206 10 110

Activity
II.06. ACADEMICS, INSTRUCTION AND RESEARCH/Research
Series Name
Research Uses of Human Subjects
Series ID
206-10-110
Custodians
Research and Innovation: Research Compliance Services
Description

Document the review of research proposals that involve any use of human subjects (research subjects) by the Institutional Review Board.

These records found in all media (paper, digital, or other) must include but are not limited to:

  • copies of all research proposals reviewed, including scientific evaluations, if any, that accompany the proposals;
  • approved sample consent documents; progress reports submitted by investigators;
  • reports of injuries to subjects; minutes of IRB meetings with sufficient detail to show attendance at the meetings;
  • actions taken by the IRB;
  • the vote on these actions including the number of members voting for, against, and abstaining;
  • the basis for requiring changes in or disapproving research;
  • a written summary of the discussion of controverted issues and their resolution;
  • continuing review activities;
  • a list of IRB members;
  • written procedures for the IRB;
  • statements of significant new findings provided to subjects;
  • related correspondence, including e-mail, between the IRB and the investigators.

 

Retention and Disposal Instructions

(a) 3 years after completion of research for approved applications, purge;

(b) 3 years for all other records (example: denied applications), purge.

Exception: In the event of a subpoena, audit, legal hold, public records or similar state or federal information request, halt until further instructed any scheduled disposal activities, including purging or transferring material to University Archives.

Citations
45 CFR 690.115 - Protection of Human Subjects
45 CFR 46.115 - IRB records
OAR Predecessors
OAR 166-475-0060 (9) Human Subjects Records