Minister as being publicly solicited, contributing to the promotion ofeducation or science, and assuredly going to urgent causes (Designated donations) 2.
Assets provided to corporations established under Civil Law Article 34 for the purpose of scientific research are exempted from the real property acquisition tax, fixed property tax, special land holding tax, and city planning tax, subject to their direct use in that research. The chassiss we are using are E.coli BL21 gold strain which are in risk group 1, Our lab has a bio-safety rating of 2. For safety in the Labs we have undergone compulsory health and safety training run by the Faulty of Biological Sciences. This form is designed to encourage the contemplation and assessment of all ethical issues involved within your iGEM project.
Bioterrorism is a relatively new concern that could become a big problem if Synthetic Biology and other Biological Science research is used in the wrong way. The Ethics Assessment Form is based on Safety assessment form which are commonly used everyday in workplaces and labs. This publication was made possible by grant number 5 U01 ES02617-15 from the National Institute of Environmental Health Sciences, National Institutes of Health, USA, and by financial support from the European Commission. The first Environmental Health Criteria (EHC) monograph, on mercury, was published in 1976 and since that time an ever-increasing number of assessments of chemicals and of physical effects have been produced.
The recommendations of the 1992 UN Conference on Environment and Development and the subsequent establishment of the Intergovernmental Forum on Chemical Safety with the priorities for action in the six programme areas of Chapter 19, Agenda 21, all lend further weight to the need for EHC assessments of the risks of chemicals. In the evaluation of human health risks, sound human data, whenever available, are preferred to animal data. The EHC monographs are intended to assist national and international authorities in making risk assessments and subsequent risk management decisions. Since the inception of the EHC Programme, the IPCS has organized meetings of scientists to establish lists of priority chemicals for subsequent evaluation. The draft document, when received by the RO, may require an initial review by a small panel of experts to determine its scientific quality and objectivity.
The Task Group members serve as individual scientists, not as representatives of any organization, government or industry.
All individuals who as authors, consultants or advisers participate in the preparation of the EHC monograph must, in addition to serving in their personal capacity as scientists, inform the RO if at any time a conflict of interest, whether actual or potential, could be perceived in their work.
When the Task Group has completed its review and the RO is satisfied as to the scientific correctness and completeness of the document, it then goes for language editing, reference checking and preparation of camera-ready copy. A WHO Task Group on Environmental Health Criteria for Biomarkers in Risk Assessment: Validity and Validation met at TNO BIBRA International, Carshalton, Surrey, United Kingdom from 3 to 6 April 2000.
The aim of risk assessments is to provide society with estimates of the likelihood of illnesses and injury as a consequence of exposure to various hazards. When used in risk assessment, information from biological markers may replace default assumptions when specific information regarding exposure, absorption and toxicokinetics is unavailable or limited (Table 3) (Ponce et al., 1998). Goldstein (1996) has identified two important impediments to the development of biomarkers of value to risk assessment.
The concepts and principles supporting the use of biomarkers in the assessment of human health risks from exposure to chemicals have been reviewed by the International Programme on Chemical Safety (IPCS, 1993). The widely accepted risk assessment paradigm includes the steps of hazard identification, dose-response assessment, exposure assessment and risk characterization (Fig.
Quantitative estimation of health risks is dependent on both exposure characterization and the nature of the dose-response relationships or toxicity of the agents involved. Historically, hazard identification has been the driving force in risk assessment (McClellan, 1999). The basic rationale for using exposure biomarkers is that they could provide, in some cases, a more accurate method for assessing exposure and, ultimately, risk (Fig. The value of biological markers in epidemiological studies that will be useful in the hazard identification step of risk assessment depends on the quality of the design and analysis of the studies.
One of the most controversial aspects of risk assessment is the extrapolation of higher-level exposure data to lower levels of exposure (Goldstein, 1996). Exposure assessment has generally been considered the weak link in hazard evaluation and risk assessment (Dary et al., 1996). There are numerous sources of measurement error in biomarkers; some of these are shown in Table 5. The lack of validation of most biomarkers of intermediate effect is probably the most critical impediment to the broad use of biomarkers in risk assessment. Perhaps the greatest potential contributions of biomarkers to risk assessment and risk management will be the inclusion of inherited susceptibility biomarkers.
One of the most widely known examples of how susceptibility biomarkers combined with an exposure measure can inform risk assessment is the metabolic polymorphism for N-acetyltransferase in the case of bladder cancer. The assessment of gene-environment interaction is important in the validation of biomarkers of susceptibility (and exposure). A parallelogram type approach (Sobels, 1993; Sutter, 1995) can be used to assess the relationship between markers and risks in those groups (Fig.
Recent developments in information technology, molecular biology and instrumentation have provided new tools for use in environmental health research and biologically based risk assessment. Introduction of new and validated methods based upon new technologies to study biomarkers of exposure, effect and susceptibility at the different levels of the risk management process will be of great assistance to risk assessors. Advances in biologically based pharmacokinetic modelling and simulations and new approaches for addressing uncertainty will be a major way for incorporating biomarkers into rich assessments. The Task Group, building on previous categorizations and evaluations of biomarkers for research, considered them for risk assessment.
A framework for selecting and validating biomarkers for risk assessment was developed by the Task Group. There have been few instances where validated biomarkers have been used in quantitative risk assessments.
Validation of biomarkers for research and risk assessment requires both laboratory and epidemiological studies.
Its primary goal is to provide universal and integrated access to scientific journals in the health science area within Ibero-american countries. To do this we undertook some research and discovered that Synthetic biologists have already taken a proactive attitude by collaborating with social scientists and engaging with the public from the outset to help further the publics understanding and help diminish controversy.


During this presentation we will be undertaking an exercise in order to make the pupils understand the importance of considering ethics in the world of science and it will hopefully give us more of an idea of what the public think about synthetic biology and what ethical concerns they have around the subject area.
Remember to review this assessment at least annually and more often if there is a material change to the work which may affect this risk assessment.
Your biodevice has to be tested in some way, but what experiments could you do that don’t involve testing on animals or humans.
These sections are; Economical Implications, Legal Implications, Bioterrorism Risks, Accidental Release, Testing and Damage to the Environment. The overall objectives of the IPCS are to establish the scientific basis for assessment of the risk to human health and the environment from exposure to chemicals, through international peer-review processes, as a prerequisite for the promotion of chemical safety, and to provide technical assistance in strengthening national capacities for the sound management of chemicals. They represent a thorough evaluation of risks and are not, in any sense, recommendations for regulation or standard setting.
Their function is to evaluate the accuracy, significance and relevance of the information in the document and to assess the health and environmental risks from exposure to the chemical. Risk assessments are needed when social policy decisions are in dispute, when the health consequences of alternative policies in question are not subject to direct measurement (at least in a timely fashion), and when the scientific analysis of a hazard is not complete (Hattis & Silver, 1993). The greatest uncertainties in risk assessment almost always arise from sparse or inadequate exposure data, inadequate understanding of mechanisms of toxicity, and insufficient understanding of the exposure-dose-response pathway (Becking, 1995; McClellan, 1995). For example, consideration of exposure will occur in two places in the risk assessment model.
In risk assessment the ascertainment of a dose-response relationship is crucial for ultimately determining the shape of the dose-response curve and for predicting a no-observed- adverse-effect level (NOAEL).
The exposure assessment component of risk assessment includes consideration of such issues as representativeness of exposure measurements for a population, differences in exposures within and between individuals, individual differences in uptake and biotransformation, identification of factors that control or modify exposures, exposure estimation methods applicable in the absence of direct measurements, and identification of the most relevant dose metric (the most relevant measure of dose) for the agent under consideration (Schulte & Waters, 1999). Once validated, these markers can serve as surrogates for disease, albeit with some probability functions since generally not all people with a given biomarker will develop the disease, but the groups with the high levels generally will be at greatest risk. Positive predictive value, the risk of disease among persons with a specific marker is important from the point of view of the individual. However, while there has been extensive use of susceptibility biomarkers in the development of pharmaceuticals (Evans & Relling, 1999), the potential contribution to risk assessment in occupational or environmental chemical exposure has rarely been realized. Gene-environment interaction is defined as "a different effect of an environmental exposure on disease risk in persons with different genotypes," or alternatively, "a different effect of genotype on disease risk in persons with different environmental exposures" (Ottman, 1996). Examples were cited of how the three types of biomarkers, of exposure, of effect and of susceptibility, could be validated for research and be used in risk assessments. Future work should include scientific, technical, organizational and administrative efforts to coordinate efforts to set an agenda for research on biomarkers that will contribute to conducting important risk assessments. However, biomarkers should be viewed as another set of tools available for researchers and risk assessors, not as a replacement for traditional approaches. All the members of the team have undergone health and safety training before working in the labs and this was given by a member of the faculty of biological science health and safety team. We hope that our biobricks are safe and don’t impose any risk to the environment or the public but as we go along with our work we will be sure to keep assessing the risks involved with our biobricks and synthetic biology in general to make sure that our work is as safe as possible!
For every new Chemical or reagent used we will follow the risk assessments put in place, and the COSHH assessments.
The concept of this is similar to a risk assessment form and adopts a pseudo-quantitative analytical approach.
This is done by using a score table where the severity of the ethical consideration and the risk of the ethical consideration in question are rated on a scale of 1-5 and then the ratings multiplied to get a final score of the severity of the ethical consideration.
A designated staff member of IPCS, responsible for the scientific quality of the document, serves as Responsible Officer (RO). The contact points, usually designated by governments, may be Participating Institutions, IPCS Focal Points, or individual scientists known for their particular expertise. Hayashi of the IPCS Central Unit were responsible for the overall scientific content of the monograph and Dr P.G. If biomarkers are to contribute to environmental and occupational health risk assessments, they have to be relevant and valid. Lessons can be learned from the cardiovascular field that can be applied to the environmental health field; notably that the validation of markers for risk assessment can take a long time and is generally expensive. They investigated how changing glutathione-S-transferase theta (GSTT1) genotype frequencies would impact cancer risk estimates from dichloromethane by the application of Monte-Carlo simulation methods in combination with physiologically based pharmacokinetic (PBPK) models.
It has also issued monographs on the methodology for the assessment of human health risks in a wider context, which includes the use of biomarkers (IPCS, 1994, 1999).
Using biomarkers to gauge exposure may contribute in various steps of the risk assessment process. These predicted measures of internal (biologically-effective) dose can then be used in dose-response modelling, in lieu of the external exposure measures, to predict disease risk.
This would be particularly true for biomarkers of effect, if the human biomarker data came from the population that was at risk, or one with similar exposures. Measurements of biological markers are the building blocks of research and mechanistically based risk assessment. A good example comes from a recent prospective study on the association between cytogenetic biomarkers and cancer risk (Hagmar et al., 1998).
This may be assessed by calculating the attributable proportion which has also been referred to in the literature as "population attributable risk" or "etiologic fraction" (Benichou, 1991; Trock, 1995). However, in a Chinese study the NAT genotype did not influence the risk of bladder cancer, but in this situation the exposure was to benzidine. Ottman (1996) has described five biologically plausible models of gene-environment interaction, each of which leads to a different set of predictions about disease risk in individuals classified by the presence or absence of a high-risk genotype or environmental exposure. It provides society with estimates of risk when uncertainty exists about the safety of prevailing or future levels of exposure to environmental and occupational toxicants. This will require long-term commitments for collaboration and the conduct of prospective studies to link biomarkers to disease risks. The main assessment component is in tabular form, below are instructions for completing these tables with each column explained. For risk assessments to be useful they should lead to projections that are close to the true risks.
The term quantitative risk assessment (QRA) has been used to describe the response associated with a specific level of exposure (Bailer & Dankovic, 1997).


In the validation efforts, laboratory scientists and epidemiologists, clinicians, exposure assessors and statisticians need to be involved.
They reported that average and median risk estimates were 23% to 30% higher when GSTT1 polymorphism was not included in the models.
This is distinct from the exposure assessment stage of risk assessment, where the extent of exposure of the population (whose risk is being characterized) to the identified hazard is determined.
The use of quantified direct measurements of personal exposures can lower uncertainty in the risk assessment process considerably compared to the use of such exposure surrogates (Schulte & Waters, 1999).
If the measurements are inaccurate, the research and risk assessments are likely also to be biased. This study, which followed five European cohorts has shown that subjects in the group with the highest frequency of chromosomal aberrations experienced an overall cancer risk more than double with respect to the lowest frequency group. These biomarkers have both promises and perils for individual and population risk estimation. The Inform section is for showing how you will ensure the public that there implications of the project are nothing to worry about; this is an important section as the public play a huge role in ethics within Synthetic Biology and scientific research in general. A strong scientific basis for conducting risk assessments is the best way to assure that projections are close to true risks or at least provide an honest depiction of the state of knowledge and the degree of certainty about risks (Bailar & Bailer, 1999). The use of relevant biomarkers allows decision-makers to answer important public health questions by being used in research or risk assessments in a way that contributes useful information that cannot be obtained better by other approaches, such as questionnaires, environmental measurements or record reviews. The second is that ethical review boards may find it difficult to sanction research where participants are exposed in a scientific study to levels they are exposed to in the general environment or at work because the participation in the study is voluntary while the latter is generally involuntary. The demand on environmental epidemiology to evaluate increasingly subtle health risks requires more accurate estimation of the quantity and timing of a toxicant reaching target tissue (Kriebel, 1994).
Biomarkers may serve to evaluate the completeness of exposure assessment information by associating environmental or source information, exposure measurements, and epidemiological and human activity data with internal dose (Dary et al., 1996).
To the laboratory scientist, validity often refers to the nature of the biomarker and the characteristic of the assay for the biomarker. These criteria allow for the assessment of whether a biomarker represents an event that is in a continuum between exposure and resultant disease, and whether the biological specimen containing the biomarkers is appropriate and the marker reflects the time period of concern. In the same study, no association was observed between sister chromatid exchange (SCE) frequency and cancer risk, whereas inconclusive results were found for the micronucleus assay. The promise is for a more refined assessment of risk through the identification of gene-gene and gene-environment interactions and also for the focusing of prevention and control programmes on high-risk individuals. The validity of a biomarker is a function of intrinsic qualities of the biomarker and characteristics of the analytic procedures (Dor et al., 1999) (see Tables 1 and 2 for an example of this distinction). Then, in the exposure assessment stage, the extent of exposure is highly dependent on the agent and environment and builds on the specific source-path-receiver model utilized during hazard identification. Kriebel (1994) described a two-stage approach to derive estimates of dose from exposure data and then linked them to epidemiological models estimating disease risk.
Thus, the sensitivity of the assay to detect a signal at a given concentration, and the ability of the signal to be specific for a particular event are indications of validity to the laboratory scientist. This type of study provides estimates of the risk of disease of individuals with and without a particular biomarker. The perils include ethical and social issues including stigmatization, discrimination and the misconception that removing a susceptible person from the exposure scenario without reducing exposure opportunities will reduce risk effectively, when it may not, on a comparative basis (Vineis & Schulte, 1995).
Therefore, accounting for genetic variability may have important implications for risk assessment (Dickey et al., 1997).
Modest exposure assessment errors may produce a biased estimate of the interaction parameter that results in a substantial increase in sample size requirements (Garcia-Closas et al., 1998). For example, adduct measurements of some alkylating agents may be used to indicate disease risks at levels too low to be detected by epidemiological means (Ehrenberg et al., 1996).
Unpublished data are used only when relevant published data are absent or when they are pivotal to the risk assessment. The source-path-receiver model is the common approach to link source chemicals, the pathway of movement in the environment, and the route(s) of exposure of various receptors, in the case of risk assessment, individuals or groups of individuals (Nelson, 1997). Additionally in the dose-response stage of risk assessment, the objective is to ascertain if there is a dose-response relationship in all the available data, identifying the shape of the curve and projecting to exposure or dose level, where health effects are reduced or believed absent. In the parallelogram experimental approach to knowledge of mechanism, in vitro data are used to test the hypothesis that a specific mechanism of action exists in rodents and humans (Sutter, 1995).
Thus, the ability to measure a biomarker after exposure to a toxicant may not be as important a question as whether individuals with exposure to the toxicant are at increased risk of disease. Critical issues in exposure assessment include characterization of the magnitude, frequency and duration of exposure, the basis for the assessment and the identification of highly exposed subgroups. Finally, the concept of susceptibility can be in action throughout the risk assessment model. The risk characterization step requires consideration of any assumptions and models used, and attendant uncertainties used in developing the risk estimates. These will allow for "compressed" evaluations of a biomarker and disease risk at the same time. These estimates are then the basis for options to be selected in the risk management stage (Schulte & Waters, 1999).
Finally, in the risk characterization stage, different risk projections could be determined for various population subgroups identified by susceptibility factors.
The use of invalid biomarkers can lead to invalid inferences and generalizations and ultimately to erroneous risk assessments.
While the impact of measurement error on exposure-disease associations has been studied extensively, the impact on estimates of interaction of two or more risk factors has been studied less thoroughly (Greenland, 1993). Assessment of interaction of multiple exposures, gene-environment or gene-gene is an important issue in environmental epidemiology and all the more important with biomarkers depicting mechanistic events.



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