List of approaches to EIA system effectiveness evaluation.
\r\n\tThere are a variety of approaches to reversing biodiversity loss, ranging from economic, to ecological and ethical. The utilitarian approach to conservation, bolstered by the concept of ecosystem services, can be utilized to improve the conservation case by supplementing the burgeoning biodiversity rhetoric. To address this issue, a pluralistic approach to biodiversity is required for conservation and sustainability.
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From there, the concept quickly spread across the world. European countries adopted EIA very early after that. Most developing countries adopted EIA after 1992. For example, although no African country had mandatory EIA procedures prior to 1992, over 40% had established EIA systems by 1997 [1]. After 1992, EIA was rapidly adopted as a national decision-making tool by many countries. This rapid adoption is in most countries was undoubtedly influenced by the Rio Summit.
\nThe Rio Declaration on Environment and Development and the Local Agenda 21 placed EIA firmly as an important concept in environmental management processes.
\nThe EIA system’s primary role is to incorporate environmental issues into decision-making to ensure that new developments include steps to protect the environment and social well-being. EIA is therefore a series of steps that enable environmentally responsible decisions to be made. A logical question that follows is whether EIA systems actually contribute to environmental protection and, if so, how effectively.
\nAlthough the finer details of how EIA is implemented vary from country to country, the basic idea is the same. In this chapter, it is assumed that the reader has reasonable knowledge about the EIA process; therefore, only a brief description is given. It starts with a detailed knowledge of the proposed project. This detailed knowledge informs the possible impacts that may arise from the implementation of the project.
\nStudies are done to determine the environmental baseline on which possible environmental impacts of the proposed project may be benchmarked. The baseline also enables experts to understand details about the potential impacts such as magnitude, type, severity, and so on. The next step is to plan for ways of reducing any negative environmental impacts that would have been identified and analyzed while enhancing any positive impacts, if any. An environmental management plan is put together and married to project implementation. One of the important steps of EIA is the consultation of affected and interested parties (stakeholder consultation) to gain and incorporate their views.
\nThe effectiveness of the EIA process is a growing subject of scholarly research [2, 3]. Governments and private companies commit many resources to implement the EIA process. The major question that remains partly unanswered is whether EIA is achieving environmental protection as expected. From this question arises another question which is the focus of this chapter. How can the effectiveness of an EIA system be measured?
\nThe MRR model is one such a means introduced to evaluate EIA system effectiveness [4]. The purpose of this chapter is to introduce an updated method, rights, and resources (MRR) model for evaluating EIA system effectiveness [4], an alternative conceptual and practical model based on the evaluation theory. The next section describes the research method of this chapter followed by presenting different approaches to evaluating EIA system effectiveness and then discussing the challenges associated with evaluating EIA system effectiveness. After that the theoretical framework of the MRR model is presented followed by the MRR model and its application and finally the conclusion and recommendations.
\nThis chapter sets out to review and improve the MRR model for EIA system evaluation. To do so, the literature review of the current EIA evaluation models was conducted together with the UN conventions on which the MRR model is based. After adding more theoretical context, the description of the MRR model was reviewed to add rigor and flow diagrams.
\nFurther improvement was made by discussing the pros and cons of the MRR model using a SWOT analysis. Further recommendations toward the application of the MRR model were added.\n
Firstly, it is important to set apart EIA review models whose primary purpose is to assess the compliance and content of EIA reports/statements. Examples of these are the Lee and Colley review package [5], the European Commission Guidelines on EIS Review, the Oxford-Brookes University EIS review package, and the Guide to Technical Analysis of Environmental Impact Studies.
\nThis chapter is concerned about evaluating the effectiveness of the entire EIA system. Effectiveness of EIA systems has been researched since EIA systems were introduced. EIA effectiveness evaluation approaches were originally divided into two categories, vis-à-vis the procedural and the substantive effectiveness [6].
\nAdherence to the stipulated method of conducting EIA is the focus of procedural effectiveness. For example, in procedural effectiveness, the focus is on whether EIA studies were conducted thoroughly, whether the public had adequate opportunity to air their views, and whether the views were taken into consideration. Hence procedural effectiveness emphasizes on assessing how well information was gathered and used for decision-making and much less on whether tangible environmental stewardship itself was actually achieved. The actual environmental protection objectives are assumed to be achieved once a certain method is followed in conducting EIA studies and making decisions about it.
\nA typical procedural effectiveness viewpoint is the “democratization of governmental decision-making processes” as suggested by Macintosh [7]. In this case, simply ensuring that affected stakeholders have contributed to the decision-making process would be considered an achievement of its objectives.
\nProcedural EIA system evaluation is the easiest to perform since the focus is on whether specific procedural steps have been complied with. There are many procedural EIA evaluation models that have been developed. Two examples are given below.
\nThe first one is the systemic and foundation measures model which was developed by Ahmad and Wood [8]. Features of EIA (system) “that are designed to deliver quality assurance in both practice and the administration are called systemic measures” [9]. Foundation measures are those “actions undertaken to improve the effectiveness of the EIA system and ensure successful application of the systemic measures” [9].
\nThe other model is the EIA evaluation criteria developed by Wood which consists of 18 questions grouped into 3 categories, namely, institutional aspects of the EIA system, EIA process, and other requirements of the EIA system [10]. The EIA evaluation criteria have been widely used [11, 12].
\nThere are a number of other criteria that have been developed and applied such as the 21 criteria [13], 5 criteria [14], 62 criteria [15], and 80 criteria [16]. All these are primarily procedural effectiveness models (\nTable 1\n).
\nApproach/model | \nEffectiveness evaluation | \nFocus | \n
---|---|---|
\n
| \nProcedural | \nQuality of EIA reports | \n
\n
| \nProcedural | \nPresence of the basic conditions and requirements for EIA system implementation | \n
\n
| \nProcedural | \nDiverse including EIA report quality, conditions, and requirements for EIA system implementation Historical view of EIA system | \n
\n
| \nTransactive | \nMore empirical measure of the effectiveness of EIA systems | \n
List of approaches to EIA system effectiveness evaluation.
Substantive effectiveness focuses on whether EIA systems are actually achieving the tangible outcomes, the ultimate tangible outcome being the protection of the environment and improving social well-being. Without achieving the actual protection of the environment, the EIA process is not adequately effective. Therefore, understanding if EIA systems protect the environment is very important.
\nFor that reason, substantive effectiveness of EIA systems is a better measure of EIA system effectiveness than procedural effectiveness because it addresses the actual environmental protection outcomes of the EIA system. To give an example, we can ask the question: “Has the implementation of the EIA system actually resulted in less pollution, less land degradation, or enhancement of the natural and social environment?”
\nTo answer this question requires the use of some metrics which quantify impacts such as pollution, land degradation, and enhancement of the natural and social environment. Only with quantitative information is it possible to objectively measure impact attributable to EIA systems and, as a result, to assert that substantive effectiveness is present. Quantitative metrics go as far as assigning monetary value to environmental goods, services, and impact, to measure whether the society has actually benefitted from implementing EIA systems.
\nHowever, there are challenges with quantitatively measuring environmental and social impacts and even more challenges with monetizing the same. For example, since any country has implemented its EIA system, how much flora and fauna has been saved, and how much is better off because of it?
\nAt a project level, it may be possible to quantify some of the impacts more objectively. For example, a single project can make a case that the level of pollution in an adjacent river has not increased, measured in terms of concentration of pollutants and compared to the baseline before the project started. However, to cascade this measurement to the EIA system level and involving all possible impacts cannot be easily demonstrated.
\nTherefore, substantive models of EIA system evaluation are much more challenging for two reasons. Firstly, methods of measuring environmental goods and services in order to measure environmental damage avoided through the EIA system are contestable. Secondly, even if there was such a widely accepted method, the attribution gap could be impossible to objectively account for.
\nBesides the procedural and substantive models postulated by Cashmore, two more models of EIA effectiveness have been added vis-a-vis the transactive and the normative [15, 17].
\nTransactive EIA effectiveness is one which focuses on relating the cost of carrying out the EIA process to the relative outcomes/benefits of doing so. Hence transactive EIA effectiveness places emphasis on efficiency of resource use. As noted by Veronez and Montaño [18], not much attention has been paid to transactive EIA effectiveness. However, in this chapter cost-effectiveness analysis and cost-benefit analysis are identified as possible tools to use for transactive EIA effectiveness.
\nCEA can be used to compare two alternative courses of action based on the ration of the cost of the course of action to an indicator of the outcomes. The outcomes are not quantified, but a suitable indicator can be used to quantify the outcomes. Although the author could not locate examples where CEA has been applied in EIA effectiveness, it is conceivable how application can be done. For example, the cost of operating the entire EIA system can be compared to its outcomes such as the number of EIA studies conducted, reviewed, and licensed. Similarly, the efficiency of monitoring EIA implementation in the post-certification stage can also be evaluated.
\nCBA [19] is similar to CEA except that in CBA, the outcomes are expressed in monetary value. For example, the efficiency of the extra costs incurred by businesses as a result of implementing the environmental management plan can be evaluated against the zero option or other options.
\nIt is important to note that the use of CBA in EIA is common but at the EIA study level in the pre-certification phase of EIA [20]. How to use CBA for EIA system effectiveness evaluation is not clear yet and still needs to be developed.
\nThe last and fourth approach to EIA effectiveness (after procedural, substantive, and transactive) also postulated by Loomis and Dziedzic [17] and Veronez and Montaño [18] is the normative approach. In normative effectiveness, the focus is on the broader impacts of EIA on “sustainable development and participatory process” involved. Normative EIA effectiveness takes into account EIA best practices for continuous improvement.
\nAs noted by Veronez and Montaño [18], there is a conceptual basis for bringing together the different EIA effectiveness models into an integrative EIA effectiveness model. The method, rights, and resources model, as described in this chapter, is one such attempt to produce a more integrative model of evaluating EIA effectiveness.
\nThis section discusses the challenges that affect evaluation or measurement of EIA effectiveness.
\nThe first is that, by design, at both policy and project levels, EIA systems lack inherent evaluation mechanisms. Concerns by US citizens over environmental degradation triggered the birth of EIA. As a result, emphasis has always been placed on the processes which support popular participation and decision-making in the pre-certification phase but less in the post-certification phase. Another characteristic of its political origins is that the EIA steps did not include a clear path to evaluate its success. The need to evaluate the effectiveness of EIA systems was almost an afterthought.
\nTherefore, EIA systems usually do not have built-in evaluation mechanisms comparable to inherent evaluation mechanisms of policies planned through the logical framework analysis. Indicators of progress to outputs, outcomes, and impact are used in LFA planning approaches to inculcate evaluation before policy implementation even starts.
\nAs discussed before, the second challenge is about quantifying environmental impact. For EIA to be considered effective, the question of how much of the environment and social well-being an EIA system saves in pertinent quantification of environmental damage and social well-being levels is necessary to ensure objective answers to this question. Empirical baseline using environmental and social well-being indicators enables future measurement of chance. For example, before a mine is set up, ground water quality can be measured as a baseline. Future periodic measurements will then be measured against the baseline to determine if negative or positive impact has been made.
\nHowever, other stakeholders may emphasize on monetary value of the impacts so that they can offset against the cost of implementing the EIA. Unfortunately, there are many models of putting a monetary value to the environment, but they all suffer from the challenge of what is the real value of nature. Hence, this challenge will continue to exist.
\nAttribution gap is another challenge. In all policy interventions such as EIA, the impact of policy is often subject to other policies or forces such that the resultant change, whether negative or positive, cannot be attributed to one intervention. Hence the attribution gap requires accounting for unplanned forces of change and unplanned change itself. Such other forces may include environmental awareness campaigns affecting the attitude of citizens toward environmental issues in general and other policies such as local environmental action plans and waste management plans.
\nThe theoretical framework for the method, rights, and resources model is derived from the outcomes of the Rio Summit of 1992. This may be unusual that a theoretical framework is derived from policy documents, but as will be demonstrated, that makes EIA effectiveness evaluation very practical and relevant.
\nThe MRR model starts by recognizing that the EIA system is enshrined in the outcomes of the Rio Summit and national policy and legal documents. Therefore, the MRR attempts to identify what these documents intended to be the elements of the EIA system and draw from them. Method, rights, and resources are the three elements of the MRR model for EIA system effectiveness evaluation.
\nIn the Rio Declaration on Environment and Development [21], the world governments agreed on 27 principles to guide the world toward sustainable development. Principle 17 states that:
\n“Environmental impact assessment, as a national instrument, shall be undertaken for proposed activities that are likely to have a significant adverse impact on the environment and are subject to a decision of a competent national authority.”
\nPrinciple 15 advanced the precautionary principle stating that:
\n“In order to protect the environment, the precautionary model shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”
\nAfter placing EIA as a tool for environmental decision-making, the necessary elements for implementing sustainable development initiatives were also identified.
\nSection 8.3 (d) of the LA 21 stipulates the need for procedures:
\n“To establish domestically determined procedures to integrate environment and development issues in decision-making.”
\nSection 22 of the LA 21 [22] states the right of affected people to participation in decision-making:
\n“One of the fundamental prerequisites for the achievement of sustainable development is broad public participation in decision-making. … the need of individuals, groups and organizations to participate in environmental impact assessment procedures and to know about and participate in decisions, particularly those which potentially affect the communities in which they live and work.”
\nPrinciple 10 of the Rio Declaration on environment and development also promulgates that “environmental issues are best handled with the participation of all concerned citizens …” and promotes “access to information” and “the opportunity to participate in decision-making processes.”
\nWe can therefore say, by design, compliance (with the method/procedure) is identified as a requirement for implementing EIA systems. The other element is participation (stakeholder’s rights), and the third one is capacity (or resources). It is proposed that EIA systems can be used to evaluate based on these three to gauge whether intended objectives are being achieved. Based on this discussion, we have the three elements as method (M), rights (R), and resources (R), respectively (\nFigure 1\n).
\nMRR model’s theoretical framework.
The figure above shows a schematic representation of the theoretical framework of the MRR model.
\nThis chapter proposes the method, rights, and resources model, which is more flexible and all-encompassing while involving less of subjective assessment of the researcher. This model proposes that the entire EIA system of any country can be broken down into three elements, namely, method, rights, and resources. From this point of view, the MRR model is an integrative model, seeking to bring together procedural, substantive, transactive, and normative issues into EIA effectiveness evaluation.
\nBy nature, evaluation is a process of collecting and analyzing information, with the aim of measuring the difference between the situation and a set standard. Since information collection is involved, decisions must be made about what information to collect and how to analyze it.
\nIn MRR model, the set standard against which effectiveness can be evaluated is derived from the founding principles of the EIA origins as discussed below. On the other hand, what information to collect is guided by indicators specifically chosen for EIA systems.
\nMethod has to do with the procedures or process putting the EIA system into practice. The procedures or process ensures that stakeholder views and environmental issues are taken account of in decision-making. This is the pre-certification phase. Procedures or process also ensures mitigation/enhancement measures stipulated for a project are implemented (post-certification phase). The pre-certification phase is often laid out in the form of step-by-step guidelines (the EIA process). Splitting the EIA process into two (pre- and post-certifications phases) makes it easier to understand.
\nThe main focus of the pre-certification phase is to produce an EIA report which a regulatory authority will use to decide whether a project should be allowed to be implemented or not. The report is produced through a scientific study of environmental and social issues relating to a specific project.
\nThe pre-certification phase process can have the following general steps: screening to eliminate activities which do not need detailed studies followed by scoping the extent of the EIA study, collecting baseline information, stakeholder participation platforms, impact identification analysis, impact analysis (e.g., magnitude, severity, etc.), formulating mitigation/enhancement measures, and formulating the environmental management plan (EMP) and impact monitoring plan (IMP).
\nThe role of the post-certification phase is the implementation of the EMP and IMP within the project activities. Often, reports about the progress of implementation of the EMP and IMP are required to be submitted to the regulatory authority on a regular basis. In this way, the method becomes a reasonable proxy for substantive effectiveness as companies report the achievement of environmental and social protection at that level.
\nGiven the importance of the process in determining the information available to regulatory authorities for decision-making, compliance with the process is a necessity. In fact, the degree of compliance with the process is a measure of the effectiveness of EIA systems including the extent of integration of environmental issues into both decision-making and, if granted permission, the implementation of projects.
\nAn important point to note here is that measurement of environmental and social impacts can be embedded in the method in the post-certification phase, hence giving the opportunity to measure substantive effectiveness, first at project level and by extension at a higher EIA system level. For example, periodic reporting of the success and failure in the implementation of the environmental and impact monitoring plan provides information about the post-certification phase, indicating potential substantive effectiveness of the EIA system.
\nCitizens who are affected by economic and social development have the right to have a say in such activities. The EIA system provides a platform for affected citizens to contribute their views to EIA decision-making. It is therefore essential to measure the effective participation of all stakeholders as this demonstrates the effectiveness of an EIA system. To effectively contribute their views, adequate information and an opportunity to contribute both need to be provided.
\nSome stakeholders participate because of their mandates as organizations. For example, a tourism project that has potential impacts on the river system may require input from the ministry responsible for water even though the ministry responsible for the environment may be responsible for facilitating the EIA system. Environmental associations may also have a say on the mandate given to them by their membership. Hence a wide array of stakeholders may participate in an EIA process where their interests may be at stake.
\nThe participation of all stakeholders can also be measured both in the pre-certification and post-certification phases. In the pre-certification phase, participation is about stakeholders having their views included in decision-making before a project can be implemented. In the post-certification phase, participation is about stakeholders being heard about the environmental and social impacts of the project. Hence a strong post-certification participation is a proxy measure for substantive effectiveness.
\nPolicy implementation requires resources. In fulfilling their roles, the capacity of the EIA system as well as that of the individual stakeholders is dependent on the resources they have. This includes financial, human, institutional, legal, and material resources for the EIA system to function. The LA21 constantly emphasizes on the need for “means of implementation” which imply capacity required to implement the dictates of the declaration.
\nJust as discussed for the method and rights above, resources can also be measured in both pre- and post-certification phases. Similarly, the post-certification measure of the resource capability of each stakeholder is a proxy measure of the substantive effectiveness of the EIA.
\nTherefore, the MRR model is about measuring the level of compliance (with the method), participation (upholding stakeholder rights), and capacity (in the form of each stakeholder’s resources) in the two phases of the EIA system which, together, give the measure of the effectiveness of the EIA system.
\nIn this section, the summarized overview of the MRR model is presented. Development of indicators of effectiveness of the EIA system at all levels is the basis for applying the MRR model. Indicators can be developed based on the three elements presented before, i.e., compliance, participation, and capacity.
\nFurther to that, the indicators must clearly measure the pre- and the post-certification phases separately. The importance of this is that by design, the post-certification phase indicators must be proxies for the actual protection and enhancement of the natural and social environment.
\nThe set of indicators suggested below are categorized according to the three pillars of the EIA system, namely, compliance, participation, and capacity. The author cannot formulate an exhaustive list of indicators. In addition, indicators can be formulated at different levels depending on the focus of the evaluation (e.g., national level or sector level). Similarly, indicators can be developed for each phase of the EIA process, i.e., pre- and post-certification phases.
\nThe indicators individually or collectively measure the effectiveness of the EIA system. The rational further emphasizes that if compliance, participation, and capacity are effective, the objectives of the EIA system are being achieved. The objectives may be procedural, substantive, transactive, or normative.
\nNext, the application of the model indicates the sources of data from where data can be collected to inform the analysis of each indicator. Data can be characterized in several ways including whether it pertains to the pre- or post-certification phase of the EIA system, whether it is secondary, primary, qualitative, quantitative, and so on. The last part of the application suggests methods of data analysis suitable to answer the question about whether a particular indicator is being achieved or not. Emphasis is placed on quantitative analysis.
\nIt is important to note that these indicators are derived from an EIA system with detailed EIA process guidelines. The EIA process guidelines provide the standard against which some of the indicators can be evaluated as shown in the following tables (Tables 2–4).
\nBelow are listed some suggested compliance indicators:
\nData source | \nIndicator explanation | \n
---|---|
Sample of approved EIA report (enumeration) | \nAverage % of steps of the EIA process guideline that are complied with by the EIA studies | \n
Questionnaire survey of EIA practitioners | \nLevel of compliance in general Level of compliance of the pre-certification stage in general Level of compliance of the post-certification stage in general Length of EIA process, from referral/prospectus/scoping to certification Length of approval/review process Integration of the approved environmental management plan and the project’s/business’s environmental management system (if any) | \n
Report of the responsible authority | \n% of EMP monitoring reports submitted to responsible authority compared to overall number of approved projects % projects stalled before certification % projects stalled due to non-compliance after certification % projects approved within prescribed timeframe Length of EIA process, from referral/prospectus/scoping to certification Length of approval/review process | \n
Compliance indicators.
Below are some suggested participation indicators:
\nData source | \nIndicator explanation | \n
---|---|
Sample of approved EIA reports (enumeration) | \nNumber of stakeholders consulted during the EIA study process Stakeholders’ recommendations that are integrated into the EIA report for decision-making Consultation methods used during EIA studies Availability of information/feedback to stakeholders before certification | \n
Report of the responsible authority | \nInvolvement of other government departments in the EIA review stage (collaboration) Involvement of other government departments in impact monitoring (collaboration) Availability of legal complaint systems | \n
Questionnaire survey of EIA practitioners | \nInvolvement of other government departments in the EIA review stage (collaboration) Involvement of other government departments in impact monitoring (collaboration) Availability of information/feedback before certification Availability of information/feedback after certification | \n
EMP monitoring reports | \nAvailability of information/feedback after certification | \n
Participation indicators.
Below are some suggested capacity indicators:
\nData source | \nIndicator explanation | \n
---|---|
Report of the responsible authority | \nCapacity to monitor EMP implementation Capacity to enforce EIA conditions Capacity to review EIA reports Stakeholder capacity to contribute to EIA process Capacity to measure the environmental baseline Capacity to identify and analyze impacts Availability of baseline information Availability of competent experts Capacity to meet EIA study costs Capacity to meet EMP implementation costs Capacity to monitor impacts | \n
Questionnaire survey of proponents and practitioners | \nCapacity to monitor EMP implementation Capacity to enforce EIA conditions Capacity to model impacts Capacity to review EIA reports Stakeholder capacity to contribute to EIA process Capacity to measure the environmental baseline Capacity to identify and analyze impacts Availability of baseline information Availability of competent experts Capacity to meet EIA study costs Capacity to meet EMP implementation costs Capacity to monitor impacts Capacity to produce EIA reports | \n
Sample of EIA reports | \nCapacity to model impacts Capacity to review EIA reports Stakeholder capacity to contribute to EIA process Capacity to measure the environmental baseline Capacity to identify and analyze impacts Availability of baseline information Availability of competent experts Capacity to meet EIA study costs Capacity to produce EIA reports | \n
EMP monitoring reports | \nCapacity to monitor EMP implementation Capacity to enforce EIA conditions Capacity to measure the environmental baseline Capacity to identify and analyze impacts Availability of baseline information Availability of competent experts Capacity to meet EMP implementation costs Capacity to monitor impacts | \n
Capacity indicators.
Data collection follows the scientific research method conventions. There are both primary and secondary sources of data from which to choose from for each indicator. Some of the indicators allow the collection of both secondary and primary data, but some may not. From the tables above, it can be observed that most of the data comes from the EIA reports and questionnaire survey of all stakeholders.
\nSecondary data sources for analyzing the indicators are documents found within the stakeholders such as the government offices, regulatory authorities, proponents, consultants, and any other institution. Reports from the regulatory authority, the EIA reports reviewed by the regulatory authority, and the EMP monitoring reports are the main sources of secondary data. If the regulatory authority produces an annual report, relevant data such as the total annual number of EIA reports approved and rejected can be found. This data is relevant for evaluating the effectiveness of the EIA systems overseen by the regulatory authority.
\nData collection from regulatory authority documents is by reviewing and capturing both qualitative and quantitative data.
\nEIA reports, environmental audit reports, impact monitoring reports, environmental management systems, prospectuses, referrals, project proposals, terms of references, environmental certificates (and conditions), and environmental management plan reviews are other important sources of secondary data. These secondary data sources are mostly found within the regulatory authority but can also be obtained from the proponents implementing approved EIA plans.
\nFrom the EIA reports, data can be collected by reading and enumerating. For example, EIA reports do show how much of the EIA guidelines are complied with during their compilation. Hence the number of the steps of the EIA process that each EIA report complies with can be counted or enumerated. Similarly, one can calculate the number of the different types of consultation methods used which indicates how well the stakeholders participated in the EIA process.
\nStakeholders’ experiences are the main source of primary data. The main stakeholders of the EIA system include the government officials, proponents of projects that have undergone the EIA process, consultants who undertake the EIA studies, the public that is affected by the projects undergoing EIA study, and the regulatory authority responsible for deciding on the EIA acceptance.
\nAny suitable primary data collection method can be used. Questionnaire instruments can be designed to collect data on most if not all the indicators. Interviews, if necessary, can be used to provide in-depth information to explain the results of quantitative analysis.
\nFrom the questionnaires, data can be collected to measure any of the indicators that show compliance, participation, and capacity. Questionnaires can be used to capture stakeholder experiences about the achievement of the procedural, substantive, transactive, and normative objectives of the EIA system. Questionnaires collect information that fills in the gaps in secondary data from the regulatory authority and proponents.
\nThe MRR model places emphasis on quantitative analysis of data since the primary focus of EIA effectiveness evaluation is to benchmark the achieved versus the planned. Below are some suggested statistical tests which can be used to analyze the quantitative data that arise from enumeration and scoring of EIA reports and regulatory authority reports as well as questionnaire data (Tables 5 and 6).
\nStatistical analyses | \nExample | \n
---|---|
\n
| \nFor example, if desired compliance is set at say 70% percent, a test of association can determine whether the compliance level is significantly below, above, or equal to 70% | \n
\n
| \nFor example, projects in the mining sector can be compared to projects in the tourism sector in terms of compliance or participation or capacity indicators | \n
\n
| \nFor example, the pre-certification phase can be compared to the post-certification phase in terms of compliance or participation or capacity indicators | \n
Set an expected benchmark of compliance, participation, or capacity, and compare with the observed/actual compliance, participation, or compliance | \nFor example, if desired capacity is set at say 70% percent, a test of association can determine whether the capacity level is significantly below, above, or equal to 70% | \n
\n
| \nFor example, from the questionnaire data, calculate the mean compliance, and perform a test of association to determine if the mean compliance level is equal or less than a set benchmark such as 70% | \n
\n
| \nFor example, grouping all EIA reports into the corresponding years of compilation, calculate the compliance indicators for each year, and observe if compliance has been increasing or decreasing | \n
\n
| \n\n |
Suggested data analysis techniques.
Advantages | \nWeaknesses | \n
---|---|
Simplicity | \nCostly extensive data collection | \n
Holistic | \nUnavailability of information | \n
Improved objectivity | \n\n |
Flexible analysis approach | \n\n |
Triangulation | \n\n |
Advantages and weaknesses.
This section will outline the advantages of the MRR model. Firstly, the MRR model has the advantage of simplicity. Being based on the simple pillars of the implementation of any policy intervention (compliance, participation, and capacity), the MRR model is very easy to conceptualize. Further, the MRR model uses the evaluation theory, a commonly accepted and widely used approach in policy interventions and development planning.
\nSecondly, the MRR model provides a framework to encompass all issues related to the implementation of an EIA system. Any conceivable EIA issues including effectiveness, efficiency, relevance, and sustainability of the EIA system can be brought down to indicators within the three elements, i.e., compliance, participation, and capacity (or method, rights, and resources).
\nThirdly, the MRR model is a possible reduction to the subjectivity that sometimes underlies the evaluation of effectiveness using other models. The MRR model ensures that the EIA system is evaluated according to its fundamental principles more than subjective concepts of researchers. For example, the idea of systemic and foundation issues [9] discussed before is very dependent on the authors’ conceptualization of issues. However, compliance, participation, and capacity are more objectively defined.
\nIn addition, the MRR model emphasizes on quantitative data obtained as objective data collection process using standardized data collection tools.
\nIn the MRR model, analysis can be adapted to suit the availability of data. The indicators can also be crafted to suit the expected scope of EIA system evaluation.
\nMultiple sources of data used toward a single indicator are a means of triangulating data collection. This allows a more robust analysis process and a richer and more representative analysis outcome.
\nLastly, the MRR model can be easily adapted to compare EIA systems from different geographical locations and jurisdictions. The MRR model is particularly suitable for use by regulatory authorities who have easy access to all the data required for a rigorous evaluation of the EIA system.
\nIt is suggested that further fine-tuning of the MRR model can enable a more objective and in-depth inter-country comparison of the performance of EIA systems.
\nThere are also challenges with the MRR model. The main challenge is that although quantitative methods can be used with the MRR model, the model still falls short of completely addressing the inherent challenge of quantifying environmental impact. Secondly, applying the model can be very costly depending on other factors. Thirdly, application will vary considerably depending on how the respective country’s EIA system is set up. The MRR model will apply best where the EIA system is elaborate including specific guidelines, monitoring, and report systems from which data can be made available. Where no such elaborate EIA system guidelines exist, applying the MRR model is likely to be more challenging. However, the MRR model can be narrowed down to suit the situation.
\nLastly, data collection proposed in the MRR model is extensive. It may not always be easy to obtain all the data. The availability of data also depends on having a well-developed system of recording and EIA reports and other sources of secondary data. Without a significant pool of practitioners effectively involved in the EIA system, it is not possible to obtain adequate information through the questionnaire surveys.
\nThis chapter introduced the MRR model for EIA system effectiveness evaluation. The chapter shows that the MRR model can address, albeit partially, some of the objectivity and comparability issues of EIA system evaluation. The MRR model does not intend to be a magic bullet to solve all the inherent challenges of quantifying environmental impact. It only suggests presumably a better approach to evaluating the effectiveness of EIA systems based on the evaluation theory and indicator formulation.
\nThe intention of the chapter was not to give a step-by-step guide but the basic thinking behind the MRR model [4], hence opening it up to trial by other evaluators of EIA systems.
\nClinical trials are an important step to ensuring the safety and efficacy of medical treatment. For radiation therapy, clinical trials have allowed us to look at important questions like dose escalation, fractionation, and new radiotherapy technologies. Much like the use of instensity-modulated radiation therapy (IMRT) was critically reviewed in the early 2000s, proton therapy has come under careful scrutiny over the past decade. Many radiation therapy departments commissioned proton therapy centers and began to integrate protons into their clinical practice.
Most people who work in radiation therapy have seen the striking treatment plan comparisons between proton therapy and traditional photon therapy for a pediatric craniospinal case, noting the marked reduction in dose to organs at risk and normal tissue outside of the target region [1]. These in-silico studies are even more exciting given the potential reduction in secondary cancer for pediatric patients. The potential benefits in these studies come with corresponding risk; if the beam modeling or treatment delivery positioning is not accurate, there is a risk of high overdose to normal tissue or severe underdose of the target. For this reason, the National Cancer Institute (NCI), the American Society for Radiation Oncology (ASTRO), and other groups have encouraged methodical, careful study of the clinical benefits of proton therapy through clinical trials [2].
The potential benefits of proton therapy are also complicated by the higher biological effectiveness of protons as compared with photons. The current clinical practice in the US is to use a relative biological effectiveness (RBE) of 1.1 for protons, but studies have shown that the true biological response is more complicated and variable [3]. While the higher RBE of protons is a potential benefit for killing tumor cells, there is potential increased biological risk to critical organs proximate to the target. Clinical trials with proton therapy can allow us to look at both sides of the coin by analyzing the correlation between RBE and clinical outcomes.
Insurance companies have played a role in driving the development of randomized proton vs. photon clinical trials as well. Due to the higher up-front cost of proton therapy for many disease sites, insurance companies have asked for data showing marked improvement in survival outcomes for patients treated with proton therapy in order to cover treatment costs. As discussed later in the chapter, this presents a bit of a catch-22 in clinical trial accrual, as insurers are waiting for trial data to approve coverage, but trial data is nearly impossible to collect without insurance coverage for patients enrolled on-study.
The largest clinical trial system that supports proton therapy protocols in the US is the National Clinical Trial Network (NCTN), funded by the NCI. The NCTN is made up of four adult and one pediatric clinical trial groups, as well as a partnership with the Canadian Cancer Trials Group. Most of the proton therapy studies run through the NCTN are large-scale, multi-institutional Phase II and Phase III trials. These trials either randomize patients to proton or photon therapy to compare treatment outcomes or imbed proton therapy as a possible treatment modality in a study designed to answer a different clinical question. The NCI has also funded proton clinical trials outside of the NCTN [4, 5, 6, 7]. These are often run by a single proton center “sponsor” in partnership with other proton facilities and funded through NCI grants.
Outside of the NCI, there are several other groups that help sponsor clinical trials for proton therapy. The National Association for Proton Therapy (NAPT) is a nonprofit group that helps facilitate proton therapy research collaborations. Most of the operational proton therapy centers in the US are members of NAPT. The Patient-Centered Outcomes Research Institute (PCORI) provides funding for clinical trials comparing proton vs. photon therapy for prostate and breast treatment. The NCI also has a Childhood Cancer Data Initiative (CCDI) that collects standard patient data, including proton therapy data, in a central repository for data sharing and analysis within the research community.
Outside of the US, several groups in Europe and Asia have proton therapy protocols open or in development. The Japan Clinical Oncology Group (JCOG) is funded by Japan’s National Cancer Center Research and Development Fund and conducts studies with proton therapy [8]. The European Organization for Research and Treatment of Cancer (EORTC) operates clinical trials within Europe and currently has two protocols with proton therapy embedded [9]. The European Society for Radiotherapy (ESTRO) recently established the European Particle Therapy Network (EPTN), which conducts a number of prospective studies looking at proton (and carbon) therapy, and works in concert with the EORTC [10, 11]. Global collaborations on clinical trials have been limited so far. The US has the largest catalog of proton therapy clinical trials and has sought participation of international proton centers, but the many steps to opening the protocols (NCTN membership, state department clearance, baseline approval quality assurance) have slowed down collaboration. The clinical trial groups are working on streamlining these processes to allow for expanded international partnerships in the future.
In order to move past in-silico studies that promise superior dosimetry with proton therapy, clinical evidence is needed. One of the best ways to get these data are through randomized clinical trials. For proton therapy trials, randomization is generally structured with two arms: proton vs. photon. In order to get enough patients for statistical significance, these trials require a lot of patients (usually hundreds) and are typically run as multi-institutional studies. These large randomized studies may be designed to show superiority of proton therapy or to demonstrate non-inferiority [12]. Most NCTN randomized proton vs. photon trials have a primary endpoint of assessing overall survival. Secondary endpoints include progression-free survival, local control, toxicities, cognitive outcomes, symptoms burden, quality of life, cost effectiveness, and cost–benefit economics. While proton therapy generally has a higher up-front cost, it is hypothesized that proton therapy may be more cost-effective for some disease sites due to reduction in acute and long-term toxicities and associated medical costs.
Typically NCTN clinical trial data is only assessed for objectives explicitly listed in the protocol and analysis outside the original scope is only permitted after the trial has been closed several years. For this reason, somewhat indefinite exploratory objectives are written into the protocol to allow for analyses that may not be understood at the time of protocol development. For randomized proton vs. photon trials within the NCTN, exploratory objectives include biospecimen and imaging data collection for the assessment of biomarkers.
Most randomized proton vs. photon studies randomize 1:1, though some protocols have randomize 2:1 in favor of proton therapy. The two arms typically have the same radiobiological dose prescription, though some studies like NRG Oncology/RTOG 1308 have low dose and high dose arms.
Clinical trials can be challenging for a number of reasons - increased personnel effort to coordinate patient enrollment and data submission, increased operational costs, low patient interest, and low physician engagement – but randomized proton vs. photon trials face a number of unique challenges.
One unique aspect of proton vs. photon trials is that it is common to create treatment plans for patients using both modalities to ensure that both can meet the planning dose constraints required by the protocol [13]. This may require increased time on the part of the participating institutions, though many proton centers may already be creating double plans for insurance purposes.
Treatment planning itself is different between proton therapy and photon therapy. The planning target volume (PTV) that is commonly used for photon plans is generally not used in the same way for proton therapy. Instead of uniform expansion from clinical target volume (CTV) to the PTV, proton treatment plans may have one pre-defined lateral margin, and a different margin in the direction of the beam range that depends on the maximum beam energy [14, 15]. In this way, the proton “PTV” is beam-specific. This presents a challenge for clinical trial data analysis, as most protocols are written with historical photon PTV constraints. Future protocols should be designed with this in mind.
Furthermore, proton therapy treatment planning has started to shift away from the standard lateral and range margins in favor of robust optimization of the CTV [16, 17]. There are many different ways to report dose when using robust optimization (e.g. voxel-wise worst-case approach, scenario-wise worst-case approach, delivered dose variance) [18]. Clinical trials should soon consider how robustly optimized treatment planning data will be collected to ensure appropriate data comparison between the proton and photon arm. This highlights the crucial role that physicists and data (i.e. Digital Imaging and Communications in Medicine (DICOM)) experts play in the development of clinical trials.
In addition to the nuances of physical dose, randomized proton vs. photon trials need to consider the implications of radiobiology. The NCTN currently uses an RBE of 1.1, but many proton centers are starting to consider variable RBE in their treatment planning practices [19, 20]. If variable RBE treatment planning becomes standard, clinical trials will need to incorporate it into treatment planning constraints, and determine what patient data needs to be collected to appropriately compare different treatment plans.
One challenge with randomized clinical trials comparing proton therapy with photon therapy is patient preference. This manifests when a patient is randomized to one arm but has a strong desire to be treated on the other arm, and thus goes off protocol. Patients randomized to the photon arm may decide they want proton therapy instead due to an impression gathered through independent online research or a preference for the “latest and greatest” technology. Conversely, some patients randomized to the proton arm may go off protocol to receive photon therapy due to mistrust of a new, “unproven” technology.
Another challenge of proton trial accrual is insurance denial for proton therapy [21]. This is particularly challenging in the case of randomized proton vs. photon trials because it can make it harder to reach accrual goals on the proton arm of the protocol. Insurance denials of proton therapy can also skew the patient demographics of the proton arm. For example, Medicare is significantly more likely to cover proton therapy than private insurers, which can skew the age of the proton cohort toward older participants [22]. This older patient cohort might have comorbidities or other characteristics that make it challenging to compare outcomes data between the two arms. Lastly, the process of appealing insurance denials can lead to delays in the start of radiation treatment [23]. Clinical trial patients may already wait slightly longer for treatment to start due to clinical trial requirements such as pre-treatment reviews of the treatment plan. These delays might result in a patient going off trial to pursue treatment sooner.
One way to counteract the deleterious effect of proton insurance denial on randomization is to use a 2:1 randomization in favor of proton therapy. This gives the trial more opportunities to accrue proton patients, even if insurance challenges persist. But most proton centers choose to challenge insurance denials, and the best way to combat insurance denial is through support networks and sharing of resources. The NAPT offers a guide for patients on steps to deal with insurance denial, many of which are applicable to clinical teams as well [24]. Many proton centers have dedicated personnel to manage insurance appeals. For the NCTN, proton insurance denials are a frequent topic at operations management and proton working group meetings. These forums allow physicians to share successful techniques to overcome insurance barriers. Physicians have banded together to publish pleas for insurance companies to change the insurance approval process for proton therapy [25]. Some proton therapy centers have negotiated with insurance companies to reimburse proton therapy at the cost of IMRT, picking up the rest of the costs themselves [25]. The NCI has also advocated on behalf of proton therapy centers in the context of clinical trial insurance reimbursement for randomized NCTN protocols [26].
Due to the limited number of proton therapy centers, many randomized proton vs. photon trials encourage partnerships between one proton center and any number of photon clinics. There are many considerations when establishing a partnership between two institutions, such as who gets “credit” for the clinical trial accrual, how clinical trial reimbursement is allocated between the institutions, which personnel have rights to upload patient data to the appropriate portals, etc. There is a possibility that a photon clinic might partner with a proton center in another country. In this case, the logistics of travel reimbursement (if provided) should be addressed, as well as clinical trial membership and state approval if the trial is run through the NCTN. This type of partnership may become increasingly common as clinical trials for carbon therapy are being developed, with most carbon centers located in Europe and Eastern Asia. A few concepts have been proposed that randomize IMRT treatment to centers in the US, and carbon therapy to centers abroad [27].
In addition to randomized proton vs. photon clinical trials, there are a number of trials that imbed proton therapy as one of several allowed treatment modalities. This practice was most common this past decade in pediatric trials, such as those conducted by the Children’s Oncology Group (COG), but has been applied to adult trials as well. While the superiority of proton therapy outcomes might not be the primary endpoint of these studies, the hope is that with enough data, secondary analyses can be performed to look at proton patient cohorts compared to others.
To date, the standard method of including proton therapy in pediatric clinical trials has been to imbed protons in the protocols. The strategy recognizes the challenges of accrual to disease-specific radiation therapy protocols in pediatric patients and permits parallel treatment strategies for both photon and proton care to successfully manage the study. Approximately 50% of pediatric malignancies are in the leukemia domain, therefore protocols requiring radiation therapy are directed to tumors of the central nervous system, sarcoma, renal, orbit including retinoblastoma, and lymphoma. Therapy volumes and target dose are uniform between proton and photon care with guidelines imbedded in the study to insure synergistic care for tumor control acknowledging subtle differences in planning target volumes and dose distribution to normal tissue. Both proton and photon patients need to meet the identical dose to tumor and normal tissue. Dose to normal tissue in most situations is more easily achieved with proton therapy. In pediatric studies, outcome analysis including imaging are part of the longitudinal aspect of protocol management, therefore colleagues in the COG and the Imaging and Radiation Oncology Core (IROC) can evaluate normal tissue endpoints with outcome imaging validation to review comparison plans in retrospect to acquire important outcome analysis for secondary study endpoints between proton and photon care.
One challenge pediatric trials have faced is the apparent racial disparities between who receives proton therapy, with non-Hispanic white pediatric patients significantly more likely to be treated with protons than black patients [28]. This presents a challenge to proportional racial representation in clinical trial data.
In the US, adult clinical trial groups have imbedded proton therapy in dozens of clinical trials. At times, proton therapy has been added through clinical trial amendments with the hope of boosting accrual to protocols struggling to accrue patients. For a number of reasons (small number of proton centers, insurance denials, competing proton-specific trials), this has not proven to be the silver bullet, however, and generally it’s not recommended to add proton therapy as an allowable modality solely to improve trial accrual for adult protocols. Despite lower accrual numbers, proton therapy can be a good addition to a trial, adding the possibility of secondary analyses to look at proton therapy outcomes in relation to other treatment modalities.
Outside of prospective clinical trials with proton therapy, there are a number of proton therapy registries. These are generally less structured than Phase II/Phase III trials and allow for more flexibility in which data are analyzed. The Proton Collaborative Group (PCG) is a registry of nearly six thousand proton patients in the US [29]. The PCG looks at survival outcomes and quality of life, and fosters peer review collaboration across centers for clinical trial development. The Pediatric Proton Consortium Registry (PPCR) is a multi-institutional collaborative registry of demographic and clinical data for pediatric patients treated with proton and photon therapy [30]. The goal of the PPCR is to compare benefits of the two radiotherapy techniques, such as disease outcomes and quality of life. Washington University School of Medicine and Radialogica, LLC have a Proton Therapy Registry for adult and pediatric patients that collects clinical and dosimetric data [31].
Proton therapy has great potential and in some cases, proven clinical benefit. The best way to gather evidence to secure proton therapy as a standard of care for cancer treatment is through thoughtful, controlled clinical trials. Much work has already been done to this effect, and with so many clinical trials for proton therapy currently accruing, we will soon have data to answer the myriad questions related to proton therapy treatment outcomes.
The author declares no conflict of interest.
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Integrity - We are consistent and dependable, always striving for precision and accuracy in the true spirit of science.
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\n\nDisruptiveness - We are eager for discovery, for new ideas and for progression. We approach our work with creativity and determination, with a clear vision that drives us forward. We look beyond today and strive for a better tomorrow.
\n\nIntechOpen is a dynamic, vibrant company, where exceptional people are achieving great things. We offer a creative, dedicated, committed, and passionate environment but never lose sight of the fact that science and discovery is exciting and rewarding. We constantly strive to ensure that members of our community can work, travel, meet world-renowned researchers and grow their own career and develop their own experiences.
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Three main elements of MARS which are the type of agents, control architectures, and communications were discussed thoroughly in the beginning of this paper. A series of problems together with the issues were analyzed and reviewed, which included centralized and decentralized control, consensus, containment, formation, task allocation, intelligences, optimization and communications of multi-agent robots. Since the research in the field of multi-agent robot research is expanding, some issues and future challenges in MARS are recalled, discussed and clarified with future directions. 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He has both an MS and Ph.D. in Biomedical Engineering. He was previously a research scientist at the University of California Los Angeles (UCLA) and visiting professor and researcher at the University of North Dakota. He is currently working in artificial intelligence and its applications in medical signal processing. In addition, he is using digital signal processing in medical imaging and speech processing. Dr. Asadpour has developed brain-computer interfacing algorithms and has published books, book chapters, and several journal and conference papers in this field and other areas of intelligent signal processing. 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Working with large volumes of data has given him a good command of big data processing tools and NoSQL databases. He has also been a visiting scholar at the Knowledge Engineering and Discovery Research Institute, Auckland University of Technology.",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"314575",title:"Dr.",name:"Jesus",middleName:null,surname:"L. Lobo",slug:"jesus-l.-lobo",fullName:"Jesus L. Lobo",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/314575/images/system/314575.png",biography:"Dr. Jesús López is currently based in Bilbao (Spain) working at TECNALIA as Artificial Intelligence Research Scientist. In most cases, a project idea or a new research line needs to be investigated to see if it is good enough to take into production or to focus on it. That is exactly what he does, diving into Machine Learning algorithms and technologies to help TECNALIA to decide whether something is great in theory or will actually impact on the product or processes of its projects. So, he is expert at framing experiments, developing hypotheses, and proving whether they’re true or not, in order to investigate fundamental problems with a longer time horizon. He is also able to design and develop PoCs and system prototypes in simulation. He has participated in several national and internacional R&D projects.\n\nAs another relevant part of his everyday research work, he usually publishes his findings in reputed scientific refereed journals and international conferences, occasionally acting as reviewer and Programme Commitee member. Concretely, since 2018 he has published 9 JCR (8 Q1) journal papers, 9 conference papers (e.g. ECML PKDD 2021), and he has co-edited a book. He is also active in popular science writing data science stories for reputed blogs (KDNuggets, TowardsDataScience, Naukas). Besides, he has recently embarked on mentoring programmes as mentor, and has also worked as data science trainer.",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"103779",title:"Prof.",name:"Yalcin",middleName:null,surname:"Isler",slug:"yalcin-isler",fullName:"Yalcin Isler",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRyQ8QAK/Profile_Picture_1628834958734",biography:"Yalcin Isler (1971 - Burdur / Turkey) received the B.Sc. degree in the Department of Electrical and Electronics Engineering from Anadolu University, Eskisehir, Turkey, in 1993, the M.Sc. degree from the Department of Electronics and Communication Engineering, Suleyman Demirel University, Isparta, Turkey, in 1996, the Ph.D. degree from the Department of Electrical and Electronics Engineering, Dokuz Eylul University, Izmir, Turkey, in 2009, and the Competence of Associate Professorship from the Turkish Interuniversity Council in 2019.\n\nHe was Lecturer at Burdur Vocational School in Suleyman Demirel University (1993-2000, Burdur / Turkey), Software Engineer (2000-2002, Izmir / Turkey), Research Assistant in Bulent Ecevit University (2002-2003, Zonguldak / Turkey), Research Assistant in Dokuz Eylul University (2003-2010, Izmir / Turkey), Assistant Professor at the Department of Electrical and Electronics Engineering in Bulent Ecevit University (2010-2012, Zonguldak / Turkey), Assistant Professor at the Department of Biomedical Engineering in Izmir Katip Celebi University (2012-2019, Izmir / Turkey). He is an Associate Professor at the Department of Biomedical Engineering at Izmir Katip Celebi University, Izmir / Turkey, since 2019. In addition to academics, he has also founded Islerya Medical and Information Technologies Company, Izmir / Turkey, since 2017.\n\nHis main research interests cover biomedical signal processing, pattern recognition, medical device design, programming, and embedded systems. He has many scientific papers and participated in several projects in these study fields. He was an IEEE Student Member (2009-2011) and IEEE Member (2011-2014) and has been IEEE Senior Member since 2014.",institutionString:null,institution:{name:"Izmir Kâtip Çelebi University",country:{name:"Turkey"}}},{id:"339677",title:"Dr.",name:"Mrinmoy",middleName:null,surname:"Roy",slug:"mrinmoy-roy",fullName:"Mrinmoy Roy",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/339677/images/16768_n.jpg",biography:"An accomplished Sales & Marketing professional with 12 years of cross-functional experience in well-known organisations such as CIPLA, LUPIN, GLENMARK, ASTRAZENECA across different segment of Sales & Marketing, International Business, Institutional Business, Product Management, Strategic Marketing of HIV, Oncology, Derma, Respiratory, Anti-Diabetic, Nutraceutical & Stomatological Product Portfolio and Generic as well as Chronic Critical Care Portfolio. A First Class MBA in International Business & Strategic Marketing, B.Pharm, D.Pharm, Google Certified Digital Marketing Professional. Qualified PhD Candidate in Operations and Management with special focus on Artificial Intelligence and Machine Learning adoption, analysis and use in Healthcare, Hospital & Pharma Domain. Seasoned with diverse therapy area of Pharmaceutical Sales & Marketing ranging from generating revenue through generating prescriptions, launching new products, and making them big brands with continuous strategy execution at the Physician and Patients level. Moved from Sales to Marketing and Business Development for 3.5 years in South East Asian Market operating from Manila, Philippines. Came back to India and handled and developed Brands such as Gluconorm, Lupisulin, Supracal, Absolut Woman, Hemozink, Fabiflu (For COVID 19), and many more. In my previous assignment I used to develop and execute strategies on Sales & Marketing, Commercialization & Business Development for Institution and Corporate Hospital Business portfolio of Oncology Therapy Area for AstraZeneca Pharma India Ltd. Being a Research Scholar and Student of ‘Operations Research & Management: Artificial Intelligence’ I published several pioneer research papers and book chapters on the same in Internationally reputed journals and Books indexed in Scopus, Springer and Ei Compendex, Google Scholar etc. Currently, I am launching PGDM Pharmaceutical Management Program in IIHMR Bangalore and spearheading the course curriculum and structure of the same. I am interested in Collaboration for Healthcare Innovation, Pharma AI Innovation, Future trend in Marketing and Management with incubation on Healthcare, Healthcare IT startups, AI-ML Modelling and Healthcare Algorithm based training module development. I am also an affiliated member of the Institute of Management Consultant of India, looking forward to Healthcare, Healthcare IT and Innovation, Pharma and Hospital Management Consulting works.",institutionString:null,institution:{name:"Lovely Professional University",country:{name:"India"}}},{id:"310576",title:"Prof.",name:"Erick Giovani",middleName:null,surname:"Sperandio Nascimento",slug:"erick-giovani-sperandio-nascimento",fullName:"Erick Giovani Sperandio Nascimento",position:null,profilePictureURL:"https://intech-files.s3.amazonaws.com/0033Y00002pDKxDQAW/ProfilePicture%202022-06-20%2019%3A57%3A24.788",biography:"Prof. Erick Sperandio is the Lead Researcher and professor of Artificial Intelligence (AI) at SENAI CIMATEC, Bahia, Brazil, also working with Computational Modeling (CM) and HPC. He holds a PhD in Environmental Engineering in the area of Atmospheric Computational Modeling, a Master in Informatics in the field of Computational Intelligence and Graduated in Computer Science from UFES. He currently coordinates, leads and participates in R&D projects in the areas of AI, computational modeling and supercomputing applied to different areas such as Oil and Gas, Health, Advanced Manufacturing, Renewable Energies and Atmospheric Sciences, advising undergraduate, master's and doctoral students. He is the Lead Researcher at SENAI CIMATEC's Reference Center on Artificial Intelligence. In addition, he is a Certified Instructor and University Ambassador of the NVIDIA Deep Learning Institute (DLI) in the areas of Deep Learning, Computer Vision, Natural Language Processing and Recommender Systems, and Principal Investigator of the NVIDIA/CIMATEC AI Joint Lab, the first in Latin America within the NVIDIA AI Technology Center (NVAITC) worldwide program. He also works as a researcher at the Supercomputing Center for Industrial Innovation (CS2i) and at the SENAI Institute of Innovation for Automation (ISI Automação), both from SENAI CIMATEC. He is a member and vice-coordinator of the Basic Board of Scientific-Technological Advice and Evaluation, in the area of Innovation, of the Foundation for Research Support of the State of Bahia (FAPESB). He serves as Technology Transfer Coordinator and one of the Principal Investigators at the National Applied Research Center in Artificial Intelligence (CPA-IA) of SENAI CIMATEC, focusing on Industry, being one of the six CPA-IA in Brazil approved by MCTI / FAPESP / CGI.br. He also participates as one of the representatives of Brazil in the BRICS Innovation Collaboration Working Group on HPC, ICT and AI. He is the coordinator of the Work Group of the Axis 5 - Workforce and Training - of the Brazilian Strategy for Artificial Intelligence (EBIA), and member of the MCTI/EMBRAPII AI Innovation Network Training Committee. He is the coordinator, by SENAI CIMATEC, of the Artificial Intelligence Reference Network of the State of Bahia (REDE BAH.IA). He leads the working group of experts representing Brazil in the Global Partnership on Artificial Intelligence (GPAI), on the theme \"AI and the Pandemic Response\".",institutionString:"Manufacturing and Technology Integrated Campus – SENAI CIMATEC",institution:null},{id:"1063",title:"Prof.",name:"Constantin",middleName:null,surname:"Volosencu",slug:"constantin-volosencu",fullName:"Constantin Volosencu",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/1063/images/system/1063.png",biography:"Prof. Dr. Constantin Voloşencu graduated as an engineer from\nPolitehnica University of Timișoara, Romania, where he also\nobtained a doctorate degree. He is currently a full professor in\nthe Department of Automation and Applied Informatics at the\nsame university. Dr. Voloşencu is the author of ten books, seven\nbook chapters, and more than 160 papers published in journals\nand conference proceedings. He has also edited twelve books and\nhas twenty-seven patents to his name. He is a manager of research grants, editor in\nchief and member of international journal editorial boards, a former plenary speaker, a member of scientific committees, and chair at international conferences. His\nresearch is in the fields of control systems, control of electric drives, fuzzy control\nsystems, neural network applications, fault detection and diagnosis, sensor network\napplications, monitoring of distributed parameter systems, and power ultrasound\napplications. He has developed automation equipment for machine tools, spooling\nmachines, high-power ultrasound processes, and more.",institutionString:"Polytechnic University of Timişoara",institution:{name:"Polytechnic University of Timişoara",country:{name:"Romania"}}},{id:"221364",title:"Dr.",name:"Eneko",middleName:null,surname:"Osaba",slug:"eneko-osaba",fullName:"Eneko Osaba",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/221364/images/system/221364.jpg",biography:"Dr. Eneko Osaba works at TECNALIA as a senior researcher. He obtained his Ph.D. in Artificial Intelligence in 2015. He has participated in more than twenty-five local and European research projects, and in the publication of more than 130 papers. He has performed several stays at universities in the United Kingdom, Italy, and Malta. Dr. Osaba has served as a program committee member in more than forty international conferences and participated in organizing activities in more than ten international conferences. He is a member of the editorial board of the International Journal of Artificial Intelligence, Data in Brief, and Journal of Advanced Transportation. He is also a guest editor for the Journal of Computational Science, Neurocomputing, Swarm, and Evolutionary Computation and IEEE ITS Magazine.",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"275829",title:"Dr.",name:"Esther",middleName:null,surname:"Villar-Rodriguez",slug:"esther-villar-rodriguez",fullName:"Esther Villar-Rodriguez",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/275829/images/system/275829.jpg",biography:"Dr. Esther Villar obtained a Ph.D. in Information and Communication Technologies from the University of Alcalá, Spain, in 2015. She obtained a degree in Computer Science from the University of Deusto, Spain, in 2010, and an MSc in Computer Languages and Systems from the National University of Distance Education, Spain, in 2012. Her areas of interest and knowledge include natural language processing (NLP), detection of impersonation in social networks, semantic web, and machine learning. Dr. Esther Villar made several contributions at conferences and publishing in various journals in those fields. Currently, she is working within the OPTIMA (Optimization Modeling & Analytics) business of TECNALIA’s ICT Division as a data scientist in projects related to the prediction and optimization of management and industrial processes (resource planning, energy efficiency, etc).",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"49813",title:"Dr.",name:"Javier",middleName:null,surname:"Del Ser",slug:"javier-del-ser",fullName:"Javier Del Ser",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/49813/images/system/49813.png",biography:"Prof. Dr. Javier Del Ser received his first PhD in Telecommunication Engineering (Cum Laude) from the University of Navarra, Spain, in 2006, and a second PhD in Computational Intelligence (Summa Cum Laude) from the University of Alcala, Spain, in 2013. He is currently a principal researcher in data analytics and optimisation at TECNALIA (Spain), a visiting fellow at the Basque Center for Applied Mathematics (BCAM) and a part-time lecturer at the University of the Basque Country (UPV/EHU). His research interests gravitate on the use of descriptive, prescriptive and predictive algorithms for data mining and optimization in a diverse range of application fields such as Energy, Transport, Telecommunications, Health and Industry, among others. In these fields he has published more than 240 articles, co-supervised 8 Ph.D. theses, edited 6 books, coauthored 7 patents and participated/led more than 40 research projects. He is a Senior Member of the IEEE, and a recipient of the Biscay Talent prize for his academic career.",institutionString:"Tecnalia Research & Innovation",institution:null},{id:"278948",title:"Dr.",name:"Carlos Pedro",middleName:null,surname:"Gonçalves",slug:"carlos-pedro-goncalves",fullName:"Carlos Pedro Gonçalves",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRcmyQAC/Profile_Picture_1564224512145",biography:'Carlos Pedro Gonçalves (PhD) is an Associate Professor at Lusophone University of Humanities and Technologies and a researcher on Complexity Sciences, Quantum Technologies, Artificial Intelligence, Strategic Studies, Studies in Intelligence and Security, FinTech and Financial Risk Modeling. He is also a progammer with programming experience in:\n\nA) Quantum Computing using Qiskit Python module and IBM Quantum Experience Platform, with software developed on the simulation of Quantum Artificial Neural Networks and Quantum Cybersecurity;\n\nB) Artificial Intelligence and Machine learning programming in Python;\n\nC) Artificial Intelligence, Multiagent Systems Modeling and System Dynamics Modeling in Netlogo, with models developed in the areas of Chaos Theory, Econophysics, Artificial Intelligence, Classical and Quantum Complex Systems Science, with the Econophysics models having been cited worldwide and incorporated in PhD programs by different Universities.\n\nReceived an Arctic Code Vault Contributor status by GitHub, due to having developed open source software preserved in the \\"Arctic Code Vault\\" for future generations (https://archiveprogram.github.com/arctic-vault/), with the Strategy Analyzer A.I. module for decision making support (based on his PhD thesis, used in his Classes on Decision Making and in Strategic Intelligence Consulting Activities) and QNeural Python Quantum Neural Network simulator also preserved in the \\"Arctic Code Vault\\", for access to these software modules see: https://github.com/cpgoncalves. He is also a peer reviewer with outsanding review status from Elsevier journals, including Physica A, Neurocomputing and Engineering Applications of Artificial Intelligence. Science CV available at: https://www.cienciavitae.pt//pt/8E1C-A8B3-78C5 and ORCID: https://orcid.org/0000-0002-0298-3974',institutionString:"University of Lisbon",institution:{name:"Universidade Lusófona",country:{name:"Portugal"}}},{id:"241400",title:"Prof.",name:"Mohammed",middleName:null,surname:"Bsiss",slug:"mohammed-bsiss",fullName:"Mohammed Bsiss",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/241400/images/8062_n.jpg",biography:null,institutionString:null,institution:null},{id:"276128",title:"Dr.",name:"Hira",middleName:null,surname:"Fatima",slug:"hira-fatima",fullName:"Hira Fatima",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/276128/images/14420_n.jpg",biography:"Dr. Hira Fatima\nAssistant Professor\nDepartment of Mathematics\nInstitute of Applied Science\nMangalayatan University, Aligarh\nMobile: no : 8532041179\nhirafatima2014@gmal.com\n\nDr. Hira Fatima has received his Ph.D. degree in pure Mathematics from Aligarh Muslim University, Aligarh India. Currently working as an Assistant Professor in the Department of Mathematics, Institute of Applied Science, Mangalayatan University, Aligarh. She taught so many courses of Mathematics of UG and PG level. Her research Area of Expertise is Functional Analysis & Sequence Spaces. She has been working on Ideal Convergence of double sequence. She has published 17 research papers in National and International Journals including Cogent Mathematics, Filomat, Journal of Intelligent and Fuzzy Systems, Advances in Difference Equations, Journal of Mathematical Analysis, Journal of Mathematical & Computer Science etc. She has also reviewed few research papers for the and international journals. She is a member of Indian Mathematical Society.",institutionString:null,institution:null},{id:"414880",title:"Dr.",name:"Maryam",middleName:null,surname:"Vatankhah",slug:"maryam-vatankhah",fullName:"Maryam Vatankhah",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Borough of Manhattan Community College",country:{name:"United States of America"}}},{id:"414879",title:"Prof.",name:"Mohammad-Reza",middleName:null,surname:"Akbarzadeh-Totonchi",slug:"mohammad-reza-akbarzadeh-totonchi",fullName:"Mohammad-Reza Akbarzadeh-Totonchi",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Ferdowsi University of Mashhad",country:{name:"Iran"}}},{id:"414878",title:"Prof.",name:"Reza",middleName:null,surname:"Fazel-Rezai",slug:"reza-fazel-rezai",fullName:"Reza Fazel-Rezai",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"American Public University System",country:{name:"United States of America"}}},{id:"302698",title:"Dr.",name:"Yao",middleName:null,surname:"Shan",slug:"yao-shan",fullName:"Yao Shan",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Dalian University of Technology",country:{name:"China"}}},{id:"125911",title:"Prof.",name:"Jia-Ching",middleName:null,surname:"Wang",slug:"jia-ching-wang",fullName:"Jia-Ching Wang",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"National Central University",country:{name:"Taiwan"}}},{id:"357085",title:"Mr.",name:"P. Mohan",middleName:null,surname:"Anand",slug:"p.-mohan-anand",fullName:"P. Mohan Anand",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Indian Institute of Technology Kanpur",country:{name:"India"}}},{id:"356696",title:"Ph.D. Student",name:"P.V.",middleName:null,surname:"Sai Charan",slug:"p.v.-sai-charan",fullName:"P.V. Sai Charan",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Indian Institute of Technology Kanpur",country:{name:"India"}}},{id:"357086",title:"Prof.",name:"Sandeep K.",middleName:null,surname:"Shukla",slug:"sandeep-k.-shukla",fullName:"Sandeep K. Shukla",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Indian Institute of Technology Kanpur",country:{name:"India"}}},{id:"356823",title:"MSc.",name:"Seonghee",middleName:null,surname:"Min",slug:"seonghee-min",fullName:"Seonghee Min",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Daegu University",country:{name:"Korea, South"}}},{id:"353307",title:"Prof.",name:"Yoosoo",middleName:null,surname:"Oh",slug:"yoosoo-oh",fullName:"Yoosoo Oh",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:"Yoosoo Oh received his Bachelor's degree in the Department of Electronics and Engineering from Kyungpook National University in 2002. He obtained his Master’s degree in the Department of Information and Communications from Gwangju Institute of Science and Technology (GIST) in 2003. In 2010, he received his Ph.D. degree in the School of Information and Mechatronics from GIST. In the meantime, he was an executed team leader at Culture Technology Institute, GIST, 2010-2012. In 2011, he worked at Lancaster University, the UK as a visiting scholar. In September 2012, he joined Daegu University, where he is currently an associate professor in the School of ICT Conver, Daegu University. Also, he served as the Board of Directors of KSIIS since 2019, and HCI Korea since 2016. From 2017~2019, he worked as a center director of the Mixed Reality Convergence Research Center at Daegu University. From 2015-2017, He worked as a director in the Enterprise Supporting Office of LINC Project Group, Daegu University. His research interests include Activity Fusion & Reasoning, Machine Learning, Context-aware Middleware, Human-Computer Interaction, etc.",institutionString:null,institution:{name:"Daegu Gyeongbuk Institute of Science and Technology",country:{name:"Korea, South"}}},{id:"262719",title:"Dr.",name:"Esma",middleName:null,surname:"Ergüner Özkoç",slug:"esma-erguner-ozkoc",fullName:"Esma Ergüner Özkoç",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Başkent University",country:{name:"Turkey"}}},{id:"346530",title:"Dr.",name:"Ibrahim",middleName:null,surname:"Kaya",slug:"ibrahim-kaya",fullName:"Ibrahim Kaya",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Izmir Kâtip Çelebi University",country:{name:"Turkey"}}},{id:"419199",title:"Dr.",name:"Qun",middleName:null,surname:"Yang",slug:"qun-yang",fullName:"Qun Yang",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of Auckland",country:{name:"New Zealand"}}}]}},subseries:{item:{id:"86",type:"subseries",title:"Business and Management",keywords:"Demographic shifts, Innovation, Technology, Next-gen leaders, Worldwide environmental issues and clean technology, Uncertainty and political risks, Radical adjacency, Emergence of new business ecosystem type, Emergence of different leader and leader values types, Universal connector, Elastic enterprise, Business platform, Supply chain complexity",scope:"