Records associated with human subjects research approved by the IRB via expedited or full board review, are subject to federal and UMBC record-keeping requirements. The IRB requires investigators to maintain an accessible protocol file for five (5) years past completion of the research activity for adult subjects and, for minor subjects, at least three years after reaching the age of 18, whichever is longer. Such records must be stored in a secure location on campus or computers, external hard drives and other portable devices with access restricted to key personnel identified in the IRB application. Data with personal identifiers stored on these devices should be password protected or encrypted to prevent unintentional breaches of confidentiality in the event the storage device is lost or stolen. The sensitivity of the data dictates the level of protection.
A protocol file must contain the following:
- All correspondence between the investigator and the IRB;
- Copies of the signed consent forms obtained from all participants. Signed informed consents must not contain participant ID numbers nor be filed with other research data files;
- Data derived from the study, including paper, audio/visual or electronic;
- Annual continuation reports;
- Reports of all protocol violations, deviations or adverse incidents and any follow-up to such incidents;
- Current contact point for the investigator (address and telephone number) should the investigator no longer be associated with UMBC.
If a researcher (faculty, staff or student) leaves UMBC, a copy of the protocol record must remain on campus. Students investigators should coordinate storage of research records with their faculty advisor(s) and/or departments. Faculty and staff should coordinate with departments.
Protocol file destruction of human subjects research records should be performed in a fashion that protects the confidentiality of the research subjects. It is recommended that paper records be shredded, audio and video recordings be erased and physically destroyed, files in electronic storage be trashed, and electronic media used to store data be scrubbed after the files are deleted.