Beneficence see Belmont Report
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.
Identifiable Personal Information
No single item (except possibly a person's Social Security Number, which by law cannot be used except for very specific circumstances) can be relied upon to identify an individual with certainty. Names, addresses or telephone numbers may more directly identify an individual than postal codes, date of birth, age, occupation, initials, hospital or student number, ethnic group or religion. Photographs and audio or video recordings may lead to identification.
Although individual items may not by themselves permit identification of an individual, taken together in a given context and with a certain amount of effort and use of other sources, a combination of items may allow an individual to be identified. This means that all items of information relating to an individual may have the potential to identify that individual.
A “strictly anonymous” study design is one in which it is impossible to trace data or information back to the research subject from whom it was obtained. In other words, the data cannot be identified to any particular research participant, not even by the researcher. There is total separation. No study design that involves the creation of a code linking the subject’s identity to a pseudonym or a number can be termed an anonymous study, as the identity of the subject can be traced to the data. Additionally, when a written consent form is collected, this consent form has to be separated from the data that the subject provides. The PI (principal investigator) needs to describe in the protocol how this will be accomplished.
Generally, on-line surveys (SurveyMonkey, Zoomerang, and others) are accomplished with anonymity. But, not always, as these examples show. The PI must assure the IRB in writing the protocol that the process does not collect IP (internet protocol) addresses which could identify the computer user. It is also possible that enough identifiers (gender, age, race, work-site, etc.) could identify a person in the dataset when downloaded.
“Confidential” research participation means that the data from the research subject(s) can potentially be identified or linked to a particular individual. Thus, any data collected face-to-face (consumer survey, focus groups, standing in front of a classroom, etc.) is automatically considered in the category of being “confidential” as opposed to “anonymous.” This is true even when the researcher assigns a coding number to the subject—and this number cannot be traced back to the subject—because the researcher him-/herself knows who provided the data.
Informed Consent is the term given to the communication process that allows individuals to make an informed choice about participation in a research study. This process is reflected in an informed consent document that contains specific, required information about the research study. The informed consent document serves as the formal authorization by an individual of their agreement to participate in the proposed research. Some research protocols may not require signed consent, or in some rare circumstances, the consent process may be waived Templates
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 contact between the investigator and a subject such as by way of interviews or survey questionnaires.
Justice see Belmont Report
Principal Investigator (PI) is the lead person who is responsible for the design, conduct, and reporting of a research project. The PI is responsible for initiation of an IRB review, completing all required training, completing the IRB application form, and gathering all required documentation and signatures. The PI is also responsible for requesting IRB approval for any protocol changes after IRB approval and for the reporting of any adverse events taking place during the research. The PI must apply for IRB renewal for projects lasting longer than one year. More....
Private information includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual in circumstances or conditions where the individual reasonably expects the information will not be made public. 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 to constitute research involving human subjects.
Protected health information is defined as individually identifiable health information maintained or transmitted by a covered entity in any form or medium and includes: demographic information; medical history; information relating to the past, present or future physical or mental health or condition of an individual that is identifiable; the provision of health care to an individual or the payment for the provision of health care; physical examinations, blood tests, x-rays; and other diagnostic and medical procedures.
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. For example, some demonstration and service programs may include research activities.
Respect for Persons see Belmont Report
Risk should be interpreted in a broad sense to mean not just physical risk but also legal, psychological, social, and economic risk. Discomfort, pain, and embarrassment should be minimized and justifiable in terms of anticipated benefit(s). ("Minimal risk" is quite explicitly defined in (45 CFR 46.) Designating a project "minimal risk" does not diminish the responsibilities of either the IRB or the investigators, nor does it eliminate the requirement for obtaining informed consent.)
Sensitive Research may involve the collection of information falling into any of the following categories:
Systematic Investigations are studies that are intended and designed to collect data about human subjects with the purpose of drawing conclusions and reporting research findings
Vulnerable Populations or Circumstances resulting in vulnerability to coercion, manipulation, or undue influence and reduced or limited voluntariness may include: (see also OHRRP Guide Chapter 6)