An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research

2005 ◽  
Vol 33 (1) ◽  
pp. 125-141 ◽  
Author(s):  
James G. Hodge
Keyword(s):  
Public Health ◽  
Health Care Providers ◽  
Human Subjects ◽  
Public Health Practice ◽  
Disease Outbreaks ◽  
Systematic Investigation ◽  
Health Data ◽  
Care Providers ◽  
Health Practice ◽  
Human Subjects Research

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance (e.g., reporting requirements, disease registries, sentinel networks), epidemiological investigations (e.g., to investigate disease outbreaks), and evaluation and monitoring (e.g., public health program development and analysis, oversight functions). Few debate that these essential public health activities, often specifically authorized by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects (or their identifiable, private data).

Recent measles outbreaks in the United States: A look at the causes and responses

2019 ◽  
Vol 14 (10) ◽  
pp. 491-496
Author(s):  
Tracy Perron ◽  
Heather Larovere ◽  
Victoria Guerra ◽  
Kathleen Kilfeather ◽  
Nicole Pare ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Health Care Providers ◽  
Personal Autonomy ◽  
Disease Outbreaks ◽  
The United States ◽  
Care Providers ◽  
Course Of Action ◽  
Public Health Officials ◽  
Measles Outbreaks

As measles cases continue to rise in the United States and elsewhere, public health officials, health care providers and elected officials alike are facing critical questions of how to protect the health of the public from current and future vaccine preventable disease outbreaks while still preserving the religious and personal autonomy of the populations they serve. As measles cases are being examined and carefully managed, public health officials are also tasked with revisiting vaccination policies and agendas to determine the best evidence-based interventions to control this epidemic. To determine the best course of action for the public's interest, research and current literature must be examined to protect and promote the health and wellbeing of those currently affected by the measles outbreak and those yet to be exposed.

scholarly journals A Public Health Systems View of Risk Communication About Zika

2020 ◽  
Vol 135 (3) ◽  
pp. 343-353
Author(s):  
Tara Kirk Sell ◽  
Sanjana J. Ravi ◽  
Crystal Watson ◽  
Diane Meyer ◽  
Laura E. Pechta ◽  
...  
Keyword(s):  
Public Health ◽  
Infectious Disease ◽  
Risk Communication ◽  
Health Care Providers ◽  
Public Information ◽  
Disease Outbreaks ◽  
The United States ◽  
Lessons Learned ◽  
Care Providers ◽  
Disease Response

Objectives The spread of Zika virus throughout Latin America and parts of the United States in 2016 and 2017 presented a challenge to public health communicators. The objective of our study was to describe emergency risk communication practices during the 2016-2017 Zika outbreak to inform future infectious disease communication efforts. Methods We conducted semi-structured telephone interviews with 13 public health policy makers and practitioners, 10 public information officers, and 5 vector-control officials from May through August 2017. Results Within the public health macro-environment, extended outbreak timeframe, government trust, US residence status, and economic insecurity set the backdrop for Zika communication efforts. Limited resources, staffing, and partnerships negatively affected public health structural capacity for communication efforts. Public health communicators and practitioners used a range of processes and practices to engage in education and outreach, including fieldwork, community meetings, and contact with health care providers. Overall, public health agencies’ primary goals were to prevent Zika infection, reduce transmission, and prevent adverse birth outcomes. Conclusions Lessons learned from this disease response included understanding the macro-environment, developing partnerships across agencies and the community, and valuing diverse message platforms. These lessons can be used to improve communication approaches for health officials at the local, state, and federal levels during future infectious disease outbreaks.

scholarly journals Surveillance System Evaluations Provide Evidence to Improve Public Health Practice

2015 ◽  
Vol 7 (1) ◽  
Author(s):  
Beverley J. Paterson ◽  
David N. Durrheim
Keyword(s):  
Public Health ◽  
Public Health Practice ◽  
Disease Outbreaks ◽  
Surveillance Systems ◽  
Health Practice ◽  
Outbreak Response ◽  
Local Public Health ◽  
Infectious Disease Outbreaks ◽  
The Pacific ◽  
Surveillance Practice

Surveillance evaluations of surveillance systems should provide evidence to improve public health practice. In response to surveillance evaluation findings amongst Pacific Island Countries and Territories that identified a critical need to better equip local public health officials with skills to rapidly appropriately respond to suspected infectious disease outbreaks across the Pacific, the RAPID (Response and Analysis for Pacific Infectious Diseases) project was implemented to strengthen capacity in surveillance, epidemiology and outbreak response. The RAPID project is a notable example of how evidence gathered through a surveillance evaluation can be used to improve public health surveillance practice.

scholarly journals Transforming Public Health Surveillance Through Open Public Health Information

2018 ◽  
Vol 10 (1) ◽  
Author(s):  
Janelle Kibler ◽  
Scott McNabb ◽  
James Lavery ◽  
Ziad Memish ◽  
Affan Shaikh ◽  
...  
Keyword(s):  
Public Health ◽  
Health Information ◽  
Public Health Surveillance ◽  
Public Health Practice ◽  
Health Data ◽  
Health Surveillance ◽  
Health Practice ◽  
Public Health Data ◽  
Health Authorities ◽  
Public Health Information

ObjectiveThe goal of this editorial is to shed light on the lack of transparency that exists in the sharing of Public Health data and to reverse this presumption in favour of open public health information properly vetted and openly accessible. Open public health information is a critical step to revitalize public health practice and is a human right.IntroductionPublic health practice that prevents, detects, and responds to communicable and noncommunicable disease threats is hindered by poor access to public health data and information. This includes timely sharing of case-based information, respecting patent and publication rights, and the ethical sharing of specimens. Disagreements about information shared and under what circumstances plus who has right to the data, clinical specimens, and their derivative products impede research and countermeasures. Delayed or inaction by public health authorities undermines trust and exacerbates the crisis. Evident in 2014 by the delayed Public Health Emergency of International Concern declaration of the Ebola virus outbreak in West Africa by the World Health Organization, the governing presumption is that access to public health information should be restricted, constrained, or even hoarded; this is a failed approach. This lack of transparency prevents information availability when and where it is needed and obstructs public health efforts to efficiently and ethically prevent, detect, and respond to emerging threats. A better way forward is to reverse this presumption in favour of open public health information properly vetted and openly accessible. Open public health information is a critical step to revitalize public health practice and is a human right.While there is limited global consensus among scientists and public health practitioners on best practices to guide national health authorities, researchers, NGOs, and industry as they navigate the ethical, political, technical, and economic challenges associated with the sharing of essential public health information (e.g., pathogen isolates, clinical specimens, and patient-related data), grounding this discussion on the guiding principles of open public health information can help navigate the complex privacy, security, communication, and access needs, and ensure that collaboration and sharing occur in a manner that is ethically and socially just, efficient, and equitable. Built on existing governance frameworks such as the International Health Regulations (IHRs) and the Pandemic Influenza Preparedness Framework (PIP), open public health can transform public health surveillance, allowing for the rapid sharing of data and products during outbreaks for mutual benefit and enhanced global health security.MethodsThis abstract represents a larger editorial style manuscript, thus no methods were developed in the abstract.ResultsThis editorial style manuscript aims to reverse the presumption that public health data is damaging to one in favour of open public health information properly vetted and openly accessible.ConclusionsSimilar to other open movements (i.e., open data, open government, open development, and open science) that seek to address the world’s greatest challenges through transparency, collaboration, reuse of and free access to ideas, open public health offers an ideal solution to overcome the challenges in the 21st century.

Use and effectiveness of mHealth technologies in tracking the spread of infectious disease outbreaks and their implications for the COVID-19 pandemic: a systematic review protocol (Preprint)

2020 ◽  
Author(s):  
Madison Milne-Ives ◽  
Simon Rowland ◽  
Alison McGregor ◽  
J Edward Fitzgerald ◽  
Edward Meinert
Keyword(s):  
Public Health ◽  
Infectious Disease ◽  
Systematic Review ◽  
Public Health Practice ◽  
Disease Outbreaks ◽  
Digital Technologies ◽  
World Health ◽  
Health Practice ◽  
Public Health Response ◽  
Infectious Disease Outbreaks

BACKGROUND The World Health Organisation (WHO) defines mHealth as medical and public health practice supported by mobile devices. A number of mHealth devices, primarily apps designed to support contact tracing, have been utilised as part of the public health response to the Covid-19 pandemic. The value of mHealth devices in augmenting public health practice is however yet to be defined. OBJECTIVE The study aims to address three research questions: (1) What digital technologies are being used to track the symptoms and spread of infectious disease outbreaks and what strategies do they use to do so? (2) How effective and cost-effective are digital technologies at tracking the spread of infectious disease outbreaks and what are their strengths and limitations? (3) What are the user perspectives on the usability and effectiveness of these technologies? METHODS The PICOS template and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) will be followed for this systematic review. The review will be composed of a literature search, article selection, data extraction, quality appraisal, data analysis, and a discussion of the implications of the data for the current COVID-19 pandemic. RESULTS N/A CONCLUSIONS This systematic review will summarise the available evidence for use of mHealth devices for tracking the spread of infectious disease outbreaks. These results are potentially valuable for informing public health policy during infectious disease outbreaks such as the current Covid-19 pandemic.

Tuberculosis surveillance and its discontents: the ethical paradox

2020 ◽  
Vol 24 (5) ◽  
pp. 9-14
Author(s):  
R. Bayer ◽  
A. L. Fairchild ◽  
M. Zignol ◽  
K. G. Castro
Keyword(s):  
Public Health ◽  
Public Health Surveillance ◽  
Ethical Issues ◽  
Human Subjects ◽  
Public Health Practice ◽  
Health Surveillance ◽  
World Health ◽  
Ethical Review ◽  
Health Practice ◽  
Health Organization

In June 2017, the World Health Organization issued the Guidelines on Ethical Issues in Public Health Surveillance. Using the frame of public health ethics, the guidance declared that countries have an affirmative duty to undertake surveillance and that the global community had an obligation to support those countries whose resources limited their capacity. The centrality of TB surveillance has long been recognized as a matter of public health practice and ethics. Nevertheless, contemporary global realities make clear that TB surveillance falls far short of the goal of uniform notification. It is this reality that necessitated the paradoxical turn to research studies that require informed consent and human subjects' ethical review, the very burdens that mandated notification were designed to overcome.

scholarly journals An Informatics Framework to Support Surveillance System Interoperability in Minnesota

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Sameul Patnoe ◽  
Martin LaVenture ◽  
Rebecca E. Johnson ◽  
Jennifer Fritz ◽  
Barbara Frohnert ◽  
...  
Keyword(s):  
Public Health ◽  
Health Care ◽  
Health Care Providers ◽  
Birth Defects ◽  
Health Data ◽  
Surveillance Systems ◽  
Care Providers ◽  
Individual Level ◽  
Health Goals ◽  
System Interoperability

ObjectiveTo create an informatics framework and provide guidanceto help Minnesota’s public health surveillance systems achieveinteroperability and transition to standards-based electronicinformation exchange with external health care providers using thestate’s birth defects registry as an initial pilot program.IntroductionThe Minnesota Department of Health (MDH) needs to be ableto collect, use, and share clinical, individual-level health dataelectronically in secure and standardized ways in order to optimizesurveillance capabilities, support public health goals, and ensureproper follow-up and action to public health threats. MDH programs,public health departments, and health care providers across the stateare facing increasing demands to receive and submit electronic healthdata through approaches that are secure, coordinated, and efficient;use appropriate data standards; meet state and federal privacy laws;and align with best practices. This framework builds upon existinginformatics models and two past studies assessing health informationexchange (HIE) conducted by the MDH Office of Health InformationTechnology (OHIT) to provide MDH surveillance systems with anoutline of the key elements and considerations for transitioning tomore secure, standards-based, electronic data exchange.MethodsDevelopment of the informatics framework incorporatesinformation gathered in several phases. The first phase involvesadditional analysis of data collected from the MDH InformaticsAssessment of Interoperability and HIE1that was conducted in 2015to evaluate the current state of interoperability and HIE readinessacross the agency. The second phase involves a comprehensiveenvironmental scan and literature review of existing standards,practices, models, toolkits, and other resources related to electronicHIE and interoperability. The third phase involves gathering additionalinformation on programmatic needs, workflows, and capabilitiesthrough key informant interviews. Key informants include programmanagers, staff, and content-area experts from select MDH programs,the state’s central information technology organization (MN.IT), andexternal health care provider organizations including hospitals.Minnesota’s birth defects registry, the Birth Defects InformationSystem (BDIS), was selected as the pilot program because it wasidentified in the 2015 MDH Informatics Assessment as having a highlevel of interest in implementing an interoperable and standards-driven approach to electronic health data exchange. The BDIS is alsoexploring options for being designated as an eligible public healthregistry for Meaningful Use. As a pilot program for this project,the BDIS assists in the development and implementation of theinformatics framework.ResultsThe 2015 MDH Informatics Assessment identified and evaluated21 MDH programs with information systems that accept and manageclinical, individual-level health information. Among these 21 MDHprograms, wide variations exist regarding information system size(range, 400 to 10,000,000 individuals), staffing numbers (range, 0.2 to21 FTEs), budgets (range, $20,000 to $1,876,000), and other keycharacteristics. Despite these variations, programs identified similarbarriers and needs related to achieving interoperability and electronicHIE. Areas of need include management and information technologysupport to make interoperability a priority; policies and governance;additional application functionality to support HIE; and additionalskills for the workforce. Results from the environmental scan and keyinformant interviews will be incorporated with additional analyses ofthe 2015 MDH Informatics Assessment to inform the development ofan agency-wide informatics framework to support MDH programs inachieving interoperability.ConclusionsMDH surveillance systems are calling for practical guidance tohelp implement and maintain a more efficient and effective wayto electronically collect, use, and share health data with externaland internal stakeholders. This informatics framework provides anoutline of the key elements and considerations for achieving greaterinteroperability across MDH surveillance systems. Additionalresearch is required to assess how system interoperability and HIEcan improve data quality and advance population health goals.

Public Health Practice vs Research: Implications for Preparedness and Disaster Research Review by State Health Department IRBs

2008 ◽  
Vol 2 (3) ◽  
pp. 185-191 ◽  
Author(s):  
David Perlman
Keyword(s):  
Public Health ◽  
Personal Information ◽  
Human Subjects ◽  
Public Health Practice ◽  
Health Department ◽  
Systematic Investigation ◽  
Research Review ◽  
Health Departments ◽  
State Health ◽  
Public Health Preparedness

ABSTRACTUnder the current US Department of Health and Human Services regulatory and ethical system for research involving human subjects, research is defined in terms of several key concepts: intent, systematic investigation, and generalizability. If an investigator engages in a systematic investigation designed or intended to contribute to generalizable knowledge, then he or she is engaged in research. If that research involves living individuals and the investigator will either interact or intervene with people or obtain their identifiable personal information, then the research must be prospectively reviewed by an institutional review board (IRB), a federally mandated committee that ensures the ethical and regulatory appropriateness of proposed research. In public health institutions, and especially at state departments of health, this definition of research may prove vexing for determining when particular public health activities must be reviewed by IRBs. This article outlines several reasons for such vexation and 2 key responses from major public health stakeholders. In the current climate of public health preparedness initiatives at state health departments for disasters and bioterrorism, how research is defined vis-à-vis public health interventions may add even more confusion to preparedness initiatives and pose difficulties in determining when IRB review and the added protections it affords are appropriate. This article suggests several practical ways to avoid confusion and attempts to strike a balance between the need for expeditious approvals of research-based responses to public health disasters and to ensure proper protections for human subjects at state health departments. It is hoped that these suggestions can assist not only state health departments but also academically based researchers who either collaborate with those departments or whose research will need to be reviewed by their IRBs. (Disaster Med Public Health Preparedness. 2008;2:185–191)

The Role of State Law in Protecting Human Subjects of Public Health Research and Practice

2003 ◽  
Vol 31 (4) ◽  
pp. 654-662 ◽  
Author(s):  
Scott Burris ◽  
Lance Gable ◽  
Lesley Stone ◽  
Zita Lazzarini
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Public Health Practice ◽  
Public Health Research ◽  
Health Practice ◽  
Research Subjects ◽  
Common Rule ◽  
Public Health Agencies ◽  
Specimen Collection ◽  
The Common

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection (blood, urine, etc.), and laboratory testing (both identifiable and anonymous).There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons.

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