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Human Subjects

Training/Education

HSO

Office Hours Calendar

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HSO Office Hours
All research staff, especially new personnel, are encouraged to take advantage of office hours for one-on-one training on IRB processes and procedures, including assistance using KC IRB, as well as help responding to pre-review or IRB provisions, completing the IRB application, or drafting consent forms.

Effective September 1, 2016, HSO will be reducing the frequency of Methodist office hours to every other week and requiring registration for both Methodist and LV office hours. Please register here, by selecting "Human Subjects/IRB" from the "List Classes for Area" drop-down.

HSO remains committed to the research community, and as such, is willing to make alternative arrangements, on a case by case basis, by contacting the HSO office.

If you have any questions about this policy, or if you need assistance registering for office hours, please do not hesitate to contact the HSO office via email at irb@iu.edu or by phone 317-274-8289.

Indianapolis campus:

  • Wednesdays, 9-11am at Lockefield Village 3331 (Registration Required).
  • Every other Thursday, 1-3pm at IU Health Methodist, Wile Hall 122 (Registration Required).

KC IRB Instructional Guides:

Instructional Guides are available for assistance in using KC IRB.

See the Kuali Coeus (KC) Instructional Guides

Classroom Training

HSO conducts periodic live training and help sessions.  If you would like to request a training session for your group or department, please contact an HSO staff member or irb@iu.edu.

See the List view to register | Calendar view

Please note: sessions with fewer than 5 participants registered by the prior business day may be canceled for resource management purposes.

CITI Completion

All key personnel and any researchers directly interacting with subjects are required to complete CITI training every three years.

You must complete one of the following courses based on your main area of research:

  • If you are mainly engaged in biomedical research complete: Biomedical Researcher, Stage 1
  • If you are mainly engaged in social or behavioral research complete: Social/Behavioral/Educational Researchers, Stage 1
  • VA researchers should complete the VA CITI course, and should affiliate their CITI account with Indiana University. The VA CITI course fulfills the Indiana University researcher education requirement for VA researchers.
  • For assistance with affiliating your CITI account with Indiana University, please email irb@iu.edu.

GCP Training

IU requires GCP training for certain clinical trials as a condition of IRB approval.

REQUIREMENTS FOR GOOD CLINICAL PRACTICE (GCP) TRAINING
IU Requirements NIH Requirements
Scope Interventional clinical trials, irrespective of funding NIH-funded clinical trials
Personnel - Principal Investigators
- Co-Principal Investigators
- Investigators
- Clinical Trial Site Staff responsible for
the conduct, management, and/or oversight of trials (‘Key Personnel’ as defined by the IU IRB)
Training via CITI GCP Course - Class/course
- Academic training program
- Certification from recognized clinical research professional organization
Refresher requirement 3 years 3 years

Access the CITI program via the CITI program log-in page

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