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Community Advisory Board
A community advisory board (often called a CAB) is a type of advisory board consisting of representatives of the general public who meet with representatives of an institution to relay information between the two groups. CABs are especially associated with clinical research, in which case they review the clinical research ethics associated with the human subject research which a medical research institution conducts. CABs are an aspect of community-based participatory research. Purpose Community advisory boards (CABs) benefit research institutions by providing advice about the efficacy of the informed consent process and the implementation of research protocols. The CAB composition is representative of the community participating in the research being reviewed. Researchers who consult with CABs get information which they would not otherwise get about the target community demographic which they are researching. Ethics The CAB is intended to be a way to respect the rights of researc ...
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Advisory Board
An advisory board is a body that provides non-binding strategic advice to the management of a corporation, organization, or foundation. The informal nature of an advisory board gives greater flexibility in structure and management compared to the board of directors. Unlike the board of directors A board of directors (commonly referred simply as the board) is an executive committee that jointly supervises the activities of an organization, which can be either a for-profit or a nonprofit organization such as a business, nonprofit orga ..., the advisory board does not have authority to vote on corporate matters or bear legal fiduciary responsibilities. Many new or small businesses choose to have advisory boards in order to benefit from the knowledge of others, without the expense or formality of the board of directors. Function The function of an advisory board is to offer assistance to enterprises with anything from marketing to managing human resources to influencing the ...
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Respect For Persons
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice. This concept is usually discussed in the context of research ethics. It is one of the three basic principles of research ethics stated in the Belmont Report issued by the Office of Human Subject Research; it comprises two essential moral requirements: to recognize the right for autonomy and to protect individuals who are disadvantaged to the extent that they cannot practice this right. An autonomous person is defined as an individual who is capable of self-legislation and is able to make judgments and actions based on their particular set of values, preferences, and beliefs. Respecting a person's autonomy thus involves considering their choices and decisions without deliberate obstruction. It also requires that subjects be treated in a non-degra ...
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Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United State ...
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Developing Countries
A developing country is a sovereign state with a lesser developed Industrial sector, industrial base and a lower Human Development Index (HDI) relative to other countries. However, this definition is not universally agreed upon. There is also no clear agreement on which countries fit this category. The term low and middle-income country (LMIC) is often used interchangeably but refers only to the economy of the countries. The World Bank classifies the world's economies into four groups, based on gross national income per capita: high, upper-middle, lower-middle, and low income countries. Least developed countries, landlocked developing countries and Small Island Developing States, small island developing states are all sub-groupings of developing countries. Countries on the other end of the spectrum are usually referred to as World Bank high-income economy, high-income countries or Developed country, developed countries. There are controversies over this term's use, which som ...
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International Development
International development or global development is a broad concept denoting the idea that societies and countries have differing levels of economic development, economic or human development (humanity), human development on an international scale. It is the basis for international classifications such as developed country, developing country and least developed country, and for a field of practice and research that in various ways engages with international development processes. There are, however, many schools of thought and conventions regarding which are the exact features constituting the "development" of a country. Historically, development was largely synonymous with economic development, and especially its convenient but flawed quantification (see parable of the broken window) through readily gathered (for developed countries) or estimated monetary proxies (estimated for severely undeveloped or isolationism, isolationist countries) such as gross domestic product (GDP), of ...
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Return Of Results
Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant. Return of results is particularly discussed in the field of biobanks, where a typical case would be that many members of a community donate biobank specimens for medical research. In the course of the research, especially in human genomics research, scientists may discover personal health information which could influence the behavior of specimen donors if they had this information. For different cases, there are arguments for and against revealing study information to participants and in many cases the morally correct choice is not self-evident. Example situation The following example shows some possible outcomes of trying to fulfill the return of results in genomic research. this example is a restatement of examples given in the article A healthy person donates a biological specimen and agrees to have tha ...
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Institutional Review Board
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 su ...
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Biological Specimen
A biological specimen (also called a biospecimen) is a biological laboratory specimen held by a biorepository for research. Such a specimen would be taken by sampling so as to be representative of any other specimen taken from the source of the specimen. When biological specimens are stored, ideally they remain equivalent to freshly-collected specimens for the purposes of research. Human biological specimens are stored in a type of biorepository called a biobank, and the science of preserving biological specimens is most active in the field of biobanking. Quality control Setting broad standards for quality of biological specimens was initially an underdeveloped aspect of biobank growth. There is currently discussion on what standards should be in place and who should manage those standards. Since many organizations set their own standards and since biobanks are necessarily used by multiple organizations and typically are driven towards expansion, the harmonization of stand ...
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Cost–benefit Analysis
Cost–benefit analysis (CBA), sometimes also called benefit–cost analysis, is a systematic approach to estimating the strengths and weaknesses of alternatives. It is used to determine options which provide the best approach to achieving benefits while preserving savings in, for example, transactions, activities, and functional business requirements. A CBA may be used to compare completed or potential courses of action, and to estimate or evaluate the value against the cost of a decision, project, or policy. It is commonly used to evaluate business or policy decisions (particularly public policy), commercial transactions, and project investments. For example, the U.S. Securities and Exchange Commission must conduct cost-benefit analyses before instituting regulations or deregulations. CBA has two main applications: # To determine if an investment (or decision) is sound, ascertaining if – and by how much – its benefits outweigh its costs. # To provide a basis for comparing inve ...
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Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United State ...
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National Institute Of General Medical Sciences
The National Institute of General Medical Sciences (NIGMS) supports basic research that increases understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS-funded scientists investigate how living systems work at a range of levels, from molecules and cells to tissues and organs, in research organisms, humans, and populations. Additionally, to ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in training the next generation of scientists, in enhancing the diversity of the scientific workforce, and in developing research capacity throughout the country. NIGMS is one of the National Institutes of Health (NIH), the principal medical research agency of the Federal Government. NIH is a component of the U.S. Department of Health and Human Services. All NIH Institutes and Centers support basic research that is relevant to the diseases, organ systems, stages of li ...
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Informed Consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning a ...
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