Human subject research definition

Human subject research means any medical or psychological research which utilizes human subjects who may be exposed to the possibility of physical or psychological injury as a consequence of participation as subjects and which departs from the application of those established and accepted methods appropriate to meet the subject's needs but does not include
Human subject research or “HSR” means any social science, biomedical, behavioral, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge in which human beings: (i) are exposed to manipulation, intervention, observation or other interaction with investigators, either directly or through alteration of their environment; or (ii) become individually identifiable through investigators’ collection, preparation or use of biological material or medical or other records.
Human subject research means any medical or psychological research which utilizes human subjects who may be exposed to the possibility of physical or psychological injury as a consequence of participation as subjects and which departs from the application of those established and accepted methods appropriate to meet the subject's needs but does not include (i) the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, (ii) epidemiological investigations, or (iii) medical treatment of an experimental nature intended to save or prolong the life of the subject in danger of death, to prevent the subject from becoming disfigured or physically or mentally incapacitated or to improve the quality of the subject's life pursuant to §37.1- 234 of the Code of Virginia.

Examples of Human subject research in a sentence

  • Human subject research, including clinical trials and observational studies, must not be disguised promotion.

  • Human subject research definitions, categories, and resource information may be found in the Human Subject Resource Document on the eBRAP website (https://ebrap.org/eBRAP/public/Program.htm).

  • Human subject research definitions, categories, and resource information may be found in the Human Subject Resource Document on the eBRAP website (https://ebrap.org/eBRAP/ public/Program.htm).

  • Human subject research studies that are not classified as exempt and that are not eligible for expedited review require review by the full Board at a convened meeting.

  • The first 3 days of the program involved heavy physical activity (push-ups, squat thrusts, and running) and hydration was likely not adequate during this time.


More Definitions of Human subject research

Human subject research means a systematic investigation, experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) in which a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual; or identifiable private information.
Human subject research means systematic investigation relating to human subjects designed to develop or contribute to generalizable knowledge. This includes study design, testing, and evaluations involving a living individual about whom a Principal Investigator or Other Key Personnel obtains data, through intervention or interaction with the individual, or through the use of identifiable private information.
Human subject research means any medical or psychological research which utilizes human subjects who may be exposed to the possibility of physical or psychological
Human subject research under the DHHS regulations means an activity that is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (If the activity is NOT a systematic investigation designed to develop or contribute to generalizable knowledge, the activity does not meet the definition of human subject research under the DHHS regulations. However, it may meet the definition of human subject research under the FDA definition.)
Human subject research means a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge and involving a living individual about whom the investigator conducting the research obtains data through intervention or interaction with the individual or identifiable private information.
Human subject research or “HSR” means any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge in which human beings: (i) are exposed to manipulation, intervention, observation or other interaction with investigators, either directly or through alteration of their environment; or (ii) become individually identifiable through investigators’ collection, preparation or use of biological material or medical or other records. “International HSR Standards” means: (i) the Declaration of Helsinki (WMA 2013); (ii) International Conference on Harmonisation. ICH Topic E6(R2): ‘Guideline for Good Clinical Practice’ 2016; (iii) World Health Organisation ‘Good Clinical Laboratory Practice’ (ISBN 978-92-4-159785-2); and (iv) the last approved version of the International Ethical Guidelines for Health Related Research Involving Humans (CIOMS). The Recipient will safeguard the rights and welfare of human subjects participating in Human Subject Research and will ensure that all Human Subject Research is carried out in accordance with: (i) national and local laws and regulations applicable to Human Subject Research; and (ii) International HSR Standards. In the event of any conflict between applicable national laws and International HSR Standards, the Recipient will comply with whichever standard provides the greater protection for research subjects, provided that the Recipient will not be in breach of any applicable national laws. The Recipient will ensure that appropriate terms are included in its agreements with any subcontractors responsible for carrying out Human Subject Research to ensure that the Recipient is able to comply with this obligation. The Recipient will not commence any Human Subject Research prior to being informed by Xxxxxxx that WHO's Research Ethics Review Committee (“WHO ERC”) has either: (i) approved the research protocol or protocols for such Human Subject Research; or (ii) issued a decision waiving the requirement for its approval. The Recipient will ensure that appropriate liability insurance coverage is obtained prior to the commencement of all Human Subject Research and is maintained at all relevant times. Such insurance will conform to all relevant standards and regulations and will be consistent with best practices applicable in the sponsor’s jurisdiction. It will be taken out with a reputable international insurance provider and will cover, as a minimum, c...
Human subject research means research conducted with human subjects by