Improved protection for human research subjects.
Explore the source record for details and available documents.
Advisory Committees↗
SEARCH · PubMed Health
Results for “Office for Protection from Research Risks”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Time for new rules on human subjects research?
Explore the source record for details and available documents.
Clinical Trials as Topic↗
Research on risk assessment and risk management: future directions.
This paper has been reviewed by the Office of Health and Environmental Assessment, U.S. Environmental Protection Agency, and approved for publication. Approval does not signify that the contents necessarily reflect the views and policies of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use. The U.S. EPA has increasingly relied upon quantitative health risk assessments as the basis for management decisions about public health protection. Full utilization of risk assessment in management applications, however, is limited by uncertainties in the resultant accuracy of the risk estimates. This paper will discuss a research strategy to address the uncertainties in the risk assessment process and describe parallel issues to address in the risk management area. An attendant need for effective communication of complex scientific concepts is also identified.
Dose-Response Relationship, Drug↗
Protecting the privacy of third-party information: recommendations for social and behavioral health researchers.
In psychosocial and health-behavioral research, we often request that research participants provide information on significant individuals in their lives, so-called "third parties". Recently there has been a greater recognition of privacy issues and risks in research pertaining to third parties. Reaction on the part of USA federal regulatory authorities to one study [Amber, D. (2000). Case at vcu bring ethics to forefront. , 14, 1], which attempted to collect survey data about the psychiatric history of respondents' parents, has generated such concern and caution that longstanding practices for the collection of social determinants of health data are being questioned and are at risk of being disallowed by Institutional Review Boards (IRBs). In this paper, we consider third party research rights and risks from the perspective of social and behavioral scientists. Focusing on research about health and quality of life, we first discuss the rationale for research methods that elicit contextual information about family members, friends, co-workers, and other social contacts. Second, we discuss the matter of 'privacy' and its central role in the current third party rights and risks dialogue. Next, we describe ways to effectively manage third-party information, building upon current recommendations by the Office for Human Research Protections (OHRP) and Botkin's [(2001). Protecting the privacy of family members in survey and pedigree research. Journal of the American Medical Association, 285(2), 207-211] treatment of the matter for survey and pedigree research. Lastly, we discuss the implications of applying these data collection and management strategies in social and behavioral research. We assert that these recommendations protect the rights of, and minimize the risks to, third parties without impeding social and behavioral health research.
Behavioral Medicine↗
Third-party rights and risks: a forum on informed consent of persons affected by the study of human subjects--conditions, experiences, and concerns in a Nordic country.
In Denmark, health research using personal information can be conducted only with permission from a regional scientific ethical committee and the national Data Protection Office. There are no rules applying to the rights and risks of third parties. In this article, the implications for third-party rights and risks of the type and level of involvement of the subjects are discussed from a Danish point of view. Particular emphasis is put on the current conditions, experiences, and concerns with regard to use of already registered personal information, which in the Nordic countries offers unique opportunities for large-scale, longitudinal, population-based studies also involving third parties. These opportunities have recently been challenged by a European Community Directive, with which all member states must comply, requiring informed consent on every transaction of personal data, but through a political process, it was possible to obtain a series of amendments allowing the special register-based research to continue. Crucial arguments favoring the amendments were that no damage has been observed so far and that such research has no interest in the individual data, only in the statistical distributions and associations. Finally, the article suggests that the rights and risks of third parties might be considered on the basis of use: third-party information provided by the subject only as a source of such information distinct from use of the information as an integral part of the subjects' information about themselves and their lives.
Denmark↗
Dose-response implications of the University of Alabama study of lymphohematopoietic cancer among workers exposed to 1,3-butadiene and styrene in the synthetic rubber industry.
New quantitative cancer risk estimates for exposure to 1,3-butadiene are presented. These estimates are based on the most recent human epidemiologic data developed by Drs Delzell and Macaluso and their colleagues at the University of Alabama at Birmingham. The implications of Poisson regression analyses of the relative rate for leukemia are explored using their updated dose estimates and lymphohematopoietic cancer data. The Poisson regression model in these analyses has the same form as in the U.S. Environmental Protection Agency (EPA)'s draft risk assessment of 1,3-butadiene [U.S. Environmental Protection Agency, Health Risk Assessment of 1,3-Butadiene - External Review Draft, National Center for Environmental Assessment, Office of Research and Development, 63 Fed. Reg. 7167 (February 12, 1998) Publication NCEA-W-0267, Washington, 1998]. Consistent with the proposed cancer risk assessment guidelines of the EPA and the EPA's draft risk assessment, the exploration includes the maximum likelihood estimate of the 'effective concentration' (EC(01)) corresponding to an extra risk of leukemia of 0.01 (1%) from a lifetime continuous exposure to 1,3-butadiene based on a linear dose-response model and the cumulative 1,3-butadiene dose metric (ppm-years). The incorporation of the most recent exposure estimates results in a 2.5-fold decrease in the estimates of leukemia risks computed by EPA. In addition, three changes proposed by the American Chemistry Council (formerly the Chemical Manufacturers Association) to the EPA's Science Advisory Board (SAB) for EPA's draft risk assessment of 1,3-butadiene are incorporated into the calculation. This results in approximately an additional fivefold decrease in the risk estimates of leukemia. The leukemia cancer risk estimates in the EPA's draft risk assessment of 1,3-butadiene decrease by approximately a factor of 13-fold when the updated epidemiologic data and the alternative numbers proposed by industry to the SAB are both incorporated. Specifically, the maximum likelihood estimate of the EC(01) increases from EPA's 1.2 ppm to 2.8 ppm on the basis of the updated epidemiologic data and increases further to 15.1 ppm when the CMA's proposed changes are also incorporated.
Alabama↗
Convening a 407 panel for research not otherwise approvable: "Precursors to diabetes in Japanese American youth" as a case study.
Subpart D of 45 CFR 46 focuses on research involving children. Section 46.407 addresses research that is not otherwise approvable. The research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to 46.407, such research can be permissible if it is approved by a panel of experts. Prior to 2000, only two 407 panels had been convened, but in 2001, the Office for Human Research Protections received more than 20 protocols for 407 review. The first, entitled "Precursors to Diabetes in Japanese American Youth," serves here as a case study in human subject protections.
Asian↗
Collaboration and importance of federally sponsored Superfund research programs.
Numerous studies have shown that the release of hazardous substances in the environment impact the environment and human health. Communities want to know if they have been exposed, if their health is affected, and how they can protect themselves. For environmental impacts the concerns include how best to clean up and manage the contamination, and protect the environment. The answers to these questions are complex and many times unknown. Three federal agencies conduct Superfund-related research to answer a wide range of questions from identifying contaminants of concern and health risks to determining effective cleanup and prevention strategies. This article discusses the research programs for the Agency for Toxic Substances and Disease Registry, U.S. Environmental Protection Agency (Office of Research and Development), and National Institute of Environmental Health Sciences (Superfund Basic Research Program). The three agencies collaborate on their research programs and research agenda setting activities. This introduction to Superfund-related research provides a foundation and context for the scientific articles in this special edition of the journal. Because of the magnitude of environmental and human health concerns, there is a critical need for additional research to address many challenging questions involving exposures, biological responses, and environmental technologies.
Environmental Pollution↗
Testing the measurement properties of risk assessment instruments in child protective services.
This study examined a population of children alleged to be at risk of abuse and the adult allegedly abusing the child for the purpose of identifying variables that were predictive of the child's risk of being abused. The study population consisted of 72 Brooklyn, New York children and the alleged adult abuser. These cases were investigated in the Child Protective Services office in Bedford-Stuyvesant by 12 workers who volunteered to participate in the research effort. The worker assigned to a case filled out the standard New York City case recording instrument (called the Child Protective Services Review Document, CPSRD for short), the Magura-Moses Child Well-Being Scales, and the Beck and Jones List of Problems and Conditions. In addition, the worker also evaluated the degree of risk of abuse that the child was exposed to from the alleged abuser using a supplemental scale created for this study. Our hypotheses were that variables from each of the instruments would be predictive of the case decision-making by protective service workers regarding the abuse to which a child was exposed, that the data from the Magura-Moses scales would have predictive value for a minority population, and that the data from the CPSRD would reflect unique dimensions of this population. The data from the 72 cases supported each of these hypotheses.
Adaptation, Psychological↗
The role of web-based environmental information in urban planning--the environmental information system for planners.
The Environmental Information System for Planners (EISP) is a proof of concept web-based system designed to support decision making within the UK planning framework by making information on environmental issues more widely accessible. It incorporates relevant outputs from the Natural Environment Research Council (NERC) Urban Regeneration and the Environment (URGENT) research programme and from research directly commissioned by the Office of the Deputy Prime Minister (ODPM). It supports three principal planning functions carried out by local authorities: pre-planning enquiries, development control decisions and strategic planning. Eleven environmental science themes are incorporated: Air quality, Shallow undermining, Landslide susceptibility, Groundwater protection, Flood risk, Drainage, Land contamination, Proximity to landfill, Biodiversity, Natural and Man-made heritage. Decision flow diagrams represent detailed analysis of workflow in each theme, taking account of best practice, regulatory responsibilities and planning guidance. Industry-standard web technologies integrate the flows and provide access to the system via secure web pages. Underpinning the system is an environmental geographical information system (GIS) containing up-to-date data, information and models relevant to each theme. The modular system design allows new legislation and local priorities and datasets to be easily incorporated. Web technology delivers information and research data that have hitherto been difficult for the non-specialist to access and have therefore been under-exploited. The study has demonstrated a successful application of the principles of e-Governance in an area where informed decisions commonly require specialist information. The system, if rolled out nationally, offers potential economic benefits and efficiency savings for both planners and developers.
City Planning↗
Privacy, families, and human subject protections: some lessons from pedigree research.
Studies that involve getting information from people about other people, including pedigree studies, create obligations to those other people. Defining them as "human subjects," however, does not solve the ethical problems and will, in some cases, make important lines of study impractical or even impossible. The more important task is to define what the ethical obligations are and how to ensure that they are carried out. Some heuristics based on the study of families with inherited Alzheimer's disease suggest that consultation with family members and attention to confidentiality should more directly address the ethical problems than try to treat families merely as collections of people with individual rights. The individual-based approach will necessarily fail when different family members differ in their judgments about the risks and benefits of disclosing information, which will, in turn, lead to the most restrictive individual controlling what others in the family can disclose. This solution is unlikely to be supported in practice by families or researchers or to be sanctioned by the courts. The current policy of the federal Office for Human Research Protections, based on an interpretation of the definition "human subject," is incoherent and will need to be changed, preferably through a process that involves broad debate among all stakeholders but most particularly involving members of families being studied.
Alzheimer Disease↗
Children as research subjects: moral disputes, regulatory guidance, and recent court decisions.
The millennium has ushered in a new era of oversight for pediatric research, with renewed moral and legal attention to the upper thresholds of potential harms to which children may be exposed in studies. Watershed events discussed include: First, the deaths of two research subjects, allegedly due to insufficient oversight by the investigators and their institutional review boards. Second, the courts expressed concerns about research policies for incompetent persons or children in two cases, T.D. v. N.Y. and Grimes v. Kennedy Krieger Institute, and reinforcement of the principle that the best interest standard must be used for incompetent persons even in research. Third, the Best Pharmaceutical for Children Act and the Pediatric Rule created incentives as well as uncertainty among Institutional Review Boards and researchers about conducting pediatric studies. Fourth, the Office of Human Research Protection signaled the start of more rigorous oversight with its public rebuke and suspension of a National Institute of Child Health and Human Development pediatric obesity study. Failure to clarify the meaning of the pediatric regulations has sometimes misled generally risk-averse institutions and dedicated investigators about what is permissible.
Biomedical Research↗
Risk assessment for children and other sensitive populations.
Children form a unique subgroup within the population who require special consideration in risk assessment. Children are not little adults. Their tissues and organs grow rapidly, developing and differentiating. These development processes create windows of great vulnerability to environmental toxicants. Furthermore, the exposure patterns of children to environmental chemicals are very different from those of adults. Traditional risk assessment has generally failed to consider the special exposures and the unique susceptibilities of infants and children. Adoption of a new child-centered agenda for research and risk assessment is necessary if disease in children of toxic environmental origin is to be identified, understood, controlled, and prevented. This agenda needs to be multidisciplinary. Specific requirements within the agenda include: (1) exploration and quantification of unique patterns of exposure for children; (2) adoption of new, more sensitive approaches to testing chemicals that can recognize the consequences of exposure during early development; (3) identification, through clinical and epidemiologic studies, of etiologic associations between environmental exposures and pediatric diseases; and (4) elucidation, at the cellular and molecular levels, of the pathogenetic mechanisms of pediatric environmental illness. In the United States, an important start toward adoption of this new agenda has occurred since passage of the Food Quality Protection Act in 1996. A Presidential Executive Order on Children's Health and the Environment has been promulgated. This Order requires all federal agencies to make protecting the health of children against environmental hazards a high priority. A new Office of Children's Health Protection has been established at the U.S. Environmental Protection Agency. Programs in children's environmental health have been created at the Centers for Disease Control and Prevention, the Agency for Toxic Substances and Disease Registry, and the National Institute of Environmental Health Sciences. A national network of eight new Children's Environmental Health Research and Disease Prevention Centers has been formed. These developments will enhance research on previously understudied issues in the environmental health of children and will provide a scientific basis for child-centered risk assessment.
Child↗
[HIV transmission in hospitals and office practice. Protection of patients and medical personnel].
Research has brought full knowledge of the identity of the human immunodeficiency virus (HIV) and its infective pathways. There are not enough diagnostic tools, however, to detect all HIV carriers in the first weeks and months after infection. This fact emphasizes that all patients should be assumed to be infectious for HIV and other bloodborne pathogens. A slight but certainly existent risk for all health-care workers is a reality. Information and recommendations concerning the protection of surgical personnel against acquisition of HIV while performing their duties, and protection of HIV carriers, were published in 1988 by the Union of Swiss Surgical Societies, Practicability and compliance with these infection-control precautions were checked in 1990 after two years' operation with the aid of a questionnaire. 89 valid answers from 110 Swiss hospitals (yielding a response rate of 81%), together with overall experience, allow us to evaluate the recommendations of 1988. We conclude that the risk of HIV infection after occupational exposure to blood and other body fluids, and the potential threat to the HIV carrier, can be minimized to a very high degree by acceptance of the recommended infection-control precautions. This is especially true in surgical units, emergencies and first aid.
Carrier State↗
The case for samples of anonymized records from the 1991 census.
"The census of population represents a rich source of social data. Other countries have released samples of anonymized records from their censuses to the research community for secondary analysis. So far this has not been done in Britain. The areas of research which might be expected to benefit from such microdata are outlined, and support is drawn from considering experience overseas. However, it is essential to protect the confidentiality of the data. The paper therefore considers the risks, both real and perceived, of identification of individuals from census microdata. The conclusion of the paper is that the potential benefits from census microdata are large and that the risks in terms of disclosure are very small. The authors therefore argue that the Office of Population Censuses and Surveys and the General Register Office of Scotland should release samples of anonymized records from the 1991 census for secondary analysis."
Censuses↗
Screening radon risks: a methodology for policymakers.
This paper provides an easy-to-use screening methodology to estimate potential excess lifetime lung cancer risk resulting from indoor radon exposure. The methodology was developed under U.S. EPA Office of Policy, Planning, and Evaluation sponsorship of the agency's Integrated Environmental Management Projects (IEMP) and State/Regional Comparative Risk Projects. These projects help policymakers understand and use scientific data to develop environmental problem-solving strategies. This research presents the risk assessment methodology, discusses its basis, and identifies appropriate applications. The paper also identifies assumptions built into the methodology and qualitatively addresses methodological uncertainties, the direction in which these uncertainties could bias analyses, and their relative importance. The methodology draws from several sources, including risk assessment formulations developed by the U.S. EPA's Office of Radiation Programs, the EPA's Integrated Environmental Management Project (Denver), the International Commission on Radiological Protection, and the National Institute for Occupational Safety and Health. When constructed as a spreadsheet program, the methodology easily facilitates analyses and sensitivity studies (the paper includes several sensitivity study options). The methodology will be most helpful to those who need to make decisions concerning radon testing, public education, and exposure prevention and mitigation programs.
Female↗
Pesticide exposures to children from California's Central Valley: results of a pilot study.
In response to concerns about pesticide use and evidence that contaminants may accumulate in house dust, the California Department of Health Services (DHS) conducted a pilot study of pesticide contamination in rural children's home environments. House dust samples for pesticide analysis were collected from eleven homes, five of which had at least one farmworker (FW) resident. Handwipe samples were collected from one child at each residence (ages 1-3 years). Ten of 33 pesticides tested in house dust were detected. Excluding non-detects, concentrations for diazinon ranged from 0.7-169 ppm in four FW homes and 0.2-2.5 ppm in three non-farmworker (NFW) homes (overall median = 1 ppm), suggesting a difference between FW and NFW homes. Chlorpyrifos ranged from 0.2-33 ppm in three FW homes and < 1 ppm in two NFW homes (overall median < 0.5 ppm). All other pesticides were detected at < 2 ppm at four or fewer homes. The sources of these compounds could not be determined. Co-located samples were considerably different in concentration and loading, indicating intra-household variation. Of nine compounds tested, diazinon and chlorpyrifos were found on the hands of two or three FW children (20-220 ng/hand). Dust ingestion scenarios show child exposures could exceed the United States Environmental Protection Agency Office of Pesticide Program diazinon chronic reference dose (9 x 10(5) mg/kg/day). The results suggested that pesticide residues are present in the home environment of some California children and are likely to contribute to exposures. Additional research is feasible and needed to assess the magnitude and distribution of these risks.
Administration, Oral↗
[Indoor air quality and occupational health, past and present].
The expression "indoor pollution" of residential, office and public buildings appeared for the first time in western societies toward the end of the '60s to indicate a complex phenomenon as important to public health as that of the "outdoor air pollution" or even more so. The demonstration of the toxic effects of passive smoking, radon, and other chemical and biological pollutants present in office and residential environments has prompted a wide spectrum of research into health risks, has led to position-taking by national and international authorities, and has given rise to a new scientific multi-disciplinary field of research, with respective international associations, scientific journals, and international conferences attended by thousands of participants. In Italy, since 1988, several scientific conferences have been organised and these have led to institutional initiatives such as the Commission set up in 1990 by the Italian Environment Ministry and the Commission set up in 1998 by the Italian Ministry of Health. The latter produced a Prevention Plan for Health Protection and Promotion in Indoor Environments which, for the first time, tackles indoor air pollution in a systematic way and provides an overall picture of the health and economic impact of the main illnesses related to indoor pollution on society. Decree 626/94 has also been affected, in some way, by these new scientific findings and in art. 33 has produced an update of the old art. 9 of the Decree 303/56. The attention to the subject of indoor air quality, in addition to that of offices and commercial buildings, has turned in more recent years to special environments such as schools and hospitals, resulting in the production of important publications. The modern frontier of research on indoor and outdoor air hazards is represented by fine air particulate matter. A large number of worldwide epidemiological studies have revealed that the daily variation in fine and ultra-fine particle air concentration in urban areas is associated with the simultaneous daily variation in the morbidity and mortality of the general population. The particle-linked increase in mortality has been attributed to respiratory and cardiovascular toxic effects, but the mechanisms by which urban air particles (indoor and outdoor) induce worsening of respiratory and cardio-vascular diseases are so far unknown and are the subject of intense investigation. Workers employed in the tertiary sector (offices, trade, banking, hospitals, schools, etc.) now account for 80% of the Italian labour force and the occupational physician is increasingly requested to assess the risk and monitor the health status of tertiary sector workers. These working environments are believed to be healthy and lacking in specific health risk factors, but such a belief is often only the result of the limited knowledge that employers, workers and the physicians themselves have about these environments and the results of international research studies over the last forty years. This issue is surely at the centre of the interest of our discipline and of public health throughout the developed western world and represents an ongoing challenge for the occupational physician, with new research topics and new problems to deal with. Recent issues include SARS and the defence of buildings and the air of working environments against terrorism attacks, such as the use of anthrax dust.
Air Pollution, Indoor↗