HRPP Policy - Exempt research

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IU Human Subjects Office
(317) 274-8289

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7.0 - Definitions

authorization Per the Privacy Rule, an individual's permission to allow a covered entity to use or disclose the individual's protected health information (PHI) described in the authorization for the purpose(s) and to the recipient(s) stated in the authorization.

biospecimen A quantity of tissue, blood, urine, or other human-derived material. A single biopsy may generate several biospecimens, including multiple paraffin blocks or frozen biological material. The molecular makeup of such specimens reflects the physiologic or pathologic condition of the person from whom they derive; therefore, they provide sensitive and specific insight into the biologic state of the donor. Examples of biospecimens include: subcellular structures (e.g., DNA), cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, and kidney), blood, buccal swabs, gametes, embryos, fetal tissue, saliva or other body fluids, and waste (e.g., urine and stool). Portions or aliquots of a biospecimen are referred to as samples.

confidentiality The assurance that certain information about individuals, which may include a subject's identity, health, behavior, or lifestyle information, or a sponsor's proprietary information, will not be disclosed without permission from the subject or sponsor.

department or agency head The head of any federal department or agency and any other officer or employee of any department or agency to whom authority provided by the Common Rule to the department or agency head has been delegated.

federally-funded Supported, either directly or indirectly, by funds provided by the federal government. This includes federal pass-through funding (i.e., received as a subrecipient through subcontracts). Use of administrative services funded by a federal grant, alone, is not sufficient to consider research federally-funded.

HIPAA The Health Insurance Portability and Accountability Act of 1996. See also Privacy Rule.

identifiable biospecimen Biospecimen for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the biospecimen.

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.

identifier Information that can be used to link a sample or scientific result with a specific person or group of people, including any of eighteen (18) identifiers defined by the Privacy Rule and defined in the IU HRPP Policy on Use of PHI in Research, section 2.3, Safe Harbor Method.

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.

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.

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 that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the OHRP Prisoner Research FAQs.

privacy Refers to persons and their interest in controlling the access of others to themselves.

privacy board Under the Privacy Rule, the group of individuals charged with the review and approval of waivers of authorization.

privacy rule Federal Rule found at 45 CFR 160, and 164 subparts A and E, which establishes national standards for protection of individuals' medical records and other personal health information; applies to covered entities.

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).

protected health information (PHI) Health information, including demographic information collected from an individual, that 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, or to the provision of health care to an individual.

recruitment Initial identification and contact with potential subjects, which may include both direct interactions with individuals and/or accessing identifiable data or specimens for the purpose of determining whether an individual or their data or specimen may participate or be included in a study.

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 (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, site-specific PI) 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.

suspension Temporary cessation of some or all activities in a currently approved research study.

test article Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or under §351 or §§354-360F of the Public Health Service Act.

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