HRPP Policy - KC IRB

About This Policy

Effective date:
03/29/2018
Last updated:
01/21/2019
Policy Contact:

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

IU HRPP Policies

Related Policy Documents

View HRPP Policies

IU HRPP Guidance

Related Guidance Documents

View Quick Guides-Kuali Coeus (KC) IRB Guidance

IU HRPP Documents

Related IRB Questionnaires

View KC Crosswalk

Related Forms and Templates

Browse IU HRPP Forms

Regulatory References

7.0 - Definitions

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.

audit trail  Documentation, including computer-generated, time-stamped electronic record, that allows reconstruction of the course of events relating to creation, modification, and deletion of data and/or records.

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.

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.

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

humanitarian use device (HUD)  As regulated by the FDA, “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is  manifested in fewer than 4,000 individuals in the United States per year.”

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.

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.

non-key personnel (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI)  Research personnel conducting research procedures under the direction of the PI or key personnel but are not considered responsible for the conduct and/or reporting of research.Definitions for each page (See Crosswalk spreadsheet).

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