HRPP Policy - Individuals Lacking Capacity

About This Policy

Effective date:
Last updated:
Policy Contact:

IU Human Subjects Office
(317) 274-8289

7.0 - Definitions

adult An individual who has reached age of majority in the relevant state. In Indiana, a person at least eighteen (18) years of age.

adult indivdiuals lacking consent capacity Individuals who, for various reasons, lack the ability to understand the research, appreciate the consequences of their participation, consider alternatives, and/or make reasoned choices, such that they cannot provide informed consent for themselves.

assent An individual's affirmative agreement to participate in research obtained in conjunction with permission of the individual's parents, guardian, or legally authorized representative. Mere failure to object should not, absent affirmative agreement, be construed as assent.

audit (see also for-cause (directed) audit, internal audit, and not-for-cause (scheduled) audit) A systematic and independent examination of study-related activities and documents to determine whether the evaluated study-related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to applicable federal regulations, state laws, and institutional policies. Includes audits, monitoring visits, and compliance inspections.

children (minor) Persons who have not attained the legal age for consent to treatments or procedures involved in the research or clinical investigation, under the applicable law of the jurisdiction in which the research or clinical investigation will be conducted. In Indiana, persons less than 18 years of age.

generalizable knowledge Information that expands the knowledge base of a scientific discipline or other scholarly field of study.

identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the information.

informed consent An ongoing process by which a subject (or, his or her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.

legally authorized representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the procedure(s) involved in the research. For definition of LAR in Indiana, see the IU HRPP Policy on Adult Individuals Lacking Consent Capacity.

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.

parent A child's biological or adoptive parent.

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., medical records).

representative As defined by Indiana Code 16-36-1, an individual delegated to consent to health care of another who for a time will not be reasonably available to exercise the authority. The delegation: (1) must be in writing; (2) must be signed by the delegate; (3) must be witnessed by an adult; and (4) may specify conditions on the authority delegated. Unless the writing expressly provides otherwise, the delegate may not delegate the authority to another individual.

research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: 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 individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, 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); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

research personnel Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.

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