Human Research Protections Program (IRB) Definitions

A 118 determination refers to regulations at 45 CFR 46.118, Applications and proposals lacking definite plans for involvement of human subjects. The Common Rule permits the IRB to make a determination for projects involving certain grants, cooperative agreements, or contracts that have been awarded with a human subjects research component, but plans for the involvement of human subjects are not yet definite. This type of determination cannot be made for projects contemplating human subjects research. Instead, this type of determination is used for instances in which human subjects research activities are planned well into the future, or there is an indefinite component of the research that is not yet developed (but needed in the IRB review process).

In order for a study to be considered human subjects research, the data obtained must be “about” the living individual. In some cases, an investigator may interact or intervene with a living individual, but the purpose is to obtain data about a topic other than the individual. These studies may not be considered human subjects research.

Some examples of activities that are not considered human subjects research because they do not meet the criteria of being about a living individual:

• Asking a nongovernmental organization about its source of funding.
• Asking an employee to describe the different functions performed by different positions at an organization and communication processes between departments, as long as no private, personally identifiable information is collected about individuals who have filled different positions.
• Asking a teacher to describe teaching methods or techniques used in the classroom. 

Some examples of activities that are considered human subjects research because they meet the criteria of being about a living individual:

• Asking a teacher to describe her or his personal experience using different teaching methods or techniques. Note: This would be considered human subjects research even if the overall purpose of the study were about teaching methods.
• Asking a political scientist who is the strongest candidate in a political race. Note: This opinion question is about the individual because it seeks a general attitude from—that is, something about—the individual; and not a concrete assessment of something within their realm of expertise.
• The purpose of the research is to determine within-rater reliability. The investigators ask engineers who have used Systems A and B to evaluate the systems (e.g., with instructions to rate each system on a scale of 1 to 10). The investigators perform an analysis that determines the engineers have low within-rater reliability.

An individual’s participation in a research study can be described as anonymous when no one, including the study investigators, can identify them as a participant.

Data/specimens are anonymous when no one, including the study investigators, can connect the data to the individual participant (i.e., no personally identifying information is collected). Keep in mind that even when study investigators do not collect direct personal identifiers such as name or student ID number, collection of indirect identifiers, taken in combination, might make it possible for someone to identify an individual participant from among a pool of subjects – for example, academic department and ethnicity.

Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. The assent procedure should reflect a reasonable effort to enable the child to understand what their participation in research would involve. The primary focus should be enabling the subject to fully understand the explanation of the study. The need for and type of assent process may vary depending on various factors including, the age of the participants, literacy, or development. More information can be found on the Informed Consent page.

In the context of Exempt Category 3, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions 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.

Children are 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 (e.g., those under 18 years old in California).

In the context of human subjects research, coded means that identifying information (such as name, address, phone number or social security number) 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 information to the private information or specimens.

In the context of Category 1 exemptions, commonly accepted educational settings include but are not limited to K-12 schools, college classrooms, after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.

Decisional capacity or decision-making capacity refers to a subject’s ability to make a meaningful decision about whether or not to participate in research. It is generally includes the following elements:

1. Understanding, which includes the ability to comprehend information about the purpose and procedures of the study, as well as the potential risks and benefits of participating;
2. Appreciation, consisting of the ability to appreciate the significance of the disclosed information and the potential risks and benefits for one’s own situation;
3. Reasoning, or the ability to process the risks and benefits of participating versus not participating; and
4. The ability to express a decision or choice about whether or not to participate.

Decisional capacity should be considered situational and specific to the particular research study, and should not be confused with the legal concept of competence. Someone who is legally deemed incompetent may be able to make informed decisions about participation in a particular study and someone with full cognitive functioning may have their decision-making capacity diminished by pain or duress.

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.

More specifically, an institution is engaged in research when ANY of the following apply:

• The institution is the awardee institution for a non-exempt human subjects research project, even if all human subjects research activities will be carried out by employees or agents of another institution. 
• An employee or agent of the institution intervenes with human subjects for research purposes through:
  • Invasive or noninvasive procedures (see examples below)
  • Manipulating the environment  (see examples below)
  • Interacting with any human subject of the research (see examples below)
  • Obtaining informed consent 
  • Obtaining identifiable private information or identifiable specimens, even if there is no direct interaction with human subjects (see examples below)

Examples

Examples of invasive or noninvasive procedures include:

• drawing blood; 
• collecting buccal mucosa cells using a cotton swab;
• administering individual or group counseling or psychotherapy;
• administering drugs or other treatments; 
• surgically implanting medical devices; 
• utilizing physical sensors; 
• utilizing other measurement procedures. 

Examples of manipulating the environment include:

• controlling environmental light, sound, or temperature;
• presenting sensory stimuli; 
• orchestrating environmental events or social interactions.

Examples of interacting include:

• engaging in protocol dictated communication or interpersonal contact; 
• asking someone to provide a specimen by voiding or spitting into a specimen container; 
• conducting research interviews or administering questionnaires. 

Obtaining identifiable private information or identifiable specimens includes, but is not limited to:

• observing or recording private behavior; 
• using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; and using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators.

All UC Santa Cruz study investigators and external (non-UC Santa Cruz) collaborating investigators who will be engaged in human subjects research should be identified and added to the “Research Personnel” section of a study submission. Engagement includes any of the following:

• Recruiting subjects (beyond just distributing a recruitment message for the UC Santa Cruz study investigators).
• Obtaining subject consent.
• Interacting or intervening with subjects for research purposes.
• Accessing private identifiable information about subjects for research purposes.
• Using institutional facilities for conducting research (beyond just posting a recruitment message).

For more information about what it means to be engaged or not engaged in research, see the Department of Health and Human Services Guidance on Engagement of Institutions in Human Subjects Research.

An investigator is any individual who is involved in conducting human subjects research studies. Investigators can include professors, scientists, administrative staff, teachers, and students, among others.

Anyone that will be intervening or interacting with human subjects or with their personally identifiable data should be listed as investigators on the study. For new investigators added after the initial approval of a study, a modification to the study must be submitted and approved before they may commence work on a human subjects study.

Examples of involvement that would not need to be listed include:

• Laboratory personnel receiving samples for analysis that do not include any subject identifiable information (de-identified samples).
• Collaborators at other institutions who are receiving survey responses that do not include subject identifiable information.
• Administrative personnel assisting with logistics who do not have access to study data/subject identifiable information.

The Federal Policy (Common Rule) for the protection of human subjects requires that each institution “engaged” in federally-supported human subject research file an Assurance with the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP). The Assurance, or FWA, formalizes the institution’s commitment to protect human subjects by complying with the requirements for human subjects research set forth in the regulations at 45 CFR 46 and the Terms of Assurance.

UCSC’s Federalwide Assurance number is FWA00002797. 

Investigators engaged in collaborative research who need to find the other institution’s FWA # for a submission can use the searchable database of assurances available at the Office for Human Research Protections.

Generalizable knowledge is information where the intended use of the research findings can be applied to populations or situations beyond that currently being studied.

The vast majority of scholarly work in academia is intended to be shared, published, presented to colleagues, and is intended to have an impact (theoretical or practical) on others within one’s discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, future research  designs, etc. are contributing to generalizable knowledge.

Guardian means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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.

For most human subjects research purposes at UCSC identifiable information means that the information includes direct/personal identifiers. Personal identifiers include the following:

• Names
• Phone numbers
• Email addresses
• IP addresses
• Social security numbers
• Photographs/images
• Audio- or video-recordings
• Street address
• Identification (ID) numbers (driver’s license, state ID card, passport, etc.)
• Biometric identifiers (finger prints, voiceprints, etc.)
• Information that would also be considered PHI. For definition of PHI see HIPAA section.
• Information regulated by the Payment Card Industry (PCI) Data Security Standard
• Codes that link unidentifiable data to identifiers

There are instances where an investigator may not be collecting any direct identifiers, such as names, but will be collecting enough indirect information about a group of people that a person familiar with the group could potentially identify subjects, or that information could be combined in such a way as to ascertain subjects’ identities.

For example:

• A study investigator collects both academic department and ethnicity at a university with a small number of ethnic minorities.
• A study investigator collects demographic information about a group of employees at a small company.
• A study investigator records the age, rank, and years of service of a group of Marines who served in a small base in Afghanistan in 2012.

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.

Informed consent involves an education and information exchange that takes place between the researcher and the potential subject. Both written and verbal consent for participation in research must involve an informed consent process.

Informed consent should be documented by an IRB-approved written consent form that is signed (including in an electronic format) by the subject or the subject’s legally authorized representative (LAR). A written copy should be given to the person signing the informed consent form. More information can be found on the Informed Consent page.

Interaction includes communication or interpersonal contact between investigator and subject.

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

In California, minors are defined as people under 18 years old.

In the context of Category 1 exemptions, normal educational practices are established teaching methods, curriculum content and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher. 

Normal educational practices are activities that would be occurring regardless of whether or not the research is conducted. Therefore, a study that evaluates a new instructional strategy or curriculum, or that randomly assigns students to different instructional strategies/curricula for the purpose of comparison, would probably not be exempt because these are not considered normal educational practices.

Oral history projects are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge. If you are unsure, the Cayuse Human Ethics Initial Submission includes questions to help make this determination.

Permission means the agreement of parent(s) or guardian(s) to the participation of their child or ward in research. In general, permission should be obtained from both parents before a child is enrolled in research. However, the IRB may find that the permission of one parent is sufficient on an individual or group basis for research when risks are minimal or the research will directly benefit the child. The requirement of obtaining parental or guardian permission can be waived in special circumstances. More information can be found on the Informed Consent page.

Prisoner is defined by HHS regulations at 45 CFR 46.303(c) as “any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.”

There are two kinds of private information included in the federal definition:

• 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 that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, such as a medical or school record.

Collection of information from public spaces occurs if there is no reasonable expectation of privacy in these spaces. On the other hand, collection of private information occurs when subjects can reasonably expect that no observation or recording are taking place and their interactions or information will not be made public.

Within the context of human subjects research, research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Generally, the IRB definition of “research” does NOT include:

• Student coursework, including undergraduate honors theses, unless they are to be made available to the public, used by other investigators, or there is a possibility that the research may lead to a formal presentation or publication.
• Oral history projects are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge.

Program evaluation, quality assurance and quality improvement activities are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge.  When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information will be used to provide feedback to improve that program, the activity is not human subjects research.  When the evaluation is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is research.

UC Santa Cruz defines student intern as a non-UC Santa Cruz student performing a supervised research internship offered by an organization (not only UC Santa Cruz) for a limited period of time. For example, the UC Santa Cruz Science Internship Program (SIP) or a non-UC Santa Cruz undergraduate or graduate visiting for a short, defined period to work on an already established research study.

If capacity assessment determines that an individual is unable to give thoroughly informed consent, surrogate consent must be obtained from the subject’s legally authorized representative such as a parent, guardian, or conservator. For more information, see Informed Consent.

A systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question(s).

Usually, to be a systematic investigation, a research design would meet all of the following criteria:

• Attempts to answer research questions (in some research, this would be a hypothesis).
• Is methodologically driven, that is, it collects data or information in an organized and consistent way. 
• The data or information is analyzed in some way, be it quantitative or qualitative.
• Conclusions are drawn from the results.

A waiver of documented consent is a waiver of the requirement to obtain a physical signature on a consent document. More information can be found on the Informed Consent page.

A waiver of informed consent is a waiver of the requirements to obtain informed consent, or a waiver or alteration of some of the required elements of informed consent. More information can be found on the Informed Consent page.

In studies that include children or minors as subjects, the consent process must include the permission of the child’s parent(s) or legal guardian(s). If the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects, such as in cases of neglected or abused children, they may approve a waiver of the requirement for permission. More information can be found on the Informed Consent page.