Glossary
0-9
- 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
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
- adverse event/effect
-
The term adverse event is generally used to refer to 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, whether or not considered related to the subject's participation in the research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research although, on occasion, they can occur in the context of social and behavioral research. See: http://www.washington.edu/research/hsd/topics/Adverse+Events+and+Unanticipated+Problems
- 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.
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, related to health or welfare. 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
-
In contrast to drugs that are chemically synthesized, biologics are derived from living sources, such as humans, animals, and microorganisms. 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.
C
- CBPR
- certificate of confidentiality
- CFR
- 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 pharmaceutical research services. The primary benefit CROs offer their clients is the experience of moving a new drug from its conception to FDA marketing approval. See: http://www.biotechmedia.com/definitions-c.html#CRO,
- 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, the use of force or pressure to override a subject's disinclination to participate in research.
- 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 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
-
Regulatory basis for allowing clinical use of an experimental drug or device prior to FDA approval. Case-by-case approval usually must be obtained in advance from the IRB for single-patient emergency use. Common term for the FDA regulatory term "expanded access".
- 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
- confidentiality
-
Can apply to either a situation in which no one except the researcher(s) knows the identities of the research participants, or to a situation where only the researcher can connect the identity of the research participants with the data. See also: coded data; anonymity
- confidentiality agreement
- conflict of interest
-
Financial or situational factors undermining one's ability to make unbiased judgements. 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.
- 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.
- 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
- 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
D
- data safety monitoring board (DSMB)
-
An independent group of experts who monitor subject safety and treatment efficacy data while research is ongoing.
- data safety monitoring plan (DSMP)
-
Principal investigator plan to oversee subject safety and welfare by monitoring research progress, reporting problems, and assuring data accuracy and protocol compliance.
- data use agreements (DUA)
-
A legally binding agreement used to control data use and protect confidentiality when an external entity requests the use of personal identifiable data that is covered by a legal entity.
- 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 a Full IRB that indicates the following: (1) the IRB has questions about the research that have bearing upon the risk/benefit analysis of the research; (2) the IRB requires significant additional information or clarification in order to understand specific parts of the application; and/or (3) the IRB is requesting changes to the research in order to address regulatory requirements or concerns arising from the risk/benefit analysis.
- 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 based on the number of production and manufacturing controls necessary to assure the safety and effectiveness of the device. See: 21 CFR 860
- DMC
-
Data Monitoring Committee See: Data Safety Monitoring Board
- DSMB
- DSMP
- DUA
-
See: Data Use Agreements
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; 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. An IRB chair or designee can authorize emergency use. (This is not related in any way to Emergency Medicine Waivers. See next item.)
- emergency medicine waivers
-
Used with research on emergency medicine procedures when it is not possible to obtain consent from the subject or family member. Obtaining such a waiver involves satisfying strict regulatory requirements including community consultation. 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]
- 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.
- exclusion criteria
-
Characteristics or traits that exclude an otherwise eligible person from a study.
- exempt research
-
To be exempt from the requirements of the Federal Policy for the protection of human subjects, research with human subjects must be no greater than minimal risk to subjects and all of the proposed research activities must fit within one or more of the six exemption categories. See: HSD's Guidance on the Categories for Exemption. See also: HSD policy: Human Subject Definition
- 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
-
A procedure through which certain kinds of research and modifications or status reports for research previously approved by a full committee may be reviewed and approved without convening a meeting of the entire IRB.
Review of proposed research 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. [45 CFR 46.110]
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
- 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
- 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
- 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
- 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
G
- GCP
- 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
-
Conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and enhance scientific or scholarly understanding. 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
H
- HDE
- 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
- human subjects
-
Individuals whose characteristics and responses are the object of study in a research project. Under the department of Health and Human Services, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. [45 CFR 46.102(f)]
Under the Food and Drug Administration, human subjects are defined as: (1) 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 medial 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. [21 CFR 50.3(g)] For more detailed information see: The HSD Human Subject Definition Policy: http://www.washington.edu/research/hsd/docs/1253
- human subjects application
-
The material submitted to the IRB for review in connection with a project. At the University of Washington, application materials consists of the appropriate form, combined with supporting materials. Application forms can be found on the Human Subjects website under "Forms". See: http://www.washington.edu/research/hsd/
- 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
I
- IBC
- IDE
- 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
- Individual Investigator Agreement
-
Used by an assured institution to extend – for one or more research protocols – the applicability of its FWA (federalwide assurance) to cover either collaborating independent investigators or collaborating institutional investigators. 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;
- Is created or received by a health care professional, health plan, employer, or health care clearinghouse; and
- 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
- That identifies the individual; or
- With respect to which there is a reasonable basis to believe the information can be used to identify the individual.
- 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.
- inclusion criteria
-
Characteristics or traits of people who are eligible for a study.
- IND
- Information Statement
-
UW Human Subjects term for a consent document used when the requirement for written consent is waived. An Information Statement has some small but important differences from a consent form.
- informed consent
-
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. 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 [45 CFR 46.116] [21 CFR 50.20]
- 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
- 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) Program
-
The Investigational New Drug (IND) program allows drug companies to ship experimental drugs across state lines before marketing has been approved. The term IND usually refers to IND applications, which are submitted to the FDA to allow testing a new drug, or allow testing an existing drug for a new use (indication, change in route of administration or dosage, change in the approved population, or a significant change in promotion). There are two categories of IND application, commercial and research (non-commercial). There are three types of IND: Investigator IND, Emergency Use IND, and Treatment IND. See also: emergency use
- 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
- IRB 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)
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
L
- LAR
- lead researcher
- legal guardian
-
See: guardian
- legally authorized representative
-
A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, an LAR is considered to have the authority to consent on behalf of a prospective subject for the subject's participation in the research [45 CFR 46.102(c)]. See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
- 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
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
- minimal risk
-
A risk is minimal if the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.
- minor
- modification
-
Any changes in IRB approved research populations, procedures or purpose; 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
N
- NIH
-
National Institutes of Health See: http://www.nih.gov
- 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))
O
- 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
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 (1, 2, 3, 4) drug trials
-
Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phases 2 and 3), to post-marketing studies (Phase 4). See: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm
- PHI
- PI
- 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
- 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
- Protected Health Information (PHI)
-
Individually identifiable health information in any form (including oral communication) that is collected or created when a covered entity provides health care.
- PPRA
-
Protection of Pupil Rights Amendment. See: http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html
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
R
- Radioactive Drug Research Committee
-
An FDA-recognized committee responsible for evaluating the use of radioactive drugs in human participants for research purposes. (At UW, a part of Environmental Health and Safety.) See: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Oncology/ucm093322.htm
- 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. See: http://www.ehs.washington.edu/rso/index.shtm
- Recombinant DNA Advisory Committee (RAC)
-
A NIH committee 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
- 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
-
A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)] See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102 See also: generalizable knowledge See also: systematic investigation
- 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
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
- 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
-
Typically involves a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Examples: observational studies, interview or survey studies, group comparison studies, program evaluation, test development, interventional research.
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 intent
-
In Phase 1 drug studies, in which the primary intent is to assess the safety and pharmacology of a drug, the hope of inducing some improvement in a patient's condition may be a secondary reason for administering drugs with an unknown effect.
- 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. 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.
U
- unanticipated problems
-
In general, includes any incident, experience, or outcome that meets all of the following criteria:
- unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- related or there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; 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.
Generally, unanticipated problems warrant considering changes in the research.
- UW Confidentiality Agreement
-
A legally binding agreement between the University of Washington and a researcher, or team of researchers, that must be approved by the IRB before a researcher may access individually-identifiable records held by the University of Washington. See: http://www.washington.edu/research/hsd/docs/393 See also: non-disclosure agreement
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 coercion and/or unable to understand the consenting process. These groups can include 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:
- Pregnant Women, Human Fetuses, and Neonates (Subpart B) See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartb
- Prisoners (Subpart C) See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartc
- Children (Subpart D) See: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd
See also: vulnerable groups; Supplement: Protected and/or Vulnerable Populations
W
- waiver of consent
-
According to 45 CFR 46.116, 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." Some, or all of the basic elements of informed consent as set forth in the regulations may be waived.
HSD provides several forms for researchers to request and provide a justification for the need to have elements of informed consent "waived".
See: Waiver Request: Consent or Consent Requirements, When minors are involved see: Supplement: Protected and/or Vulnerable Populations
For FDA Regulated Research See: emergency medicine waivers
- waiver of documentation of consent
-
In general, researchers may involve a human being as a subject only if the researcher has obtained and documented by means of a signed consent process the informed consent of the subject or the subject's legally authorized representative. However, according to 45 CFR 46.117(c) the written documentation of informed consent as set forth in the regulations may be waived.
HSD provides several forms for researchers to request and provide a justification for the need to have documentation of informed consent "waived".
See: Waiver Request: Consent or Consent Requirements, When minors are involved see: Supplement: Protected and/or Vulnerable Populations
For FDA Regulated Research: the FDA has no mechanism for waiver of documentation of consent
- 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
-
Under certain circumstances, according to 45 CFR 46.116, elements of informed consent can be waived or altered. HSD provides several forms for researchers to request and provide a justification for the need to have consent waived or altered.
See: Waiver Request: Consent or Consent Requirements, When minors are involved see: Supplement: Protected and/or Vulnerable Populations
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