• Storage, Retention and Disposition Requirements
• Data Retention When Subjects Withdraw From Research
• Administrative Records Relating to Research
• Investigator Records - Signed Consent Forms
• Resources

Storage, Retention and Disposition Requirements

The Space@UCSF page has information on research record storage and data retention at UCSF. The UC Office of the President has policies on research record management, including requirements for human subjects research studies. The Administrative Records Related to Research: Retention and Disposition Requirements matrix summarizes these requirements.

Data Retention When Subjects Withdraw From Research

Guidance differs based on whether the study is regulated by the FDA and/or DHHS. 

FDA-Regulated Research: FDA published guidance on requirements for retention of data by clinical investigators in studies regulated by FDA. The guidance focuses on what data must be retained by the investigator when a subject withdraws from a study and what data an investigator may continue to obtain when a subject withdraws from a study.

Note that the FDA’s guidance differs from DHHS guidance, discussed below. In brief, FDA states that:

• When a subject withdraws from a study, the investigator may not remove data from the study database that has already been collected on that subject;
• The researcher may ask the withdrawing subject to allow the researcher to obtain follow-up data through non-invasive means such as chart review. In this case, the investigator may continue to obtain data as agreed by the subject;
• If the subject does not agree to continued follow-up, then the investigator must not access the subject’s records for purposes of the research study once the subject has withdrawn. The investigator may, however, review data already collected and may review publicly available records to obtain data on the subject (e.g., for survival status).

DHHS-Regulated Research: The U.S. Department of Health and Human Services (DHHS) issued its own guidance on data retention when subjects withdraw from a study. As noted above, the DHHS guidance differs from the FDA’s guidance in that the DHHS states that when a subject withdraws from a study, the investigator may honor the subject’s wishes to remove all data collected from the study database.

Administrative Records Relating to Research

** Per UC Policy on the Protection of Human Subjects in Research, “regulations of the Department of Health and Human Services (HHS), set forth in 45 CFR Part 46, are applicable to all research involving human subjects, as defined by these regulations, for which the University is responsible, regardless of the source of funding, or whether the research is funded.” Note: 45 CFR 46 and 21 CFR 56 specify minimum legally-required retention periods; the University has adopted a longer (10-year) retention requirement for all IRB administrative records.   

8/7/2018 Revision History Note: The 10-year retention period for all IRB administrative records reflects the retention period adopted in the current (revised) UC Records Retention Schedule, and replaces guidance contained in previous versions of this RPAC records retention matrix, which had specified that all categories of IRB administrative records were to be kept for 3 years, except for records relating to: 1) children as research subjects (which were to be kept for 7 years after the child reaches the age of maturity), and 2) research pertaining to in vitro studies or pregnant women (which were to be kept for 25 years). Since legal requirements do not mandate longer retention periods for the two categories, this retention matrix was updated to state that the retention period for ALL categories of IRB administrative records should be 10 years. The separate retention periods for research pertaining to children and in vitro/pregnant women were not based on any statutory or regulatory requirement. The University has now replaced those separate retention periods with the current uniform 10-year retention period (which, it should be noted, exceeds the minimum 3-year retention period specified in 45 CFR 46.115 and 21 CFR 56.115).

Investigator Records - Signed Consent Forms

Signed consent forms are not considered an IRB administrative record for the purposes of the UC Records Retention Schedule, so the retention period specified in the schedule that requires IRBs to retain sample consent documents does not apply to signed consent forms. However, investigators have a responsibility to retain signed consent forms. Required retention periods may vary depending on the research sponsor; researchers are advised to check with their sponsoring agency to verify the length of time required for record retention.

 Resources

• UC Records Retention Schedule (UCOP)
• Administrative Records Relating to Research (UCOP)
• RPAC Records Retention Guidance (UCOP) includes a section on “Investigator Records” that explains that signed consent forms are not considered an IRB administrative record for the purposes of the UC Records Retention Schedule, however, investigators have a responsibility to retain signed consent forms. This section includes a table of required retention periods for signed consent forms.