Retention of Records

The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. 

All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.

The Ursinus College IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:  

  • Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
  • Minutes of IRB meetings, which shall be in 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; and a written summary of the discussion of controverted issues and their resolution. 
  • Records of continuing review activities.
  • Copies of all correspondence between the IRB and the investigators.
  • A list of IRB members, in the same detail as described in §46.103(b) (3).
  • Written procedures for the IRB, in the same detail as described in §46.103(b) (4) and §46.103(b) (5).
  • Statements of significant new findings provided to subjects, as required by§46.116(b) (5).