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Human Subjects Research (IRB) - Definitions
IRB Application Definitions
For purposes of the IRB, research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge [45 CFR 46.102(a)].
- Systematic investigation is the gathering and analysis of information.
- Generalizable knowledge is determined by whether results are published, presented to the public, or developed for others to build upon. This includes journal articles, oral or poster presentations, theses, dissertations, and oral histories.
- Some creative components will meet the definition of human subjects research, contact the IRB with your concerns.
Any activity that fails to meet either of these criteria is not considered research for the purposes of the IRB. This definition applies regardless of what a funding agency may call the activity (i.e., demonstration grant).
For purposes of the IRB, a human subject is defined as a living individual about whom an investigator conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect will not be made public (a medical record, for example). Private information must be individually identifiable in order for obtaining the information to constitute research with human subjects [45CFR 46.102(f)].
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.”
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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.
For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
The risks to subjects in social and behavioral research are more often psychological and social than physical; however, these risks are just as real to the subjects who experience them. Powerful emotions that may be drawn out through participation in certain social and behavioral research can result in both short and long-term suffering. Breaches of confidentiality that can occur in behavioral and social research can be stigmatizing, place a subject at risk of criminal or civil liability, or result in serious and perhaps permanent damage to a subject's financial standing, employability, insurability, or reputation.
Many of the risks can be minimized considerably with careful planning. As an example, where strong emotions may be released as a result of participation, appropriate interventions need to be identified beforehand and clearly stated in the application, and should be part of the consent process.
Where breaches of confidentiality can be a source of risk, investigators should attempt to identify potential opportunities for breaches and document mitigating measures. An example of this is the storage of sensitive data with identifiers in a database on an internet connected computer. This increases the potential for the database to be accessed by unauthorized individuals (hacked). A mitigating measure would be to store data on a password protected non-networked computer.
When issues of this nature are clearly spelled out in the application, it is often possible for the IRB to conclude that the research presents no greater than minimal risk to the subjects, and that the risks to the subjects are no greater than those they might encounter in everyday life. Often, too, when this is the case, the research may qualify for a waiver from the requirements for written documentation of consent, so long as the process for obtaining voluntary and informed consent is clearly an integral part of the methodology.
- hair and nail clippings in a non-disfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excreta and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
- sputum collected after saline mist nebulization.
- vaginal swabs that do not go beyond the cervical os;
- rectal swabs that do not go beyond the rectum; and
- nasal swabs that do not go beyond the nares.
IRB Special Populations Definitions
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.402(a)].
A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage or procreation.
The OSU-Stillwater Office of Legal Counsel has provided the following guidance on the age of legal majority in Oklahoma:
By law (10 O.S. Section 10) the authority of a parent over a minor child ceases upon the child’s marriage. Therefore, a married minor, regardless of whether he/she is living with or dependent on his/her parents, is free to agree to participate in a research project.
Section 2601, et. seq of title 63 of the Oklahoma Statutes provides that minors may self-consent to receive medical treatment if they are married, have a dependent child or have been emancipated by a court order. This authority is limited, however, to medical treatment which would not include participation in human subject research. Oklahoma law does not recognize the concept of “emancipated minor” for the purpose of research.
Except in those rare situations where the minor is married, consent should be obtained from the minor’s parent/guardian.
Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor.
A child's biological or adoptive parent
An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(e)].
A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent [45 CFR 46.402(b)].
The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].
A valued or desired outcome; an advantage.
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution in a penal institution [45 CFR 46.303(c)].
The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons . Note: The definition of minimal risk for prisoners as human subjects is different. It refers to physical or psychological harm as opposed to harm or discomfort, and uses “healthy persons” standard. The risks to which prisoners may be exposed by participating in the research are not compared with risks normally encountered by prisoners, but rather with risks normally encountered in the daily lives or psychological examination of healthy persons (e.g., non-prisoners).