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.  

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

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.

Exempt Research

Refers to studies that fall under one or more of the eight exempt categories outlined in federal regulations at § __.104. 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. NIH Infographic

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).

Generalizable Knowledge

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.

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:

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 subject is someone who becomes a participant in research, either as a recipient of the test article or as a control.

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

1. Involve no greater than minimal risk.
2. Examples of minor modifications include personnel changes (not including PLI/co-PLI); minor procedural changes; changes that reduce risks; changes to existing procedures that add minor risks (e.g., adding a second small blood draw); changes to wording in the application, consent form, or other documents.

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: 

• Information that is observed or recorded about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place;
• Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, e.g., a medical record or a utility bill.
• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information
• An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
  

Protocol Lead Investigator

The researcher with primary responsibility for oversight of  human subjects research under a specific protocol.

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 Subject

AKA participant, is a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.  

In clinical research, a subject is someone who becomes a participant in research, either as a recipient of the test article or as a control.

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: 

1. results in death;  
2. is life-threatening;  
3. requires 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.  

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 study or examination involving a methodical procedure or plan. Typically includes a scientific question and hypothesis that the study is designed to answer.

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

1. Influence by which a person is induced to act otherwise than by their own free will or without adequate attention to the consequences. 
2. Undue influence […] occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. (From The Belmont Report).

Vulnerable Subject

A subject potentially vulnerable to coercion or undue influence, such as children, fetuses, prisoners, individuals with impaired decision-making capacity, or economically- or educationally-disadvantaged persons. Certain circumstances may make some subjects situationally vulnerable (e.g., college students or employees, illness) and certain groups may be vulnerable to group harms (e.g. ethnic or racial minorities).

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.

FDA

HARC

The Human and Animal Regulatory Committees Office. 

Operated as a part of the EH&S division, staff are responsible for the administration of the Human Subjects Committee, Animal Welfare and Research Committee, and the Radioactive Drug Research Committee.

HARP

The Human/Animal Research Protocol Management System. The system housing online "smart" forms that lead all Berkeley Lab researchers through protocol application, renewal, amendment, and adverse/unexpected event reporting processes.

HSWG

Human Subjects Working Group

HSPP

Human Subjects Protection Program

OHRP

SME

Subject Matter Expert