HRPP Policy - IRB review process

About This Policy

Effective date:
03/29/2018
Last updated:
02/15/2019
Policy Contact:

IU Human Subjects Office
(317) 274-8289
irb@iu.edu

IU HRPP Documents

Related IRB Questionnaires

  • Conflicts of Interest
  • A – Level of Review Assessment
  • B – Lay Summary & Research Design
  • C – Sites & Collaborations
  • D – Recruitment Materials
  • E – Risks, Benefits, Protections
  • F – Data Safety Monitoring
  • G1 – Children
  • G2 – Individuals Lacking Consent Capacity
  • G3 – Prisoners
  • G4 – Transnational Research
  • H – Informed Consent Process
  • J – Child Assent & Parental Consent Process
  • K – HIPAA
  • L – VA Research
  • Amendment
  • Renewal
  • Reportable Event (FYI)
  • Study Closure/Closeout Report

View KC Crosswalk

Related Forms and Templates

  • Drug or Biological Product Form
  • Medical Device Form

Browse IU HRPP Forms

7.0 - Definitions

2018 requirements Federal Policy for the Protection of Human Subjects, effective January 21, 2019, available at 45 CFR 46

adverse event  Any untoward or unfavorable occurrence, including medical, physical, and psychological harms, in a human subject associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.

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.

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.

biological product or biologic  As regulated by the FDA, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings; regulated as a drug.

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.

corrective action  Action taken to correct a noncompliant situation that has occurred.

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.

device (medical device)  As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 2) 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 3) intended to affect the structure or any function of the body of man or other animals, and; which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.

drug  As regulated by the FDA, A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and B) rticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and D) articles intended for use as a component of any articles specified in clause (A), (B), or (C).  See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.

enrollment  Enrollment begins at the time of consent for the study. For research for which consent is not required, enrollment begins at time of data collection or when the subject agrees to participate.

exempt from IDE requirements  There are several categories of device studies that are exempt from investigational device exemption (IDE) requirements if certain criteria are met:  (A) certain studies of custom devices; (B) studies involving certain device modifications, combinations, or consumer preference testing of already-approved or cleared devices; (C) studies involving non-invasive diagnostic devices; and (D) studies involving already cleared or approved devices.

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.

federalwide assurance (FWA)  Written assurance of compliance with the Common Rule to OHRP from institutions engaged in non-exempt human subjects research conducted or supported by HHS.

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

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/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.

interaction   Includes communication or interpersonal contact between research personnel and the 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.

investigational device exemption (IDE)   As regulated by the FDA, authorization allowing an investigational device to be used in a clinical investigation in order to collect safety and effectiveness data.

investigational new drug application (IND)  Request for authorization from the FDA to administer an investigational drug or biological product to humans.

investigator (FDA, see also research personnel, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI)  In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

IRB-approved protocol  Refers to all IRB-approved study information, including the human subject application, formal protocol document, consents, etc.

key personnel (see also research personnel, Investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI)  research personnel, other than the PI, who are responsible for the conduct and/or reporting of research. Such individuals may include, among others: Individuals making critical decisions regarding eligibility of subjects; Individuals obtaining consent for a study that is greater than minimal risk (Full Board); Individuals listed on Form FDA 1572 or the investigator agreement.

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.

noncompliance  (see also continuing noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.05, or institutional policies governing human subjects research or the requirements or determinations of the IRB.

noninvasive  When applied to a diagnostic device or procedure, means one that does not by design or intention: 1) penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or 2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. Blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive.

nonsignificant risk (NSR) device Investigational device that does not meet the definition for a significant risk device.

principal investigator (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, student, fellow, resident PI, site-specific PI)  Responsible leader of a team of research personnel who has the ultimate responsibility for the conduct of the research.

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 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.

significant risk device  Per 21 CFR 812.3(m), investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

sponsor  An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.

student, fellow, resident PI (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), site-specific PI)  Student responsible for design and/or conduct of the research under the mentorship of a PI in order to complete an education requirement.

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

termination  Determination made by the IRB to permanently withdraw approval for some or all activities of 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.

transnational research  Any human subject research conducted at international sites (not within the United States, its territories, or commonwealths) or research using either human biological specimens or human data originating from an international site.

written/in writing  Writing on a tangible medium (e.g. paper) or in an electronic format.

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