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Human Research News v9, n4: New and Revised IRB Application Forms Posted

Apr 17, 2009

Phase II and most of Phase III of the Human Research Protection Program Improvement Plan has been completed. The following revised or new IRB application forms have been posted on the OPRS Human Research website forms page and are available for immediate use:

• The HS-1 Application for the Involvement of Human Subjects in Research has been revamped and separated into two types of research:
  • Social Behavioral, Education and Health Services (HS-1)
  • Biomedical (HS-1)
  • These applications will serve as the primary applications and can be used for either expedited or full committee studies. Part 2 of the applications allow investigators to indicate if they believe the study qualifies for expedited review. If so, the investigator should indicate the appropriate expedited category(ies). This information will be used in triaging the applications for review.
• The HS-9 Medical Records Review application has been replaced with the Application for Human Subjects Research Involving no Subject Contact (for studies accessing or studying data and/or human biological specimens with identifiers)
• Application Supplements will, as the name implies, supplement the information in the HS-1 Application as needed. If a supplement is required, the HS-1 Application will indicate that the investigator should attach a supplement and provides a link to the supplements section of the OPRS website. Supplements will provide additional information, only as needed, about
• study populations (children, pregnant women, neonates, prisoners)
• methods and procedures (genetic analysis, investigational drugs or devices, multi-institutional research, establishing data and/or specimen repositories)
• consent (waiver of informed consent, use of surrogate consent)
• disclosure of financial interest
  • Changes in Formatting: The revised forms will be in the format of the current Continuing Review Form; that is,
• a table format is used with shading and checkboxes
• links will be provided within the application as guidance
• the form will indicate when an investigator should attach additional information
  
  Frequently Asked Questions
  
  
• When do I have to start using the new forms? The applications described above, as well as the other recently posted applications, are the only ones now available on the OPRS Human Research website. However, if investigators are in the process of preparing an application using the old forms or are not quite ready to make the transition, a grace period will be allowed before the new forms are required. By September 1, 2009, only the currently posted versions of the forms will be accepted for review. This date will allow time for researchers to make the transition and will coincide with the requirement for CITI on-line training and certification.
• Why did you make all these changes? The previous versions of the forms are outdated. They did not include all the information that the IRBs are required to review in order to determine if the studies meet the federal criteria for IRB approval of a human research study. Because not all the information was requested in the application itself, the IRB members often had to ask investigators additional questions of investigators in order to obtain sufficient information to approve submissions. These revised applications are intended tol facilitate both the review and approval of IRB applications through reducing the number of additional questions that IRB members will need to ask.
• What if I have questions about how to fill out the applications? Training will be provided. The first Town Hall Meeting has been scheduled for April 23rd. Additional meetings are in the process of being scheduled. Please watch the What’s New section of the Human Research website for announcements. You may also call the numbers listed on the applications if you have immediate questions.
• What if I find errors in or have comments about the applications? Please send any comments about the applications to any of these e-mail boxes: PUBLIC@OPRS.UCLA.EDU; GCIRB@OPRS.UCLA.EDU; MIRB@OPRS.UCLA.EDU or to Sharon Friend at sfriend@oprs.ucla.edu. Errors will be corrected and comments are welcome.
• Was there any faculty input into these changes? Yes, a number of faculty members reviewed these applications before they were posted. Additionally, many of the questions were developed by a faculty advisory group who are helping develop the upcoming WebIRB application. Of course, the WebIRB application will be much easier to use than the paper version and many of the questions will be filtered out once that application is implemented. The Application Supplements replicate, to some extent, the branching that will be used in the on-line version.
• Why didn’t you wait for the WebIRB application to make all these changes? The changes are long overdue and it is important for UCLA to have applications and processes that meet the current national standards.