As defined within Section 24 of these policies, all records and documents relating to research studies and participants must be kept confidential to the extent permitted by law; however, records and documents shall be available in a timely manner to University authorized employees or other agents authorized by the University including IRB members and HSRO staff and appropriate governmental agencies including but not limited to the DHHS, OHRP and the FDA. All others requesting access to or copies of confidential study records and documents must obtain written approval from the Principal Investigator or the Associate Vice Provost for Human Subject Research. The Principal Investigator must describe in study documents for review by the IRB, and in consent forms, the extent, if any, to which confidentiality of study records identifying the subject will be maintained.
Although principal investigators are responsible for the creation and maintenance of research records and documents, such records and documents (including data collected pursuant to research) are the property of the University. Until the temporal requirements for record/document retention are met (c.f. Section 28.2- below), investigators or others may not remove or destroy research records or documents (or copies of such records or documents) without written permission from an authorized representative of the University. This permission requirement extends to investigators leaving the University even if they plan to continue the research at another institution.