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Compliance Services

Human Subjects

Recent Announcements

IU Human Research Protection Program Receives Full Reaccreditation

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has granted Indiana University full reaccreditation status.

The IU HRPP has been accredited since 2005 and now includes the human research programs on all Indiana University campuses.

New Good Clinical Practice Training Requirement

The IRB will require Good Clinical Practices (GCP) training for Principal Investigators and Co-Principal Investigators beginning July 1, 2016, for interventional clinical studies. New interventional clinical studies and renewals of interventional clinical studies submitted after July 1 will invoke this training requirement. For the purposes of consistency and tracking, GCP training must be completed through the CITI program. CITI GCP training is valid for three years, and CITI GCP training completed within the last three years will be accepted. A GCP refresher course is now available in CITI for expired GCP courses. Sponsors may accept completion of CITI GCP training in lieu of sponsor-provided GCP training.

To complete GCP training in the CITI program, visit the IU CITI program Log-in page.

New and Updated Guidance

The IRB has released two new guidance documents: FERPA and Quality Improvement vs. Research.

The FERPA (which stands for Family Educational Rights and Privacy Act) guidance was written to offer investigators additional factors to consider when designing and conducting research involving students and student records. These factors originate from the federal law governing the access of educational information and records.

Quality Improvement vs. Research guidance is intended to assist investigators in making the determination whether a project represents a quality improvement initiative, or alternatively whether it constitutes research with human subjects and thus invokes IRB oversight.

Guidance on Informed Consent has been updated to include information regarding electronic consent options.

All documents are located on the Policies and Guidance webpage.

Revised notification process regarding IRB pre-review

Beginning June 30, 2016, study teams will receive emails directly from the KC IRB system when the HSO has completed pre-review on their protocols. This email will provide basic protocol information, links to pre-review comments and revised documents, detailed instructions on how to respond to the pre-review, and contact information for their HSO screener.

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).

Lifecycle Basic Steps

1. Level of review

How to decide if your study needs review and how it should be submitted to the IRB

Learn More >

2. Getting started

Information and preparation needed prior to submitting to the IRB

Learn More >

3. Submission

How to submit a study to the IRB

Learn More >

4. Review

What does the IRB do, and how does the process work?

Learn More >

5. Post-Approval

What happens after my study is approved?

Learn More >
Information for Sponsors Information for Subjects

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