Chapter 21 - IRB Recordkeeping and Retention
The staff of the HRP is responsible for maintaining records related to the functions and activities of the IRB.
IRB Membership Records
The HRP maintains documentation of IRB committee members identified by name; earned degree(s); indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s primary anticipated contributions to IRB deliberations; representative capacity (e.g., scientific or non-scientific reviewer); and any employment or other relationship between the member and the University of Pittsburgh, UPMC, UPMC Cancer Centers, or Magee Women’s Research. This information will be utilized when formulating the roster and registering IRBs as required by federal agencies.
Changes in IRB committee membership will be reported to OHRP in a timely manner.
HRP will maintain records of all research submitted for IRB review and approval.
- Electronic records will be maintained within the PittPRO system and can be accessed through a variety of search mechanisms.
- Submissions will be retained for a period of at least three years beyond the termination date regardless of whether subjects were enrolled.
No Human Subjects Research Designation/Exempt Submissions
For projects determined by the IRB to qualify for a no human subject research designation or exempt status the IRB record will contain the applicable application form, all relevant investigator-IRB correspondence related to the submission and the letter of exempt determination.
Expedited or Full Board Submissions
For research submitted for expedited or full board review, the IRB record contains:
- the initial research application;
- the approved informed consent document (if applicable);
- the initial IRB approval letter;
- modification requests and the applicable IRB approval letter;
- continuing review requests and the applicable IRB approval letter;
- for multicenter studies, the sponsor’s protocol;
- for studies involving an investigational drug or device, the investigational drug brochure
- for federally funded studies, the federal grant application;
- for investigator-initiated studies involving a drug or device, all correspondence with the FDA including the IND or IDE application and any other pertinent documentation;
- any reports of unanticipated problems involving risks to human subjects or others (including adverse events) encountered in the conduct of the research;
- advertisement used to recruit potential subjects as well as screening scripts;
- non-standard measures;
- all relevant correspondence between the investigator/research team and the IRB;
- a summary of audits conducted by Education and Compliance Support. Full audit reports, responses from investigators, as well as actions taken by the IRB Executive Committee (Committee F) will be available for review upon request from Education and Compliance Support;
- documentation of actions taken by the IRB Executive Committee (Committee F) in response to unanticipated problems involving risks to human subjects or others and/or identified non-compliance and the corresponding responses of investigators.
Research files are maintained by HRP at a secure storage facility until three years following termination of IRB approval of the research (up to 25 years for research involving children). Following the required maintenance interval, research files may be shredded.
The following IRB documents will be retained indefinitely either in an electronic format or at a secured storage facility:
- Full Board agendas
- Full Board meeting minutes (including Committee F)
- IRB Membership Records .
Research Subject Complaints
HRP maintains files of research subject complaints and the actions taken by HRP staff, IRB Committee(s), or investigators to resolve such complaints. Such files are maintained until 3 years following termination of IRB approval of the research study.
Reportable New Information
Reportable New Information are submitted by the principal investigator through PittPRO and are maintained for at least three years following termination of IRB approval of the research study.
Emergency Use Reports
Emergency Use requests are submitted by the requesting physician through a separate pathway in PittPRO. Records pertaining to emergency use requests will be maintained in PittPRO for an indefinite period of time.
Inspections by Authorized Representatives
IRB records are accessible for inspection and copying by authorized representatives.