HRPP Policy - research personnel responsibilities

About This Policy

Effective date:
07/19/2018
Last updated:
01/21/2019
Policy Contact:

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

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7.0 - Definitions

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.

clinical trial A research study in which one or more human subjects are prospectively assigned to one more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

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.

continuing noncompliance (see also noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) A pattern of the same or similar instances of noncompliance, occurring in reasonably close proximity, which continues to occur after discovery of noncompliance and implementation of a preventive action plan, or results from failure to implement a preventive action plan approved by the IRB.

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.

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.

fetus The product of conception from implantation until delivery.

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

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.

IU-affiliated research personnel (see also research personnel, Investigator, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) research personnel who are Indiana University faculty, staff, and students or employees and staff of IU affiliate institutions that have contracted with the IU IRBs for review and oversight of human subjects research. IU affiliate institutions include Goodman Campbell Brain & Spine, Eskenazi Health, Indiana State Department of Health, IU Health, Purdue Pharmacy Practice, Regenstrief Institute, Rehabilitation Hospital of Indiana, Roudebush VAMC, and Sigma Theta Tau International.

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.

neonate A newborn child less than four weeks old. A Bold-nonviable neonate-Bold is an expelled or delivered fetus who, although living, cannot sustain life independently, even with medical intervention.

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 Link-OHRP Prisoner Research FAQs.-Link

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.

reportable event An event which may represent noncompliance or an unanticipated problem involving risks to subjects or others. Reportable events are reported to the IRB in accordance with the IU HRPP Policy on Reportable Events.

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.

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