Modification

Once the HSRB has approved a project, it must be carried out as planned. Any changes in subject population, recruitment plans, research procedures, measures/instruments, study location, consent process, or major research personnel must be approved by the HSRB prior to implementation. You must submit a Modification Form to the HSRB via IRBNet.org. Enacting changes without prior approval constitutes a protocol violation.

  • Name and HSRB approval number of the study
  • Description of the proposed change
  • Explanation of why the change is needed
  • Description of the implications for subjects
  • Revised consent documents, if the change will affect the subjects
  • Revised interviews, instruments, etc. (if changed)

Minor changes are handled by administrative action or expedited review. Changes that affect the risk/benefit ration may require full board review. Implementation of the change must wait for the HSRB's approval.

Adverse Event Report

Adverse events are unexpected problems whose nature, severity, and frequency are not described in the information provided to the HSRB or to subjects. Examples include unexpected complications for a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events must be reported to the HSRB within 10 working days of the event. The RPI is responsible for completing and submitting an "adverse event report" to

The HSRB office. The report must discuss:

  • The facts of the case, including the date and a description of the subject
  • Whether the event is related to the study's procedures or to the subject's situation (e.g., underlying disease or condition)
  • The steps that have been taken to address the problem
  • Whether the event is likely to recur
  • Whether the event provides new information about the study's risks that should be conveyed to participants, and if so, attach a revised consent form.

Keeping Records

Researchers must maintain a file of all documents concerning the use of human subjects in research for at least three (3) years. The documents that researchers must have on file are as follows:

  • A copy of the original application submitted to the HSRB
  • The HSRB response and/or notice of approval or approval renewal
  • Copies of all other correspondence with the HSRB.

Original signed consent forms must be kept in a secure location within Metropolitan State University property and separate from all other research and correspondence files. HSRB records are subject to inspection by federal authorities. Sanctions for incomplete or nonexistent records include suspension of funding, fines, and exclusion from future funding.