Human Subjects Application
Human Subjects Application (doc)
Those planning to conduct any type of research with humans, including survey or interview research or evaluation studies, should complete the Application well in advance of data collection.
Definitions
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Code of Federal Regulations TITLE 45 – Public Welfare Department of Health and Human Services Part 46.102 Definitions (2005, June 23)
Who are “investigators”?
The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
- obtaining information about living individuals by intervening or interacting with them for research purposes;
- obtaining identifiable private information about living individuals for research purposes;
- obtaining the voluntary informed consent of individuals to be subjects in research; and
- studying, interpreting, or analyzing identifiable private information or data for research purposes.
Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
http://www.hhs.gov/ohrp/investigatefaq.html
Generalizable Knowledge:
An understanding or comprehension developed from scholarly activity in a specified field of study. The findings are sourced from actions taken to further develop or advance a scholarly endeavor. Contributions to generalizable knowledge are expected to induce conclusions from the activity or derive particulars from data or information. The distribution of results can be a sufficient measure for identifying generalizable knowledge.
Examples:
Generalizable Knowledge includes one or more of the following:
- The data are geared for scholars, practitioners, and/or researchers within a specified field of study
- Results of the study are presented either by presentation or publication in order to illuminate some topic/issue within one's field of
- The study’s results can be replicated by others
- The study provides input into some field of study (adapted from the University of Michigan)
*UW-Stout Human Subjects Training (2006, July 21) Retrieved August 28, from http://www2.uwstout.edu/rs/hstraining/13.html
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