12.    What records must I keep of my research project? Researchers should maintain a file of all documents concerning the use of humans in research, to include original paperwork whenever possible, and a copy of everything else. The principal investigator's records should be a mirror image of the IRB's records: where the IRB holds an original, the principal investigator should hold a copy, and vice versa.

The documents that researchers should have on file include:
 

  • a copy of the original application submitted to the IRB, including the consent form and the research protocol;
  • an original of the IRB's response;
  • a copy of responses to IRB stipulations or requests for additional information;
  • the original notice of final approval;
  • a copy of the "Certification of Approval" sent by the IRB to any funding agencies;
  • copies or originals of all other correspondence with the IRB;
  • copies of completed "Continuing Review" forms and attachments;
  • the original notice of renewal of approval and certification, where applicable; and
  • copies of any inspection or audit reports.
    •      Original signed consent forms should be kept in a secure location separate from correspondence with the IRB but readily available to inspectors. IRB records are subject to inspection by federal authorities. Sanctions for incomplete or nonexistent records include suspension of funding, fines, exclusion from future funding, and suspension of laboratory access.