Certified IRB Professional
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Certified IRB Professional
The Certified IRB Professional (CIP) program is a certification initiative in the United States for individuals administering and overseeing the daily activities of institutional review boards (IRBs). IRBs are committees that are charged with determining if a research project conforms to ethical principles and federal regulations that protect the rights and welfare of human research subjects. The CIP program was developed by Public Responsibility in Medicine and Research (PRIM&R) to promote standards for professional knowledge and to support adherence to regulatory requirements, best practices, and ethical standards in the conduct of research. At present, there are more than 2,500 individuals who have attained their certification and have been authorized to use the CIP designation. Background Created in 1999, the CIP program is a result of many years of discussions and planning by organizational members and leaders. It is endorsed by federal regulatory officials, professional asso ...
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Certification
Certification is the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. It is the formal attestation or confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of external review, education, assessment, or audit. Accreditation is a specific organization's process of certification. According to the U.S. National Council on Measurement in Education, a certification test is a credentialing test used to determine whether individuals are knowledgeable enough in a given occupational area to be labeled "competent to practice" in that area. Types One of the most common types of certification in modern society is professional certification, where a person is certified as being able to competently complete a job or task, usually by the passing of an examination and/or the completion of a program of stu ...
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United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ...
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Institutional Review Boards
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes. A key goal of IRBs is to protect human subjects ...
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Public Responsibility In Medicine And Research
Public Responsibility in Medicine and Research (PRIM&R) is a 501(c)(3) nonprofit organization based in Boston, Massachusetts. The organization was formed in 1974 by a group of researchers who sought to ensure that the concerns and experiences of those working in biomedical research would be reflected in the growing body of federal regulations governing the field. Among PRIM&R's principal activities are education, membership services, certification programs, public policy initiatives, and professional development programs. The key constituencies for PRIM&R's programming are human research protection professionals, animal care and use professionals, federal representatives, institutional officials, researchers and research staff, representatives of pharmaceutical and biotechnology companies, those working with community and voluntary health organizations, and ethicists. PRIM&R has a membership of more than 4,000 individuals worldwide. Educational Programs Annual Conferences ...
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Regulatory
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restriction ...
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Best Practices
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements. Best practices are used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking. Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001. Some consulting firms specialize in the area of best practice and offer ready-made templates to standardize business process documentation. Sometimes a best practice is not applicable or is inappropriate for a particular organization's needs. A key strategic talent required when applying best practice to organizations is the ability to balance the unique qualities of an organization with the practices that it has in commo ...
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Ethical Standards
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory. Three major areas of study within ethics recognized today are: # Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determined; # Normative ethics, concerning the practical means of determining a moral course of action; # Applied ethics, concerning what a person is obligated (or permitted) to do in a sp ...
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Research
Research is "creativity, creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error. These activities are characterized by accounting and controlling for biases. A research project may be an expansion on past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole. The primary purposes of basic research (as opposed to applied research) are documentation, Discovery (observation), discovery, interpretation (philosophy), interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge. Approaches to research depend on epistemology, epistemologies, which vary considerably both within and between humanities and sciences. ...
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Social Science
Social science is one of the branches of science, devoted to the study of societies and the relationships among individuals within those societies. The term was formerly used to refer to the field of sociology, the original "science of society", established in the 19th century. In addition to sociology, it now encompasses a wide array of academic disciplines, including anthropology, archaeology, economics, human geography, linguistics, management science, communication science and political science. Positivist social scientists use methods resembling those of the natural sciences as tools for understanding society, and so define science in its stricter modern sense. Interpretivist social scientists, by contrast, may use social critique or symbolic interpretation rather than constructing empirically falsifiable theories, and thus treat science in its broader sense. In modern academic practice, researchers are often eclectic, using multiple methodologies (for instance, by ...
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Behavioral
Behavior (American English) or behaviour (British English) is the range of actions and mannerisms made by individuals, organisms, systems or artificial entities in some environment. These systems can include other systems or organisms as well as the inanimate physical environment. It is the computed response of the system or organism to various stimuli or inputs, whether internal or external, conscious or subconscious, overt or covert, and voluntary or involuntary. Taking a behavior informatics perspective, a behavior consists of actor, operation, interactions, and their properties. This can be represented as a behavior vector. Models Biology Although disagreement exists as to how to precisely define behavior in a biological context, one common interpretation based on a meta-analysis of scientific literature states that "behavior is the internally coordinated responses (actions or inactions) of whole living organisms (individuals or groups) to internal and/or external stim ...
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Biomedical
Biomedicine (also referred to as Western medicine, mainstream medicine or conventional medicine)Biomedicine
" NCI Dictionary of Cancer Medicine. .
is a branch of that applies biological and physiological principles to . Biomedicine stresses standardized, evidence-based treatment validated through biological research, with treatment administered via formally trained ...
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Institutional
Institutions are humanly devised structures of rules and norms that shape and constrain individual behavior. All definitions of institutions generally entail that there is a level of persistence and continuity. Laws, rules, social conventions and norms are all examples of institutions. Institutions vary in their level of formality and informality. Institutions are a principal object of study in social sciences such as political science, anthropology, economics, and sociology (the latter described by Émile Durkheim as the "science of institutions, their genesis and their functioning"). Primary or meta-institutions are institutions such as the family or money that are broad enough to encompass sets of related institutions. Institutions are also a central concern for law, the formal mechanism for political rule-making and enforcement. Historians study and document the founding, growth, decay and development of institutions as part of political, economic and cultural history. Def ...
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