New Rules in Effect January 20, 2019
§ 46.102 Definitions
(a) Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
(b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include
(c) Department or agency head means 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.
(d) 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).
(e)(1) 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,
(e)(2) 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.
(e)(3) Interaction includes communication or interpersonal contact between investigator and subject.
(e)(4) 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.
(e)(5) 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.
(e)(6) 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.
(e)(7) Federal departments or agencies implementing this policy shall:
(i) Upon consultation with appropriate experts (including experts in data matching and re-identification), reexamine the meaning of “identifiable private information,” as defined in paragraph (e)(5) of this section, and “identifiable biospecimen,” as defined in paragraph (e)(6) of this section. This reexamination shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. If appropriate and permitted by law, such Federal departments and agencies may alter the interpretation of these terms, including through the use of guidance.
(ii) Upon consultation with appropriate experts, assess whether there are analytic technologies or techniques that should be considered by investigators to generate “identifiable private information,” as defined in paragraph (e)(5) of this section, or an “identifiable biospecimen,” as defined in paragraph (e)(6) of this section. This assessment shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. Any such technologies or techniques will be included on a list of technologies or techniques that produce identifiable private information or identifiable biospecimens. This list will be published in the Federal Register after notice and an opportunity for public comment. The Secretary, HHS, shall maintain the list on a publicly accessible Web site.
(f) Institution means any public or private entity, or department or agency (including federal, state, and other agencies).
(g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
(h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
(i) Legally authorized representative means 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 non research context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research.
(j) Minimal risk means that 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.
(k) Public health authority means 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.
(l) Research means 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. For purposes of this part, the following activities are deemed not to
(1) Scholarly and 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.
(2) 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, monitor, 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).
(3) 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.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
(m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.
Deception in research
Deception in research involves withholding information from or deliberately giving false information to human participants about the hypothesis or methods of a research project. Deception cannot be used in order to obtain consent from human participants. From the APA guide to ethics (http://www.apa.org/ethics/): 8.07
- Researchers do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study's significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.
- Researchers do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.
- Researchers explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and
permitparticipants to withdraw their data. see APA; Debriefing (http://www.apa.org/ethics/): 8.08
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published. -Kris A. Monahan, Ph.D., Director, Sponsored Research & Programs, Providence College
Identifiable Personal Information
No single item (except possibly a person's Social Security Number, which by law cannot be used except for very specific circumstances) can be relied upon to identify an individual with certainty. Names, addresses or telephone numbers may more directly identify an individual than postal codes, date of birth, age, occupation, initials, hospital or student number, ethnic group or religion. Photographs and audio or video recordings may lead to identification.
Although individual items may not by themselves permit identification of an individual, taken together in a given context and with a certain amount of effort and use of other sources, a combination of items may allow an individual to be identified. This means that all items of information relating to an individual may have the potential to identify that individual.
A “strictly anonymous” study design is one in which it is impossible to trace data or information back to the research subject from whom it was obtained. In other words, the data cannot be identified to any particular research participant, not even by the researcher. There is total separation. No study design that involves the creation of a code linking the subject’s identity to a pseudonym or a number can be termed an anonymous study, as the identity of the subject can be traced to the data. Additionally, when a written consent form is collected, this consent form has to be separated from the data that the subject provides. The PI (principal investigator) needs to describe in the protocol how this will be accomplished.
“Confidential” research participation means that the data from the research subject(s) can potentially be identified or linked to a particular individual. Thus, any data collected face-to-face (consumer survey, focus groups, standing in front of a classroom, etc.) is automatically considered in the category of possibly being “confidential” as opposed to “anonymous.” This is true even when the researcher assigns a coding number to the subject—and this number cannot be traced back to the subject—because the researcher him-/herself knows who provided the data. Claims of confidentiality are usually qualified with the statement of "to the best of my ability." A PI may ask a focus group to maintain confidentiality, but cannot guarantee it.
Informed Consent is the term given to the communication process that allows individuals to make an informed choice about participation in a research study. This process is reflected in an informed consent document that contains specific, required information about the research study. The informed consent document serves as the formal authorization by an individual of their agreement to participate in the proposed research. Some research protocols may not require signed consent, or in some rare circumstances, the consent process may be waived.
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.
Interaction includes communication or interpersonal contact between the investigator and a subject such as by way of interviews or survey questionnaires.
QA/QI Quality Assurance or Quality Improvement
QA/QI projects assess how an organization, group, faculty, department, or program is doing. QA/QI activities at Kenyon are usually undertaken by members of Kenyon College for administrative or operational reasons. Some QA/QI activities may be considered "not research", or do not contribute to "generalizable knowledge." QA/QI projects should still conform to the basic ethical principles of human subjects research; Respect for Persons, Beneficence, and Justice.
Principal Investigator (PI) is the lead person who is responsible for the design, conduct, and reporting of a research project. The PI is responsible for
Private information includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual in circumstances or conditions where the individual reasonably expects the information will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to constitute research involving human subjects.
Protected health information is defined as individually identifiable health information maintained or transmitted by a covered entity in any form or medium and includes: demographic information; medical history; information relating to the past, present or future physical or mental health or condition of an individual that is identifiable; the provision of health care to an individual or the payment for the provision of health care; physical examinations, blood tests, x-rays; and other diagnostic and medical procedures.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or 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.
Research consists of an investigation that:
- seeks answers to a question
- systematically uses a predefined set of procedures to answer the question
- collects evidence
- produces findings that were not determined in advance
- produces findings that are applicable beyond the immediate boundaries of the study
Risk should be interpreted in a broad sense to mean not just physical risk but also
Designating a project "minimal risk" does not diminish the responsibilities of either the IRB or the investigators, nor does it eliminate the requirement for obtaining informed consent.
Sensitive Research may involve the collection of information falling into any of the following categories:
- Information relating to sexual attitudes, preferences, or practices;
- Information relating to the use of alcohol, drugs, or other addictive products;
- Information pertaining to illegal conduct;
- Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
- Information that would normally be recorded in a subject's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
- Information pertaining to an individual's psychological well-being or mental health.
- Information in other categories not listed may also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.
Systematic Investigations are studies that are intended and designed to collect data about human subjects with the purpose of drawing conclusions and the reporting research findings.
Vulnerable Populations or Circumstances resulting in vulnerability to coercion, manipulation, or undue influence and reduced or limited voluntariness may include:
Children/minors have a wide range of capacity depending on age, maturity and psychological state. There is potential for control, coercion, undue influence, or manipulation by parents, guardians, or investigators, particularly of young children. see Subpart D
- Pregnant women (the concern is focused on the fetus) see Subpart B
- Embryos and Fetuses have absolutely no capacity and are under the direct control of the mother. see Subpart B
- Prisoners "A prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under
criminalor 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." Included are those in hospitals or alcohol and drug treatment facilities under court order. Individuals in work-release programs and in at-home detention programs also qualify as prisoners. The definition applies to minors as well as to adults. see Subpart C
- Mentally Disabled Individuals have problems with capacity, which may be continuous or fluctuating, depending on the disability. In addition, they may have limitations on voluntariness because often they are institutionalized or hospitalized, are economically and educationally disadvantaged, and suffer from chronic diseases. As a result, they are potentially subject to control, coercion, undue influence, or manipulation.
- Educationally Disadvantaged Subjects may have limitations on understanding of the study they will participate in, and may even be illiterate. The possibility exists for undue influence and/or manipulation.
- Economically Disadvantaged Subjects may be vulnerable due to a limitation on voluntariness. They may enroll in research only to receive monetary compensation, or they may enroll in research to obtain
medicalcare they cannot otherwise afford. There is potential for undue influence or manipulation.
- Marginalized Social Groups may lack influence in society as a result of race, age, disease, sexual orientation, or caste systems. These groups often do not have full access to social institutions such as the legal system. There is potential for control, coercion, undue influence, or manipulation.
- Individuals with Incurable or Fatal Diseases often have limitations on voluntariness, and in addition, may have problems with capacity caused by disease or medications. These individuals may accept very high risks in desperation for a cure, even when there is little or no prospect of direct benefit.
- Emergency Situations can create a situation where capacity and voluntariness is compromised. There are often limitations to capacity due to the emergency condition. There are often limitations on voluntariness due to time constraints or hospitalization. An example is
researchon heart attack medications, in which the subjects are asked to consent in the ambulance on the way to the hospital. There is potential for control, coercion, undue influence, or manipulation.
- Hierarchical Social Structures that confront hospitalized patients, nursing home residents, employees, students, prisoners, military personnel, and some ethnic groups can create situations where voluntariness can be compromised. There is potential for control, coercion, undue influence, or manipulation.
A vulnerable subject may be any person with substantial incapacity to protect one’s own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities or being a junior or subordinate member of a hierarchical group.