Continuing Review and Study Termination
|Study termination||Record retention|
It is the principal investigator's responsibility to ensure timely submission of the Continuing Review Form as well as a current Consent Form for the IRB to complete the review. The IRB and investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must cease unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval. When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval automatically expires.
You will receive notice of continuing review three to four months prior to the expiration date. Though the IRB Office will try to give you one final notice, this may not always be possible.
If a study is complete, results/conclusions should be provided. If a study is incomplete, an explanation of why it has not been completed should be provided. If a study was not started, explain why the study was not started.
- All medical and other records* of human research subjects who participate in a clinical research study conducted at Children's Hospital or at another site but approved through the Children's Hospital IRB must be retained until all subjects are at least 25 years of age or be at least 10 years after the subject's last date of study participation, whichever is longer.
- If a study was open but never enrolled any subjects, all study records including IRB approvals and communications should be kept for six years after termination, due to any potential HIPAA questions regarding recruiting and screening practices.
- An investigator may be required to retain human research subject records for a longer period of time if required by a research study sponsor, a federal agency (such as the Food and Drug Administration), or pursuant to the terms of a grant or other investigator agreement.
- All records must be retained in a manner that protects patient confidentiality and privacy in accordance with applicable law.
- After the expiration of the applicable retention period, records may be disposed of or destroyed by shredding. However, records should not be destroyed if they are less than 10 years for medical records and study subject records, and never less than six years for study records that never enrolled any subjects.
- Upon study termination, an individualized plan (including specific storage locations) for long-term retention of the study records should be developed by the study team and implemented by the study team. Principal investigators and research coordinators should both retain copies of the retention plan.
*Medical and other records refer to all files of the research study that contain any information about the demographics, financial status, health or other personal attributes of human research subjects participating in the study.