Legal authority

Standard The maximum level of an air contaminant allowed in workplace or external air as defined by a legal authority, Or any national or international standard relating to a product or code of practice. 

Legal support involves granting legal authority to organizational and other bodies to perform stated regulatory functions as well as the authority to impose sanctions when violations occur. 

Existing legal authorities are inadequate and new legal authorizations are required. Those authorities included in the President s February 71 report were ... 

Upon receipt of a PMN, EPA has little direct recourse for requiring a company to develop and otherwise provide more production and use information. Section 5(e) is EPA s major legal authority for obtaining additional information, and that section focuses upon health and environmental effects data, rather than exposure information. 

The FDA has the legal authority to regulate clinical investigations in the United States when the investigational products move across state or national boundaries. Under the FDA regulations, review and approval by an IRB is required for any experiment that involves a test article and one or more human subjects, either patients or healthy persons, and that is subject to the requirements for prior submission to the FDA (21 CFR 50.3). Such review is also required for any experiment the results of which are intended to be submitted later to, or held for inspection by the FDA. 

Informed consent will be sought from each prospective subject or the subject s legally authorized representative. 

Governing Board The group in which legal authority is vested for the control of health-related institutions and organizations. [NIH]... 

Informed consent will be obtained from each prospective participant or the participant s legally authorized representative and will be documented in accordance with IRB, FDA, and ICH informed consent regulations and guidelines. Adequate provisions are made for monitoring the data collected to ensure the safety of participants. 

For over 20 years two improvised explosives containing the peroxide group have been of constant concern to legal authorities. Both triacetonetriperoxide (TATP) (2) and hexamethylenetriperoxide diamine (HMTD) (3) are easily prepared from readily available starting materials. Both compounds have been encountered for the first time by the Israel Police in the late 1970s and early 1980s [60], but... 

US Department of Justice, Legal Authorities Supporting The Activities of the National Security Agency Described by the President, 19 January 2006. 

Patients with Cluster A disorders may go unnoticed for years until some crisis leads to the need for acute psychiatric treatment. By contrast. Cluster B patients more often come with an extensive history dating back to childhood of encounters with mental health professionals, school counselors, and legal authorities. However, like other personality-disordered patients. Cluster B patients typically present for treatment when in crisis. 

For decades, FDA has worked with product manufacturers to request, and to help carry out, the recall of illegal products from the market. Courts have disagreed on whether the FD C Act authorises an injimction that includes a requirement for product recall. As a practical matter, however, the precise legal authority of FDA on this matter is irrelevant. Manufacturers routinely cooperate with FDA on the recall of any dangerous product. FDA has established detailed administrative policy governing recall procedures. ... 

When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 

Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. 

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