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Certificate Of Confidentiality
In the United States, a certificate of confidentiality (CoC) is issued by the National Institutes of Health (NIH) and other Health and Human Services (HHS) agencies to protect identifiable research information from forced or compelled disclosure. It allows the investigator and others who have access to research records to refuse to disclose identifying information on research participant A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A rese ...s in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. Certificates of confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation. By ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Institutes Of Health
The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in 1887 and is part of the United States Department of Health and Human Services (HHS). Many NIH facilities are located in Bethesda, Maryland, and other nearby suburbs of the Washington metropolitan area, with other primary facilities in the Research Triangle Park in North Carolina and smaller satellite facilities located around the United States. The NIH conducts its scientific research through the NIH Intramural Research Program (IRP) and provides significant biomedical research funding to non-NIH research facilities through its Extramural Research Program. , the IRP had 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, being the largest biomedical research institution in the world, while, as of 2003, the extramural arm provided 28% of biomedical ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health And Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the US federal government created to protect the health of the US people and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW). HHS is administered by the secretary of health and human services, who is appointed by the president with the advice and consent of the United States Senate. The United States Public Health Service Commissioned Corps, the uniformed service of the PHS, is led by the surgeon general who is responsible for addressing matters concerning public health as authorized by the secretary or by the assistant secretary for health in addition to his or her primary mission of administering the Commissioned Corps. History Federal Security Agency The ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Subpoena
A subpoena (; also subpœna, supenna or subpena) or witness summons is a writ issued by a government agency, most often a court, to compel testimony by a witness or production of evidence under a penalty for failure. There are two common types of subpoenas: # '' subpoena ad testificandum'' orders a person to testify before the ordering authority or face punishment. The subpoena can also request that the testimony be given by phone or in person. # '' subpoena duces tecum'' orders a person or organization to bring physical evidence before the ordering authority or face punishment. This is often used for requests to mail copies of documents to a requesting party or directly to a court. Etymology The term ''subpoena'' is from the Middle English ''suppena'' and the Latin phrase ''sub poena'' meaning "under penalty". It is also spelled "subpena".See, e.g., ; ; ; and . The subpoena has its source in English common law and it is now used almost with universal application throughout the E ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Investigator
A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors. See also * Clinical site * International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) * Drug development * Data monitoring committees * Food and Drug Administration (FDA) * European Medicines Agency (EMA) * European Forum for Good Clinical Practice (EFGCP) * American Society for Clinical Investigation The American Society for Clinical Investigation (ASCI), established i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Research Participant
A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as children, infants, and animals. Such individuals are preferentially referred to as subjects. Rights In accordance with modern norms of research ethics and with the Declaration of Helsinki, researchers who conduct human subject research should afford certain rights to research participants. Research participants should expect the following: *to be the target of Beneficence (ethics), beneficence *to experience Justice (ethics), research justice *to get respect for persons *to have privacy for research participants *to be informed *to be safe from undue danger Terminology There are several standard themes in the choice of words (''participant, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Research Study
Research is 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 of 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, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge. Approaches to research depend on epistemologies, which vary considerably both within and between humanities and sciences. There are several forms of research: scientific, humanities, artistic, economic, s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
21st Century Cures Act
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations. The approval of drugs and devices would be streamlined, according to supporters, and treatments would reach the market more quickly. The argument made by opponents was that it would allow the marketing of riskier or less effective treatments by allowing the approval of drugs and devices on the basis of flimsier evidence, bypassing randomized, controlled trials. The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-Congressman Tim Murphy, R-Pa., which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and su ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biospecimen
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 standard op ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Confidential Information
Confidentiality involves a set of rules or a promise sometimes executed through non-disclosure agreement, confidentiality agreements that limits the access to or places restrictions on the distribution of certain types of information. Legal confidentiality By law, lawyers are often required to keep confidential anything on the representation of a client. The duty of confidentiality is much broader than the attorney–client privilege, attorney–client evidentiary privilege, which only covers ''communications'' between the attorney and the client. Both the privilege and the duty serve the purpose of encouraging clients to speak frankly about their cases. This way, lawyers can carry out their duty to provide clients with zealous representation. Otherwise, the opposing side may be able to surprise the lawyer in court with something he did not know about his client, which may weaken the client's position. Also, a distrustful client might hide a relevant fact he thinks is incrimin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Human Subject Research In The United States
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. (A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
