Adults Unable to Consent for Themselves: adults lacking the ability to provide valid informed consent to participate in research (e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia) for whom a legally authorized representative will provide informed consent. Note: Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.
Additive (food): any substance the intended use of which results or may reasonably be expected to result–directly or indirectly–in its becoming a component or otherwise affecting the characteristics of any food (FDA).
Adversely Impact (as related to Students’ Opportunity to Learn Required Content or assessment of educators who provide instruction): students or teachers could be impacted in a negative way. It may be difficult to determine what the threshold will be where a proposed activity is likely to have an adverse impact on students’ opportunity to learn required educational content or the assessment of educators who provide instruction. Reviewers / IRBs may need to ask the researcher to provide an initial assessment of the likelihood of the research having such an impact on subjects.
To assess potential issues impacting the opportunity to learn required educational content, reviewers could consider whether the proposed activity requires students to deviate from a curriculum that is aligned with any national or state-level indicators of student achievement (e.g., state end of grade testing) or if the activity will take instructional time away from students. When assessing the impact on the assessment of educators, reviewers may want to ascertain whether participation, or the refusal to participate, in research will be a factor in the assessment of educators. In a similar manner, IRB reviewers may question whether the outcomes of the research will be a factor in the assessment of participating instructors. (SACHRP Recommendations).
Anonymous: Unidentified (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and can no longer be retrieved or linked by anyone); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).
Agricultural chemical, or environmental contaminant: can include fertilizers, herbicides and insecticides; organic matter such as animal wastes and decaying plant material; irrigation residues like salts and trace metals; and microorganisms.
Assent: Agreement to participate in research expressed by an individual (e.g., a child) who cannot provide legally effective informed consent to participate on his/her own behalf. Note: Failure to object does not constitute assent.
Behavioral Interventions: research procedures that are employed in the study of psychological states and processes, cognition, ideas and attitudes, or behavior, and generally do not include physical (bodily) tasks or physical manipulations (e.g., range of motion activities, physical exercise). (SACHRP Guidance)
Benign Behavioral Interventions: Behavioral interventions that 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. (45 CFR 46).
In general, these do not include physical (bodily) tasks or physical manipulations (e.g., range of motion activities, physical exercise) unless these are minor activities that are incident to the behavioral intervention and do not increase risk. For example, manipulating a keyboard, doing a puzzle, or walking while listening to music would be physical activities that could be considered minor activities that are taking place incident to the benign behavioral intervention. Physical interventions that are physically invasive; or, those that could be harmful or painful would not meet the exemption.
Behavioral interventions are not physically invasive when they do not involve the introduction or administration of instruments, substances or energy onto or into the body.
Alterations in the subject’s physical or sensory environment may be considered behavioral interventions to this exemption. Such interventions may not be harmful, painful or distressing, such as exposure to extremes of heat, cold, noise or light. (SACHRP recommendation)
Biological Specimens (biospecimen): material obtained from a living or deceased individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties. This definition includes solid tissues, cells, cell cultures, molecules derived from tissues (DNA, RNA, proteins, etc.) and body fluids, and generally any associated data and information.
Brief in Duration: Brief in duration is intended to refer to the intervention as opposed to the intervention and the data collection activities together. Thus, the data collection activities could proceed over a longer period of time without precluding the applicability of this exemption. If the intervention and the data collection are intertwined or difficult to separate, the entirety of the activity should be brief in duration. To meet the requirement of brief in duration, the benign behavioral intervention should last a few minutes to a few hours. While it does not have to occur in a single session, the entire time for the intervention should generally occur on a single day and not exceed a few hours in its entirety. (SACHRP Recommendation)
Broad Consent: consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Elements:
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others that may reasonably be expected from the research
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
- A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)
- A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted
- A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens
- A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite)
- Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies
- Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject
- An explanation of whom to contact for answers to questions about the subject’s rights (e.g., SBS IRB Office)
- An explanation of whom to contact for answers to questions about storage and use of the subject’s identifiable private information or identifiable biospecimens
- An explanation of whom to contact in the event of a research-related harm
Category 5 Exemption: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
Child/Children: Person(s) who have not attained the legal age for consent to the treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. For purposes of UChicago IRB policy, individuals under 18 years of age are considered children in Illinois unless they meet the definition of emancipated minors. Please note that the age may differ in other states and countries (For example, see https://statelaws.findlaw.com/family-laws/legal-ages.html and https://simple.wikipedia.org/wiki/Age_of_majority).
Clinical Investigation (FDA Regulations): Also: Research, Clinical Research, Clinical Study. Any experiment that involves a test article and one or more human subjects that either:
- Meets the requirements for prior submission to FDA under sections 505(i) or 520(g) of the Food, Drug, and Cosmetic Act; or
- Need not meet the requirements for prior submission to FDA under the sections noted above, but the results of which are intended to be later submitted to or held for inspection by FDA as part of an application for a research or marketing permit.
Clinical Trial (DHHS and NIH Regulations): Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes (45 CFR 46).
Coded: Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s), but the original identifiers are retained in such a way that they can be traced back to the source(s) by someone with the key to the code. Note: A code is sometimes also referred to as a “crosswalk,” “key,” “link,” or “map.”
Cognitively Impaired: Individuals having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases 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 interests.
Confidentiality: In the context of human subjects research, the condition that results when data are maintained in a way that prevents inadvertent or inappropriate disclosure of participants’ identifiable information.
Conflict of Interest: in general, a situation in which a person is in a position to derive personal benefit from actions or decisions made in their official capacity. A financial interest or other opportunity for tangible personal benefit of an individual or his/her immediate family that may exert a substantial and improper influence on the individual’s professional judgment in exercising any institutional duty or responsibility, including the review or oversight of research. Note: For IRB members and consultants, conflicts may be financial or non-financial interests/opportunities.
Consumer Acceptance Study: food taste evaluation, a taste test
Data Use Agreement (DUA): agreement that defines the rights, responsibilities, and obligations of both the providing and receiving parties regarding issues such as permitted use, ownership, publications, intellectual property, and liability.
Debriefing: Information about the research that is provided to participants after study completion. A debriefing session is used to provide important information about the nature of the research, additional information for educational purposes, or additional resources that may be appropriate for, or useful to, participants. It is often required when the research involves deception or incomplete disclosure. In general, this type of debriefing explains any deception or incomplete disclosure, provides information about why it was necessary to use deception or incomplete disclosure to conduct the research, and provides other options available to participants as applicable (e.g., the ability to withdraw their data).
De-Identified (and de-identified to HIPAA standards) All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). Note: For purposes of HRPP policy, protected health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule).
Deception (or Incomplete Disclosure): Deception occurs when an investigator gives false information to, or otherwise intentionally misleads, a research participant about some material aspect of the research (generally to avoid biased responses). If participants are given false information or are otherwise misled during a study, then the participants are not considered to have been provided with all of the required elements of informed consent, and approval for a waiver or alteration of informed consent is required. Incomplete Disclosure: occurs when an investigator withholds or conceals information from a participant about the specific purpose of, or activities involved in, the research. If material information or activities are withheld that could potentially influence the decision of prospective participants to take part in the research, then the participants are not considered to have been provided with all of the required elements of informed consent: in these instances, approval for a waiver or alteration of informed consent is required.
Department or Agency Head: the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated (45 CFR 46).
Device (also, Medical Device): Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article (including a component part), or accessory that is recognized in the official National Formulary or United States Pharmacopoeia (or any supplement to these) and is:
- Intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, that does not achieve any of its primary intended purposes through chemical action within or on the body, and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Devices Used to Collect Data: devices used as labeled/intended (not under study) such as MRI, Ultrasound, EEG, blood pressure cuff, sensors
Drugs: Substance recognized in the United States Pharmacopoeia, Homeopathic Pharmacopoeia of the United States, or National Formulary (or any supplement to any of these), and is an article:
- Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or intended to affect the structure or any function of the body (other than food), or
- Intended for use as a component of any substance described above.
Educational Test: standardized educational test or educational assessment (e.g., test of knowledge gains, reading level, etc.)
Federal Department or Agency: refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (45 CFR 46)
Federally-Funded: funded by a federal agency. Note that funding should be followed to the source as sub awards from another entity can have a federal origin.
FERPA: (Family Educational Rights and Privacy Act of 1974) is federal legislation in the United States that protects the privacy of students’ personally identifiable information (PII). The act applies to all educational institutions that receive federal funds. (https://www2.ed.gov/policy/gen/guid/fpco/ferpa/students.html)
FDA Regulations: The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
GRAS (Generally Recognized as Safe): Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise exempted from the definition of a food additive. GRAS substances are distinguished from food additives by the type of information that supports the GRAS conclusion, that it is publicly available and generally accepted by the scientific community, but should be the same quantity and quality of information that would support the safety of a food additive. Additional information on GRAS can be found on the GRAS Notification Program page. https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras
Greater than Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are greater than those risks ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Harmless: inoffensive; not able or likely to cause harm.
Health Care Operations: certain administrative, financial, legal, and quality improvement activities of a covered entity that are necessary to run its business and to support the core functions of treatment and payment. These activities, which are limited to the activities listed in the definition of “health care operations” at 45 CFR 164.501, include:
- Conducting quality assessment and improvement activities, population-based activities relating to improving health or reducing health care costs, and case management and care coordination;
- Reviewing the competence or qualifications of health care professionals, evaluating provider and health plan performance, training health care and non-health care professionals, accreditation, certification, licensing, or credentialing activities;
- Underwriting and other activities relating to the creation, renewal, or replacement of a contract of health insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to health care claims
- Conducting or arranging for medical review, legal, and auditing services, including fraud and abuse detection and compliance programs;
- Business planning and development, such as conducting cost-management and planning analyses related to managing and operating the entity; and
- Business management and general administrative activities, including those related to implementing and complying with the Privacy Rule and other Administrative Simplification Rules, customer service, resolution of internal grievances, sale or transfer of assets, creating de-identified health information or a limited data set, and fundraising for the benefit of the covered entity. General Provisions at 45 CFR 164.506.
HIPAA: Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), also known as The Privacy Rule, provides standards that address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals’ privacy rights to understand and control how their health information is used. Within HHS, the Office for Civil Rights (“OCR”) has responsibility for implementing and enforcing the Privacy Rule with respect to voluntary compliance activities and civil money penalties.
Human Subject: means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46)
Identifiable (or Potentially Identifiable): the identity of the participant is or may readily be ascertained by the investigator or the investigator’s staff, or can be associated with the information. Note: Individually identifiable for the purposes of IRB policy may be similar to, but is not the same as, individually identifiable health information or protected health information as defined by the HIPAA Privacy Rule at 45 CFR Part 160. Limited data sets released from data banks/repositories with approval to release such data sets under data use agreements are not considered to be individually identifiable.
Identifiable Private Information: private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. (45 CFR 46)
Identifiable Biospecimen: a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. (45 CFR 46)
Identifiable Health Information: HIPAA defines “individually identifiable health information” as information that is a subset of health information, including demographic information collected from an individual, and:
- Is created or received by a health care provider, health plan, employer, 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; and
- That identifies the individual; or
- With respect to which there is reasonable basis to believe the information can be used to identify the individual.
Identifiers: Any unique information or code that permits the data to be linked an individual. Examples of identifiers include names, social security numbers, medical record numbers. Note: 18 specific identifiers defined under HIPAA.
Incidentally (as related to including prisoners): prisoners are considered incidentally included when research is aimed at a broader population and prisoners are involved incidentally. The “incidental involvement” is generally when one or two people who are involved in a study may end up as prisoners or turn out to be prisoners as defined by the regulations (e.g. a longitudinal survey study of the general population where a subject or two may end up imprisoned during the course of the survey waves of the study, or a study of a hospital’s medical records regarding a specific condition where one or two of the people treated out of the hundreds end up being flagged as patients who are prisoners). The intent is to allow inclusion of those individuals (the random medical record, the random member of the general population who becomes a prisoner) to be included in the study without having to stop and make a case for inclusion of prisoners (or require investigators to exclude them or their records once they became a prisoner). When a study is specifically looking at criminal justice decisions and outcomes or conducting a study where data on prisoners is expected to be accessed, then such studies would not be considered to only incidentally involve prisoners.
Incomplete Disclosure (or Deception): Incomplete Disclosure: occurs when an investigator withholds or conceals information from a participant about the specific purpose of, or activities involved in, the research. If material information or activities are withheld that could potentially influence the decision of prospective participants to take part in the research, then the participants are not considered to have been provided with all of the required elements of informed consent: in these instances, approval for a waiver or alteration of informed consent is required. Deception occurs when an investigator gives false information to, or otherwise intentionally misleads, a research participant about some material aspect of the research (generally to avoid biased responses). If participants are given false information or are otherwise misled during a study, then the participants are not considered to have been provided with all of the required elements of informed consent, and approval for a waiver or alteration of informed consent is required.
Informed (of deception, incomplete disclosure, or interventions): the subject agrees to participate in research following disclosure of the intervention activities, or disclosure of the fact that he or she will be unaware of or misled regarding the nature or purpose of the research.
Interactions: include communication or interpersonal contact between investigator and subject. (45 CFR 46)
Interventions: include 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. (45 CFR 46)
Legally Authorized Representative: an individual or 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. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. (45 CFR 46)
Limited Data Set: Health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual’s relatives, employers, or household members. Note: Limited data sets may be used or disclosed for purposes of research with a data use agreement as described by the HIPAA Privacy Rule at 45 CFR Part 164.
Letter of Support: written documentation from businesses, entities, data providers, etc. that show understanding of the research to be conducted and agreement to have their data, individuals, and/or organization participate.
Medical interventions: measures and research interventions taken to improve health, alter the course of an illness or condition, or be used to prevent, diagnose, and treat a disease or condition.
Minimal risk: the probability and magnitude of harm or discomfort anticipated in the research 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. For federally-funded research with prisoners subject to subpart C, Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. (45 CFR 46)
Normal Educational Practices: those activities that are routinely used in similar educational settings and/or are considered proven educational practices with the population under study.
Not Offensive or Embarrassing: Ordinary, mild, transient forms of discomfort, such as the stress associated with completing a timed cognitive task, anxiety about performance, and boredom, are consistent with the intent of the exemption. Similarly, while research cannot meaningfully eliminate all risk of embarrassment or offense, the research should include only interventions that the researcher has no reason to think subjects will find offensive or embarrassing considering the characteristics of the subject population, the research context, and how they might impact the subject’s experience of the research intervention. (SACHRP)
PHI (Protected Health Information): The HIPAA Privacy Rule protects most “individually identifiable health information” held or transmitted by a covered entity or its business associate, in any form or medium, whether electronic, on paper, or oral. The Privacy Rule calls this information protected health information (PHI).
Physically Invasive: activities that involve the introduction or administration of instruments, substances or energy onto or into the body.
PII (Personally Identifiable Information): any information that can be used to distinguish or trace an individual’s identity, such as name, social security number, date and place of birth, mother’s maiden name, or biometric records; and any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information.
PPRA (The Protection of Pupil Rights Amendment): a federal law that affords certain rights to parents of minor students with regard to surveys that ask questions of a personal nature. https://www2.ed.gov/policy/gen/guid/fpco/ppra/parents.html
Prisoner: 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. (45 CFR 46)
Privacy: The state of being free from the observation, intrusion, or attention of others.
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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). (45 CFR 46)
Prospectively Agree: Prospective agreement must be meaningful, but it is not the same as a requirement for explicit consent. For example, individuals who are simply made aware that research data will be collected as they voluntarily complete a computer task may be understood as having agreed to participate. Research for which prospective agreement is not possible would not be eligible for exemption. For example, research involving the videotaping of pedestrians’ behavior when the timing of a public Walk/Don’t Walk is manipulated would not be exempt under this category unless they agreed in advance to participate. (OHRP Guidance)
Prospective Agreement (to deception): As with the requirement for prospective agreement, the exemption permits research involving deception only when the subject agrees to participate in research following disclosure of the fact that he or she will be unaware of or misled regarding the nature or purpose of the research. Researchers should consider debriefing after the intervention, as appropriate (OHRP Guidance)
Public Behavior: behavior taking place in a publicly accessible location in which the subject does not have a reasonable expectation of privacy.
Publicly Available: information that is generally accessible to the interested public and made available without restriction.
Public Health Activities and Purposes: In general, public health surveillance involves collecting, testing, analyzing, and using information or biospecimens to improve public health and prevent disease. It provides timely and useful evidence, and it enables public health authorities to be more effective in their efforts to protect and promote public health. Thus, public health surveillance is an important element of public health practice. Public health surveillance uses information and biospecimens from a variety of sources, including mandatory reporting of certain conditions, routine monitoring, vital records, medical records, medical billing records, clinical specimens, and public health investigations. Further, it often uses the same analytical and laboratory techniques as epidemiological research. However, the difference between public health surveillance and research in this context is that the purpose of the surveillance is to inform the decisions or actions that must be made by a public health authority.
The direct link to decision making and action by a public health authority is a hallmark of public health surveillance. In the context of public health surveillance, the collection, management, analysis, and interpretation of surveillance information or biospecimens is designed to inform a public health authority, and generally is followed by public health action or by the dissemination of information to public health programs and others to stimulate public health action.
For the purposes of this guidance, OHRP views surveillance activities that are not undertaken for the purpose of directly informing public health decision making or action generally not to be public health surveillance, even if they might be considered surveillance for other purposes.
While the best recognized public health surveillance use of information or biospecimens is the monitoring of diseases and detection of outbreaks in the population, this category of activities includes many other uses that are critical to public health practice. For instance, public health surveillance includes the collection and use of information or biospecimens to estimate the scope and magnitude of a public health problem, including the geographic and demographic distribution of a health event to facilitate public health planning. Public health surveillance also includes the use of information or biospecimens to detect changes in relevant practices or behaviors, monitor changes in infectious disease agents and environmental factors, evaluate control measures and response efforts, and actively monitor, identify, and assess the safety of medical products (OHRP Guidance)
Public Health Authority: an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. (45 CFR 46)
Readily Ascertained: the individual to whom the private information or specimens pertain can be identified by the investigator or others, or otherwise associated with the information, without going to extreme lengths to decipher the identity.
Regular Educational Setting: commonly accepted educational settings can be almost anywhere as long as the setting is one where specific educational offerings normally take place or a setting where one would go in order to have an educational experience.
Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (45 CFR 46)
Secondary Research: Study of existing information or materials (e.g., data or specimens) that have been previously collected for a purpose (including non-research purposes) other than the currently proposed activity.
Significant, Adverse, Lasting Impact: activities expected to cause lasting physical or emotional harm, persistent discomfort, be experienced by the subject as embarrassing, or be offensive. Ordinary, mild, transient forms of discomfort, such as the stress associated with completing a timed cognitive task, anxiety about performance, mild embarrassment, and boredom, would not qualify as having a significant, adverse, lasting, impact.
Steward of the Data: an individual within an organization responsible for carrying out data access, usage, and security policies.
Supplements: products taken by mouth that contain a “dietary ingredient,” including vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances, that can be used to supplement the diet. (FDA)
Taste and Food Quality Evaluation: taste test or evaluation of food (for color, flavor, odor, texture, appearance, etc.).
Ward (Ward of the State): A ward is a person, usually a minor or incompetent, who has a guardian appointed by the court to care for and take responsibility for that person.
Wholesome Foods Wholesome Ingredients: foods or ingredients with no additives (FDA).
Research-Related Policies and Procedures:
- University Research Administration Policies: https://ura.uchicago.edu/page/policies
- Conflict of Interest: https://ura.uchicago.edu/page/conflict-interest-conflict-commitment-coi-coc
- Principal Investigator (PI) Eligibility: https://ura.uchicago.edu/page/principal-investigator-eligibility
- Mandatory Reporting Requirements: https://provost.uchicago.edu/handbook/clause/mandatory-reporting-suspected-child-abuse-and-neglect
- University Policy on Compensation: https://finserv.uchicago.edu/payroll/independent/subjects.shtml
Data Access, Storage, and Transfer:
- University Research Data Retention Policy: https://adminet.uchicago.edu/admincompt/finpolic/2708.shtml
- Data and Material Transfer Agreements (Contracts, MTAs, DUAs, CTAs): https://ura.uchicago.edu/page/contracts
- UChicago Data Classification Guide: https://its.uchicago.edu/data-classification-guideline/
- UChicago Data Usage Guide: https://dataguide.uchicago.edu/
- Accessing and Utilizing University Data for Research: https://dsc.uchicago.edu/
- Secure Data Enclave (SDE): https://securedata.uchicago.edu/
- Center for Research Informatics (CRI): https://cri.uchicago.edu/
International Travel & Research:
- Travel Toolkit for International Research: http://www.traveltoolkit.uchicago.edu/
- Export Control: https://ura.uchicago.edu/page/export-controls
- International Human Subjects Research Standards: https://www.hhs.gov/ohrp/international/
Main US Ethical Codes & Regulations:
- Office for Human Research Protections (OHRP): https://www.hhs.gov/ohrp/
- 45 CFR 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- 21 CFR 50: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50
- 21 CFR 56: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56
- Belmont Report: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
- Link to guidance on common state requirements to explore (such as age of majority): https://en.wikipedia.org/wiki/Age_of_majority