According to hhs regulations, research must be systematic, which means that it
Determining whether a project requires review by the IRB is sometimes difficult and for this reason it is always best to consult with the Human Research Protection Office (HRPO) for guidance. Show The HRPO makes the determination whether or not a project meets the definition of human subject research. Federal regulations require that proposed research involving human subjects be reviewed and approved by the Institutional Review Board prior to project initiation. If you are unsure if your project meets the definition of research or if you require documentation that your project does not require IRB review, complete and submit a Determination in Kuali. The determination of whether or not a project or activity is defined as human subject research rests on the answers to the following three questions:
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. For purposes of this document, coded means that:
Determinations of what does or does not involve human subject research must be made by the IRB or individuals designated by the IRB Chair who have sufficient training and expertise in making such determinations. In analyzing a particular activity under this question, it is important to focus on what is being obtained by the investigators. If the investigators are not obtaining either data through intervention or interaction with living individuals, or identifiable private information, then the research activity does not involve human subjects. What about Research Involving Coded Private Information or Biological Specimens? Whether or not an activity is classified as “not involving human subjects” or qualifies for exemption under 45 CFR 46.101(b)(4) is determined by the following:
Research involving only coded private information or specimens is not considered human subject research if both of the following conditions are met:
The exemption under 45 CFR 46.101(b)(4) applies to research involving private information and specimens when:
This exemption would not apply if the investigators, having obtained identifiable private information or specimens from existing records or specimens, record the data or information in a coded manner, since the code would enable subjects to be identified through identifiers linked to the subjects. What is meant by research is a systematic investigation?Research means a systematic investigation designed to develop or establish principles, facts generalizable knowledge, or any combination of them, and includes the development, testing and evaluation of research.
What are the criteria for the regulatory definition of research?Defining Research
The Common Rule defines research as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
What is a systematic investigation designed to develop or contribute to generalizable knowledge?Research - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.
Why research needs a systematic investigation?Generally, research is the organised and systematic method of finding answers to questions. It is systematic because it is a process broken up into clear steps that lead to conclusions. Research is organised because there is a planned structure or method used to reach the conclusion.
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