This guideline was developed to advise investigators and help them with the responsibility of record retention. There are many ways in which record retention can be accomplished, but the following criteria are required: a) the confidentiality of the subject must be maintained; b) the records must be stored appropriately, locked, and accessible to only those listed in the approved study; c) the records including the signed informed consent forms are kept for at least 3 years (6 years if PHI); and d) the signed informed consent forms must be effectively destroyed and therefore no longer accessible to anyone. The Office for Research Protections does not retain signed informed consent forms for investigators. These requirements are the responsibility of the principal investigator and must be considered at all times.
Record Retention of Informed Consent Forms
The confidentiality of research subjects in any particular study is of the utmost importance when handling and receiving the signed informed consent forms. At all times, research participation in any project is confidential and should only be accessed by individuals as outlined in the approved study. Accordingly, measures to retain, destroy, and handle signed consent forms must recognize confidentiality of the participants when fulfilling the following suggestions/requirements.
Informed Consent Procedures
Procedures must be followed, as outlined in the approved study, as to how the informed consent forms will be handled. For example, if the study stated signed consent forms would be stored in a locked file cabinet, or if the study stated signed consent forms would not be kept with the raw data, these statements must be followed above and beyond the guidelines listed here.
Signed informed consent forms must be kept in appropriate storage, such as a locked file cabinet, and unavailable to anyone except those individuals outlined in the approved study. A helpful hint may be to keep all the forms relative to each study in the same envelope and list the title and IRB number on the outside of the envelope for quick reference, if and when necessary. It is not necessary to seal the envelopes with a sticker label; however, it is important that there is a seal in place such that it would be obvious if the envelope were tampered with and the confidentiality of the participants compromised.
Signed informed consent forms are to be retained for at least 3 years following the close of the study. This time frame is determined by the need for access to this information in the unfortunate case of an unanticipated problem or a complaint. It is extremely important that each investigator understand specific requirements may differ depending on the discipline and /or funding source(s). For a longitudinal study where the research is being conducted over a number of years or a study that involves high risk to subjects, it may be important for the principal investigator (PI) to retain the forms longer than 3 years in case any problems arise at a later date. Moreover, if it is stated that the forms will be kept for a prescribed amount of time longer than 3 years, this promise must also be fulfilled. If a research study accesses protected health information (PHI) and is covered under the Health Insurance Portability Accountability Act (HIPAA) policy, consent forms are to be retained for a minimum of 6 years after the close of the study.
Once the 3 years (or longer depending on the decision of the principal investigator or other requirements) has passed, the signed informed consent forms must be effectively destroyed. Destroying the records can be achieved in a number of ways including shredding, burning, etc. The documents cannot merely be recycled or simply thrown away as the information would then continue to be viewable and available. This is the final step in the retention of the signed informed consent forms and must be carried out to complete the retention process.
Destruction of audio- and/or video-taping must also go beyond erasing or disposing of these recordings to insure confidentiality.