NOTE: THESE DEFINITIONS ARE GUIDELINES. BEFORE ENGAGING IN ANY HUMAN SUBJECTS RESEARCH, PLEASE CONTACT THE IRB FOR A DETERMINATION OF REVIEW REQUIREMENTS. Source: United States Department of Health and Human Services Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects
Anonymous Data: refers to research information that is collected without any personal identifiers. An example would be survey research that does not ask for the participants’ names or any other form of personal identification.
Benefit: is a research outcome that may be valuable or desired by participants, for example learning about ways to increase academic success. Note: a payment or reward for research participation is not a benefit.
Children: are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.402(a)]
Confidentiality: means the protection of private information that an individual has disclosed in a relationship of trust. Research participants are frequently asked to provide personal or private information for the purposes of the research. In some research, the private information could be linked to the individual participant. For example, a research study on improvement in student achievement might include work products with individual children’s names. In the informed consent process the researcher explains exactly what will be done with the private information and what he or she will do to keep the information confidential--safe from any other type of disclosure. [see Privacy]
Engaged in Research: In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. For a detailed discussion, see http://www.hhs.gov/ohrp/policy/engage08.html
Exempt from Further IRB Review: When the IRB Office receives an Application, the IRB Chair and IRB Coordinator will determine whether it may be considered exempt from further IRB review. To be considered exempt, the research may only involve human subjects in one of 6 categories. Briefly described, these are:
- Research conducted in normal educational settings, using normal educational practices.
- Anonymous educational tests, surveys, interviews or observations
- Types of educational tests or surveys when the research subjects are public officials
- Collection or study of existing data if individuals cannot be identified
- Investigation of public benefit or service programs
- Taste and food evaluations and acceptance studies.
Please see the Research Application form and 5 CFR 46.101(b) for full details. See Research Involving Children
Expedited Review: Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through an expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review—expedited or convened—utilized by the IRB. Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Briefly described, the categories of research that may be reviewed using an expedited procedure are:
- Clinical studies of drugs and medical devices only when an investigational new drug application is not required, or an investigational device exemption is not required.
- Collection of limited amounts and frequency of blood samples by finger stick, heel stick, ear stick, or venipuncture from certain categories of adults and children.
- Prospective collection of biological specimens for research purposes by noninvasive means and in a nondisfiguring manner, such as hair and nail clippings, saliva, or mucosal and skin cells collected by swab.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
- For further details, please see the Research Application form, 45 CFR 46.100 and Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure. Office for Human Research Protections (OHRP)
Full IRB Committee Review: is required for research that is neither exempt from further IRB review nor expeditable.
Human Subject: A human subject is a living individual with whom an investigator interacts in order to gather private information. Gathering information about deceased individuals is not an activity subject to IRB review. However, caution is needed because the health privacy law (HIPAA) does mandate review of research that gathers information about deceased individuals. [45 CFR 46.102(f)]
Intervention and Interaction: Interventions include physical procedures such as drawing blood as well as manipulation of the subject or the subject’s environment for research purposes, as might occur in a classroom setting. Interactions are conversations and interpersonal contact between the investigator and the subject. Examples are interviews, telephone conversations, focus groups, classroom observations and email interchanges [45 CFR 46.102(f)(2)].
Individually Identifiable Information: Some information gathered by researchers contains data points that allow the researcher or others to determine who has provided the information. Identifiers include, but are not limited to names, social security numbers, student ID numbers, date of birth, addresses, videos and photos. Researchers should be aware that with very small sample sizes, especially in qualitative research, it can be relatively easy to piece together a subject’s identify from anecdotal information. Assigning pseudonyms in this type of research will usually not prevent identification.
Informed Consent: A person's voluntary agreement to participate in research. Informed consent is a process, not only a document. The researcher must ensure that the person receives enough information to clearly understand what the person will be asked to do in the research project. IRB’s devote a great deal of attention to informed consent documents and processes. Federal regulations require that certain pieces of information are included in informed consent documents. For a checklist of informed consent requirements, see http://www.hhs.gov/ohrp/policy/consentckls.html
Institutional Review Board (IRB): is a committee that is established in accordance with federal policy for the protection of human subjects. [45 CFR 46.102(g)]
IRB approval: means the determination of the IRB that the research reviewed may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. [45 CFR 46.102(h)]
Minimal Risk Research: is research that will most likely be safe for participants and not expose them to any type of harm. 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. [45 CFR 46.102(i)]
Principal Investigator: The principal investigator is the researcher who is responsible for the ethical conduct of the research protocol. Responsibilities include safeguarding the rights and welfare of human subjects, conducting the research according to the IRB-approved protocol, promptly reporting any adverse effects or subject complaints, submitting an amendment request if any changes are being considered, and submitting a Continuing Review form for any research expected to continue beyond the initial approval period.
Privacy: The OHRP online guidebook defines privacy as "control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others." Loss of privacy is considered to be a risk factor.
Privacy includes both personal behavior and information that a person has provided for other purposes. In most daily situations, individuals can reasonably expect that their behavior is not being observed or recorded; for example in a public park, store fitting room, or restroom. Unless persons have been told that there are security cameras in operation, they can assume that no one is watching them. Researchers must inform participants about any method involving observation or recording of personal behavior 45 CFR 46.102(f)
Individuals often provide private information for purposes such as education, social or psychological services, or medical care. Individuals expect and trust that this information will not be made public. Researchers who wish to access this private information must obtain informed consent from research participants [See Confidentiality]
Private Information: includes both personal behavior and information that a person has provided for other purposes. In most daily situations, individuals can reasonably expect that their behavior is not being observed or recorded; for example in a public park, store fitting room, or restroom. Unless persons have been told that there are security cameras in operation, they can assume that no one is watching them. Researchers must inform participants about any method involving observation or recording of personal behavior.
Also, individuals often provide private information for purposes such as education, social or psychological services, or medical care. Individuals expect and trust that this information will not be made public. Again, researchers who wish to access this private information must obtain informed consent from research participants [45 CFR 46.102(f)(2)].
Research: in general is any form of investigation that seeks to contribute to generalizable knowledge [45CFR 46.102(d)]. Research includes many different styles of inquiry, including scholarly investigation, survey research, and experimental research. What these styles have in common is the process of posing a question, gathering data, analyzing information, drawing conclusions and publishing results for the wider scholarly community. Research subject to IRB review and approval involves interacting with human subjects to gather private information that is individually identifiable. [45 CFR 46.102(d)]
Vulnerable Adult: is any person older than age 18, or emancipated by marriage who has a substantial mental or functional impairment.