Download Determining Human Research Activity and more Study notes Data Communication Systems and Computer Networks in PDF only on Docsity! WORKSHEET: Human Research NUMBER DATE PAGE HRP-310 10/12/12 1 of 2 The purpose of this worksheet is to provide support for individuals in determining whether an activity is Human Research or how it is regulated. This worksheet is to be used. It does not need to be completed or retained. Is activity “Human Research” as defined by DHHS? Is activity “Human Research” as defined by FDA? “Human Research” under DHHS and FDA Is activity “Human Research” as defined by FDA? “Human Research” under DHHS only NOT “Human Research” “Human Research” under FDA only No NoNo Yes Yes Yes START 1 Research as Defined by DHHS Regulationsi (Check if “Yes”.) Is the activity an investigation? (Investigation: A searching inquiry for facts; detailed or careful examination.) Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.) Is the systematic investigation designed to develop or contribute to knowledge? (Designed: observable behaviors used to develop or contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.) Is the knowledge the systematic investigation is designed to develop or contribute generalizable? (Generalizable: Universally or widely applicable.) 2 Human Subject Under DHHS Regulations (Check if “Yes”.) Is the investigator conducting the Research gathering data about living individuals? 3 Human Subject Under DHHS Regulations (Check if “Yes”.) Will the investigator gather that data through either of the following mechanisms (specify which mechanism(s) apply): Physical procedures or manipulations of those individuals or their environment for research purposes (“intervention”). Communication or interpersonal contact with the individuals. ("interaction”). 4 Human Subject Under DHHS Regulations (Check if “Yes”) Will the investigator gather data that is either? Specify which category(s) apply if yes: The data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place (i.e. “Private information”). Individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will NOT be made public, such as a medical record (i.e. “Private information”). Can the individuals’ identities be readily ascertained or associated with the information by the investigator (i.e. “Identifiable information”)? If all items are checked under 1, 2, and 3 or 1, 2, and 4, the activity is Human Research under DHHS regulations. 5 Human Research Under FDA Regulations (Check if “Yes”) Does the activity involve any of the following? (Check all that apply) In the United States: The use of a drugii in one or more persons other than use of an approved drug in the course of medical practiceiii. In the United States: The use of a deviceiv in one or more persons that evaluates the safety or effectiveness of that device. Data regarding subjects or control subjects submitted to or held for inspection by FDAv. Data regarding the use of a device on human specimens (identified or unidentified) submitted to or held for inspection by FDAvi. If “Yes”, the activity is Human Research under FDA regulations. If the activity is Human Research under DHHS regulations or under FDA regulations, it is Human Research under organizational policy. 6 Engagement (Complete if the activity is Human Research. (Check if “Yes”) The organization is engaged in Human Research. Use WORKSHEET: Engagement Determination (HRP-311))
