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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.
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:
- Information relating to sexual attitudes, preferences, or practices;
- Information relating to the use of alcohol, drugs, or other addictive products;
- Information pertaining to illegal conduct;
- Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
- Information that would normally be recorded in a subject's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
- Information pertaining to an individual's psychological well-being or mental health.
- Information in other categories not listed may also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.
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:
Children/minors have a wide range of capacity depending on age, maturity and psychological state. There is potential for control, coercion, undue influence, or manipulation by parents, guardians, or investigators, particularly of young children.
Pregnant women (the concern is focused on the fetus)
Embryos and Fetuses have absolutely no capacity and are under the direct control of the mother.
Prisoners "A prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing." Included are those in hospitals or alcohol and drug treatment facilities under court order. Individuals in work-release programs and in at-home detention programs also qualify as prisoners. The definition applies to minors as well as to adults.
Mentally Disabled Individuals have problems with capacity, which may be continuous or fluctuating, depending on the disability. In addition, they may have limitations on voluntariness because often they are institutionalized or hospitalized, are economically and educationally disadvantaged, and suffer from chronic diseases. As a result, they are potentially subject to control, coercion, undue influence, or manipulation.
Educationally Disadvantaged Subjects may have limitations on understanding of the study they will participate in, and may even be illiterate. The possibility exists for undue influence and/or manipulation.
Economically Disadvantaged Subjects may be vulnerable due to a limitation on voluntariness. They may enroll in research only to receive monetary compensation, or they may enroll in research to obtain medical care they cannot otherwise afford. There is potential for undue influence or manipulation.
Marginalized Social Groups may lack influence in society as a result of race, age, disease, sexual orientation, or caste systems. These groups often do not have full access to social institutions such as the legal system. There is potential for control, coercion, undue influence, or manipulation.
Individuals with Incurable or Fatal Diseases often have limitations on voluntariness, and in addition may have problems with capacity caused by disease or medications. These individuals may accept very high risks in desperation for a cure, even when there is little or no prospect of direct benefit.
Emergency Situations can create a situation where capacity and voluntariness is compromised. There are often limitations to capacity due to the emergency condition. There are often limitations on voluntariness due to time constraints or hospitalization. An example is research on heart attack medications, in which the subjects are asked to consent in the ambulance on the way to the hospital. There is potential for control, coercion, undue influence, or manipulation.
Hierarchical Social Structures that confront hospitalized patients, nursing home residents, employees, students, prisoners, military personnel, and some ethnic groups can create situations where voluntariness can be compromised. There is potential for control, coercion, undue influence, or manipulation.