Glossary | Human Research Protections

Safe Harbor De-Identification:

Potential identifiers include obvious ones like name and social security number, and also:

All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and [t]he initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
Voice and fax telephone numbers;
Electronic mail addresses;
Medical record numbers, health plan beneficiary numbers, or other health plan account numbers;
Certificate/license numbers;
Vehicle identifiers and serial numbers, including license plate numbers;
Device identifiers and serial numbers
Internet Protocol (IP) address numbers and Universal Resource Locators (URLs);
Biometric identifiers, including finger and voice prints;
Full face photographic images and any comparable images; and
Any other unique identifying number, characteristic, or code.

Under HIPAA's "safe harbor" standard, information is considered de-identified if all of the above have been removed, and there is no reasonable basis to believe that the remaining information could be used to identify a person.

Scientific Merit:

An assessment of whether or not a study represents good science. For example a study with scientific merit addresses an area of importance to the discipline, utilizes established scientific principles, exhibits alignment within the study, offers congruence among research questions and study design, and is likely to contribute to scientific knowledge.

Screening Log:

An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

Screening Process:

A process designed to determine individual’s eligibility for participation in a clinical research study.

Secondary Data:

Secondary data is data collected by someone other than the user. Common sources of secondary data for social science include censuses, surveys, organizational records and data collected through qualitative methodologies or qualitative research. Primary data, by contrast, are collected by the investigator conducting the research.

Sensitive Information at Risk of Subpoena:

Any information which could be of interest to the court in civil, criminal or other judicial proceedings. Most commonly this includes the use of alcohol, illegal drugs or addictive products and illegal behavior. Other examples which may in some instances be of interest to the court include information regarding HIV, AIDS, and other STDs; sexual practices or preferences; the participant's psychological state or mental health; information that can be linked to a participant's financial standing, employability or reputation within the community or that might lead to social disgrace or prejudice; genetic information or identifiable biological samples and corresponding data that may be used to demonstrate predisposition to disease or disputes in paternity; or information regarding behavioral interventions.

Serious Adverse Event (SAE):

Any adverse event that:

Results in death
Is life threatening, or places the participant at immediate risk of death from the event as it occurred
Requires or prolongs hospitalization
Causes persistent or significant disability or incapacity
Results in congenital anomalies or birth defects

Is another condition which investigators judge to represent significant hazards

Serious Noncompliance:

Any behavior, action or omission in the conduct or oversight of human research that has been determined to:

Affect the rights and welfare of participants and others;
Increase risks to participants and others, decrease potential benefits or otherwise unfavorably alter the risk/benefit ratio;
Compromise the integrity or validity of the research; or
Result from the willful or knowing misconduct on the part of investigators or study staff.

Examples include, but are not limited to the following:

Failing to obtain Informed consent before enrolling a participant in a research study;
Conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval;
Enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion of the IRB Chair, designee, or convened Committee, places the participant(s) at greater risk; or
Failing to report adverse events, unanticipated problems, or substantive changes to the proposed protocol to the IRB in accordance with IRB policy.

Side Effect:

Any undesired action or effect of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects.

Significant Risk (SR) Device:

A device that presents a potential for serious risk to the health, safety, or welfare of a subject and:

Is intended as an implant, or
Is used in supporting or sustaining human life, or
Is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or
Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Source Document:

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.

Special Guardian:

A guardian of a person of limited capacity, including, without limitation, such a guardian who is appointed because a person of limited capacity has voluntarily petitioned for the appointment and the court has determined that the person has the requisite capacity to make such a petition.

Sponsor:

A person, federal agency, corporation, or other entity that provides funds for a research project.

Sponsor-Investigator:

An individual who both initiates and actually conducts - alone or with others - a clinical investigation. Corporations, agencies, or other institutions do not qualify as Sponsor-Investigators.

Standard Operating Procedures (SOPs):

Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

Standard Treatment/Standard of Care:

A treatment or regimen in wide use and considered to be effective in the treatment of a specific disease or condition. (Often used as comparator for a new drug, device, biologic or treatment).

Stopping Rules:

Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.

Study Arm:

Any of the treatment groups in a randomized trial. Most randomized trials have two “arms” but some have three or more.

Surrogate Consent:

Consent for an individual to participate in research given by an appropriate surrogate (e.g., next of kin including spouse, parent, child, sibling) when an individual is assessed as not capable of providing fully informed and legally effective consent.

Survey:

A means to obtain information from respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.

Suspension/Termination of IRB Approval:

A determination by the IRB Chair, a designated IRB member, or the convened IRB to temporarily interrupt some or all previously-approved research activities. The suspended activities could include, but not be limited to, recruiting and enrolling new subjects. Suspended studies remain open and require continuing review. NOTE: Suspensions of IRB approval apply to interruptions in research activities due to concerns about the safety, rights, or welfare of human research subjects or others. They do not include interruptions in human research resulting solely from the expiration of the IRB approval period.