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Indiana University
Research Compliance Quarterly 8th Edition
October 7th, 2016
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
REMINDER: 2016-2017 "Research-Related Conflict of Interest Disclosure" Now Due

All individuals responsible for the design, conduct, or reporting of research, regardless of funding and/or without reportable outside interests, are required to complete the 2016-2017 Research-related Conflict of Interest Disclosure Form.

If your last completed disclosure form was submitted prior to August 15, 2016, please submit a new disclosure form today.

IU Participates in Demonstration Project Studying the Impact of a 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 an 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 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.

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 ctsisrc@iupui.edu.

New NIH Policy on Use of a Single IRB for Multi-site Research

On June 21, 2016, the National Institutes of Health released the Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research. The policy, effective May 25, 2017, requires all sites participating in human subjects research funded by NIH utilize a single IRB. 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. Read more about the policy and IU’s response here.

Kuali Enterprise Dashboard (KED) Now Available

Due to the retirement of existing portals to access the Kuali Financials System (KFS) and the Kuali Coeus (KC) IRB and Grants systems, a new combined Kuali Enterprise Dashboard (KED) portal was designed and is now available for use. KED replaces existing portals and contains all the KC and KFS links to which you already have access. You can access this new portal via a link that has been added to the existing KC IRB portal page or here. For questions about the new portal, access the Kuali Enterprise Dashboard (KED) FAQ's.

KC IRB Reminders

➺ How to Access Previously Approved Submissions in KC IRB

If you need to access protocol information and documents for a previously approved submission (e.g. amendment, renewal) you may do so by following these steps:

  1. Access the main KC Protocol for your study (for help accessing your protocol, view our KC IRB eLearning Videos & Training Guides);
  2. Go to the Protocol Actions tab;
  3. Click show on the Summary & History panel;
  4. Click show on the History section;
  5. Locate the approval for the previously approved submission;
  6. Click show for the Notification associated with that approved submission;
  7. Click the link in the message to the previously approved submission.

➺ Modifying Study Documents

Study teams are reminded to refrain from modifying study documents to apply an “IRB reviewed” or “IRB approved” stamp.

Modifying IRB-approved documents without prospective IRB approval is considered noncompliance. If you require an updated document, please contact the HSO for assistance.

Human Subjects Office (HSO) Staffing Updates

The HSO is pleased to announce the promotion of Danielle Giltner to Senior Research Compliance Consultant. In her new role, Danielle will be responsible for IRB logistics and membership, including managing and overseeing the meeting process for each of the IU IRBs – pre-meeting, meeting facilitation, and post-meeting – as well as overseeing IRB membership appointments and rosters. Danielle will begin to transition out of screening over the next several weeks. This promotion recognizes Danielle’s significant contributions to the HSO over the past four years. Congratulations, Danielle!

The HSO also welcomes a new Research Compliance Associate to our team. Robin Anderson most recently worked as a commercial property manager responsible for leasing compliance. She also has experience in the publishing industry and previously worked for the IU Kelley School of Business. Robin will join the HSO in early October.

New Requirements for ClinicalTrials.gov Upcoming

The Food and Drug Administration (FDA) has published a final rule updating the requirements to register and maintain a record in ClinicalTrials.gov. Applicable Clinical Trials, as defined in the final rule, will be subject to new data element and timeline requirements when registering and maintaining a record in ClinicalTrials.gov.

The National Institutes of Health (NIH) has additionally published a final policy requiring registration and maintenance of a record in ClinicalTrials.gov. Clinical trials, as defined in the final policy, will be subject to the same requirements identified in the final rule from the FDA.

The effective date for both the final rule from the FDA and the final policy from the NIH is January 18, 2017. Specific information about these changes can be found here on the NIH website.

To inform the research community of these changes, the Office of Research Compliance will be presenting via several platforms, in addition to providing updates through newsletters. If any questions arise, or if a departmental training on the new requirements is desired, please email ctgov@iu.edu.

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