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Indiana University
Research Compliance Quarterly 4th Edition
October 9th, 2015
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
HHS Announces Proposal to Revise Rules Governing Human Subjects Research

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research (the “Common Rule”). A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015.

The NPRM does not represent the final rule that will be published; rather, it lists proposed revisions to the Common Rule. HHS is soliciting comments from the research community and other interested parties to be considered in drafting the final rule. The Human Subjects Office is coordinating IU’s comments to be submitted to HHS.

Please contact Shawn Axe at saxe@iu.edu if you would like to participate in formulating IU’s comments. Individual or group comments can also be submitted directly to HHS. To be assured consideration, comments should be submitted by December 7, 2015. See the HHS website for additional information regarding submission of comments.

Timeframes for publication of the final rule and implementation of revisions have not yet been determined. As HHS provides additional information, it will be communicated via future editions of the newsletter and/or ORA News emails.

HIPAA for Pregnancy and Neonate Research

Recent discussions with study teams have prompted the Human Subjects Office (HSO) and the University HIPAA Privacy Officer to offer suggestions on obtaining neonate authorization from the parent, or legal guardian, during pregnancy.

This discussion applies only to research that includes intervention during pregnancy (pregnant female is the study subject) for which neonate outcomes are collected. It does not refer to studies in which the neonate is enrolled after birth for the purposes of research or treatment intervention for a neonate-related medical condition or status....To read the full discussion, click here.

OneStart to One.IU Transition

We hope you know…OneStart will retire on October 21st!  One.iu.edu is the new directory for university services, including KC IRB.

Make your way to One.iu.edu and add the task "All IRB Services" to your favorites so you'll be able to find information about your IRB protocols once OneStart retires.

As always, reach out for assistance with KC IRB by email at kcirb@iu.edu or by phone at (812) 856-4242.

Upgrade to KC (Kuali Coeus) at IU

On Saturday, December 5th, IU will upgrade to a newer version of KC (Kuali Coeus). The upgrade will bring improved usability features and a more stable platform for future maintenance.

Stay tuned for more details from the Human Subjects Office!

Requests for Research Access to Cerner

IU Health has made available a form for non-IU Health employees to request research access to the Cerner medical records system. In addition, IU Health has supplied a FAQ document.

Both forms are now available on the HSO website forms page here.

New Dual Use Research of Concern Policy

The United States government issued new regulation, United States Government Policy for Institutional Oversight of Life Science Dual Use Research of Concern, governing the oversight and use of certain select agents and certain experiments of concern.

In order to comply with the new regulations, IU has established a new policy Dual Use Research of Concern (“DURC”) that can be found under the research section of policies.iu.edu. Under the new policy, anyone using one of the 15 biological agents and toxins of concern will be required to complete appropriate training. (See definitions in the policy here for the list.)

These agents are already restricted and heavily regulated as “select agents”; however, one difference between the two regulatory schemes is that small amounts of botulinium neurotoxin are exempt from the select agent regulation, but they will now fall under the DURC.

Please contact the IBC office if this is in your lab, so we can provide the appropriate training. The Principal Investigator must also provide information about whether the research being conducted falls under one of the seven categories of experiments that may be dual use research of concern.

If you are unsure if your research falls under the new regulation and IU policy, please contact our offices for further assistance by phone at (812) 855-0656 or via email at ibcbhc@iupui.edu (IUPUI) or iubibc@indiana.edu (IUB).

External Audits - IU Expectations

As stated in the Indiana University Standard Operating Procedures for Research Involving Human Subjects (Auditing Human Subjects Research, section 2.6), “When an investigator receives notification of an upcoming compliance inspection by a regulatory agency, funding agency, or study sponsor, he or she shall immediately notify the IU Quality Improvement Office (QIO).” This policy does not refer to routine monitoring visits or periodic audits conducted by the sponsor, Contract Research Organization (CRO), or coordinating center as part of the study’s approved Data and Safety Monitoring Plan. Rather, it includes one-time audits by entities such as the National Institutes of Health (NIH), Office of Research Oversight (VA), Office of Human Research Protection (OHRP), Food and Drug Administration (FDA), and the sponsor (in instances of for-cause or FDA audit preparation).

During external audits, IU QIO staff will serve as the institution designated liaison to monitor the progress of the inspection, and to serve as a resource to the PI and study team. QIO staff will also coordinate and review any written response to the auditing agency, such as the response to the FDA Form 483.

Audit preparation materials are available on the IU QIO website here and QIO staff are available for consult as you prepare for your external audit.

ClinicalTrials.gov Training

Need to learn the basics of the ClinicalTrials.gov, Protocol Registration and Results system? Need to better understand how to complete an initial registration in the ClinicalTrials.gov, Protocol Registration and Results system?

The Office of Research Compliance, along with the Clinical and Translational Sciences Institute (CTSI), is offering training on the ClinicalTrials.gov, Protocol Registration and Results system with a focus on system basics and registration. Below, please find the offered training opportunities:

Date: 11/02/2015
Time: 9-10 AM
Location: Indianapolis, Lockefield (LV) 3301
Course Name: ClinicalTrials.gov Registration Module Training

Date: 12/03/2015
Time: 3-4 PM
Location: Indianapolis, Lockefield (LV) 3301
Course Name: ClinicalTrials.gov Registration Module Training

Please reserve your spot in an upcoming training session by visiting the University-wide Research Education Sessions & Registration class schedule.

To view these training opportunities, select "Quality Improvement Office" in the "List classes for Area" drop-down.

Please note: Enrollment is capped at 15 participants and a minimum of 10 participants is required to conduct the training.

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