Chapter 21 - IRB Recordkeeping and Retention

The HRPO is responsible for maintaining records related to the functions and activities of the IRB.

IRB Membership Records

The Associate Director of Education maintains a database 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, Children’s Hospital of Pittsburgh, Magee Women’s Research Institute or the VA Pittsburgh Healthcare System. This information will be utilized in formulating the roster for OHRP.

Changes in IRB committee membership will be reported to OHRP in a timely manner by the Associate Director of Education.

Research Submissions

HRPO will maintain records (paper or electronic) of all research submitted for IRB review and approval.

  • Paper files will be maintained within HRPO by IRB number.
  • Electronic records will be maintained within the OSIRIS 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 investigator-IRB correspondence related to the submission and the letter of exempt concurrence.

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 correspondence between the investigator/research team and the IRB;
  • a summary of audits conducted by the Education and Compliance Office. 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 in the Education and Compliance Office;
  • 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 HRPO at a secure storage facility until three years following termination of IRB approval of the research (21 years for research involving children). Following the required maintenance interval, research files will be shredded.  

IRB Minutes

The agendas and minutes of full-board IRB as well as Executive Committee (Committee F) meetings will be maintained indefinitely either at HRPO or at a secured storage facility.   

Research Subject Complaints

HRPO maintains files of research subject complaints and the actions taken by HRPO 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 Events

Reportable events are submitted by the principal investigator through OSIRIS 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 OSIRIS. Records pertaining to emergency use requests will be maintained in OSIRIS for an indefinite period of time.

Inspections by Authorized Representatives

IRB records are accessible for inspection and copying by authorized representatives.

 

version 12.2.2015