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Compliance Services

Human Subjects


Coming Soon – Expansion of Flexibility
Implementation of the new Common Rule has been delayed until at least July 19, 2018. While we await further information from the federal government regarding the new Common Rule, the IU IRB is moving forward with some of the changes outlined in the new rule.

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New Common Rule Delayed
Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) were expected to go into effect on January 19, 2018; however, last-minute government action delayed implementation.

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Nationwide Shortage of IV Material (effective 12/01/2017)

A nationwide shortage of IV fluid materials (i.e. IV bags and bottles) is affecting research protocols conducted at IU and our affiliates. The shortage may ultimately result in Investigational Drug Services (IDS) being unable to fulfill requests for trial-related IV drug preparation. The HRPP is aware of the issue and has notified IRB members. As such, there is no need to report the existence of shortage to the IRB; however, if it affects your protocol specifically, additional reporting may be required.

  • Investigators may want to consider voluntarily holding the enrollment of new subjects. The IRB does not consider a voluntary enrollment hold unrelated to risk, safety, or compliance issues to be promptly reportable. As such, if you implement a voluntary enrollment hold due to the shortage, there is no need to promptly report the hold to the IRB. You may report that information at time of renewal.
  • If the shortage will require your IRB-approved protocol to change or remove research procedures, you will need to submit an amendment for review and approval to the IRB. Many protocols do not specifically address product preparation or administration so please read your protocol carefully to determine whether the shortage will result in changes that need to be approved by the IRB. Investigators are encouraged to work with IDS to determine the appropriateness and feasibility of modifying such elements of the protocol and/or associated pharmacy instructions. Sponsor-investigators of FDA regulated research are also reminded that any significant change in the design of a protocol, including drug dosage and safety procedures, or changes to technical product information may also require reporting to the FDA as well as distribution of such information to local study related staff and other participating sites.
  • As always, study teams may implement protocol changes that are necessary to eliminate apparent immediate hazards to subjects without prospective IRB approval. If the shortage causes you to implement such a change immediately, you must report that change to the IRB within 5 days, and follow up with a timely protocol amendment. Investigators are reminded of the need to adequately and accurately document subject participation including information about protocol deviations that may occur because of the shortage, as well as the investigator’s assessment of such events as it relates to potential impacts on subject safety and data integrity.

Please contact HSO with any questions or concerns regarding IRB reporting as a result of the shortage.

Changes to the IRB Reliance Process (effective 10/26/2017)

IU Human Research Protection Program (HRPP) staff are pleased to announce a revised reliance policy, effective October 26, 2017, which provides increased flexibility for relying on external IRBs.

Please read the Changes to the IRB Reliance Process full announcement for more information.

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 several have achieved the Certified IRB Professional certification. Staff are divided into four teams, based on level of review and type of research. Team listings are available in HSO Support Teams or you may search our Staff Directory for a specific person.

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

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2. Getting started

Information and preparation needed prior to submitting to the IRB

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3. Submission

How to submit a study to the IRB

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4. Review

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

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5. Post-Approval

What happens after my study is approved?

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Information for Sponsors Information for Subjects