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.

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.

A public health outbreak management framework applied to surges in opioid overdoses

2017 ◽  
Vol 13 (5) ◽  
pp. 273 ◽  
Author(s):  
Kieran Moore, MD, CCFP (EM), FCFP, MPH, DTM&H, FRCPC ◽  
Maximilien Boulet, BSc ◽  
Julia Lew, BSc ◽  
Nicholas Papadomanolakis-Pakis, BSocSc, MPA
Keyword(s):  
Public Health ◽  
The United States ◽  
Opioid Overdose ◽  
Prescription Opioids ◽  
Outbreak Management ◽  
Management Framework ◽  
Public Health Agencies ◽  
The Past ◽  
Health Agencies ◽  
Related Mortality

Objective: Over the past decade, Canada and the United States have been facing an epidemic of harms from prescription opioids. More recently, opioid-naïve individuals have been exposed to illicit opioids through adulterated combination products. This has resulted in sudden surges of opioid-related mortality. A proactive public health solution is needed to prevent further death. We propose examining these surges in opioid overdoses as outbreaks and investigating them in a similar way to an outbreak of an infectious disease. An epidemiologic investigation model for opioid overdose outbreaks, that could be modified by other public health agencies,is discussed.

scholarly journals Field epidemiology training in Europe faces a bright future

2001 ◽  
Vol 6 (3) ◽  
pp. 33-34
Author(s):  
Arthur L. Reingold
Keyword(s):  
Public Health ◽  
50Th Anniversary ◽  
Local Public Health ◽  
Public Health Agencies ◽  
Field Epidemiology ◽  
Epidemic Intelligence ◽  
Health Agencies ◽  
Control And Prevention ◽  
Training Programmes ◽  
Intelligence Service

It is fitting that the group of articles describing various field epidemiology training programmes published here should appear in 2001, the 50th anniversary of the Epidemic Intelligence Service (EIS) of the Centers for Disease Control and Prevention (CDC). Were he still alive today, Alex Langmuir (founder of EIS) would be delighted to see how well established and successful such training programmes have become in Europe. Similar ‘on-the-job’ training programmes intended to provide health professionals with the practical skills needed to conduct relevant and timely applied epidemiological investigations in the ‘real world’ of public health are also burgeoning in Latin America, Asia, and Africa. Some of these training programmes are being developed and offered jointly with local academic institutions, others involve formal partnerships with CDC itself, and some are stand alone efforts of local public health agencies.

The African Union Makes Its Mark in the Pandemic

2021 ◽  
Vol 120 (826) ◽  
pp. 172-177
Author(s):  
Thomas Kwasi Tieku
Keyword(s):  
Public Health ◽  
South African ◽  
African Union ◽  
Public Health Agencies ◽  
Global Challenges ◽  
Collective Response ◽  
Health Agencies ◽  
Pan Africanism ◽  
National Public Health ◽  
Control And Prevention

A new spirit of pan-Africanism guided the continent’s response to the pandemic. Led by South African President Cyril Ramaphosa, the African Union provided multilateral coordination and worked with external partners to obtain support, while the Africa Centres for Disease Control and Prevention organized the pandemic responses of national public health agencies. The pandemic showed the risks of continued reliance on foreign donors for resources such as vaccines, but the collective response demonstrated that the AU has become a strong institution capable of addressing regional and global challenges.

The Swine Flu of 1976

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Disease Control ◽  
Influenza A ◽  
Swine Influenza ◽  
Neurological Complications ◽  
Health Problems ◽  
Swine Flu ◽  
Public Health Agencies ◽  
Health Agencies ◽  
Control And Prevention

Early in 1976, the Centers for Disease Control and Prevention proposed and President Gerald Ford approved a plan to vaccinate the country against swine influenza, a new infection that had only recently appeared on a New Jersey army base. While agency leaders imagined themselves rising to the challenge of a crisis, mismanagement and poor communication led to a debacle for public health. Problems included logistical difficulties in manufacturing the vaccine, disputes with Congress, and the inability to revise the vaccination goal in light of the fact that the disease never returned. When people who were vaccinated fell ill with neurological complications, the vaccine effort ended, but not before causing grave damage to confidence in public health agencies.

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.

A Review of Sentinel Laboratory Performance: Identification and Notification of Bioterrorism Agents

2010 ◽  
Vol 134 (10) ◽  
pp. 1490-1503
Author(s):  
Elizabeth A. Wagar ◽  
Michael J. Mitchell ◽  
Karen C. Carroll ◽  
Kathleen G. Beavis ◽  
Cathy Anne Petti ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
The United States ◽  
Time Interval ◽  
Reference Laboratory ◽  
Tularensis Subsp ◽  
Public Health Agencies ◽  
Response Network ◽  
Health Agencies ◽  
Control And Prevention

Abstract Context.—The anthrax incident of 2001 in the United States prompted the College of American Pathologists (CAP), the Association of Public Health Laboratories, and the Centers for Disease Control and Prevention to develop exercises for Laboratory Response Network (LRN) sentinel laboratories. Objective.—To provide an overview of the results of the CAP bioterrorism Laboratory Preparedness Survey (LPS, 2007) and Laboratory Preparedness Exercise (LPX, 2008) and assist LRN sentinel laboratories and public health agencies in planning for bioterrorism events. Design.—Bioterrorism agents and nonbiothreat mimic organisms were provided in 2 mailings per year (2007 and 2008, 20 total challenges). Within each mailing, 2 to 3 agents were category A or category B bioterrorism agents (total of 10 categoric challenges). Some category A/B isolates were modified/vaccine strains. The total number of laboratories participating in these exercises ranged from 1316 to 1381. Isolate characteristics used to identify the organisms were compiled along with the participants' reporting actions. Educational commentary was provided with each exercise. Results.—Acceptable identification responses were as follows: Bacillus anthracis, 90% (2007) and 99.9% (2008); Yersinia pestis, 83.8% (2007) and 87.6% (2008); and Francisella tularensis subsp Holarctica, 86.6% (2007) and 91.6% (2008). The time interval between specimen receipt and notification of results to an LRN reference laboratory decreased from more than 10 days in 2007 to 3 or 4 days in 2008 for some challenges. Conclusions.—The bioterrorism challenge program (LPS, LPX) provides important comparative data from more than 1300 sentinel laboratories that can be used by individual laboratories to evaluate their identification and LRN reporting performance.

scholarly journals Collecting COVID-19: Documenting the CDC Response

Collections ◽  
2020 ◽  
pp. 155019062098041
Author(s):  
Heather E. Rodriguez
Keyword(s):  
Public Health ◽  
Disease Burden ◽  
Social Aspects ◽  
The Political ◽  
Minority Communities ◽  
Public Health Agencies ◽  
Health Agencies ◽  
Control And Prevention ◽  
Work Done

The COVID-19 pandemic has fundamentally altered perceptions of the role of public health in our lives. In the U.S., the activities of federal and state public health agencies have dominated national conversations. Whether discussing testing, debating the use of cloth face coverings in public, or examining the work done to alleviate disease burden among minority communities, the Centers for Disease Control and Prevention (CDC) sits at the center of these debates. In March 2020, the David J. Sencer CDC Museum assembled a team of archivists and curators to collect material to document CDC’s response. Since the beginning of the pandemic, CDC’s response has been entangled in the political and social aspects of the pandemic. To reflect this, the CDC Museums’ COVID-19 Collection Project team has addressed which artifacts would be considered, opening the collection to include materials that reflect the dynamic social environment in which CDC operates.

Sign in / Sign up

Export Citation Format

Share Document