers, avoidance of pain and distress, use of proper anesthesia and analgesia, euthanasia, appropriate living conditions for animals, qualifications of investigators, and that any deviation from the principles are to be reviewed by a committee such as the IACUC. The concepts behind the US Government Principles are expanded on in the Guide for the Care and Use of Laboratory Animals and the published PHS policy.

The Guide for the Care and Use of Laboratory Animals (the Guide) [24] is the descendent of the original Guide for Laboratory Animal Facilities and Care mentioned earlier. Prepared by the Institute for Laboratory Animal Research of the National Research Council, the Guide is essentially an informational handbook about best practices that are intended to help institutions properly care for and use laboratory animals. The PHS policy (IV,A,1) requires institutions to use the Guide “as a basis for developing and implementing an institutional program for activities involving animals.” Because the Guide and the PHS policy are published as separate documents, it is not unusual for people to refer to them separately (e.g., the Guide says . . . and the PHS Policy says . . .), but it should be clearly understood that NIH/OLAW Assured institutions are expected to follow the recommendations of the Guide unless deviations are approved by the IACUC.

As indicated earlier, APHIS/AC has regulatory authority and published policies to help clarify some of the AWA regulations. NIH/OLAW oversees the implementation of the PHS policy and the Guide, but it is not a regulatory agency. Therefore, instead of formal policies, it provides responses to frequently asked questions [26] and has other useful information on its website [27] to help institutions remain in compliance with the PHS policy.

Public Health Service

The PHS requires disclosure of significant financial interests by investigators who participate in PHS-funded research either as direct recipients or when participating as subrecipients. The goal of this disclosure is to make sure that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias by any conflicting financial interest of an investigator.

The definition of an “investigator” according to the PHS is the project director (PD)/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, including collaborators or consultants. PHS requires all persons meeting this definition to submit a financial disclosure at the time of proposal. When submitting a grant application, the signature of the applicant’s AOR certifies that the applicant is in compliance with these requirements.

If a “positive” disclosure is made by an investigator, before an award can be established, the financial conflict must be either managed or eliminated. Thereafter, each investigator must make an annual disclosure of any financial conflicts of interest (FCOIs) during the life of the award. This typically occurs with the submission of a noncompeting continuation proposal, but PHS expects such conflicts to be disclosed as they occur.

When the Institution determines that an FCOI exists, the institution must report to the NIH awarding IC through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module. The institution also must require each investigator to complete training prior to engaging in NIH-supported research and at least every 4 years, and immediately under the designated circumstances.

Public Health Service and National Science Foundation Regulations

The Public Health Service (PHS) regulations (42 CFR Part 50, Subpart F and 45 CFR Part 94) and National Science Foundation (NSF) policy (National Science Foundation, and 45 CFR 680) are intended to promote objectivity in funded research. They require disclosure of significant financial interests (SFI) from all individuals who are responsible for the design, conduct, or reporting of research to be funded by any PHS agency and the NSF. The regulations require that the applicant institution has a conflicts policy and that it “manages, reduces, or eliminates” any conflicts that are identified “when the designated official reasonably determines that SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.”

The regulations contain no prohibitions, leaving that determination to the applicant institution. For PHS, all such conflicts must be reported to the awarding agency, with assurances that the conflicts have been appropriately handled.2

Abstract

Public health care fraud often involves false reports of medical conditions made to health care providers and/or the government. Sometimes this includes fabricating reports relating to patient disease, addiction, accidents, or crime; and sometimes it means fabricating reports to conceal patient neglect and abuse. Fraud schemes range from the simplistic to the complex.

False reporting intended to defraud publicly funded health care is widespread and growing. This reflects the size of the health care system's bureaucracy, the lack of oversight and communication in the reimbursement process, and the tremendous amount of money involved. All of these things make public health care an irresistible target.

The public perception of health care fraud does not accurately reflect the most representative cases. Most believe fraud originates from individuals abusing state assistance. In reality, cases reflecting the fraud of individual patients involve low dollar amounts. However, cases involving health care providers and suppliers, acting alone or as part of an ad hoc criminal syndicate, can bilk state and federal programs out of millions of dollars. They also evidence the tendency of health care fraud schemes to be not only lucrative and complex, but long term.

Licensing of Biologics

The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are issued by CBER. Licensing of biologic products under the PHS Act is very similar to the new drug approval process for human drugs. Following initial laboratory and animal testing, a biological product is studied in clinical trials in humans under an investigational new drug application (IND). If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted to CBER as part of a biologics license application (BLA) for review and approval for marketing.

Macro-Ethics

Public health services approach patients primarily as participants in the affairs of the societies they affect, which are often those in which they reside, rather than as individuals who have obtained health care services. Governmental public health officers often prefer emphasis on the health services they perform, but their constitutional status and ethical capacity arise from a state’s police powers. Like other police, they sometimes appear in uniform, and they frequently have powers of involuntary detention of suspected persons (quarantine), to interrogate them for information (contact tracing), and may be empowered to compel treatment to protect and cure when there is danger to the community. The practice of epidemiology (classically meaning the study of epidemics) is a routine instrument of public health care that may include consultation of patients’ identifiable medical records without their consent or knowledge and, as discussed previously, health care providers’ duties to report patients’ information given in confidence. The need for information is to know the prevalence of disease in order to provide protective and preventive health care for communities at risk.

The ethical justification for many public health practices is that they are not governed by principles that are applied at the micro-ethical level of analysis, where involuntary detention and data disclosure are usually considered unethical, but at the level of macro-ethics. Here, the social principle of justice has priority. Societies decide at a collective or political level what measures of individual restraint and individual and collective protection are required and how conflicts between patients’ individual rights and collective rights as citizens are to be resolved. Patients dissatisfied with how the balance between their rights as private persons and their rights as citizens have been resolved are free in democracies to resort to political action to change the balance.

Hospitals and clinics are also able to apply ethical principles at the macro-ethical level to address patients’ interests as citizens. Both public facilities and private hospitals and clinics, including nonprofit facilities and those operated commercially, may apply ethical principles to decide which services to offer and how they propose to allocate their resources. As its population ages, for instance, a community hospital may reduce pediatric services in order to expand geriatric care. Hospitals may determine by what application of justice organs are to be allocated for transplantation or with which organ-sharing arrangement they will collaborate, and teaching hospitals responsible for training future health care practitioners may decline to provide the volume of services for which there is a local demand in order to expose students to a full experience of treatments and not just those for which demand is greatest. The interests of patients proposed to be served by these policies are rights in only a moral sense because they are not enforceable by legal or disciplinary means, unless governments operate public facilities or license private facilities in ways that afford individuals means of legal resort to enforce ethical accountability.

Abstract

Public health care in Africa is facing challenges from communicable and noncommunicable diseases and it is under pressure due to scarcity of resources. Noncommunicable diseases, especially metabolic syndrome (MetS) are now prevalent, adding to the pressure and what is to be evaluated is whether African countries have public health policy for MetS or guidelines for use of medicinal spices in the context of medical nutritional therapy. This chapter reviews literature on prevalence of MetS and public health policies on MetS in Africa. There is indication that (1) about 87% of African countries lack any form of multisectoral national policy or action plan that integrates several noncommunicable diseases (e.g., various components of MetS); and (2) medicinal herb/spice propositions and research has yet to articulate a scientific fact sheet (including dynamics and kinetics) or validation procedures that would enable a successful bureaucratic process of public health policy development. A case narrative of a medicinal spice is also presented to highlight some of the pathological biochemical bases of medical nutritional therapy, including adoptability in policy formulation.

7 Addressing Noncompliance

PHS regulation requires policies to cite disciplinary procedures. Institutional policies must provide for sanctions or administrative actions in the event an investigator fails to comply with the policy. Although institutions maintain umbrella policies that trigger disciplinary review if an investigator violates institutional policies or research regulations, the COI policy itself needs to incorporate this type of provision.

Determining deliberate versus unintentional noncompliance. Given the complexity of the regulation, institutional COI policies, and in many cases the administrative procedures needed to stay in compliance, it is not uncommon for investigators to under-disclose or disclose their financial interests belatedly. Even at institutions that do a good job of educating investigators and providing them tools to comply with COI policies, disclosures are sometimes late or incomplete. The COI staff members need to judge when an investigator has made an honest or unintentional error and to provide ongoing guidance and education. Of course, there are cases of knowing and intentional failures to disclose financial interests or comply with management plans. It is incumbent on institutions to address those situations promptly under their disciplinary procedures, not only to be in compliance with regulation but also to signal that the institution takes its policies, particularly those related to ethical conduct of research, seriously.

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