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Adverse Event: 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 associated with the subject’s participation in the research/project, whether or not it is considered to be related to the subject’s participation in the study/project.

Allegation of Non-Compliance: An unproved assertion of Non-Compliance.

Children: Persons who have not attained the legal age for consent to treatment or procedures involved in the project, as determined under the applicable law of jurisdiction in which the project will be conducted.

Cognitive Impairment: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental handicap/disability) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative disease affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interest.

Continuing Non-Compliance: A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.

Designated Reviewer: The IRB chair or administrator, or an Experienced IRB Member designated by the IRB chair or administrator to conduct a Non-Committee Review (e.g., expedited or exempt).

Engagement in Research: An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].

An institution is automatically considered to be "engaged" in human subjects research whenever it receives a direct HHS award to support such research. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.

For more details, including examples of situations where an institution may or may not be considered engaged, please refer to the guidance  provided by OHRP on this topic.

Experienced IRB Member: An IRB member is considered experienced if the member has served for three years or more years as an IRB member.

Expiration Date: The first date that the protocol is no longer approved. The date after the end date of the approval period.

Finding of Non-Compliance: Non-Compliance in fact.

Human Participant (or Subject): A living individual about whom an investigator (whether professional or student) obtains data through intervention or interaction with the individual, or obtains identifiable private information.

Data through intervention or interaction with the individual, or identifiable private information.

Identifiable Information: Information that is individually identifiable (i.e., the identity of the subject is or may readily or potentially be ascertained by the investigator or associated with the information).  This information often is Protected Health Information (PHI) that is subject to protection by HIPAA regulation (see http://www.hhs.gov/ocr/privacy).

Immediate Family: Spouse, domestic partner; and dependent children.

Informed Consent: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in a study or project, 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.

Institutional Review Board (IRB): A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research or projects.

IRB Approval: The determination of the IRB that the research or project 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.

Note that there are several possible outcomes of an IRB review.   These include approval, approval with contingencies, approval with modifications, tabling, requesting more information prior to approval, and disapproval.  Note that if a project is disapproved by an IRB, it cannot be overruled, per federal guidelines, by a person or entity.  However, if a project is approved by an IRB, it may be overruled by a person or entity.

Interaction: Communication or interpersonal contact between investigator and subject.

Intervention: Includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research or project purposes. Intervention includes communication or interpersonal contact between investigator and participant.

Investigator (Principal Investigator or PI): The individual(s) designated to have the appropriate level of authority and responsibility to direct the research project and/or activity.

Key Personnel: Individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested on the corresponding grant application/contract proposal.  Key personnel include the principal investigator, co-principal investigator, supervising faculty members, and any other individuals who will have contact with the participants or the participants' data.

Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the participant’s participation in the research or project activities.

Limited Data Set: Data sets that contain health information but exclude specific direct identifiers as outlined in the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Limited data sets are considered identifiable even without the specific direct identifiers.  All disclosers of the limited data set require a signed Limited Data Set Data Use Agreement between the requester and the institution from which the limited data set is requested.  The Data Use Agreement ensures compliance with both the Privacy Act and HIPAA.

Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research/project 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.

Non-Compliance: Failure to follow the regulations or the requirements or determinations of the IRB.

Office for Human Research Protections (OHRP): The Health and Human Services (HHS) office that oversees the regulation of research involving human research participants.

Principal Investigator: The individual with primary responsibility for the design and conduct of a research or project.

Prisoner: An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trail, 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.

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 (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

Protected Health Information (PHI or Identifiable Private Information): Name, address, elements of dates related to an individual (e.g., birthdate), email address, numbers; telephone, fax, social security, medical record, health beneficiary/health insurance, certificate or license numbers, vehicle, account numbers, characteristics, or codes (e.g., Global Positioning System (GPS) readings), Web URLs, Internet Protocol (IO) addresses, biometric identifiers (e.g. voice, fingerprints), full face photographs or comparable images.

PHI includes any information, whether oral or recorded in any form or medium, that is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, 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.

Quorum: A quorum will be a simple majority (e.g. , greater than 50%) of the voting members of the IRB. For reasons other than conflict of interest, abstentions do not alter the quorum or change the number of votes required.

Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities and they would be included in this definition of Research.

Restricted: Applies to investigators or research staff members who are delinquent in meeting IRB requirements.

Secondary Data Set: Data that can be used in research and comes from public or private documents, including medical records, police reports, vital statistic records, student record.

Serious Adverse Event: Any Adverse Event that (1) results in death, (2) is life-threatening (places the subject at immediate risk of death from the event as it occurred), (3) results in inpatient hospitalization or prolongation of existing hospitalization, (4) results in a persistent or significant disability/incapacity, (5) results in a congenital anomaly/birth defect, or (6) based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Serious Non-Compliance: Non-Compliance that affects the rights or welfare of participants.

Specimen: A sample (e.g., human tissue, blood, or urine) used for diagnostic or pathological analyses.

Suspension of IRB Approval: An action of the IRB to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval.  Suspended studies remain open and are subject to continuing review.

Termination of IRB Approval: An action of the IRB to permanently withdraw IRB approval of all research procedures.  Terminated studies are permanently closed and no longer require continuing review.

Unanticipated Problem: An unanticipated problem involving risk to human participants or others is one that (1) was unforeseen at the time of its occurrence, and (2) indicates that participants or others are at an increased risk of harm.

Vulnerable Populations: Populations that may be used in research or projects, but that are considered vulnerable in some way.  The vulnerable populations include children, prisoners, pregnant women and fetuses, and decisionally impaired individuals (e.g., mentally challenged, those with dementia).  Additionally, those with low education or low income may also be considered as vulnerable populations.

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