Search
Print Page
Email Page

Human Subjects Office Process & Procedures Update

February 15, 2012

In our ongoing effort to increase efficiency and improve customer service to the Indiana University research community, the IU Human Subjects Office will implement several changes which will decrease the burden on investigators and staff alike, effective immediately.

Changes include:

  • Team Structure: reorganization of the HSO into three functional teams which will serve specific academic departments throughout the entire IRB process
  • Co-Investigator Update Process: changes in the way co-investigators are recorded and reported to the HSO. Investigators will be categorized into co-investigators, which are key personnel, and research personnel, which are non-key. The process for updating co-investigators and co-investigator requirements will depend on the investigator’s categorization.
  • Co-Investigator Requirements: acknowledgement of willingness to participate is no longer required.
  • Continuing Review Process: addition of a form for studies in data analysis only which will expedite the review process and require fewer documents at time of continuing review.
  • New VA Form: new Request Form - VA Research is now required for all studies funded by the VA, utilizing VA effort, property or resources, or enrolling VA patients.
  • Administrative Withdrawal Policy: change to HSO policy which allows HSO staff to withdraw submissions for lack of response to pre-review and/or IRB requests

Forms updated with these changes include:

  • Amendment Form and Continuing Review Form: new section added for investigator updates
  • Continuing Review Form - Data Analysis Only - new form
  • Co-Investigator Update Form retired
  • Investigator List: revised
  • Request Form - VA Research: new form

Please see the attached Summary of Changes document and listing of HSO Service & Support Teams for more information.

Please join HSO staff at one of the three following community outreach meetings to discuss these updates:

  • February 23, 11am-1pm, Riley Outpatient Auditorium (Indianapolis)
  • February 24, 7-9am, Riley Outpatient Auditorium (Indianapolis)
  • February 28, 8-10am, IMU Dogwood Room (Bloomington)

Please visit http://researchadmin.iu.edu/EO/eo_sessions.html to sign up for the above sessions.