Definitions

Glossary of Terms (Alphabetical)

Agent of the Organization – Agents include all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility.

Chair – Chair or Vice-Chair, as designated on UI IRB roster submitted to OHRP, unless otherwise indicated.

Children (Child) – DHHS definition: persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

FDA definition: persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.

**For purposes of research conducted in Iowa, the term “child” as used in both the DHHS and FDA regulations is analogous to “minor” under Iowa Code and is viewed as “an unmarried person under the age of eighteen years.” (Based on Iowa Code §600A.2 (12))

Clinical Investigation – FDA definitions:

• any experiment that involves a test article and one or more human subjects and that is one of the following:
  • subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or
  • is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act but the results of which are intended to be submitted later to , or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
  • The term does not include experiments that are subject to the provision of 21 CFR 58, regarding nonclinical laboratory studies. (From 21 CFR 50.3(c); 21 CFR 56.102(c))
• any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. (From 21 CFR 312.3(b))

(Investigation): a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. (From 21 CFR 812.3(h))

Confidentiality – the ethical or legal right that information is considered private and will be held secret unless consent is provided permitting disclosure.

Conflict of Interest – 

• Conflict of interest in research involves situations in which an investigator has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. The terms "investigator" and "significant financial interest" are defined below.
• Investigators conducting research funded by the Public Health Service (including National Institutes of Health) and National Science Foundation, as well as those conducting studies regulated by the Food and Drug Administration, are subject to agency specific regulations (II-18.8 below). These regulations set forth the obligations of investigators, sponsors and institutions for research involving significant financial or other conflicts of interest, and affected parties are advised to review the relevant regulations prior to submission of a research proposal or application.
  • "Investigator" means the principal investigator and any other person, whether faculty, staff, or student, who is responsible for the design, conduct, or reporting of research. "Investigator" also includes the investigator's spouse and dependent children.
  • "Significant financial interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (patents, copyrights, and royalties from such rights) held by an investigator or the investigator's immediate family(Immediate family means spouse or domestic partner, and dependent children), individually or in aggregate, when such interest involves:

1. Payments in excess of $10,000 (including salary, consulting fees, royalty or licensing payments from intellectual property, and honoraria and/or gifts) received within the past 12 months or anticipated for the next 12 months (excluding salary and other payments for services from the University);
2. An equity interest in a publicly traded company worth more than $10,000 or more than 5 percent of the business entity as determined by reference to its publicly listed price (excluding mutual funds);
3. Any equity interest if the value cannot be determined by reference to publicly listed prices (i.e., an equity interest in a privately held company, such as a start-up company);
4. A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any other position of management; or
5. Intellectual property rights (patents or copyrights) or royalties from such rights whose value may be affected by the outcome of the research, including royalties distributable under University policy or any royalty-sharing agreements involving the University.

• Personal agreements between sponsors and investigators, IRB members, or their immediate family members where the amount of compensation (consulting, board honoraria, or any other kind) could change depending on the outcome of a study or any other activity the faculty/IRB member performs as part of their University service are prohibited. In some cases, such arrangements are illegal under state law.

For UI IRB members only, the following indicate a conflict of interest with a protocol under review:

• s/he serves as a co-investigator or other member of the research team or
• a member of his/her immediate family serves as a co-investigator or other member of the research team.

Immediate family means spouse or domestic partner, and dependent children.

Continuing Noncompliance – Any noncompliance that occurs repeatedly to the point of suggesting a pattern or an underlying problem. Continuing noncompliance may occur due to lack of knowledge (unintentional) or due to deliberate choice to ignore regulations or determinations of the IRB (intentional).

Covered Entity - A covered entity is:

1. a health plan
2. a health care clearinghouse (billing service)
3. a health care provider that transmits health information electronically

Existing (Data, Documents, Records, Pathological or Diagnostic Specimens) – Existing with regards to these materials means the items must be “on the shelf” or in existence at the time the project is submitted to the IRB for review.

Federal Agency Other than DHHS that is subject to “The Common Rule” 

Any one of the following:

• Agency for International Development (22 CFR 225)
• Central Intelligence Agency (Executive Order)
• Consumer Products Safety Commission (16 CFR 1028)
• Department of Agriculture (7 CFR 1c)
• Department of Commerce (15 CFR 27)
• Department of Defense (32 CFR 219)
• Department of Education (34 CFR 97)
• Department of Energy (10 CFR 745)
• Department of Homeland Security (Public law 108-458 Sec. 8306)
• Department of Justice (28 CFR 46)
• Department of Transportation (49 CFR 11)
• Department of Veteran’s Affairs (38 CFR 16)
• Environmental Protection Agency (40 CFR 26)
• Housing and Urban Development (24 CFR 60)
• National Aeronautics and Space Administration (14 CFR 1230)
• National Science Foundation (45 CFR 690)
• Office of Science and Technology Policy (Adoption of policy)
• Social Security Administration (Public law 7.5.26)

Guardian – a person who is not the parent of a child, but who has been appointed by a court or juvenile court having jurisdiction over the child, to have a permanent self-sustaining relationship with the child and to make important decisions which have a permanent effect on the life and development of that child and to promote the general welfare of that child. A guardian may be a court or a juvenile court.

Unless otherwise enlarged or circumscribed by a court or juvenile court having jurisdiction over the child or by operation of law, the rights and duties of a guardian with respect to a child shall be as follows:

1. To consent to marriage, enlistment in the armed forces of the United States, or medical, psychiatric, or surgical treatment.
2. To serve as a guardian ad litem, unless the interests of the guardian conflict with the interests of the child or unless another person has been appointed guardian ad litem.
3. To serve as custodian, unless another person has been appointed custodian.
4. To make periodic visitations if the guardian does not have physical possession or custody of the child.
5. To consent to adoption and to make any other decision that the parents could have made when the parent-child relationship existed.
6. To make other decisions involving protection, education, and care and control of the child.

[From Iowa Code 232.2(21)]

Human subject – DHHS definition: a living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual, or b) identifiable private information. (From 45 CFR 46.102.(d))

FDA definitions (human participant):

• an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient. (From 21 CFR 50.3(g))
• (Subject): a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control A subject may be in normal health or may have a medical condition. (From 21 CFR 812.3(p))

Identifiable Private Information - Private 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). This information is considered individually identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information. (From 45 CFR 46.102(f)(2)

If information includes Protected Health Information (as defined later under Protected Health Information), identifiable information includes any of the following information for the individual, relative, employer, or household member of the individual:

• Name, street address, city, county, precinct, zip code, geocodes smaller than state
• Date of birth, ages > 89 years of age; or other dates such as diagnosis dates, procedure dates, admission or discharge dates
• Telephone numbers, fax numbers, e-mail addresses, social security numbers, medical record number
• Health plan beneficiary numbers, account numbers, certificate/license numbers
• Vehicle identifiers and serial numbers or license numbers, device identifiers and serial numbers
• Web URLs, Internet Protocol (IP) address numbers, biometric identifiers including finger/voice prints
• Full face photographic images and any comparable images.

Interaction - An interaction includes communication or interpersonal contact between investigator and participant.

Intervention - An intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes.

Legally authorized representative (LAR)- An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

studies involving children in the state of Iowa, the LAR is:

• the parent, OR
• the court-appointed guardian.

In studi​es involving cognitively impaired adults in the state of Iowa, the LAR is:

• the designated proxy (such as a Durable Power of Attorney for Health Care)
• the court-appointed guardian
• spouse
• adult child
• parent
• adult sibling

In studies that involve cognitively impaired adults, permission must be sought from the first existing person in the above list, even if another relative is more conveniently available.

Minimal risk – 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) and 21 CFR 50.3(k)).

In research involving prisoners – 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. (45 CFR 46.303(d)).

Minor modifications – modifications to a research project and/or consent documents

that pose no additional risk to subjects (e.g. changes in title, co-investigator(s), funding sources).If the modification is an addition or modification of procedures they must fall into one of the categories eligible for expedited review. To be considered a minor modification, it must also maintain similar or increased safeguards to protect the subject.

Noncompliance – failure to follow the federal regulations with respect to protection of human subjects in research or failure to follow the determinations of the IRB with respect to conduct of the research as approved by the IRB.

Nonscientist - an individual who has little or no formal scientific or medical training orexperience.

Nonsignificant Risk (NSR) device investigation - one that does not meet the FDA definition for a Significant Risk study.

Privacy – freedom from unauthorized intrusion or the state of being let alone and able to keep certain personal information to oneself.

Protected Health Information (PHI) – information that:

1. is transmitted or maintained in any form (electronic, oral, paper) by a covered entity, and

2. identifies the individual or could reasonably be used to identify the individual; and

3. relates to the past, present or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past,present or future payment for the provision of healthcare to an individual. (From 45 CFR 160.103)

Quorum – a majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.

Research - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration.) (From 45 CFR 46.102(d))

Research Misconduct – fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data or creative innovations that are nonetheless ethical, legal and meet professional standards.

Risk – 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 may vary from minimal to significant.

Serious adverse drug experience – Any adverse drug experience (associated with the use of the drug) occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention toprevent one of the outcomes listed above. (from 21 CFR 312.32(a))

Serious Noncompliance – Noncompliance that materially increases risks or that results in unexpected substantial harm to subjects or others. In addition the following instance(s) of noncompliance, as defined by OHRP, will always be determined as serious noncompliance:

• Non-Exempt human subjects research being carried out without IRB review and approval or without appropriate informed consent.
• Substantive modifications to IRB-approved research without IRB approval.