UNIVERSITY OF SOUTHERN CALIFORNIA
UNIVERSITY PARK INSTITUTIONAL REVIEW BOARD
FWA 00007099

Determination of NOT Human Subjects Research
 
 

The Director of the University Park Institutional Review Board has reviewed the information you submitted pertaining to your study on 6/22/2006 and concluded that the project does not qualify as Human Subjects Research.* The research activities as described are not subject to the requirements of 45 CFR 46 or continuing review.

This project is not human subject’s research. It does not meet the definition of human subject. The project is not collecting private identifiable information about the subject. The study aims to analyze dialogue amongst computer science and engineering student who utilize an on-line discussion board to assist with problem solving related to class work and to assess if the software tools used are helpful to students. This project is not subject to IRB review. The use of the information sheet is acceptable and may be helpful.

Please note that the Information Sheet will not be stamped by the UPIRB, and can be accessed under the “Documents” tab in the study workspace in iStar.

This review and opinion is based on the information provided and is not valid if the proposed project is not exactly as described, or if information has been withheld. If your project design changes in ways that may affect this determination, please contact the IRB for guidance.

You are encouraged to follow the University’s Code of Ethics and policies when designing and conducting research projects.

OHRP does not consider research involving ONLY coded private information or specimens to involve human subjects as defined under 45 CFR 46.102(f) if the following conditions are both met:

1. the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
2. the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because:
   1. the key to decipher the code is destroyed before the research begins;
   2. the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);
   3. there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
   4. there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

Kristin J. Allen, M.P.H., CIP, Director, UPIRB

*From 45 CFR 46.102, The Federal Regulations on Human Subjects Research

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains:

1. data through intervention or interaction with the individual, or
2. identifiable private information.

Research : A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

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