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.

Ethics of Population-Based Research

2007 ◽  
Vol 35 (2) ◽  
pp. 295-299 ◽  
Author(s):  
Holly A. Taylor ◽  
Summer Johnson
Keyword(s):  
Public Health ◽  
Health Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Public Health Practice ◽  
Public Health Research ◽  
Population Based ◽  
Health Practice ◽  
Ethical Implications ◽  
Definition Of

Multiple scholars and institutions have asked what distinguishes public health research from public health practice. Most often, they ask in order to have a clear definition of what one does in various public health settings to assess oversight and/or regulation of human subjects research. More importantly, however, whether something is considered public health research or public health practice has real ethical implications in terms of the general moral considerations at stake and the obligations of public health researchers/practitioners to the populations they serve or study.Numerous examples in recent history of research ethics, including the Kennedy Krieger Lead Abatement Study and EPA’s Children’s Environmental Exposure Research Study (CHEERS), suggest that an exploration of the ethics of public health, or more generally population-based research, may be warranted. Although we acknowledge that there are important ethical issues to consider in the implementation of public health practice, we leave that discussion for other authors.

Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers about a Separate Regulatory Regime

2003 ◽  
Vol 31 (4) ◽  
pp. 638-653 ◽  
Author(s):  
Scott Burris ◽  
James Buehler ◽  
Zita Lazzarini
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Regulatory System ◽  
Regulatory Regime ◽  
Common Rule ◽  
Public Health Agencies ◽  
The Past ◽  
Health Agencies ◽  
Control And Prevention ◽  
The Common

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention (CDC) has adopted guidelines that require Common Rule review for “research” but not “practice” activities.

scholarly journals Scraping the Web for Public Health Gains: Ethical Considerations from a ‘Big Data’ Research Project on HIV and Incarceration

2020 ◽  
Vol 13 (1) ◽  
pp. 111-121 ◽  
Author(s):  
Stuart Rennie ◽  
Mara Buchbinder ◽  
Eric Juengst ◽  
Lauren Brinkley-Rubinstein ◽  
Colleen Blue ◽  
...  
Keyword(s):  
Public Health ◽  
Ethical Issues ◽  
Health Planning ◽  
Public Health Practice ◽  
Public Health Research ◽  
Health Practice ◽  
Ethical Considerations ◽  
Individual Level ◽  
Hiv Surveillance ◽  
The Web

Abstract Web scraping involves using computer programs for automated extraction and organization of data from the Web for the purpose of further data analysis and use. It is frequently used by commercial companies, but also has become a valuable tool in epidemiological research and public health planning. In this paper, we explore ethical issues in a project that “scrapes” public websites of U.S. county jails as part of an effort to develop a comprehensive database (including individual-level jail incarcerations, court records and confidential HIV records) to enhance HIV surveillance and improve continuity of care for incarcerated populations. We argue that the well-known framework of Emanuel et al. (2000) provides only partial ethical guidance for the activities we describe, which lie at a complex intersection of public health research and public health practice. We suggest some ethical considerations from the ethics of public health practice to help fill gaps in this relatively unexplored area.

Ethical principles and ethical issues in public health

2021 ◽  
pp. 261-272
Author(s):  
Nancy Kass ◽  
Amy Paul ◽  
Andrew Siegel
Keyword(s):  
Public Health ◽  
Medical Ethics ◽  
Health Research ◽  
Public Health Practice ◽  
Public Health Research ◽  
Public Health Ethics ◽  
Health Practice ◽  
Health Ethics ◽  
1960S And 1970S ◽  
Social Justice Theory

Public health ethics considers moral dimensions of public health practice and research. While medical ethics dates back hundreds of years, and bioethics writings emerged in the 1960s and 1970s, ‘public health ethics’, articulated as such, did not appear significantly in the literature for several more decades. There has been great interest recently in defining public health ethics, examining how it resembles or differs from medical ethics or bioethics, outlining frameworks and codes, and providing conceptual and practical guidance on how ethics can inform public health practice and research. This chapter describes the emergence of public health ethics; work in bioethics with relevance for public health; the relevance of social justice theory in addressing public health problems; and discusses literature on ethics and public health research, including whether public health research ethics might differ from ethical guidance for other human research. The chapter concludes with an overview of ethics issues related to genetic research and emerging technologies.

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.

Currents in Contemporary Ethics

2005 ◽  
Vol 33 (1) ◽  
pp. 154-159 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
Privacy Protection ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Common Rule ◽  
Privacy Rule ◽  
Institutional Review ◽  
The Common ◽  
Protection Of Human Subjects ◽  
Privacy Issues

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

scholarly journals Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

2013 ◽  
Vol 41 (2) ◽  
pp. 440-453 ◽  
Author(s):  
Brett A. Williams ◽  
Leslie E. Wolf
Keyword(s):  
Human Services ◽  
Human Subjects ◽  
Regulatory System ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Common Rule ◽  
Department Of Health ◽  
Initial Interaction ◽  
Research Protections ◽  
The Common

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.

The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research

2003 ◽  
Vol 31 (1) ◽  
pp. 149-153 ◽  
Author(s):  
T. Howard Stone
Keyword(s):  
Human Subjects ◽  
Disabled Persons ◽  
Federal Regulations ◽  
Research Subjects ◽  
Undue Influence ◽  
Common Rule ◽  
Educationally Disadvantaged ◽  
Mentally Disabled ◽  
The Common ◽  
Protection Of Human Subjects

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

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).

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