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Results for “Office for Human Research Protection”

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[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↗

Protecting mental health research subjects without prohibiting progress.

Federal regulations governing the protection of human research subjects fail to specifically address research involving persons with mental illness. In 1990 the New York State Office of Mental Health issued regulations covering such research. The regulations are designed to respect the autonomy of psychiatric patients to make decisions about participation in research while protecting patients whose capacity to consent may be impaired. Patients who lack sufficient capacity may be included in research with the consent of a specified legally authorized surrogate if the facility's institutional review board determines that the research cannot be done without the participation of incapable subjects and it is considered likely to produce knowledge of overriding therapeutic importance for persons with the patients's condition or it has the possibility of directly benefiting the patient. In all cases involving more than minimal risk, the consent of the patient's treatment team must be obtained.

Clinical Trials as Topic↗

Unsolicited narratives from the Internet: a rich source of qualitative data.

Recently, the Internet has become a forum for informal communication. Many--whose voices may have been unheard--can now express themselves through this medium. Rich narratives are available to the qualitative researcher from bulletin boards, guestbooks, Web pages, and listservs on the Internet. In this article, these data sources are defined and described. Strategies for using these data are discussed. One concern with using unsolicited data from the Internet is the protection of human subjects and the requirement for consent. A proposed model describing the process for deciding when such data are publicly available, as defined by the Office for the Protection of Rights of Research Subjects, and when the use of the data requires consent is presented.

Data Collection↗

Of whistleblowers, investigators, and judges.

CONCLUSION: Deliberate misrepresentation continues. Needleman attacks the whistleblowers, the NIH, and his own University to deflect attention from the indications of misconduct in his research. Federal agencies base policies on his research and on his assertions regarding the purported effects of low-level lead exposure on children. The policies divert resources and attention from the real needs of children. Misconduct issues will ultimately be resolved by the ORI and the courts. Public policy issues may require reconsideration in light of further evidence.

Biomedical Research↗

Summary of a workshop on the development of health models and scenarios: strategies for the future.

A workshop was convened in July 2003 by the Global Change Research Program, Office of Research and Development at the U.S. Environmental Protection Agency, to review current strategies for developing human health models and scenarios in the context of global environmental change, particularly global climate change, and to outline a research agenda that effectively characterizes the interplay of global change with the health of human populations. The research agenda developed at the workshop focused on three issues: a) the development of health models, b) the development of health scenarios, and c) the use of health models and health scenarios to inform policy. The agenda identified research gaps as well as barriers to the development and use of models and scenarios. This report summarizes the workshop findings.

Environmental Health↗

New home for OPRR.

Explore the source record for details and available documents.

Federal Government↗