The HSO has updated two smart forms (KC IRB questionnaires):
- Updates to Questionnaire B – Lay Summary & Research Design include revised wording and a new question to better elicit funding details, as well as new multiple choice question options to clearly identify clinical studies in partnership with the OnCore efforts by the Clinical Trials Office. This questionnaire is a required component for protocols requiring Expedited or Full Board review, unless the protocol has an approved version of the previous HSO form: Summary Safeguard Statement.
- Completion of the revised questionnaire is required for New Studies and Renewals submitted on or after March 31, 2016.
- For renewals due after March 31, create a ‘Renewal with Amendment’ and select Questionnaire B to amend.
- Renewals will be Returned to PI if:
- Questionnaire B was not selected to amend when submitting a Renewal with Amendment; or
- A Renewal only (without Amendment) was submitted.
- Studies approved pre-KC IRB Questionnaire functionality (pre-July 31, 2014) have no action required.
- For more information regarding the OnCore initiative, please click HERE.
- Updates to the Request to Defer IU IRB Review questionnaire include revised wording, new questions, and new multiple choice question options to clearly identify clinical trials in partnership with the OnCore efforts by the Clinical Trials Office. This questionnaire is a required component for protocols submitted as a Deferral type in KC IRB.
- GCP Training
The training display of PI and Co-PI on the Personnel tab has been adjusted to now account for Good Clinical Practices (GCP) CITI training (if required and missing). GCP training will be required beginning on July 1, 2016 for interventional clinical studies. The current display is simply a warning. The IRB will take no action on missing GCP training until studies submitted on or after July 1, at which time GCP training will be a condition of IRB approval.
- The NIH's National Center for Advancing Translational Sciences (NCATS) is leading an initiative to promote Good Clinical Practice (GCP) training to ensure that all investigators who conduct clinical trials are appropriately trained. Indiana CTSI supports this training initiative as an essential step toward further ensuring the protection of trial participants and the quality of clinical trial results.
Welcome to the Human Subjects Office
The IU Human Subjects Office is the administrative office that supports the Indiana University Institutional Review Boards (IRBs), which are responsible for the review and approval of all research involving human subjects conducted at IU and its affiliated institutions. The HSO administers the human research protection program (HRPP) at IU. IU’s HRPP, which will include the regional campuses effective July 1, 2015, is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
The HSO includes about 30 staff members who support more than 5,000 active human subjects studies, seven IRBs, and the IRB Executive Committee comprised of Chairs and Vice Chairs of each IRB. HSO staff are experts in human subjects protections, and about half have achieved the Certified IRB Professional certification. Staff are divided into three teams, each of which serves a specific set of IU departments. Each department is assigned to a designated staff member who serves as the main contact for that department. Department/team listings are available in HSO Support Teams.
Please see the links below for more information on how to conduct human subjects research at Indiana University (or an affiliated institution).
1. Level of review
How to decide if your study needs review and how it should be submitted to the IRB
2. Getting started
Information and preparation needed prior to submitting to the IRB
How to submit a study to the IRB
What does the IRB do, and how does the process work?
What happens after my study is approved?