By Federal Regulations the IRB Is Required to Keep Paper and Electronic Copies of All Approved

By Federal Regulations the IRB Is Required to Keep Paper and Electronic Copies of All Approved

Records

Introduction:

By Federal regulations the IRB is required to keep paper and electronic copies of all approved protocols on file or in the iMedris electronic database and available for inspection by authorized representatives of the DHHS, the Office for Human Research Protection (OHRP) and the FDA. The IRB is also required to maintain files indicating documentation of all actions taken by the IRB, membership of the IRB and attendance records for five years. IRB documentation includes the following:

  • Minutes of IRB meetings.
  • A list of IRB members in the same detail as described in 45 CFR 46.103(b)(3).
  • Written procedures for the IRB in the same detail as described in 45 CFR 46.103(b)(4) and 45 CFR 46.103(b)(5).
  • Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).
  • Reports of injuries to subjects.

Policy:

The IRB will maintain protocol files both paper and electronic on each study as stipulated by DHHS regulations at 45 CFR 46.115(a)(1),(3),(4), and (7) and 21 CFR 56.115. The minutes of IRB meetings will include all the information stipulated by DHHS regulations 45 CFR 46.115(a)(2) and 21 CFR 56.115.

The Federal regulations require all IRB protocol records related to research which is conducted, to be retained for at least three years after study completion; and all other IRB records to be retained for three years (45 CFR 46.115(b)). The UH IRB shall maintain records according to the above regulation, and will keep paper copies secure in lockable filing cabinets or storage rooms and all electronic submission secure in the iMedris electronic database. At present it is the policy of the UH IRB to keep all IRB protocol records (paper and electronic) as well as other IRB records indefinitely. These records are available to the IRB.

A)IRB Protocol File

The following are the basic elements of the paper & electronic IRB protocol file for each study:

  • Completed IRB application(s) (e.g., N form, A, form, CR form)
  • Complete approved protocol.
  • Signed IRB approval letters, which also denotes the frequency for the next continuing review.
  • All approved versions of consent/assent forms (with IRB stamp), including copies of DHHS-approved sample consent documents.
  • Copy of full grant application or full industry protocol, when applicable.
  • Scientific and ethical evaluations (e.g., consultant’s reports and Department approvals).
  • Progress reports/continuing review.
  • Amendments to protocol.
  • Correspondence between IRB and investigator.
  • Administrative actions
  • Documentation of IRB determinations required by the regulations and protocol-specific findings supporting determinations (for Expedited review, the completed IRB Reviewer checklist is also included).
  • Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).
  • Copies of approved recruiting advertisement/ brochures/materials.
  • File Checklists including investigator brochures, data safety monitoring reports, and other items submitted with a File Checklist.
  • Reports of internal/external adverse events.
  • Local context review information from investigator and/or consultant (if applicable).
  • Translated consent forms (if applicable).
  • Closure Checklist and final report, or other relevant information (e.g., IRB Continuing Review reminder notices, notice of study archive for failure to submit continuing review).
B)IRB File for protocol determined to be Exempt

The following are the basic elements of the IRB protocol file for Exempt research protocols:

  • Request for Exemption application
  • Exemption Determination form citing the specific approved exemption category for the research.
  • Signed approval letter stating the specific category under which the study was determined to be exempt.
  • Department review and approval
  • Any changes or revisions to the exempt protocol, and affirmation of continued exempt status
  • Any continuation of exempt research after a period of six years will need to be submitted as a new request of exemption.
C)IRB Minutes

The minutes of the meetings of the fully convened IRB are confidential, and are available only for inspection by authorized representatives of the DHHS, OHRP, FDA, UH Clinical Council, and UH Board of Directors. For studies conducted using their resources, minutes may be reviewed by Department Chairs, Department Research Review Committees, and the William T. Dahms Clinical Research Center. Documentation of compliance with the Federal regulations is noted in the minutes. Hard copy and electronic versions of the meeting minutes are maintained by the IRB Administration Office.

D)IRB Membership Rosters

The IRB Administration Office maintains electronic lists of IRB members for each committee that includes name, professional degree, and area of expertise and professional competency. The IRB membership lists will be retained permanently.

The IRB will neither provide nor publish the names of the members of the IRB except to Federal regulatory agencies requiring specific disclosure. Others, such as industry sponsors, upon request, are given access to a list of IRB members identified by initials, area of specialization, and gender on the UHCMC IRB Administration Office’s website.

E)IRB Policies and Procedures

The IRB Administration Office maintains a current Policy and Procedure Manual reflecting polices to implement Federal regulations for protection of human subjects and the operational implementation of these policies by the UHCMC IRB. These policies are maintained electronically and are available for review on the UHCMC IRB Administration Office’s website. Previous versions of the policies will be retained for reference.

F)IRB Database

Since 2003, the IRB Administration Office has maintained an electronic database of studies reviewed by the UHCMC IRB with relevant information relating to the status of each protocol and IRB actions. This database, which resides on a server that is housed within the UHCMC Center for Clinical Research and Technology, is secured maintained by the IRB Administration staff as well as UH Information Technology Services (IT&S). Access to the server must be obtained through a formal request placed to IT by a CCRT manager or above and is limited to only staff members of the CCRT. Access to the database requires a log in and a password. User audit trails are available. Information on the server is backed up according to UHCMC IT&S policy and procedures. The IRB complies with Federal regulation 21 CFR Part 11 relating to the electronic IRB database.

G) IRB Electronic Submission System

Starting in December 2009 the UH IRB required thatall NEW protocol submissions be submitted to the IRB Administration Office electronically, using the new electronic system (iRIS). This included New protocols (N), New Chart Reviews/ Discarded Tissue studies (NC-DT), New Requests for Exemption (EXMT) and New Requests for Determination of Human Subjects Research (DET). The iRIS™ system from iMedRIS ™ will allow for documents to be submitted to the IRB electronically. In addition, research-related documents, board/committee meetings and review records will be managed electronically.

H) Non-Compliance Information

Any information related to allegations of non compliance with institutional policies or federal regulations pertaining to human subject protections are maintained with the UHCMC Office of Research Compliance. Copies of relevant information related to compliance investigations, including compliance summaries, IRB findings and letters to investigators, OHRP, etc, are maintained in the IRB protocol file.

I) Format and Retention Period for IRB Records

Currently all IRB records are maintained in either hard (paper) copy, the IRB database, or in The iRIS™ system from iMedRIS ™. Federal regulations require that the IRB protocol file be maintained for three years after completion of the study; and other IRB records be maintained for three years. The IRB complies with the regulations and maintains complete records of all protocols that have been completed; or canceled without participant enrollment. It is the current practice of the UHCMC IRB to retain all IRB protocol files and IRB records indefinitely. Inactive paper IRB records are maintained in the UHCMC Archives Department.

J) Access to IRB Records

All IRB records, in any format, are considered confidential and may be accessed only by authorized individuals or regulatory agencies as required by law. Access to IRB records is limited to the IRB, IRB Administration Office staff, authorized IRB representatives, and officials of Federal and state regulatory agencies. Investigators or their designated staff shall be provided reasonable access to files related to their research. Department Chairs can access the files of faculty or staff in their Departments. All other access to IRB records is limited to those who have legitimate need for access, as determined by the Manager of the IRB Administration Office or the Vice President for Research and Technology. All records shall be accessible for inspection and copying by authorized representatives of approved organizations or entities at reasonable times.

K) Investigator Records

Each investigator is required to maintain accurate and complete files for each IRB approved protocols (for details seeIRB Policy, Investigator Responsibilities, section G). Investigators must maintain original signed consent forms in their study files. Investigators’ files must be available upon request for IRB review. Investigators must maintain their study files in a secured and confidential manner to protect subject confidentiality and sponsor confidential information. Investigator records must be kept for a minimum of three years following the end of the study. In addition, research regulated by the FDA may have additional record retention requirements (please refer to IRB Policy, Investigator Responsibilities, section H).

References and/or Regulatory Citations:

45 CFR 46.103(b)(3)

45 CFR 46.115

OHRP Guidance on Written IRB Procedures, Jan 2007

21 CFR 56.115

FDA Guidance on Electronic Records, Electronic Signatures (21 CFR Part 11), August 28, 2003.

Related Policies:

IRB Policy, Membership

IRB Policy, Board Meetings and Administrative Policies

UHCMC IRB Policies and Procedures

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