Adverse Event | Any 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. A Serious Adverse event is defined as any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:
A significant adverse event is an adverse event that is unexpected and substantively impacts the human subjects. |
Benign Behavioral Intervention | An intervention brief in duration, harmless, painless, not physically invasive, unlikely to have a significant adverse lasting impact, and for which there is no reason to believe the subjects will find offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. |
Clinical Trial | Research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include place or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. FDA regulated. |
Cognizant IRB | This is the regulatory phrasing for the IRB that is aware of and responsible for oversight of the HSR activity. |
Common Rule | Also known as “Federal Policy for the Protection of Human Subjects,” is the regulatory language originally published in 1991 and codified in separate regulations by 15 Federal departments. The 2018 revision of these regulations, sometimes called the Final Rule, has been adopted by 20 agencies at this time. The basis of the regulations is 45 CFR 46 for the Department of Health and Human Services, and they are found in different CFRs based on the agency (e.g. 10 CFR 745 Department of Energy). To refer to all of the regulatory versions the annotation § __ will be used with a specific section noted subsequently when applicable. |
Compensation | Monetary support provided to participants for financial impacts, losses, or inconveniences occurring due to study participation. |
Direct Supervisor | The technical and/or administrative individual(s) or line management who direct(s) an individual’s work and/or are responsible for performance evaluation of that individual. An employee cannot be recruited or consented by a direct supervisor who is the PI and/or a member of the research team, except in unusual circumstances approved by the IRB. |
Exempt Research | Refers to studies that fall under one or more of the eight exempt categories outlined in federal regulations at § __.104. NIH Infographic While such research is exempt from the requirements of The Common Rule, it remains subject to specific institutional and Department of Energy (DOE) guidelines at Berkeley Lab, as outlined in HSC policy and DOE Order 443.1C.chg1. |
Expedited Review | A human subjects research protocol review conducted by the HSC Chair or his/her designee(s), rather than by a convened quorum of the HSC. To qualify for this type of review the protocol must meet the Expedited Review Criteria or qualify as a minor change (defined below). |
Full Board Review | Full Board Review is conducted when HSR protocols are designated as requiring review by a convened quorum of HSC members. This is typically required due to regulatory criteria, such as not meeting any of the Expedited or Exempt Review Categories or being more than minimal risk. HARC staff and the HSC Chair always retain discretion to require full board review for protocols that otherwise meet the criteria for an expedited or exempt category review. |
Generalizable Knowledge | The information is typically expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
Formal DOE definition: Information or research findings that are intended to be applied to populations or situations beyond those studied that will have meaning and impact outside of the single immediate activity itself. |
Human Subject | A living individual about whom an investigator conducting research: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens or (2) Obtains, uses, studies, analyzes, or generates identifiable private information. In clinical research, a human subject is someone who becomes a participant in research, either as a recipient of the test article or as a control, or by having their biospecimens used when the research involves an FDA-regulated product. |
Identifiable | In the context of information - Being able to distinguish or trace an individual's identity, either directly or indirectly. This applies to information that can be used on its own or combined with other data to infer an individual's identity. Examples include names, social security numbers, biometric records, medical and financial information, and other data linked to a specific person. |
Immediate Reporting | Reporting as soon as feasible upon learning of an event. Sequential reporting may be needed in certain cases, e.g., loss/breach of PII should be reported to the iJC3 first, and then to the IRB. In all cases it is expected that required reporting would be completed within a few hours of the PI learning of an HSR-related event. |
Incentives | Payment or items provided to participants to entice or encourage study participation. |
Injury | Is a physical or psychological harm that generates medical costs and that is directly caused by the product or procedures required by the research study as described in the informed consent form. Injury specifically excludes the natural progression of an underlying or preexisting condition, unless the worsening condition is determined to be a direct result of the subject's participation in the research study described in the informed consent form. |
Institutional Review Board | A committee or board established by an institution that performs initial and continuing reviews of research involving human subjects and is registered with the OHRP and designated on an FWA. At Berkeley Lab, the IRB is called the Human Subjects Committee (HSC). |
Intervention | Includes both physical procedures by which data or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. |
Interaction | Communication or interpersonal contact between investigator and subject. Includes electronic communication or contact only through the research materials in cases where subjects provide information back to the investigator. |
Lottery | A lottery is any scheme for the disposition of property by chance among persons who have paid or promised to pay any value for the chance of obtaining the property, with the understanding that it will be disposed of by chance. As defined by the California Department of Consumer Affairs. |
Minimal Risk | The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. |
Minor Changes | Changes, if considered independently from the overall research, involve no significant alteration in study design or fall into one or more categories allowing exempt or expedited review, AND
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Private Information | Information associated with individuals or groups of individuals and that could reveal details of their lives or other characteristics that could impact them. Private information includes:
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Protected Class of Human Subjects | Populations who may be more vulnerable to coercion or undue influence when participating as research subjects, such as children, prisoners, individuals with impaired decision-making capacity, economically or educationally disadvantaged persons, and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept confidential. |
Protocol Lead Investigator (PLI) | The PLI is the person who will have direct oversight of the performance of the HSR being performed. This person should have Principal Investigator (PI) status at Lawrence Berkeley National Laboratory, have a Co-PLI listed with PI status to assist with oversight, or have a documented exception. PLI oversight is essential to maintaining compliance and safeguarding the rights and welfare of participants. The PLI must agree to:
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Research | A systematic investigation, including research development, testing and evaluation, designed to 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. Exclusions: Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. |
Research Participant | A Human Subject, see definition above, who has been recruited to be part of a human subjects research project, even when that participant is later withdrawn. The number of research participants enrolled and withdrawn must be reported on an annual basis to satisfy HSRD requirements. |
Risk | The probability of discomfort, harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible risks may vary from minimal to significant. |
Serious | In reference to an adverse event - temporally associated with the subject’s participation in research that meets any of the following criteria:
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Significant | In reference to an adverse event - unexpected and substantively impacts the human subjects. |
Subject Matter Expert | An individual who is asked to contribute expertise from a specific subject based on their training and experience in the field. |
Substantive Changes | Any change to a study that may increase the risk or level of discomfort to subjects or significantly affects the nature of the study. Examples include: changes to the recruitment plan; adding or revising eligibility criteria; changes in the costs of participation or the payment made to subjects; adding a research site; the addition, deletion or change in research staff responsible for the design, conduct, or reporting of a study; or changing the consent form to include a newly identified side effect or adverse event related to the study drug or intervention. |
Systematic Investigation | A methodical, planned approach to gather and analyze data (qualitative or quantitative) to answer specific questions, test hypotheses, or develop theories, aiming to produce generalizable knowledge beyond a single case, often for scientific or scholarly purposes, involving clear objectives and structured procedures. |
Unanticipated Problem | In general, to be classified as an unanticipated problem, any incident, experience, or outcome should meet all three of the following criteria: (1) 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. (2) Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research). (3) Likely to place subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. |
Undue Influence |
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Vulnerable Subject | For DOE Applicability, see Protected Class of Human Subjects. The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects provides a succinct and useful definition; Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. |
Acronyms
Acronym | Definition/Description |
CFR | Code of Federal Regulations: The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
COI | Conflict of Interest: A situation in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. |
DOE | Department of Energy: The federal agency that sponsors research and mandates specific protections for human subjects under DOE Order 443.1C. |
FDA | Food & Drug Administration: The federal entity that regulates drugs, biologics, and medical devices. IRB regulations for this agency are found at 21 CFR Parts 50 and 56. |
FWA | Federalwide Assurance: The agreement in which an institution commits to the federal government that it will comply with the regulations set forth in the Common Rule. |
GDPR | General Data Protection Regulation: The European Union privacy law governing data protection and privacy for all individuals within the EU. |
HARC | Human and Animal Regulatory Committees Office: The office responsible for the overall compliance of the animal care and use program and the human subjects protection program at Berkeley Lab. |
HARP | Human/Animal Research Protocol Management System: The online system used at Berkeley Lab for protocol application, renewal, and reporting processes. |
HHS | Department of Health and Human Services: The U.S. government's principal agency for protecting the health of all Americans; it houses the Office for Human Research Protections (OHRP). |
HIPAA | Health Insurance Portability and Accountability Act: The U.S. federal law that established national standards to protect sensitive patient health information from being disclosed without consent. |
HSC | Human Subjects Committee: The specific name for the Institutional Review Board (IRB) at Berkeley Lab. |
HSPP | Human Subjects Protection Program: The system of institutional policies and procedures designed to protect the rights and welfare of human subjects. |
HSWG | Human Subjects Working Group: The DOE complex-wide subject matter expert working group for Human Subjects Protection Programs. |
IDE | Investigational Device Exemption: An FDA-approved exemption that allows an investigational device to be used in a clinical study to collect safety and effectiveness data. |
IND | Investigational New Drug: A program by which the FDA grants permission to ship an experimental drug across state lines for use in clinical trials. |
IRB | Institutional Review Board: An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities. |
LAR | Legally Authorized Representative: An individual, 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. |
OHRP | Office of Human Research Protections: The federal office that oversees HSPPs and enforces the federal regulations at 45 CFR 46 (The Common Rule). |
PII | Personally Identifiable Information: Information that can be used on its own or with other information to identify, contact, or locate a single person, or to identify an individual in context. |
PLI | Protocol Lead Investigator: The researcher with primary responsibility for oversight of human subjects research under a specific protocol at Berkeley Lab. |
SME | Subject Matter Expert: An individual who contributes expertise to the IRB review process based on their specialized training and experience in a particular field. |
SOP | Standard Operating Procedure: Detailed, written instructions intended to achieve uniformity in the performance of a specific function within the HSPP. |
