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IRB Terms & Definitions

Amendment

The use of express or implied threats of violence, reprisal, or other intimidating behavior to compel a person to act against their own will. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.

 

Anonymized Data

Previously identifiable data that have been de-identified and for which a code or other link no longer exists. An investigator has no means for linking anonymized data back to a specific subject.

 

Anonymous Data

Data originally collected without identifiers and were never linked to an individual. To remain anonymous a study cannot ask participants personal information that could possibly give away their identity.

 

Approval Date

The first date that research can be performed. The approval date is reflected on the Texas State IRB approval letter.

 

Assent

A child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent. The child must actively show a willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way.

 

Assurance

A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.

 

Autonomy

Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

 

Behavioral Research

The scientific study of the interactions and activities of people in naturalistic settings. The focus of this type of research can include both the exploration of the decision processes and individual functioning.

 

Biologic

Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries. Biologics include vaccines, blood and blood products, cellular and gene therapy products, tissue and tissue products, and allergenics.

 

Biomedical Research

The study (i) to increase scientific understanding about normal or abnormal physiology, disease states, or development; and (ii) to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention.

 

Clinical Research

The evaluation of biomedical or behavioral interventions related to disease processes or normal physiological functioning.

 

Clinical Trials

Research studies involving human participants assigned to an intervention designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.

 

Coded Data

Data separated from personal identifiers through use of a code. As long as a link exists, data are considered indirectly identifiable and not anonymous, anonymized, or de-identified.

 

Coercion

The use of express or implied threats of violence, reprisal, or other intimidating behavior to compel a person to act against their own will. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.

 

Cognitively Impaired

Individuals having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

 

Common Rule

The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies. The Health and Human Services (HHS) regulations, 45 CFR Part 46, include four subparts:

  • subpart A, also known as the Federal Policy or the “Common Rule”;
  • subpart B, additional protections for pregnant women, human fetuses, and neonates;
  • subpart C, additional protections for prisoners; and
  • subpart D, additional protections for children.

 

Compensation

Payment for participation in research or for medical care provided to subjects as a result of being injured in research.

 

Confidential Data

Information collected from research participants which only the investigator(s) or individuals of the research team can identify the responses of individual subjects. Researchers must take every effort to prevent anyone outside of the project from connecting individual subjects with their responses.

 

Continuing Review or Renewal

The mechanism by which the IRB annually reviews the conduct of research. Continuing Reviews (Renewals) only apply to Expedited and Full Board protocols which extends a protocol’s original expiration date.

 

Data Use Agreement (DUA)

Contractual document used for the transfer of data that has been developed by a nonprofit, government or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use.

 

Deception

Occurs as the result of investigators providing false or incomplete information to participants for misleading research subjects. The IRB accepts the need for certain types of studies to employ strategies that include deception.

 

De-identified Data

A data set in which identifying information has been removed by the original researcher and does not include any of the 18 HIPAA Privacy Rule identifiers which could be used alone or in combination with other information to identify the subject.

 

Directly Identifiable Data

Any information that includes personal identifiers.

 

Education Research

The scientific study of how humans (both adults and children) learn in various educational settings, while examining the effectiveness of educational interventions, or attempting to understand the constructive teaching methods or curricula, in addition to investigating the social psychology of academic settings.

 

Epidemiology Research

A study that targets specific health outcomes, interventions, or disease states and attempts to reach conclusions about cost-effectiveness, efficacy, interventions, or delivery of services to affected populations.

 

Equitable

Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.

 

Ethnography Research

The study of people in their natural environments where people live and work or in any other surrounding where people interact.

 

Exempt Review

Research can be approved as “Exempt” if it is no more than minimal risk and fits one of the 6 federally designated categories. These categories of research are not exempt from review by the Texas State IRB, state laws, or the requirements for ethical research. Typically, Research Integrity and Compliance or the IRB chairperson rather than by the entire IRB conducts an Exempt review.

 

Expedited Review

Expedited review is applicable for research activities that involve no more than minimal risk to the human participants and that can be placed in one or more of the 9 federally defined categories. Expedited review is conducted by the IRB chairperson or by one or more of the experienced IRB members designated by the chairperson or Research Integrity and Compliance to conduct the review. The IRB member conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research.

 

Expiration Date

The date after the end date of the approval period. All research activities involving data collection or analysis of identifiable information must cease the day after the expiration date unless a Continuing Review (Renewal) is granted. An expiration date may not be longer than one year from the date the original approval or Continuing Review.

 

Full Board Review

A full board review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.

 

The following categories of research require full IRB approval:

  • Projects for which the level of risk is determined by the IRB Chair to be greater than minimal
  • Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants
  • Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals)
  • Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).

 

Generalizable Knowledge

Information intended to be shared, published, presented, and is intended to have an impact (theoretical or practical) on others within one’s discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, or future research designs are contributing to generalizable knowledge.

 

HIPAA

The Health Insurance Portability and Accountability Act of 1996. Also known as “The Privacy Rule,” HIPPA regulations are intended to protect patients from inappropriate disclosures of their protected health information (PHI) that could cause harm to their insurability, employability and/or their privacy.

 

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information (no intervention or interaction required).

 

Identifiable

Investigator can readily ascertain or associate the information with the individuals’ identities.

 

Identifiable Private

Information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

 

Indirectly Identifiable Data

Data that do not include personal identifiers, but link the identifying information to the data through use of a code. These data are still considered identifiable by the Common Rule.

 

Informed Consent

A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. The information that is given to the subject shall be in language understandable to the subject. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

 

Institutional Review Board

A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

 

Interaction

Includes communication or interpersonal contact between investigator and subjects. The interaction may be as remote as an anonymous, online survey.

 

Intervention

A manipulation of research participants’ environment for modifying one or more health-related or behavioral processes or endpoints.

 

Journalism

The production and distribution of reports on the interaction of events, facts, ideas, and people that are the "news of the day" and that informs society to at least some degree of accuracy.

 

Key Personnel

Those involved in the design, conduct, or reporting of the research. Research personnel can include students.

 

Medical Device

Any health care product that does not achieve its primary intended purposes by chemical or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins.

 

A Medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or
  • intended to affect the structure or any function of the body.

 

Minimal Risk

The probability and magnitude of harm or discomfort anticipated in the proposed research are no greater than those encountered in daily life.

 

Minors

Individuals under 18 years of age, regardless of the jurisdiction in which the research is performed.

 

Noninvasive

A medical procedure that does not enter or penetrate the body (e.g., ultra-sound, collection of sweat, hair or nail clippings).

 

Personal Identifiable Information

Information about an individual including but not limited to, education, financial transactions, medical history and criminal or employment history, and information that can be used to distinguish or trace an individual’s identify, such as name, Social Security number, address, phone number, date and place of birth, mother’s maiden name, biometric data, and including any other personal information that is linked or linkable to a specific individual.

 

Principal Investigator (PI)

The PI is the person who is ultimately responsible for the conduct of the study. For student-initiated research, the student’s faculty advisor serves as the PI and is ultimately responsible for the conduct of the study.

 

Private information

Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.

 

Prospectively Assign

A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

 

Protected Health Information (PHI)

Any information in the medical record or designated record set that can be used to identify an individual and that was created, used, or disclosed in the course of providing a health care service such as diagnosis, treatment, or payment.

 

The following is the list of 18 identifiers under HIPPA:

  1. Names;
  2. All geographical subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
  3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
  4. Phone numbers;
  5. Fax numbers;
  6. Electronic mail addresses;
  7. Social Security numbers;
  8. Medical record numbers;
  9. Health plan beneficiary numbers;
  10. Account numbers;
  11. Certificate/license numbers;
  12. Vehicle identifiers and serial numbers, including license plate numbers;
  13. Device identifiers and serial numbers;
  14. Web Universal Resource Locators (URLs);
  15. Internet Protocol (IP) address numbers;
  16. Biometric identifiers, including finger and voice prints;
  17. Full face photographic images and any comparable images; and
  18. Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data).

 

Public Behavior

Anything that is heard, seen, or witnessed by other people in a public place.

 

Publicly Available Data

Information in the public domain that can be freely used reused and redistributed by anyone with no existing local, national or international legal restrictions on access or usage.

 

Repository Research

The examination of stored data (retrospective or prospective data, various outcome measures or artifacts, photographs and recordings) or materials (cells, tissues, fluids, and body parts) from individually identifiable living persons.

 

Research

A systematic investigation designed to develop or contribute to generalizable (widely applicable) knowledge.

 

Risk

The discomforts, hazards, or inconveniences to the subjects related to the subjects’ participation in the research. The probability, magnitude, duration, and reversibility of the risks should be described in the application. Consider physical, psychological, social, legal, and economic risks

 

Scholarly and journalistic activities 

The collection and use of information, that focus directly on the specific individuals about whom the information is collected. 

Examples include the following: 
 oral history 
 journalism 
 biography 
literary criticism 
legal research 
historical scholarship 

 

Social Research

The scientific study of how people and groups interact. This research may explore social behavior and mental processes but with an emphasis on how humans think about each other and how they relate to each other.

 

Surveys

Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, email, social media, or similar procedures.

 

Systematic Investigation

Predetermined method for studying a specific topic, answering question(s), testing a specific hypothesis, or developing theory. A scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective and a set of procedures intended to reach the objective. Examples of systematic investigations include (but are not limited to):

  • surveys and questionnaires
  • interviews and focus groups
  • public or private observations
  • evaluations of social or educational programs
  • cognitive and perceptual experiments
  • medical chart or student record review studies

 

Undue influence

Occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized.

 

Voluntary

Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.

 

Vulnerable Populations

Special classes of subjects who may be vulnerable in terms of their research participation. Subjects are considered vulnerable when they are not respected as autonomous agents and/or their voluntariness is compromised.

 

There are two important types of vulnerability:

  1. Decisional impairment, whereby potential subjects lack the capacity to make autonomous decisions in their own interest, perhaps as a result of undue influence/inducement
  2. Situational/positional vulnerability, whereby potential participants may be subjected to coercion