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Human Subjects Division (HSD)

Glossary

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510k device

A 510(k) is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device [21 CFR 807.92(a)(3)]. See: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm See also: pre-market approval

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A

academic records

Documentation of a student's achievement in school, college or university. (FERPA and PPRA regulations may apply.) See also: FERPA and PPRA

administrative closure

Closure of a study that does not have IRB approval, due to: (1) a lapsed approval, or (2) a failure to respond to conditions of approval). Initiated by HSD, not the researcher or the IRB.

adverse event (AE)

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the subject’s participation in the research, and does not imply any judgment about causality.

approved drug

Drug products approved by the FDA. See: FDA web site at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm

assent

Regulatory term. Agreement to participate in research by an individual who is not competent to give legally valid informed consent (e.g., a child or cognitively impaired person).

assurance

Regulatory term. 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. [45 CFR 46.103]

Authorized Institutional Official

Regulatory term. An office of an institution who has the authority to speak for and legally commit the institution to compliance with the requirements of the federal regulations regarding the involvement of human subjects in research.

autonomy

An individual's right to consider alternatives, make choices, and act without undue influence or interference of others. See: Belmont Report.

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B

Belmont Report

A report that sets out basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. See: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

beneficence

An ethical principle discussed in the Belmont Report that entails an obligation to promote good (or benefits).

benefit

In the research context, something of positive value derived from research procedures. Per OHRP regulations and guidance (45 CFR 46.116, http://answers.hhs.gov/ohrp/questions/7250.html) payments, gifts, course credit, etc. for research participation are not considered to be a benefit. See also: Belmont Report.

biologic

Biologics are derived from living sources (such as humans, animals, micro-organisms) in contrast to most drugs which are chemically synthesized and have a known structure. Most biologics also meet the definition of "drugs". These products are regulated by the Food and Drug Administration, Center for Biologics Evaluation and Research. See: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123340.htm

biological specimen

A physical sample used for analysis, for example: urine, hair saliva, blood, or other tissues.

botanical
A finished, labeled product that contains vegetable matter, which may include plant materials, algae, macroscopic fungi, or combinations of these. Depending in part on its intended use, a botanical product may be considered a food, drug, medical device, or cosmetic.

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C

CBPR

See: community-based participatory research

certificate of confidentiality

See: federal certificate of confidentiality

CFR

See: Code of Federal Regulations

child

Person who has not attained the legal age (as defined by a state or country) for consent to treatment or procedures involved in the research. Special regulatory requirements apply to research with children. See: 45 CFR 46 Subpart D See also: assent

Clinical Research Organization

Also referred to as "Contract Research Organization", an organization that provides for a fee a wide range of research services. This may include: regulatory and compliance filing and oversight; training of study staff; data quality control; assistance with recruiting, etc.

clinical trial

For information about IRB review of clinical trials at the University of Washington see: http://www.washington.edu/research/hsd/topics/Clinical+Trials

closure, study

For information about closing IRB applications see: http://www.washington.edu/research/hsd/topics/Closing+a+Study+and+IRB+Application

Code of Federal Regulations

For regulations governing research with human subjects see 45 CFR 46 and 21 CFR 50. See also: Common Rule

coded data

Data set in which direct subject identifiers have been replaced with a study code. The link between the study code and direct subject identifiers are kept separate from the data to minimize the ability to identify the subject from the data set.

coercion

In human subjects research, coercion occurs when an overt or implicit threat of harm (such as loss of services or access to programs to which the potential participant is otherwise entitled) is intentionally presented by one person to another in order to obtain compliance or research participation. This is often confused with undue influence. See also: undue influence

co-investigator

Researcher who works alongside the Principal Investigator or Lead Researcher. Co-Investigators can be delegated all of the duties of a Principal Investigator, but do not have final responsibility for the conduct of the study.

Common Rule

Regulations governing research with human subjects, and adopted by many federal agencies; as stated in 45 CFR 46(Subpart A) of the Code of Federal Regulations. See: 45 CFR 46

community-based participatory research

Although the term is widely used to describe many forms of community participation in research, from a regulatory perspective the essential issue is whether there is an independent, community-based, entity (not created solely for a specific research project) whose involvement in the research constitutes "engagement" per federal guidance. See: http://www.hhs.gov/ohrp/policy/engage08.html See also: engagement

compassionate use

Refers to the clinical use of an experimental device prior to FDA approval. Case-by-case approval usually must be obtained in advance, following the procedures outlined in the SOP Device Compassionate Use.

compensation

See: payment

competence

A legal term denoting capacity to act on one's own behalf; the ability to understand information presented, to understand the consequences of acting (or not acting) on that information, and to make a choice. See: 45 CFR 46 http://answers.hhs.gov/ohrp/questions/7266

conditional approval

IRB determination that the applicable criteria for IRB approval of an item have been met based on the assumption that specific conditions will be met by the researcher and subsequently verified.

confidentiality

Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. Confidentiality is about identifiable data, and an agreement about maintenance and who has access to identifiable data.

confidentiality agreement

See: UW Confidentiality Agreement

conflict of interest

Financial or situational factors that potentially could undermine one's ability to make unbiased judgements. In research, refers to factors that could directly and significantly affect the design, conduct, or reportong of research. See also: Financial Conflict of Interest (FCOI); http://www.washington.edu/research/osp/gim/gim10.html

consent form

Document describing the risks, benefits, and study procedures so that potential subjects can make an informed decision whether or not to participate in the research.

continuing non-compliance

A pattern of non-compliance that:

  • Suggests that non-compliance will continue, if there is no intervention, or,
  • Increases the risk of serious non-compliance. See: non-compliance
controls/control subjects

Subjects who are not exposed to the research intervention, treatment or manipulation, or who are exposed but do not have the characteristics under investigation.

controverted issues

An issue discussed at an IRB meeting for which there is a disagreement between some IRB members, or there are opposing viewpoints among IRB members that are voiced during the IRB deliberations. Federal regulations require a summary of controverted issues and their resolution to be included in IRB meeting minutes.

cooperative agreement

When two institutions are frequently engaged in research projects that would require IRB review by both institutions, standing agreements can be developed to govern which institution will provide sole review for a given study. Such agreements are often reciprocal, but do not have to be. Current UW cooperative agreements can be found at: http://www.washington.edu/research/hsd/topics/Cooperative+Agreements

COPPA (Children’s Online Privacy Protection Act)

These federal regulations pertain to online collection of personal information from children under the age of 13. The regulations describe what the researcher must include in a posted privacy policy; the requirement to seek verifiable parental consent and how to do so; and other responsibilities of the researcher.

covered entity

This refers to those individuals, organizations, and institutions that maintain or transmit PHI, and that are required to comply with HIPAA regulations. See: HIPAA and Research http://www.washington.edu/research/hsd/docs/1259, on the HSD web site. See also: hybrid covered entity; PHI

CRO

See: Clinical Research Organization

custom device

A device that is not generally available and that is not be used to determine its safety and effectiveness. Additional specific requirements for a device to be considered a "custom" device are described in the SOP FDA-Regulated Research.

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D

data safety monitoring board (DSMB)

An independent group of experts who monitor subject safety, study outcomes, and study progress while research is ongoing.

data safety monitoring plan (DSMP)

The researcher’s plan to oversee subject safety, study outcomes, and study progress monitoring research progress and quality, reporting problems, and assuring data accuracy and protocol compliance.

data use agreements (DUA)

A legally binding agreement between two parties when data is being transferred from one party to the other. It describes any limitations on the use of the data as well as any confidentiality and access protections.

dead fetus

Special regulatory procedures apply for research with an expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)].

debriefing

In the context of informed consent, the process of providing information to participants at the conclusion of study procedures. The intent of debriefing is to provide participants with previously undisclosed information, to make sure that they are fully informed about their experience, and to repair breaches in the informed consent process.

deception

In the context of informed consent, the omission of relevant information and/or presentation of misleading information about a study.

Declaration of Helsinki

A code of ethics for clinical research first approved by the World Medical Association in 1964. See: http://www.wma.net/en/30publications/10policies/b3/

deferral

The decision (vote) by an IRB that the IRB is unable to approve the research because it cannot make the determinations required for approval. In other words, the applicable criteria for IRB approval have not been met. The IRB defers the item for further review at a future date after changes and/or additional information have been provided by the researcher.

de-identified data

Information is de-identified if there is no reasonable basis to believe that the data can be linked to specific individuals. This has a special definition under HIPAA. See: http://privacyruleandresearch.nih.gov/pr_08.asp#8a

device, FDA classification

Medical devices are classified into one of three groups (Class I, II, or III based on the type of controls necessary to assure the safety and effectiveness of the device. See: 21 CFR 860

DMC

Data Monitoring Committee See: Data Safety Monitoring Board

DOHR (Delayed Onset Human Research)

This determination is granted by HSD to research that meets certain requirements specified by federal regulations. It allows the grant funds for the research to be released and used (for non-human subjects purposes) without IRB approval. It is not a substitute for IRB approval. See also: SOP Delayed Onset Human Research.

DSMB

See: Data Safety Monitoring Board

DSMP

See: Data Safety Monitoring Plan

DUA

See: Data Use Agreements

dual review

This refers to research that requires the review of more than one IRB, because the research engages more than one institution or organization. Dual review can be avoided through the use of "central" IRBs, cooperative agreements, or IRB authorization agreements.

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E

emancipated minor

An emancipated minor is a child who is legally considered an adult. In Washington State, emancipated minor status is not automatic for those who have simply moved away from their parents' home or who have married; rather the child is granted the status of adulthood by a court order or other formal arrangement. Other states have different rules and requirements. For research purposes, this is an important distinction as children are a protected population under the federal regulation 45 CFR 46 subpart D See also: child; federally protected populations

emergency use

The one-time clinical use of an investigational drug or device with a patient in a life-threatening or seriously disabling situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. (This is not related in any way to Emergency Medicine Waivers. See next item.)

emergency medicine consent waivers

Refers to a waiver of consent for emergency medicine research that involves more than minimal risk to subjects and for which it is not possible to obtain consent from the subject or family member. Numerous regulatory criteria and requirements must be met. See: "Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research" (This is not in any way related to emergency use or single patient use. See previous item)

embryo

Early stages of a developing organism, broadly referring to the time from implantation through the eighth week after conception. [45 CFR 46 subpart B]

employee or agent

Refers to someone who: acts on behalf of an organization; exercises institutional authority or responsibility; or performs institutionally-designated activities.

engagement

An institution becomes "engaged" in human subjects research when its employees or agents: (1) Intervene or interact with living individuals for research purposes; or (2) Obtain individually identifiable private information for research purposes; or (3) Have significant responsibility for design and conduct of the study. When an institution is a direct recipient of federal funding (prime awardee) for a human subjects research project, even if it conducts no work with human subjects itself, the institution is engaged. Whether an institution is engaged in research is addressed in detail in the OHRP memo "Engagement of Institutions in Research" http://www.hhs.gov/ohrp/policy/engage08.html and in the SOP Engagement and WORKSHEET Engagement.

exclusion criteria

Characteristics or traits that exclude an otherwise eligible person from a study.

exempt research

Research that meets the definition of “human subjects research” but that is determined by HSD to be exempt from the federal human subjects regulations because it involves no more than minimal risk to subjects and all of the proposed research activities fit within one or more of certain methodological categories. See: HSD Standard Operating Procedure: SOP Exempt Determination. See also: HSD Standard Operating Procedure: SOP Human Subjects Research

expanded access

Expanded access is the FDA mechanism allowing the use of an investigational drug or device outside of a clinical trial to treat a patient. See also: compassionate use; emergency use

expedited review

IRB review that is conducted by the IRB chair, or a designated voting member or group of voting members, rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. Expedited reviews apply the same criteria for IRB approval as reviews conducted by the full convened IRB. [45 CFR 46.110] See:SOP Expedited Review. See also: WORKSHEET Expedited Review Eligibility.

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F

Family Educational Rights and Privacy Act

The Family Educational Rights and Privacy Act (FERPA) [20 U.S.C. § 1232g; 34 CFR Part 99] is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education. See: http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html

FCOI

Financial Conflict of Interest See: conflict of interest

FDA

See: Food and Drug Administration (http://www.fda.gov)

federal certificate of confidentiality

A federal certificate of confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. If granted, certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. See: http://www.washington.edu/research/hsd/topics/Certificates+of+Confidentiality

federally protected populations

See: vulnerable populations See also: Supplement: Protected and/or Vulnerable Populations

Federalwide Assurance (FWA)

Through the FWA, an institution commits to the Department of Health and Human Services that it will comply with the requirements in the HHS Protection of Human Subjects regulations, 45 CFR 46. A Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by the Office for Human Research Protections (OHRP).

FERPA

See: Family Educational Rights and Privacy Act

fetal material

The placenta, amniotic fluid, fetal membranes, and umbilical cord. See: Federally Protected Populations, Subpart B: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartb

fetus

The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. See: Federally Protected Populations, Subpart B: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartb

FHCRC

See: Fred Hutchinson Cancer Research Center

Financial Conflict of Interest (FCOI)

Significant Financial Interest of an Investigator that could directly and significantly affect the design, conduct, or reporting of research. See: GIM 10, Significant Financial Interest

Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. See: http://www.fda.gov

full board review

When proposed research does not meet criteria to be reviewed by either exempt or expedited procedures, proposed research is reviewed at a convened meeting of the Institutional Review Board. [45 CFR 46.108(b)]

FWA

See: Federalwide Assurance

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G

GCP

See: Good Clinical Practice

general controls (FDA)

Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act [21 U.S. Code §360(c) (Food, Drug and Cosmetic Act §513)].

generalizable knowledge

Truths, facts, information or conclusions that are intended to apply more broadly beyond the individuals studied, or beyond a specific time and/or location, such as to other settings or circumstances. Note that the intent to publish is irrelevant.

GIM 10

Grants Information Memorandum (GIM 10) is the Significant Financial Interest Disclosure Policy at the University of Washington Office of Research, Office of Sponsored Programs. See: http://www.washington.edu/research/osp/gim/gim10.html See also: Financial Conflict of Interest

Good Clinical Practice (GCP)

An international quality standard for clinical care, including but not limited to clinical trials involving human subjects. The standard is provided by International Conference on Harmonisation (ICH/GCP). See: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

guardian

An individual who is authorized by court appointment to oversee and make decisions in the best interests of a child, or incapacitated adult. This may include consent to provide medical care or to participate in research activities as a human subject. [45 CFR 46.402(3)] A guardian is one type of legally authorized representative (LAR). See also: legally authorized representative

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H

HDE

See: humanitarian device exemption

Health Insurance Portability & Accountability Act of 1996 (HIPAA)

Contains provisions to protect the confidentiality and security of individually identifiable health care information about patients (Protected Health Information, or PHI) that arises in the course of providing health care in the United States. HIPAA applies only within the jurisdiction of the United States.

HIPAA

See: Health Insurance Portability & Accountability Act of 1996

HIPAA Authorization

The formal documentation of consent for release of protected health information, given by either the patient or a legally authorized representative. For the authorization to be valid, the elements specified by the regulations must be present in the HIPAA Authorization Form. The University of Washington HIPAA Authorization Form must be used for all research access to PHI held by the University of Washington or its affiliated agencies.

HUD

See: humanitarian use device

human subjects

The UW IRB applies two definitions of human subjects. The generic definition of “human subject” is: a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. In addition, for research involving items regulated by the Food and Drug Administration, human subjects are defined as: (1) Living individuals who are or who become a participant in research, either as a recipient of a test article or control. A subject may be either a healthy individual or a patient (have a medical condition or disease); or (2) Individuals on whose specimens an investigational device is used, even when the specimen is a "leftover" clinical specimen that is not individually identifiable. See: http://www.washington.edu/research/hsd/docs/1253

human subjects application

The UW IRB applies two definitions of human subjects. The generic definition of "human subject" is: a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. In addition, for research involving items regulated by the Food and Drug Administration, human subjects are defined as: (1) Living individuals who are or who become a participant in research, either as a recipient of a test article or control. A subject may be either a healthy individual or a patient (have a medical condition or disease); or (2) Individuals on whose specimens an investigational device is used, even when the specimen is a "leftover" clinical specimen that is not individually identifiable. See: SOP Human Subjects Research

humanitarian device exemption

Is a status granted by the Food and Drug Administration (FDA) to devices intended for treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States per year.   This status indicates that the FDA has granted an exemption from the effectiveness requirements of the Food, Drug, and Cosmetic Act.  The device manufacturer is still required to provide sufficient information for the FDA to determine that the device does not pose unreasonable or significant risks and that the probable benefit outweighs the risks, in comparison to the probable risks and benefits of currently available devices or alternative forms of treatment. HDE status provides an incentive for the development of devices for use in limited populations.   See also: humanitarian use device

humanitarian use device

A medical device (1) intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year, and (2) that has been granted Humanitarian Device Exemption status by the Food and Drug Administration (FDA). There are fewer FDA requirements for approval of these devices to encourage manufacturers' research and development of medical devices for use with limited populations. See also: humanitarian device exemption

hybrid covered entity

HIPAA term for entities that have both covered and non-covered components. See also: covered entity

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I

IBC

See: Institutional Biosafety Committee

IDE

See: Investigational Device Exemption

identifiable data

Data which are either (a) directly connected to name/other identifiers, or (b) indirectly connected via a study number or other coding scheme. Even if neither condition applies, it might still be possible to infer identity via descriptors such as age, gender, ethnicity, etc.

Note that this is different from the definition of “identifiable” in the HIPAA regulations about health care regulations. Information that is considered an “identifier” by HIPAA regulations may not meet the federal human subjects definition of “identifiable”. See also: individually identifiable health information

impracticable

Refers to practical barriers (not just inconvenience) to conducting aspects of the research. Consent may be impracticable when the group is very large or its members are deceased, geographically dispersed or difficult to track. Financial, human and other resources required to contact individuals and seek consent may impose undue hardship on the researcher. In some jurisdictions, privacy laws may preclude researchers from using personal information to contact individuals to seek their consent for secondary use of information.

Individual Investigator Agreement

This is a formal binding agreement signed by individuals who are collaborating on research conducted by an institution, but who themselves are not acting as employees or agents of an institution that has a FWA or that regularly conducts human subjects research. The agreement describes the expectations and responsibilities for the individual. See: Individual Investigator Agreement Form See also: Federalwide Assurance

individually identifiable health information

As defined by the HIPAA regulations, this is a subset of health information, including demographic information collected from an individual, and;

  1. Is created or received by a health care professional, health plan, employer, or health care clearinghouse; and
  2. 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 health care to an individual; and
  3. That identifies the individual; or
  4. With respect to which there is a reasonable basis to believe the information can be used to identify the individual.
inclusion criteria

Characteristics or traits of people who are eligible for a study.

IND

See: Investigational New Drug

Information Statement

UW Human Subjects term for a document used to provide information to research participants when the requirement for written consent has been waived.

informed consent

A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence

Institutional Biosafety Committee (IBC)

The IBC evaluates human gene transfer investigations focusing on public protection (i.e., research personnel, care givers, general public, etc.) This review complements IRB review; both are necessary prior to subject enrollment. At the University of Washington, this committee is under Environmental Health and Safety. See also: the IBC guidelines established by NIH: http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc7261582

Institutional Official

See: Authorized Institutional Official

Institutional Review Board (IRB)

A review body established in accordance with the federal regulations for protecting the rights and welfare of human research subjects. [45 CFR 46.103]

interaction

Communication or interpersonal contact between the investigator and the subject. Examples: questionnaires, interviews, surveys. May be by in-person, web-based, mail, e-mail, text, phone, social media, etc.

intervention

Could include: a) physical procedures; b) social, psychological, or emotional manipulations, by which data are gathered; or c) manipulations of the subject or subject’s environment performed for research purposes. “Environment” includes an individual’s social and virtual environments as well as physical environment.

Investigational Device Exemption (IDE)

Exemption from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].

Investigational New Drug (IND)

An IND application is the document submitted to the Food and Drug Administration (FDA) for permission to conduct a clinical study using a drug or biologic that is new or not approved for a given dosage, formulation, route, or indication. When the FDA approves an IND application, it assigns an IND number to the specific use of the item.

investigator's brochure (IB)

A comprehensive document summarizing the body of information about an investigational drug. The IB should include a brief description of the drug substance and formulation, a summary of the drug’s pharmacological and toxicological effects, safety and effectiveness in humans, and possible risks and side effects based on prior experience with the drug under study or with related drugs.

IO

Institutional Official See: Authorized Institutional Official

IRB

See: Institutional Review Board

IRB application

See: human subjects application

IRB Authorization Agreement

An agreement that authorizes one institution to provide IRB review for another. See: http://www.washington.edu/research/hsd/docs/459 See also: Federalwide Assurance (FWA)

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J

justice

An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly. See also: Belmont Report

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L

LAR

See: legally authorized representative

lead researcher

See: Principal Investigator

legal guardian

See: guardian

legally authorized representative

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 research. In Washington State, the following individuals are considered to be LARs (RCW 7.70.065), in order or priority as listed below. It is UW policy that the LAR must have a reasonable knowledge of the subject. It is UW policy that no individuals other than those described here may serve as LARs for research participation.

  • The appointed guardian
  • The person to whom the subject has given a durable power of attorney, which must include the authority to make health care decisions
  • The subject's spouse or state-registered domestic partner
  • The adult children of the subject
  • The parents of the subject
  • The adult siblings of the subject
limited data sets

Protected Health Information (PHI) that excludes specific individual identifiers as described in HIPAA regulations. See: UW Medicine Privacy Policy PP-19 for more information. http://depts.washington.edu/comply/docs/PP_19.pdf

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M

material transfer agreement (MTA)

A contract that protects ownership of research materials transferred between research institutions or corporate entities. Examples include: cell lines, cultures, bacteria, nucleotides, proteins, transgenic animals, pharmaceuticals, and chemicals. Each exchange of research material requires an MTA. For repeated exchanges of the same research material, standardized MTAs can help streamline the process. See: http://depts.washington.edu/uwc4c/for-researchers/material-transfers/

medical device

A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, orthopedic pins or other orthopedic equipment and therapeutic hypnosis recordings. See: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

medical problem

A physical or psychological disorder diagnosed by a licensed health care practitioner that:

  • Has a recognized treatment;
  • Occurs in the course of UW-conducted research;
  • Is discovered within one year of the research intervention, treatment, item, design, or procedures;
  • Is more likely than not directly caused by the research intervention, treatment, item, design or procedures; and
  • Does not include problems that are due to:
    • Unusual and ordinary patient care (i.e., the standard course of medical treatment for the subject’s disease or condition);
    • The normal course of the subject’s disease or underlying medical condition; or
    • Substantial or deliberate non-compliance by the subject with the research procedures or process approved by the IRB.
minimal risk

The UW applies the definition of minimal risk provided in federal regulations (45 CFR 46.102): The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

For prisoners: Minimal risk is defined by federal regulation as 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 a healthy person.

minimal risk review

The term commonly used by the UW research community to refer to the expedited review process, as in "Minimal Risk review".

minor

See: child; See also: assent

minor change

Minor changes to IRB-approved research may be approved by the expedited review process (see Minimal Risk review). A Minor change neither materially increases risk, nor materially decreases benefit, when considered in light of any changes proposed to mitigate risk and improve benefit; does not materially decrease scientific merit; and does not adversely affect the assessment of the research with respect to the criteria for approval.

minor non-compliance

Non-compliance that is neither serious nor continuing.

modification

Any changes to an IRB-approved study, such as procedures, purpose, subjects, recruiting materials, study staff, location, etc. Changes must be approved in advance by the IRB. A Modification Form requesting approval of the change must be submitted to the Human Subjects Division. See: http://www.washington.edu/research/hsd/docs/325

monitor, study/research

Responsible for overseeing the progress of a clinical trial and for ensuring that the study is conducted, recorded and reported according to the study protocol, standard operating procedures of the sponsor, Good Clinical Practice (GCP) and local regulatory requirements. Monitors are most commonly required in biomedical and sponsored research.

multi-site trial

Research study conducted in more than one institution. Each site must have local IRB approval to conduct the study, or one IRB must approve all of the sites engaged in the research study. See also: IRB Authorization Agreement

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N

NIH

National Institutes of Health See: http://www.nih.gov

non-compliance

A situation, event or process in human subjects research that is under the researcher’s control and that is inconsistent with the following. This can include inquiries and complaints directed to the researcher that involve an allegation of non-compliance as defined here.

  • The ethical principles of human subjects research as described in the Belmont Report;
  • Federal, state, and/or local regulations applicable to human subjects research under the jurisdiction of the UW IRB;
  • UW policies and procedures governing human subjects research; or
  • The research activities as approved by the UW IRB, including any IRB requirements or determinations.
non-disclosure agreement

A legal contract between at least two parties that outlines confidential materials, knowledge or information and prohibits divulgence of said information.

non-significant risk device study

A study of a device that does not meet the definition for a significant risk device. See: Significant Risk Device

non-viable fetus

An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)] (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.203). Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams a specific determination as to viability must be made by a physician in each instance. [Federal Register 40 (August 8, 1975): 33552] (http://www.hhs.gov/ohrp/archive/documents/19750808.pdf See Page 5 §46.203(d))

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O

off-label use

The clinical use of an FDA-approved drug, device or biologic for a purpose or population that has not been approved by the FDA, or in a route or dose that has not be approved by the FDA. Off-label use is not regulated by the IRB or the FDA; it is subject only to any policies and procedures of the clinician’s institution.

offsite adverse event

Regulatory term See: http://www.washington.edu/research/hsd/topics/Adverse+Events+and+Unanticipated+Problems. Offsite refers to the fact that the event occurred away from the primary research location.

OSP

(UW) Office of Sponsored Programs See: http://www.washington.edu/research/?page=osp

over-enrollment

The number of subjects who completed their participation in a study is greater than was approved in the initial IRB application or in a subsequent modification. The UW IRB considers over-enrollment to be equivalent to collecting data without IRB approval and it meets the definition of non-compliance.

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P

package insert

Document that lists the most common adverse effects for an approved drug.

payment

A term used broadly in HSD documents referring to payment for study participation, for example: money, class credit, or gift cards.

permission (parental)

The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].

phases (0, 1, 2, 3, 4) drug trials

Different stages of testing drugs in humans, from first application in humans (Phase 0), through safety screening (Phase 1), establishing efficacy,(Phase 2), confirming safety and efficacy (Phase 3) and post-marketing sentry studies (Phase 4). See: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

PHI

See: Protected Health Information

PI

See: Principal Investigator

premarket approval (PMA)

Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices. See: FDA Premarket Approval See also: device, FDA classification

Principal Investigator

The person with ultimate responsibility for the design and conduct of a research project.

prisoner

An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (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 or incarceration in a penal institution [45 CFR 46.303(c)]. See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.303

privacy

Privacy is about having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. It includes: a sense of being in control of access that others have to ourselves; a right to be protected; and is in the eye of the participant, not the researcher or the IRB. Privacy is about people; confidentiality is about data. See: confidentiality.

Privacy Certificate

This is the equivalent of a federal Certificate of Confidentiality, but it is provided (and required by) the federal Department of Justice (DOJ) for any research involving DOJ. This includes any research that is conducted in a federal prison facility.

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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable. Usually, if permission is required to obtain information, then the information is private.

There are numerous “gray” areas in distinguishing “private” from “non-private”. For example, there are some situations that are best considered “semi-private”. This may include some behaviors, communications, and interactions that occur in electronic or social media.

protected group

See: vulnerable populations

Protected Health Information (PHI)

Individually identifiable health information that is transmitted or maintained in any form or medium by a covered entity (a health plan, healthcare clearinghouse, health care provider that transmits healthcare information electronically), or its business associates, excluding certain educational and employment records. See: SOP HIPAA and Research

PPRA

Protection of Pupil Rights Amendment. This federal law applies to all children not over age 21 who are in elementary or secondary programs and institutions that receive funding for any purpose (research or otherwise) from the U.S. Department of Education. It is intended to protect the rights of students and their parents in educational settings. Among other things, it requires researchers to obtain prior written consent from parents before conducting research activities with studies that involve eight sensitive areas (such as sex behavior or attitudes). See: http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html

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Q

QA

See: Quality Assurance

QI

See: Quality Improvement

Quality Assurance

Planned activities implemented within a system to ensure that the system is producing the best possible results. Quality Assurance is not research when there are no intentions to contribute to generalizable knowledge. See: http://answers.hhs.gov/ohrp/categories/1569 See also: generalizable knowledge

Quality Improvement

The use of planned activities or methods within a system to improve the effectiveness of said system. Quality Improvement is not research when there are no intentions to contribute to generalizable knowledge. See: http://answers.hhs.gov/ohrp/categories/1569 See also: generalizable knowledge

quorum

Quorum refers to the minimum number of IRB members who must participate in an IRB meeting in order for the meeting to occur. The UW defines quorum as a simple majority of the members listed on the IRB membership roster registered with the federal Office of Human Research Protections. When the membership roster consists of an even number (N), quorum is defined as (N/2)+1.

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R

Radioactive Drug Research Committee (RDRC)

This committee is established at an institution and approved by the Food and Drug Administration (FDA) for the purpose of approving and monitoring the use of an investigational radioactive drug or biologic for basic human research when the research is not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the radioactive drug or biologic. When an RDRC has approved the use, the FDA does not require an IND for the use of the investigational radioactive item in the research. See: http://www.fda.gov/downloads/Drugs/Guidances/UCM163892.pdf

Radiation Safety Committee

At the University of Washington, the Radiation Safety Office is the operational arm of the University Radiation Safety Committee and is responsible for developing and carrying out a radiation safety program that ensures the safe use of ionizing radiation, and compliance with regulations. The committee reviews the use of radiation in human subjects research, including information provided in the consent form. See: http://www.ehs.washington.edu/rso/index.shtm

Recombinant DNA Advisory Committee (RAC)

A federal committee at the National Institutes of Health that makes recommendations on research involving the use of recombinant DNA and also reviews individual applications to do research with recombinant DNA. See: http://oba.od.nih.gov/rdna_rac/rac_about.html

At the University of Washington, the Institutional Biosafety Committee (IBC) reviews applications involving recombinant DNA prior to IRB review. See: http://www.ehs.washington.edu/rbsresplan/clinical.shtm

recusal

An IRB member's absence from the IRB meeting due to a conflict of interest with respect to the item under consideration. The member no longer counts towards the quorum. Recusals are indicated in the meeting minutes as "recusal".

registry

A list of names and contact information of people who are willing to be contacted about research related to a specific topic. A registry might include information that would assist in selecting candidates appropriate to recruit for a specific study.

repository

A collection of data, samples or both made available to researchers for analyses intended to answer various research questions.

research

The UW IRB applies the following definition: A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)] In addition, for activities involving the use of an item (for example, drugs and medical devices) subject to Food and Drug Regulations, the UW IRB applies the FDA’s definition of research: the use of a drug in one or more living persons other than the use of an approved drug in the course of medical practice; the use of a device in one or more living persons that evaluates the safety or effectiveness of the device; or the use of an item regulated by the FDA to obtain data regarding subjects that is intended to be eventually submitted to or held for inspection by the FDA. See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102 See also: generalizable knowledge See also: systematic investigation.See also: HSD Standard Operating Procedure: SOP Human Subjects Research See also: HSD Worksheet: WORKSHEET Human Subjects Research

respect for persons

As discussed in the Belmont Report the principle that individual autonomy be respected and that persons with diminished autonomy be protected. See also: Belmont Report

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S

senior/key personnel (per NIH)

The PI and other individuals so designated on an NIH funding proposal. They contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. They typically have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets the definition. Consultants also may be considered senior/key personnel if they meet the definition. See also: http://grants.nih.gov/grants/policy/senior_key_personnel_faqs.htm

serious adverse event

See: adverse event/effect

serious non-compliance

Non-compliance which could significantly:

  • Increase the risks to, or jeopardize the safety, welfare, and/or rights of subjects or others, or,
  • Decrease the potential benefits (including the scientific integrity of the research).
short form consent process

This is an alternative method of obtaining and documenting consent, when a researcher occasionally and unexpectedly encounters a non-English-speaking subject in a study for which no consent form in the subject’s language has been prepared and there is insufficient time and opportunity to obtain an appropriate written translation of the IRB-approved English version consent form. See also: SOP Consent Documentation

significant financial interest

Refers to financial interests related to the institutional responsibilities of an investigator that meet certain criteria, as defined in GIM 10. Financial interest means anything of monetary value, including but not limited to compensation, equity, gifts, and intellectual property of an investigator or the immediate family member of an investigator, whether or not the value is readily ascertainable. See also: Financial Conflict of Interest

significant risk device

Under 21 CFR 812.3(m), a significant risk device means an investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject and is: intended as an implant; purported or represented to be for use supporting or sustaining human life; for a use of substantial importance in diagnosing, curing, mitigating, treating disease; or otherwise preventing impairment of human health. See:http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdfSigni

site, study

Institution or agency at which study procedures are conducted. Entities that are not "engaged in the research" per OHRP definition are not considered to be "sites." See also: engagement

sponsor (of a drug trial)

A person or entity that initiates a clinical investigation of a drug - usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. A clinical investigator may serve as a sponsor-investigator. The sponsor or sponsor-investigator is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA. See also: sponsor-investigator

sponsor-investigator

An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies, or other institutions do not qualify as sponsor-investigators.

subject identifier

Information that identifies the subject. Under HIPAA certain items are specified as subject identifiers; under OHRP regulations, any set of information that renders a person "readily identifiable" constitutes a subjects identifier.

subjects

See: human subjects

systematic investigation

A searching inquiry for facts, or detailed or careful examination that has or involves a prospectively identified approach to the investigation, based on a system, methods, or plan. See: HSD Standard Operating Procedure: SOP Human Subjects Research for more details.

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T

test article

Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act or under sections 351 or 354-360F of the Public Health Service Act.

therapeutic misconception

The purpose of a clinical trial is to evaluate an experimental therapy or intervention, not to provide therapy. Clinical trial participants, hoping for therapeutic benefits, may not realize that research is aimed primarily at producing knowledge, or that elements of a clinical trial may interfere with their own health care. This failure to distinguish between research and usual clinical care may result in an underestimation of the risks or overestimation of the benefits of research participation. See also: clinical trial

third party subjects

An informal name for living individuals about whom researchers obtain individually identifiable private information from someone else but who themselves have no interaction with the researcher. Third party subjects are considered to be human subjects.

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U

unanticipated adverse device effect

Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a medical device (if that effect, problem or death was not previously identified in nature, severity, or degree of incidence in the materials reviewed by the IRB), or any other unanticipated serious problem associated with a medical device that relates to the rights, safety, or welfare of subjects.

unanticipated problem

A problem or event that meets all of the following criteria:

  • Unexpected;
  • Related or possibly related to participation in the research; and
  • Suggests that the research places (or could have placed) subjects or other at a greater risk of harm than was previously known or recognized. This includes physical, psychological, economic or social harm.
    • Unexpected: The harm (or potential harm) is inconsistent with risk information previously reviewed by the IRB in terms of nature, severity, or frequency as well as the characteristics of the subject population.
    • Possibly related: There is a reasonable probability that the incident, experience or outcome may have been caused by the procedures involved in the research, or that it is associated with the use of any drug, biologic, or medical device that is part of the research.
undue influence

Undue influence refers to the use of persuasion, authority figures, or the offer of an excessive or inappropriate reward or other overture in order to obtain research participation or 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.

UW Confidentiality Agreement

A legally binding agreement between the University of Washington and a researcher, or team of researchers, that is required by Washington State Law RCW 42.48 before the UW may release individually-identified UW records without the consent of the individuals to whom the records pertain. The agreement specifies certain limitations and responsibilities that the researcher must observe. It cannot be finalized until the UW IRB has approved a waiver of consent for the use of the records. See: http://www.washington.edu/research/hsd/docs/393

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V

voluntary

In the research context refers to a subject's decision to participate, or to continue to participate, in a research activity free of coercion, duress, or undue inducement.

vulnerable groups

Groups of subjects who may be at higher risk for effects of undue influence or coercion on their decision about whether to participate in a research study, or who may be unable to understand the consenting process. Depending upon the circumstances, these groups may include individuals who are decisionally impaired due to illness, injury or other conditions; students; employees; illiterate individuals; and non-English speakers or English as a second language speakers. See: Supplement: Protected and/or Vulnerable Populations See also: vulnerable populations

vulnerable populations

The Office for Human Research Protections (OHRP) recognizes certain populations to be protected, and special considerations should be made when including these populations in research. These populations include:

See also: vulnerable groups; Supplement: Protected and/or Vulnerable Populations

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W

waiver of consent

According to federal regulations, researchers may not involve a human being as a subject in research unless they have obtained the "legally effective informed consent of the subject or the subject's legally authorized representative." However, the regulations also allow an IRB to waive the requirement for some, or all, of the basic elements of informed consent when certain criteria are met.

HSD provides a form for researchers to request a waiver and to justify the need for it. The consent requirement can be waived for FDA-regulated research only in certain specific situations involving emergency medicine research or in vitro use of de-identified specimens.

See: SUPPLEMENT: Waiver Request, Consent, When minors are involved see: Supplement: Protected and/or Vulnerable Populations

For FDA Regulated Research See: emergency medicine waivers

waiver of documentation of consent

Federal regulations require a researcher to document that the research participants have provided informed consent. This is typically accomplished by signing a consent form. However, the regulations allow an IRB to waive the requirement for documentation of consent when certain criteria are met.

HSD provides a form for researchers to request this waiver and to justify the need for it.

See: SUPPLEMENT: Waiver Request, Consent, When minors are involved see: Supplement: Protected and/or Vulnerable Populations

waiver of HIPAA authorization

A request for permission to access, obtain, use or disclose a research subject's Protected Health Information (PHI) for research purposes without obtaining the subject's specific authorization for that access, use, or disclosure. A waiver of HIPAA authorization for research use is required even if the researcher has clinical access to the subject's health care records.

See: Waiver Request: HIPAA Authorization See also: Protected Health Information (PHI)

waiver or alteration of elements of consent

See: waiver of consent