A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

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1 Glossary of Terms and Acronyms A B C D E F G H I J K L M N O P Q R S T U V W X Y Z A AAHRPP Association for the Accreditation of Human Research Protection Programs Adverse Event (AE) Any harm or untoward medical occurrence in a research participant administered a medical product, medical treatment or procedure even if it does not necessarily have a causal relationship with the product, treatment, or procedure. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medical product, medical treatment or procedure whether or not considered to be related. [FDA: 21 CFR ] Adverse Reaction (AR), Adverse Drug Reaction (ADR) Pre-Approval Clinical Use of a Product All noxious and unintended responses to a medicinal product related to any dose. Marketed Medicinal Product A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. [FDA: Guideline for Industry, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting] Affiliated IRB members are considered affiliated if they, their spouse, domestic partner, or dependent children are an employee, contractor, student, board member, or have any other similar affiliation with Fred Hutch, UW, SCCA, or Seattle Children's. Allegation of Noncompliance An assertion that noncompliance has or may have occurred that requires further investigation to determine whether noncompliance has in fact occurred. Assent Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Assurance See Federalwide Assurance. 050IRBform_Glossary / Version 6.00 / / Page 1 of 30

2 Attachment A The internal routing and approval form submitted along with a proposal for an activity to be performed at Fred Hutch under a grant, contract or other sponsored agreement. Attachment B The internal routing and approval form submitted along with a proposal for an activity to be performed at Fred Hutch funded by Center funds, discretionary funds, royalties, or other nonsponsored funding source. Attachment C The internal routing and approval form for commercial and non-commercial research agreements. Authorized Institutional Official An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. Autonomy Personal capacity to consider alternatives, make choices, and act without undo influence or interference of others. B Belmont Report The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical Behavioral Research is a statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in Beneficence An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm. Benefit A valued or desired outcome; an advantage. Broad Consent Under the 2018 requirements of the Common Rule, a type of informed consent that allows for the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Broad consent is less specific than consent for each use, but narrower than open-ended permission without any limitations. 050IRBform_Glossary / Version 6.00 / / Page 2 of 30

3 C Cancer Consortium A research partnership between the institutions of Fred Hutch, the University of Washington, Seattle Cancer Care Alliance, and Seattle Children s Hospital. Also called the Fred Hutch/University of Washington Cancer Consortium. Children Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. [HHS: 45 CFR (a)] In most states, including Washington state, the legal age at which a person is able to consent to participate in research is 18 years. Investigators should check appropriate State laws and regulations before conducting research to determine the definition of a child for the purposes of participation in research studies. In the case of research studies conducted outside the United States, the relevant laws and regulations of the research participants country of residence should be applied. CITI Collaborative Institutional Training Initiative ( an online provider of research ethics, compliance, and professional development education. Fred Hutch, University of Washington, and SCCA have subscriptions for a number of CITI courses available to researchers, including Human Subjects and Good Clinical Practice training. Clinical Investigation Any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA, or is not subject to requirements for prior submission but the results are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. [FDA: 21 CFR 50.3(c)] This term is used by the FDA to describe research that is subject to FDA regulations relating to informed consent and review by an IRB. Additional information regarding FDA clinical investigation definitions for drug or device studies is found at 21 CFR 312.3(b) and 21 CFR 812.3(h), respectively. Clinical Research Support (CRS) The Fred Hutch Office that promotes, supports, and facilitates research trials within the Cancer Consortium. CRS supports the Cancer Consortium Data and Safety Monitoring Committee and the Scientific Review Committee. (See: Data and Safety Monitoring Committee and Scientific Review Committee.) Clinical Trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. [NIH Policy: Notice of Revised NIH Definition of Clinical Trial ] Clinical Trial Staff Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data 050IRBform_Glossary / Version 6.00 / / Page 3 of 30

4 management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator. [NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials] Closure A study is closed when accrual of research participants is complete and all research activities have ceased. This means no interaction/intervention is planned for the purpose of research with research participants and no long-term follow-up. Data collection and analysis are complete. Coded When identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code) AND a key to decipher the code exists, enabling linkage of the identifying to the private information or specimens. [OHRP Guidance: Coded Private Information or Specimens Use in Research] Cohort A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences. Common Rule See Federal Policy. Confidentiality The treatment that must be afforded to individually identifiable information about research participants or potential research participants. Confidential treatment of information in the context of research is required for all non-public information that has been disclosed by or about research participants to researchers with the expectation that it will not be disclosed to others without permission. The term confidentiality relates to information about research participants whereas the term privacy concerns research participants or potential research participants as individuals. (See also: Privacy.) Confirmed Noncompliance A report of noncompliance that can be determined to be true without further investigation or an allegation of noncompliance that is determined to be true after investigation by the IRB. Conflict of Interest (IRB member) See IRB Policy 1.5 IRB Member Conflict of Interest (020). Consent See Informed Consent. 050IRBform_Glossary / Version 6.00 / / Page 4 of 30

5 Continuing Noncompliance Noncompliance that, while not necessarily serious, evidences a pattern of behavior that, if unaddressed, might jeopardize the rights and welfare of research participants the integrity of the study data or the integrity of the HRPP. Control (Subjects) or Controls Subject(s) A group of subjects used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled. Controlled-Access Data are available to an investigator for a specific project only if certain stipulations are met. (See also: Unrestricted-Access.) Coordinating Center The central site that is responsible for organizing and managing activities and logistics, including oversight and coordination, of multi-site collaborative research. The coordinating center facilitates communication and collaboration among grantees, guides research activities, and leads data analysis efforts. Also known as an operations center. CORE Clinical Oncology Research Entrance (CORE) is a secure website through which ereview is accessed. Covered Entity Those individuals, organizations and institutions required to comply with HIPAA with respect to the use and disclosure of Protected Health Information or PHI. Examples of covered entities include hospitals, clinics, health care professionals and health plans. D Data and Safety Monitoring Board (DSMB) A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial. Data and Safety Monitoring Committee (DSMC) A Cancer Consortium committee of scientists, physicians, statisticians, and others that performs ongoing review and monitoring throughout the accrual life of Cancer Consortium intervention studies. Data and Safety Monitoring Plan (DSMP) A plan for appropriate oversight and monitoring of the conduct of a research study involving human subjects to help ensure the safety of the research participants and the validity and integrity of the research data. 050IRBform_Glossary / Version 6.00 / / Page 5 of 30

6 dbgap (Database of Genotypes and Phenotypes) A central data repository at the National Center for Biotechnology Information (NCBI), a branch of the National Library of Medicine. (See also: NIH GWAS data repository.) De-identified Information Information relating to individuals that has been de-identified according to the following criteria: the identifiers of data subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users [HHS: 45 CFR46.102(f)]; a statistical expert has determines that the risk or re-identification is small as described at 45 CFR (b)(1) (the HIPAA Privacy Rule); the 18 identifiers enumerated at 45 CFR (b)(2) (the HIPAA Privacy Rule) are removed; and the submitting institution has no actual knowledge that the remaining information could be used alone or in combination with other information to identify the subject of the data. Note that this definition is specific to NIH s Genomic Data Sharing policy. Declaration of Helsinki A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and Delayed Onset Research Research for which funding applications may be submitted to a sponsoring agency with the knowledge that human subjects will be involved during the period of support, but definite plans for this involvement are not yet known and so cannot be described in the application. Department of Defense Addendum to DHHS Federalwide Assurance (FWA) A formal written, binding commitment that is submitted to a DoD component in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the additional procedures for research involving DoD components. Department of Defense Component Department of Defense components include, but may not be limited to: Department of Defense Navy Office of Naval Research Naval Academy U.S. Naval Observatory Army U.S. Army Corps of Engineers Military Academy (West Point) Air Force Air Force Academy Marines Coast Guard Coast Guard Academy National Guard Missile Defense Agency Defense Advanced Research Projects Agency (DARPA) Pentagon Force Protection Agency Defense Intelligence Agency National Geospatial-Intelligence Agency National Security Agency 050IRBform_Glossary / Version 6.00 / / Page 6 of 30

7 National War College Other DoD facilities Designated Government Department or Agency The federal department or agency that conducts, supports, or otherwise has regulatory oversight over human subjects research to which Reportable Incidents must be reported under this policy and applicable federal regulations. If there is more than one Designated Government Department or Agency the reports will be made to all Designated Government Departments or Agencies. This may include, but is not limited to: The Office for Human Research Protections (OHRP) in accordance with federal regulations and the institution s Federalwide Assurance. The appropriate institute at the National Institutes of Health (NIH) if the research is conducted, funded or overseen by the NIH. The Department of Defense (DOD) if the research is conducted, funded or otherwise subject to regulatory oversight by the DOD and/or one of its components in accordance with federal regulations and the institution s Federalwide Assurance DOD addendum. The FDA for research regulated by the Food and Drug Administration (FDA). Other departments or agencies conducting, funding, or overseeing research that are signatories to the Common Rule. Double-Blind A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes referred to as double-masked. E Elements of Consent By regulation, the information to be provided to each prospective research participant. Basic and additional elements of consent are listed at 45 CFR and 21 CFR Emancipated Minor A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being selfsupporting and not living at home, marriage, or procreation. Emergency Use The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. [FDA: 21 CFR (d)] Engaged in Research In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. [OHRP Guidance: Engagement of Institutions in Human Subjects Research (2008)] 050IRBform_Glossary / Version 6.00 / / Page 7 of 30

8 Equitable Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed. ereview A secure, web-based, electronic retrieval system that IRB Committee members and IRO staff use to access relevant documents and provide comments for items listed on the full and expedited IRB agendas. Exempt HHS FDA Certain human subjects research that is excepted from the requirements of the Common Rule because if it falls within one or more categories of research described in 45 CFR (b). Certain clinical investigations that are excepted from the requirements of IRB review as described at 21 CFR Expedited Review A review procedure conducted by either the IRB chairperson or by one or more IRB members designated by the chairperson rather than by the full IRB committee for certain kinds of research involving no more than minimal risk, or for minor changes in approved research. Expedited Reviewer The IRB Chairperson or one of more IRB members designated by the chairperson to perform Expedited Review rather than by the full IRB committee. Experimental Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered experimental without necessarily being part of a formal study (research) to evaluate its usefulness. F FDA-Regulated Research Research that is subject to the oversight of the U.S. Food and Drug Administration. The following activities are FDA-regulated research: Any use of a drug other than the use of a marketed drug in the course of medical practice. (Clinical investigations subject to requirements for prior submission to the FDA under section 505(i) of the Federal Food Drug and Cosmetic Act.) Any use of a device to evaluate its safety or efficacy. (Clinical investigations subject to requirements for prior submission to the FDA under section 520(g) of the Federal Food Drug and Cosmetic Act.) Any collection of data to submit to FDA or hold for inspection by FDA in support of a marketing application. Federal Policy, The Also known as the Common Rule, the federal policy codified by Health and Human Services at 45 CFR 46 that provides regulations for the involvement of human subjects in research. The Federal Policy applies to all research involving human subjects conducted, supported, or 050IRBform_Glossary / Version 6.00 / / Page 8 of 30

9 otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Sixteen federal agencies adopted the Federal Policy. Federalwide Assurance (FWA) 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. [HHS: 45 CFR ] Fetus The product of conception from implantation until delivery. [HHS: 45 CFR (c)] Fred Hutch Institutional Official (IO) A Senior Official at the institution who is credentialed through NIH era Commons system and is authorized to enter the institution into a legally binding contract and sign on behalf of an investigator who has submitted data or a data access request to NIH. The Fred Hutch Institutional Official who has the authority to provide institutional certification for data sharing under GWAS and GDS Policies is the Fred Hutch Director of the Office of Sponsored Research. (See also: Institutional Official.) Fred Hutch Personnel Individuals directly employed by Fred Hutch, non-employee volunteers performing similar research functions as a Fred Hutch employee, or those designated in Fred Hutch PeopleSoft system as non-employee but who are performing similar research functions as a Fred Hutch employee (e.g., interns, visiting fellows). Full Committee Review Review of proposed research at a convened IRB meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. Funding Source Document (FSD) The grant, contract, agreement, or other document that describes the scope of work supported by the funding. G Gateway Fred Hutch Research database; also used for clinical purposes by SCCA. Gene Therapy The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells. Generalizable Knowledge In general, a set of conclusions, facts or principles that enhances scientific or academic understanding by applying broadly to a whole category such as a population or field of knowledge. 050IRBform_Glossary / Version 6.00 / / Page 9 of 30

10 Genotype An individual s collection of genes. GOG Gynecological Oncology Group Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Grant Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant. Guardian An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care. [HHS: 45 CFR (e)] H HIPAA The federal law called the Health Insurance Portability and Accountability Act that regulates, among other things, the disclosure of protected health information ( PHI ) about patients treated by most health care providers, third party payors and related organizations in the United States ( Covered Entities ). In the context of human subjects research, HIPAA establishes a federal standard for the manner in which the confidentiality and security of PHI will be maintained by Covered Entities and prescribes a process through which researchers can obtain PHI about patients who are sought by researchers to be research participants or potential research participants. HRPP Human Research Protection Program Human Research Protection Training Training that covers, at a minimum, the history of human subjects research, ethical principles, HHS and FDA regulations, IRB structure and function, and the protection of vulnerable populations of research. Also called human subjects training. 050IRBform_Glossary / Version 6.00 / / Page 10 of 30

11 Human Subject Also known as Human Research Participant. HHS FDA A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR (f)] An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. [21 CFR 50.3(g)] For research involving medical devices, a human subject is also an individual on whose specimen an investigational device is used or as a control. [21 CFR 812.3(p)] Washington State When medical device research involves in vitro diagnostic and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects. Under Washington State law, the term human subject(s) is not defined but the authority of institutional review boards to approve the release of health care information of patients for research purposes without the consent of the patient or a legally authorized representative (in the case of death or incapacity) is recognized and confirmed. The Washington Uniform Healthcare Information Act protects the confidentiality of health care information of patients who are deceased. [RCW Chapter 70.02] Human Subjects Research Any activity that either: Meets the FDA definition of clinical investigation and involves human subjects as defined by FDA; OR Meets the DHHS definition of research and involves human subjects as defined by DHHS; OR Involves the research use of health care information of a patient as defined by Washington s Uniform Health Care Information Act. HVTN HIV Vaccine Trials Network I Identifiable Biospecimen A biospecimen for which the identity of the participant is or may readily be ascertained by the investigator or associated with the biospecimen. [HHS: 45 CFR (e)(6)] 050IRBform_Glossary / Version 6.00 / / Page 11 of 30

12 Identifiable Private Information Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [HHS: 45 CFR (f)] Identifiable, Sensitive Information Information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur: An individual is identified; or For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual. [NIH Policy for Issuing Certificates of Confidentiality] Independent Ethics Committee (IEC) An independent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of participants involved in a clinical investigation and is adequately constituted to ensure that protection. An IEC is similar to an IRB, but is generally the term for such a panel outside the United States. [FDA: 21 CFR 812.3(t)] Individual Investigator An investigator at an institution which does not hold a Federalwide Assurance who is collaborating and engaged in research overseen by Fred Hutch IRB. Individual Investigator Agreement (IIA) An agreement used when Fred Hutch agrees to extend our FWA to cover an Individual Investigator engaged in a research project overseen by Fred Hutch IRB. Individuals with Impaired Decision-Making Capacity Persons whose decision-making capacity is restricted, wholly or in part, due to illness, mental disability or other circumstances. Individually Identifiable Health Care Information Any information that identifies or can readily be associated with a patient and directly relates to the patient s health care. Individually identifiable health care information is the term generally used to describe information subject to protection under the Uniform Health Care Information Act which has been adopted in many states, including Washington State. Industry Contract Any agreement involving a commercial entity and either Fred Hutch or another organization that describes support for the research being provided by the commercial entity. This support is typically monetary but it can also include provision of study drug, equipment, facilities, or other non-monetary research support. 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 050IRBform_Glossary / Version 6.00 / / Page 12 of 30

13 institution or agents thereof from liability for negligence. [HHS: 45 CFR ; FDA: 21 CFR and 50.25] Institutional Biosafety Committee (IBC) A body established under NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. Over time, many institutions have chosen to assign their IBCs the responsibility of reviewing a variety of experimentation that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens). Institutional Official (IO) The person authorized to act for the institution and assumes overall responsibility for compliance with the federal regulations for the protection of human research participants. This individual is the person who signs the Office for Human Research Protections assurance of compliance. Institutional Review Board (IRB) A review body established by the organization to protect the rights and welfare of research participants recruited to participate in research activities. An IRB is organized in accordance with the Department of Health and Human Services (DHHS) at 45 CFR 46 and for studies involving products regulated by the Food and Drug Administration (FDA), the IRB complies with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812. Interaction Includes communication or interpersonal contact between investigator and subject. [HHS: 45 CFR (f)] Interpretation Facilitating oral communication in more than one language; performed by an interpreter. Interpreter A person who translates orally for individuals conversing in different languages. Intervention Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. [HHS: 45 CFR (f)] Investigational Device Exemption (IDE) An action taken by the Food and Drug Administration (FDA) to permit the investigational use of a Medical Device in a clinical study in order to collect safety and effectiveness data. [FDA: 21 CFR Part 812] Investigational Drug or Biological Product A drug or biological product that has not yet been determined to be safe and effective for a particular use in the general population and not yet approved by the Food and Drug Administration (FDA) for commercial marketing. [FDA: 21 CFR Part 312] 050IRBform_Glossary / Version 6.00 / / Page 13 of 30

14 Investigational New Drug Application (IND) A request for Food and Drug Administration (FDA) authorization to administer an Investigational Drug or Biological Product to humans. [FDA: 21 CFR Part 312] Investigator FDA Drug Trials FDA Device Trials NIH OHRP An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Subinvestigator includes any other individual member of that team. [21 CFR 312.3(b)] An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. [21 CFR 812.3(i)] The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials] An individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an investigator to be any individual who is involved in conducting human subjects research studies. Such involvement would include: obtaining information about living individuals by intervening or interacting with them for research purposes; obtaining identifiable private information about living individuals for research purposes; obtaining the voluntary informed consent of individuals to be subjects in research; and studying, interpreting, or analyzing identifiable private information or data for research purposes. [OHRP: Investigator Responsibilities FAQ] (See also: Principal Investigator and Subinvestigator.) In Vitro Literally, in glass or test tube ; used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo. 050IRBform_Glossary / Version 6.00 / / Page 14 of 30

15 In Vivo Literally, in the living body; processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro). Involving DoD Research is considered to involve DoD when: The research is funded by a component of DoD. The research involves cooperation, collaboration, or other type of agreement with a component of DoD. The research uses property, facilities, or assets of a component of DoD. The subject population will intentionally include personnel (military and/or civilian) from a component of DoD. IR Institutional Review, as in IR File Number (e.g., IR 9999). IRB Approval The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. [HHS: 45 CFR (h)] IRB Authorization Agreement (IAA) A written agreement that establishes the relationship between two IRBs that hold Federalwide Assurances, in which one institution defers IRB review responsibility to the other institution s IRB in order to avoid dual review. IRB Certification A document used when Fred Hutch acts as the coordinating center of a multi-center study. It assures the Fred Hutch IRB that each performance site s IRB of record conducts its own review and approval of the research activity. IRB Pre-Reviewed Source Sources of de-identified or coded human information or biospecimen resources that have been evaluated by Institutional Review Office (IRO) Director or IRO Assistant Director, and an IRB Chair or designee to ensure they have appropriate gatekeeping procedures in place to prohibit the release of identifiable private information to the Fred Hutch investigator utilizing information or biospecimens from the source. Refer to the list of IRB Pre-reviewed Sources of De-identified Human Specimens and/or Data (0332) available at: IRB of Record The IRB responsible for review and oversight of research and determining the research meets the regulatory criteria for approval at a participating site. IRB Reliance Agreement The agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization serving as the IRB of record and a participating site relying on the IRB of record. An IRB reliance agreement is an umbrella term 050IRBform_Glossary / Version 6.00 / / Page 15 of 30

16 that encompasses individual investigator agreements, IRB authorization agreements, cooperative review agreements among IRBs of Washington state, and IRB services contracts. IRO Institutional Review Office IRO Staff Staff employed within the IRO that are responsible for the IRB operations and HRPP which includes support to four IRB committees. 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. K Key Personnel The PI and other individuals who 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. [NIH Glossary of Terms] L Large-Scale Genomic Data The GDS Policy applies to all NIH-funded research that generates large-scale human or nonhuman genomic data as well as use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomics, epigenomic, and gene expression data. Examples are included below. See Supplemental Information to the NIH Genomic Data Sharing Policy for more examples. Sequence data from more than one gene or region or comparable size in the genomes of more than 1,000 human research participants. Sequence data from more than 100 genes or region of comparable size in the genomes of more than 100 human research participants. Sequence data from more than 100 isolates from infectious organisms. 050IRBform_Glossary / Version 6.00 / / Page 16 of 30

17 Legally Authorized Representative HHS FDA An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject s participation in the procedure(s) involved in the research. [45 CFR (c)] An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject s participation in the procedure(s) involved in the research. [21 CFR 50.3(l)] Legally Effective Consent Informed consent is legally effective if it is both obtained from the participant or the participant s legally authorized representative and involves a process that provides the prospective participant or legally authorized representative sufficient opportunity to consider whether to participate, and minimizes the possibility of coercion or undue influence; and, includes a consent discussion and/or consent document that is both (i) understandable to the participant or the participant s legally authorized representative, and (ii) free of exculpatory language. To demonstrate that legally effective informed consent has been obtained, documentation should be maintained consistent with the HHS protection of human subjects regulations and with applicable laws of the jurisdiction in which the research is conducted. [HHS: 45 CFR ; FDA: 21 CFR 50.20] Life-threatening Adverse Event An adverse event that places the subject, in the view of either the investigator or sponsor, at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death. [FDA: 21 CFR (a)] (See also: Adverse Event and Suspected Adverse Reaction.) Limited Data Set Protected Health Information (PHI) that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual: Names; Postal address information, other than town or city, State, and zip code; Telephone numbers; Fax numbers; Electronic mail addresses; Social security numbers; Medical record numbers; Health plan beneficiary numbers; Account numbers; Certificate/license numbers; Vehicle identifiers and serial numbers, including license plate numbers; Device identifiers and serial numbers; Web Universal Resource Locators (URLs); Internet Protocol (IP) address numbers; Biometric identifiers, including finger and voice prints; and 050IRBform_Glossary / Version 6.00 / / Page 17 of 30

18 Full face photographic images and any comparable images. [HHS: 45 CFR (e)(2)] (See also: Protected Health Information.) Limited IRB Review Under the 2018 requirements of the Common Rule, exempt Categories 2 and 3 include a provision for limited IRB review. Limited IRB review under exempt categories 2(iii) and 3(i)(c) requires the Expedited Reviewer to determine that when appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. Local Research Context Information provided to the IRB of record by a local context reviewer, consultant, or a participating site s IRB regarding the participating site s local community, geographical area, institution, and/or other factors that may influence the conduct of the proposed research, including local laws, regulations, customs, and practices. Longitudinal Study A study designed to follow subjects forward through time. M Medical Device An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. [FDA: 21 USC 321(h)] Minimal Risk Where the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [HHS: 45 CFR (i); FDA: 21 CFR 50.3(k)] Prisoner Research Where the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. [45 CFR (d)] OHRP interprets the term healthy persons in this definition as referring to healthy persons who are not prisoners. [OHRP FAQ on Prisoner Research] 050IRBform_Glossary / Version 6.00 / / Page 18 of 30

19 Department of Defense Research For purposes of research Involving DoD, the phrase ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests in the definition of minimal risk (32 CFR (i)) shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain). [DoD Instruction ] Minor Noncompliance Noncompliance that is neither serious nor continuing. Minor noncompliance includes, but is not limited to, individual instances of the omission or modification of research activities that are in the best interests of human research participants; provided, that the omission or modification does not materially increase the risks to or otherwise seriously jeopardize the rights and welfare of human research participants or materially impair the integrity of the study data. Modification Any change to a research study that is made after initial IRB review and approval. Monitoring The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections. MTA Materials Transfer Agreement Multi-center Study A study involving more than one performance site engaged in research. Multi-site Study A study that uses the same protocol to conduct non-exempt human subjects research at more than one site. Also known as a multi-center study. [NIH Single IRB Policy for Multi-site Research] N Neonate HHS WA State A newborn. [HHS: 45 CFR (d)] A newly born infant less than 28 days of age. [WAC (38)] NIH-designated Repository Any data repository maintained or supported by NIH either directly or through collaborative. 050IRBform_Glossary / Version 6.00 / / Page 19 of 30

20 NIH GWAS Data Repository Also known as the Database of Genotype and Phenotype (dbgap), the NIH Genome-Wide Association Studies (GWAS) Data Repository is a database developed by the National Center for Biotechnology Information (a division of the National Library of Medicine) to archive and distribute the results of studies that have been investigated. Nonaffiliated Member Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker). Noncompliance An intentional or unintentional action or activity relating to human subjects research by a person subject to the human research protection program of Fred Hutch (HRPP) that violates or otherwise fails to adhere to one or more of (i) the requirements or determinations of the IRB, (ii) the HRPP, or (iii) laws or regulations governing the conduct of human subjects research, including applicable FDA and DHHS regulations. Normal Volunteers Volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition. Normal may not mean normal in all respects. For example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, patients with heart disease but without diabetes may be the normals in a study of diabetes complicated by heart disease. NHS or Not HS Not Human Subjects; a determination that the research does not involve human subjects. (See also: Research Not Involving Human Subjects.) Nuremberg Code A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects. O Operations Center See Coordinating Center. OWL Research charts on-line (Fred Hutch, SCCA). Scanned documents. P Parent A child s biological or adoptive parent. [HHS: 45 CFR (d)] 050IRBform_Glossary / Version 6.00 / / Page 20 of 30

21 Participating Site A domestic entity or performance site in a multi-site study that will rely on the IRB of record to carry out the site s IRB review of human subjects research for the multi-site study. Such deferment of IRB review is documented and agreed upon in a reliance agreement. [Final NIH Policy on the Use of a Single IRB for Multi-Site Research] PDF Protocol Disposition Form Performance Site A site whose staff, facilities or private records of identifiable individuals are engaged in the conduct of research; or, a site that receives HHS funds. The performance site is the actual place where the research activity takes place (e.g., clinic or hospital). The performance site s location may be different from the location where the IRB review takes place. Permission The agreement of parent(s) or guardian to the participation of their child or ward in research. [HHS: 45 CFR (c)] PeopleSoft A software tool managed by Financial Management Information Systems (FMIS) that allows for personnel management, ordering supplies, producing reports, etc. Phase 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 (Phase 3), to postmarketing studies (Phase 4). Phase 1 Drug Trial Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as research participants. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug s pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of research participants involved in Phase 1 investigations is generally in the range of Phase 2 Drug Trial Phase 2 trials include controlled clinical studies conducted to evaluate the drug s effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred research participants. 050IRBform_Glossary / Version 6.00 / / Page 21 of 30