More Information on the NIH Single IRB Policy
Earlier this year, the NIH released a new policy that all sites participating in human subjects research funded by NIH utilize a centralized, single IRB (sIRB). The sIRB will provide IRB review for all participating sites and all sites will be expected to accept the review and approval of the sIRB. Since the release, the IU Human Subjects Office has received a number of questions. Click HERE to find out what you need to know about the new policy.
IU Participates in Demonstration Project Studying the Impact of Scientific Review Committee Process for Clinical Research
Indiana University and the Indiana CTSI are taking part in a nationwide demonstration project lead by Tufts University on the implementation and evaluation of a Scientific Review Committee (SRC) process for clinical research. This project aims to test a SRC process that positively affects the scientific quality and feasibility of a study without causing meaningful delays on a small number of trials that meet specific criteria.
For the purposes of this project, the SRC will serve in an advisory role to the IRB. At the time of submission to the IRB, the Human Subjects Office will identify studies that meet the criteria for SRC review. Studies that are new full Board investigator-initiated, non-peer reviewed studies that have not been reviewed by the IUSCC SRC or the CTSI Project Development Teams (PDTs) will undergo review by the CTSI SRC. The 6-month SRC pilot runs from October 1, 2016, until April 1, 2017.
The SRC review will happen concurrently with the HSO pre-review process in order to minimize delays. Notification of any recommended revisions will be sent directly to PIs who must adequately address these prior to IRB review. The IRB will consider SRC recommendations and responses from the PI in its review.
Would you be interested in having your study reviewed by the SRC prior to IRB submission? If so, PIs are also welcome to submit protocols directly to the SRC for review. For more information, contact email@example.com.
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?