Foreseeable risks

The rights, safety, and well-being of the trial subjects should prevail over the interests of science or society Prior assessment should indicate that the anticipated benefits would outweigh any foreseeable risks or inconveniences The medical care given to, and medical decisions made on behalf of subjects should always be the responsibility of qualified medical personnel... 

CONFINED SPACE A spacc which is substantially, although not always entirely, enclosed and where there is a reasonably foreseeable risk of serious injury from hazardous substances or conditions within the space or nearby. The risks may include flammable substances oxygen deficiency or enrichment toxic gases, fume or vapour ingress or presence of liquids free-flowing solids presence of excessive heat. For the purpose of the Confined Spaces Regulations 1997 a confined space means any place, including any chamber, tank, vat, silo, pit, trench, pipe, sewer, flue, well or other similar space in which, by virtue of its enclosed nature, there arises a reasonably foreseeable specified risk. 

Article 6(1) states that each PMN must include a "technical dossier which supplies "the information necessary for evaluating the foreseeable risk, whether immediate or delayed, which the substance may entail for man and the environment." This includes the... 

A description of any reasonably foreseeable risks or discomforts to the subjects. 

To ensure that the rights and welfare of human research participants are protected, the IRB takes on the task of performing a risk vs. benefit analysis. Before a clinical trial can be initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the trial participant and for society (Section 22.2). Risks associated with participation in research should be justified by the anticipated benefits only then, can the trial be initiated. Because this requirement is clearly stated in the federal regulations, it is, therefore, one of the major responsibilities of fhe IRB to assess fhe risks and benefits associated with proposed research. Definitions of fhe terms fhaf fhe IRB uses to assess risk include the following ... 

The approximate number of participants involved in the trial and the participant s responsibilities A description of any reasonably foreseeable risks or discomforts to the participant A description of any benefits to the participant or to others that may reasonably be expected from the research when there is no intended clinical benefit to the participant, the participant should be made aware of this fact... 

Clearly, there is an ethical question as to whether the foreseeable risks and inconveniences to a study subject or patient participating in a clinical trial are outweighed by the anticipated benefits to that patient. Even more critical is the question of whether the risks being undertaken by the healthy volunteer are considered acceptable when the volunteer will not benefit medically. 

Reasoning. This is the ability of the individual to balance risks and benefits and to foresee risks and anticipated benefits. 

Identification and assessment of risk. When a reasonably foreseeable risk is identified, the responsible individual should appoint a person to take managerial responsibility and to provide supervision for the implementation of precautions. 

Project portfolio management besides the obvious prioritization by value, it is necessary to have a clear understanding of foreseeable risks and available capabilities as well as the fit with the application roadmap ... 

Often an effective way of reducing risk is by substituting hazardous chemicals with more harmless ones. To enable substitution, the users of chemicals and products further down the supply chain need to have appropriate and sufficient information on the technical and hazardous properties associated with the chemicals they purchase. Such information is necessary in order to assess potential risks at the point of intended use and to compare different alternatives from a risk reducing perspective. Therefore, suppliers of chemicals, especially manufacturers and importers, need to identify and assess all of the hazardous properties and foreseeable risks - to human health, to the environment and to property due to fire or explosion - in order to be able ... 

To establish a product liability claim, it must be shown that the product is defective. This term was redefined (in 1998) as follows A product is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe. See the Restatement (Third) of Torts. Products Liability, issued by the American Law Institute. 

A description of the scope and aims of the research, and whether or not there may be benefits to patients exposed to the test medications. The foreseeable risks and discomforts should also be disclosed. The possibility of placebo treatment and the probability of being treated with each test therapy should be stated. 

Foreseeable risks, discomforts, side effects and inconveniences Known therapeutic benefits, if any. The benefits must not be oversold ... 

Before the trial is started, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. [However, the Declaration has a central tenet that civilians must not be subjected to undue clinical hazards, without any potential for benefit themselves, but in order to benefit society at large.]... 

Member States must legislate to protect from abuse individuals who are incapable of giving informed consent. Thus, a CT may be only undertaken if in particular the foreseeable risks and inconveniences have been weighed against anticipated benefit for individual trial subjects. The CT may only proceed if the IEC and/or the CA conclude that anticipated therapeutic and public health benefits justify the risks and continue only if compliance with this requirement is permanently monitored. 

Based on these findings, EPA scientists were then able to conclude that the proposed small scale applications of INA-bacteria would pose no foreseeable risks to humans or the... 

Freely given informed consent should be obtained from every subject prior to clinical trial participation. Informed consent of a subject includes informing the subject that the trial involves research, their participation is voluntary, and they may refuse to participate or withdraw at any time without penalty or loss of benefits. The subject is also informed of the purpose of the trial and the probability of being assigned to each treatment in the trial, the trial procedures to be followed, and the subject s responsibilities in the trial. The subject is informed of any reasonably foreseeable risks and potential benefits of the study and any alternative courses of treatment other than participation in the study. 

The jury could have determined that the physical aspects of this label were not inadequate in light of the foreseeable risk of injury, and that if a larger, more conspicuous label was attached, it would have been seen, read and heeded. 

Agency scientists use this information to construct a risk scenario appropriate to the particular microorganism. If the proposed field test poses no foreseeable risks and no additional data are needed, then no EUP is needed before the field test. If significant risk questions or the need for additional data or monitoritg is... 

Foreseeable risks are the unwanted situations that may be expected but can be averted by taking the right countermeasures beforehand. 

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