Definitions

A

Administrative Hold - An administrative hold is a voluntary action by an investigator, institutional official, or sponsor to temporarily or permanently stop some or all approved research activities. The administrative hold does not apply to interruptions of research related to concerns regarding the safety, rights or welfare of human research participants or others. Administrative holds are not suspensions or terminations, and do not meet reporting requirements to OHRP, FDA, and other federal agencies. Protocols on administrative hold remain open and are subject to continuing review and requirements for reporting non-compliance and unanticipated problems involving risks to participants or others.

---

Adverse Event - Any untoward physical or psychological occurrence in a human subject participating in research. An AE can be any unfavorable or unintended event including abnormal laboratory findings, symptoms, or diseases associated with the research or associated with the use of a medical investigational test article.

---

Agent - Agents include all individuals performing designated activities or exercising institutionally delegated authority or responsibility.

---

Allegation - An assertion made by a party that must be proved or supported with evidence.

---

Anonymized Data - Previously identifiable data (indirectly or individually identifiable) that have been de-identified and for which a code or other link no longer exists. A researcher has NO way to link anonymized data back to a specific participant.  Anonymized data IS NOT the same as anonymous, coded, or de-identified data.

---

Anonymous Data - Data collected without identifiers and never linked to an individual.  Anonymous data is not the same as coded, anonymized or de-identified data as the researcher has NO way to link the data to a participant.

---

Approval - The study approved as submitted, or when requested revisions have been addressed and approved. A signed approval letter from the staff must be received before any research activity begins.

---

Audit - A systematic review, inspection, or verification, typically conducted by an independent individual or group.

---

Authorization Agreement - (Also called a Reliance Agreement) identifies and describes the respective authorities, roles, responsibilities, and methods of communication between an institution/organization providing the ethical review of research and a participating site relying on the institution/organization.

B

Biological product (also: biologic) - A virus, therapeutic, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, gene therapies, cellular therapies, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.

C

Central IRB (CIRB)/Single IRB (sIRB) - The selected IRB of record that conducts the ethical review of research for all participating sites of a multi-site study.

---

Child/Children - Person(s) 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. For purposes of WVU OHRP policy, individuals under 18 years of age are considered children in West Virginia unless they meet the definition of emancipated minors.

---

Clinical investigation (also: research, clinical research, clinical study) - Any experiment that involves a test article and one or more human subjects that either:

• Meets the requirements for prior submission to FDA under sections 505(i) or 520(g) of the Food, Drug, and Cosmetic Act; or
• Need not meet the requirement prior submission to FDA under the sections noted above, but the results of which are intended to be later submitted to or held for inspection by FDA as part of an application for a research or marketing permit. 

Clinical Trial - A research study in which one or more human subjects are prospectively assigned to one or more interventions (including a placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

---

Coded - Data are 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 - Persuasion (i.e., of an unwilling person) to do or to agree to something by using obvious or implied force or threats.

---

Common Rule - The Common Rule refers to the “Federal Policy for the Protection of Human Subjects” adopted by a number of federal agencies. Although the Common Rule is codified by each agency separately, the text is identical to the Department of Health and Human Services (DHHS) regulations in 45 CFR 46 Subpart A. For the purposes of this document, references to the Common Rule will cite the DHHS regulations.

---

Continuing Non-Compliance -  A pattern of repeated actions or omissions to act that suggest a future likelihood of reoccurrence and that indicate a deficiency in the ability or willingness to comply with federal regulations or the policy, requirements, and determinations of the IRB governing human subject research. These actions can also compromise the scientific integrity of a study such that important conclusions can no longer be reached, and can suggest a likelihood that non-compliance will continue without intervention, or involves frequent instances of minor non-compliance. Continuing non-compliance may also include failure to respond to a request from the IRB to resolve an episode of non-compliance or a pattern of minor non-compliance.
PLEASE NOTE: Noncompliance can be continuing if it persists after the investigator/PI knew or should have known about the event(s). In such cases, the WVU IRB holds a presumption of continuing noncompliance, placing the burden on the PI to present compelling, mitigating circumstances. The period in which the continuing noncompliance occurred could be days or weeks (depending on the seriousness of the matter), and the IRB does not need to call an issue noncompliance before being able to call it continuing noncompliance.

---

Custom Device - A device that necessarily deviates from devices generally available or from an applicable performance standard or pre-market approval requirement to comply with the order of an individual physician or dentist and that is:

• Not generally available or generally used by other physicians or dentists;
• Not generally available in finished form for purchase or for dispensing upon prescription;
• Not offered for commercial distribution through labeling or advertising; and
• Intended for use by an individual patient named in the order of a physician or dentist and is to be made in a specific form for that patient or is intended to meet the special needs of the physician or dentist in the course of professional practice.

D

Data Use Agreement (DUA) - An agreement between the research (recipient) and the covered entity that the researcher will protect the protected health information in a Limited Data Set and use it for the agreed-upon purposes.

---

De-Identified - Data in which identifying information is removed. Under HIPAA Privacy Rule, data are de-identified if either:

• Expert Determination - An experienced expert determines that the risk that certain information could be used to identify an individual is "very small" and documents and justifies the determination
  OR
• Safe Harbor - The data do not include any of the 18 identifiers (of the individual or his/her relatives, household members, or employers), which could be used alone or in combination with other information to identify the subject. Note that even if these identifiers are removed, the Privacy Rule states that information will be considered identifiable if the covered entity knows that the identity of the person may still be determined. An expert is not involved in the Safe Harbor method.

E

Emancipated Minors - For purposes of WVU OHRP policy, the following persons under the legal age of 18, who because of their unique circumstances have the legal rights of adults, including the right to consent to treatments or procedures involved in research:

• Married persons over 16 but under 18 years of age.

F

Family Member - For purposes of the waiver of informed consent for emergency research, any one of the following legally competent persons: spouse, parent, child (including an adopted child), brother, sister, spouse of a brother or sister, and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.

---

Federalwide Insurance - A formal, written, binding attestation in which an institution ensures to the U.S. Department of Health and Human Services (HHS) that it will comply with applicable regulations governing the protection of human subject.

---

Fetus - Unborn child; the product of conception from implantation until delivery.

G

Guardian - An individual who is authorized under applicable state or local law to consent on behalf of a child to generate medical care. In West Virginia, a guardian may be any individual, family member, association, or agency other than the biological or adoptive parents who has been formally appointed as a guardian or legal representative by a court to care for a child, including to consent on behalf of child to general medical care.

Note: Grandparents or other family members who are not formally appointed as guardians or legal representatives by a court generally do not have the authority to provide consent on behalf of a child without consent by the child’s parents.

H

HIPAA Identifiers - List of 18 identifiers - Protected Health Information (PHI)

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
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)

I

Identifiable Specimen - A biospecimen for which the identity of the participant is or may be established by the researcher or associated with the biospecimen.

---

Identifiable Private Information - Private information for which the participant's identity is or may be established by the researcher or associated with the information.

---

Indirectly Identifiable - Data that do not include personal identifiers but link the identifying information to the data using a code. These data are still considered identifiable by the Common Rule. To determine what data may be considered identifiable, please see de-identified.

---

Individually Identifiable (HIPAA) - Information that includes personal identifiers. The 18 HIPAA Identifiers or any subset of health information that identifies the individual can reasonably be used to identify the individual.

---

Intervention - Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes. Also includes communication or interpersonal contact between the researcher and the participant.

---

Implant - A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more.

---

Individual Investigator Agreement (IIA) - The agreement of an individual investigator (also referred to as research study personnel) to Institutional Human Subject Protection Policies and IRB Oversight, particularly those outlined by the institution which extends its FWA to cover the individual investigator under specified research protocols.

---

Informed Consent (also, legally effective informed consent) - Agreement to participate in research expressed by an individual their legally authorized representative) authorized under applicable law to make such decisions, based on sufficient information (e.g., regarding possible risks and benefits of the research) and adequate opportunity to consider voluntary participation.

---

Institutional Official (IO) -  Agreement to participate in research expressed by an individual their legally authorized representative) authorized under applicable law to make such decisions, based on sufficient information (e.g., regarding possible risks and benefits of the research) and adequate opportunity to consider voluntary participation.

---

Institutional Review Board (IRB) - An IRB is a board designated by WVU to review, to approve the initiation of, and to conduct a periodic review of research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The IRB may be assigned other review functions as deemed appropriate by the Organization.

---

Investigational Device - A device (including a transitional device) that is the object of an investigation.

---

Investigational Drug (also investigational new drug) - A new drug or biologic (i.e., not approved for marketing by FDA) used in a clinical investigation, including a biological product used in vitro for diagnostic purposes.

---

Investigational New Drug Application (IND) - An application that permits an investigational drug that would otherwise be required to have pre-market approval by FDA to be legally shipped for a clinical investigation.

---

In Vitro Diagnostics - In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

---

IRB Authorization Agreement (IAA) - see "Reliance Agreement."

---

IRB of Record - An IRB that assumes IRB responsibilities for another institution or independent investigator for a specific study, group of studies, or for all research conducted by another institution/investigator. This relationship must be documented in advance by a written reliance agreement.

J

K

L

Limited Data Set - A “limited data set” is a limited set of identifiable patient information as defined in the Privacy Regulations issued under HIPAA. A “limited data set” of information may be disclosed to an outside party without a patient’s authorization if certain conditions are met. First, the purpose of the disclosure may only be for research, public health or health care operations. Second, the person receiving the information must sign a data use agreement with WVU.

A “limited data set” is information from which “facial” identifiers have been removed. Specifically, as it relates to the individual or his or her relatives, employers or household members.

The health information that may remain in a Limited Data Set includes:  It is important to note that this information is still protected health information or “PHI” under HIPAA. It is not de-identified information and is still subject to the requirements of the Privacy Regulations. All the following identifiers MUST be removed in order for health information to be a “limited data set”

• Names
• Street addresses (other than town, city, state and zip code);
• Telephone numbers
• Fax numbers
• Email addresses
  
• Social Security numbers
• Medical records numbers
• Health plan beneficiary numbers
• Account numbers
• Device identifiers and serial numbers
• URLs
• IP address numbers
• Biometrics identifiers (including finger and voice prints); and
• Full face photos (or comparable images)

M

Minimum Necessary -  This standard does not apply to uses and disclosures for treatment purposes (so as not to interfere with treatment) or to uses and disclosures that an individual has authorized, among other limited exceptions. Justification regarding what constitutes the minimum necessary will be required in some situations (e.g., disclosures with a waiver of authorization and non-routine disclosures).

---

Minimal Risk (for 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.

Note: the regulatory definition of of minimal risk for research involving prisoners differs from the definition of minimal risk for research involving participants who are not prisoners.

---

Multi-site/Collaborative/Cooperative Research Study - The conduct of non-exempt human subjects research at more than one site.

N

Need to Know - A security principle stating that a user should have access only to the data needed to perform a particular function.

---

Non Compliance - Failure to abide by the policies, requirements, and determinations of the IRB, or federal rules and regulations.

---

Non-Significant Risk (NSR) Device - An investigational device that does not meet the definition of a significant risk device.

---

Nonviable Neonate - A neonate that (although alive following delivery) is not capable of surviving to the point of sustaining life independently, even with the support of available medical treatment, as determined by a physician who is engaged in research.

O

P

Parent -  A child’s biological or adoptive mother or biological or adoptive father.

---

Participant Site - Entity that will rely on the IRB of another institution/organization (a.k.a. an external IRB) to carry out the IRB review of human subjects research for a multi-site study.

---

Permission - The agreement of a parent(s) or legal guardian to the participation of his/her child or ward in the research.

---

Planned Emergency Research - Research involving human subjects who require emergency medical intervention (e.g., comparison of methods of treating acute ischemic strokes), but who cannot give informed consent because of their life-threatening medical conditions and who do not have available legally authorized representative to provide consent.

---

Pregnancy - The period of time from implantation (of a fertilized egg with the uterus) until delivery of the fetus.

---

Prisoner - An individual involuntarily confined or detained in a penal institution (e.g., prison, jail, or juvenile offender facility), with restricted ability to leave the institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Q

Quality Improvement - A process initiated to develop and/or enhance a practice or procedure and to institutionalize the practice or procedure.

R

Reliance Agreement - A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution.

---

Relying Institution or Organization - Is relying on the review of or has ceded IRB review to another IRB to provide oversight for a specific research study or set of studies. This process is also referred to as deferring (or ceding) IRB review.

---

Research - The Common Rule Defines research as a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalized knowledge.

---

Research Misconduct - Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or reporting research results. Instances meeting the definition of research misconduct will be reported to the Institutional Official (IO) by the OHRP Director, IRB Chair, or IRB Vice Chair. Attempts to unduly influence an IRB member or OHRP staff are not considered research misconduct under federal or WVU policy. IRB members or staff members who believe that they have been subject to undue influence must report this to the IO or OHRP Director, IRB Chair, or IRB Vice Chair. The OHRP Director, IRB Chair, or IRB Vice-Chair will report all allegations of undue influence to the IO, who will coordinate the inquiry, investigation, and hearing phases as needed. All investigations and reporting will be conducted according to the policies outlined by the Office of Academic Integrity.

---

Research Under the Auspices of WVU - Research under the auspices of WVU includes research conducted at WVU, conducted by or under the direction of any employee or agent of WVU (including students) in connection with his or her institutional responsibilities, conducted by or under the direction of any employee or agent of WVU using any property or facility of WVU, or involving the use of WVU’s non-public information to identify or contact human subjects.

---

Reviewing IRB - see "IRB of Record."

---

Routine (Not-for-Cause) Review - An assessment or examination of something (e.g., a research practice or procedure) with the possibility or intention of instituting change if necessary.

S

Safe Harbor - A HIPAA de-identification method.  The PI or member of the research team, de-identify the data without expert assistance by removing the HIPAA identifiers of the individual or of relatives, employers, or household members of the individual:

• Names
• All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geocodes, except for the initial three digits of the ZIP code if, according to the current publicly available data from the Bureau of the Census:
• The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and
• The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people is changed to 000
• All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, 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
• Telephone numbers
• Vehicle identifiers and serial numbers, including license plate numbers
• Fax numbers
• Device identifiers and serial numbers
• Email addresses
• Web Universal Resource Locators (URLs)
• Social security numbers
• Internet Protocol (IP) addresses
• Medical record numbers
• Biometric identifiers, including finger and voice prints
• Health plan beneficiary numbers
• Full-face photographs and any comparable images
• Account numbers
• Any other unique identifying number, characteristic, or code, and
• Certificate/license numbers
• The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.

T

Termination -  A termination of IRB approval is a directive of the convened IRB, or designee, to permanently stop all activities in a previously approved research protocol. Terminated protocols are considered closed and no longer require continuing review.

---

Test Article - Items covered under the FDA regulations include human drugs, medical devices, and biological products.

---

Transitional Device - A device subject to section 520(l) of the Food, Drug, and Cosmetic Act; a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.

U

Unanticipated Problems - Unanticipated problems involving risks to participants or others are defined as any incident, experience, or outcome that meets all of the following criteria:

• Unexpected (not foreseeable by the researcher or the research participant) given the research procedure and the subject population being studied;
• Related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights, and welfare of current participants; and
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

V

Viable Neonate -  A neonate able to survive, given the benefit of available medical treatment, to the point of independently maintaining heartbeat and respiration as determined by a physician who is not engaged in the research.

W

WVU Official - A WVU Official is a person employed by the University in an administrative, legal, supervisory, academic, research, or support staff position (including law enforcement unit personnel and health staff); or a person serving on the board of governors; or a student serving on an official committee, such as the Committee on Student Rights and Responsibilities. It may also include a volunteer or contractor outside of the institution who performs an institutional service or function for which the school would otherwise use its own employees and who is under the direct control of the school with respect to the use and maintenance of Personally Identifiable Information (PII) from education records, such as an attorney, auditor, or collection agent or a student volunteering to assist another University official in performing his or her tasks.

X

Y

Z