18th Edition - April 12, 2019

Becca Hopson has moved from the Research Integrity Office to the ORC Leadership team as the Assistant Director for Education and Outreach.

Amy Waltz has moved from the Human Subjects Office to the Research Integrity Office as the Associate Director.

Megan Bettag joins the Human Subjects Office as the new IRB Meetings Specialist.  Megan will assist in coordination of IRB meetings and maintain regulatory documentation related to convened meetings, including minutes and IRB membership.  Previously, Megan worked as an Administrative Coordinator in the IU School of Social Work.

Tim Roberts and Sierra Williams join HSO as new Research Compliance Associates. They will screen biomedical IRB submissions advising researchers on IU policies and regulatory requirements affecting human subjects research. Previously, Tim worked as a Senior Import Coordinator with FedEx. Sierra worked as a Regulatory Affairs Specialist with Brulin Holding Company.

The National Science Foundation (NSF) requires that each institution submitting a proposal certify that it has a plan to provide appropriate training and oversight in the ethical conduct of research to all undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.  This policy requires that Institutions are responsible for verifying training has been received.                

To meet the NSF RCR training requirement, undergraduates, graduate students, and postdoctoral researchers receiving NSF funding need to successfully complete IU’s two-part program:

• Successful completion of the Responsible Conduct of Research (RCR) course of the online program hosted by Collaborative Institutional Training Initiative (CITI); and
• Discipline-specific mentoring by the principal investigator and lead investigators during the course of the grant.

The Office of Research Compliance will conduct audits of online completion of CITI RCR training and will notify individuals when they are non-compliant. Notifications are sent via email to the Principal Investigator, undergraduate students, graduate students, and postdoctoral researchers, and the grant account Fiscal Officer. The schedule of notifications provides 30 days to complete the online RCR requirement. If the requirement has not been met at 15 days, a second (reminder) notification will be sent. If the requirement has not been met at 25 days, a third (final) notification will be sent. Undergraduates, graduate students, and postdoctoral researchers supported by NSF funding, who have not completed the online CITI RCR training within 30 days from the initial notification, will have compensation charges removed from the grant.   

If you have any questions about this requirement, please contact our office at researchcompliance@iu.edu.

The Office of Vice Provost for Graduate Education and Health Sciences, in collaboration with the Office of Research Compliance within the Office of the Vice President for Research, is pleased to continue offering the IU Bloomington, Responsible Conduct of Research (RCR) Series. This series is designed to satisfy the in person requirements for RCR Education and is open to all members of the IU research community.

Date: April 18, 2019
Location: IU Bloomington Campus, Indiana Memorial Union, Dogwood
Sessions Held: 4:00 – 6:00 pm
Facilitators: Norika Hara, PhD, Professor, Information Science & Claire Walczak, PhD, Professor, Biochemistry & Molecular Biology, Assistant Director for Research, Medical Sciences, Indiana University

Reporting/Reviewing Research

• Peer Review
• Publications practices and responsible authorship

Register in Advance

Investigational medical devices are classified according to the risk of how the device will be used, and fall into one of 3 categories:  significant risk (SR) devices, non-significant risk (NSR) devices, or exempt devices.  Both SR and NSR devices are subject to the FDA's IDE regulation.

Of the IDE regulated devices, the FDA generally defines non-significant risk devices as those that are not intended for implantation, will not be used to support or sustain human life, and do not present a potential for serious risk to the health, safety, or welfare of a subject.  It is important to remember, however, that the NSR classification applies only to the investigational device itself and is not the same as “minimal risk.”  “Minimal risk” is an IRB determination made about a study in its entirety (all components, all procedures) and the associated IRB review level required. While a minimal risk study may use an NSR device, the terms are not synonymous.

Studies using NSR devices are obligated to comply with a portion of the FDA’s full investigational device regulations (cited in 21 CFR 812). This subset of regulations, also known as the “abbreviated IDE requirements,”  includes both investigator and sponsor responsibilities (outlined in 21 CFR 812.2b).  When an NSR device study is investigator-initiated and there is no external sponsor who will fulfill the relevant sponsor responsibilities, the investigator then assumes the responsibilities of being both the investigator and the sponsor (i.e., a sponsor-investigator). 

Sponsor responsibilities that would be absorbed by the investigator in such situations include labeling of the NSR device, monitoring of the study, and some reporting to the FDA, and are summarized here.

• The NSR device must be labeled with specific information outlined in 21 CFR 812.5 including identification of the device as for investigational use only, the manufacturer’s name and address, and applicable contraindications or warnings.
• The NSR device study must be monitored for compliance with the investigational plan, applicable FDA regulations, and any conditions imposed by the IRB as outlined in 21 CFR 812.46. Noncompliant investigators must be brought back into compliance or their access to the device and their participation in the study must be terminated. Study monitoring of this type is separate from the trial’s data and safety monitoring plan, which serves to ensure subject safety and the scientific validity of the study data.  As described in the sponsor’s general responsibilities, monitors selected for this role must be qualified by training and experience.  The IU CTSI’s Clinical Research Monitoring Service may be able to assist the investigator in meeting this requirement.
• Finally, unanticipated adverse device effects and other events that may occur in an NSR device study, such as the withdrawal of IRB approval, must also be reported to the FDA as described in 21 CFR 812 Subpart G.

Systematic and streamlined data management processes are critical to successful data analysis. The development of standardized data collection forms is then an important strategy to utilize in accomplishing this goal. Ideally, data collection forms will facilitate the consistent recording of data, in both paper and electronic source formats.

Well-designed data collection forms should not only identify the data to be collected, but also any relevant parameters around that data. For example, should weight be measured in pounds or kilograms and recorded to what decimal place? Should blood pressure be measured on the same arm at each visit, or can the assessment arm be varied? Are timed tasks be recorded to the nearest second or millisecond of duration? Consistent recording of data will reduce time-consuming data manipulation prior to analysis.

Data collection forms should also assist the study team in maintaining compliance with both protocol requirements and with data collection standards. Forms should be built to guide the collection of data in the required sequence of events, and under the required conditions as applicable. If the protocol requires sitting blood pressure to be collected after 5 minutes of rest, followed by an immediate standing blood pressure, a purposeful form would appropriately sequence the data collection procedures and include pertinent instructions for the data collector. Further, the form should prompt collection of information regarding who performed the procedure and recorded the data, in accordance with the ALCOA principles of good documentation practices.

An expanded set of commonly used data collection form templates has recently been made available on the IU HRPP Website. Available templates now include, but are not limited to, subject demographics, eligibility, medical history, physical examination, vital sign assessment, concomitant medication log, adverse event log, protocol deviation log, and drug and device accountability forms. Template forms are intended to be modified by the study team to more specifically support a particular study's needs. Additional forms may be need to be developed in order to complete your required set of data collection tools. Consultation with a statistician and a developer for your preferred data management system are encouraged during the form development process.

Advarra has acquired Quorum Review IRB.  For now, submissions can continue to either Quorum or Advarra.  In the fall, Quorum studies will be transferred to Advarra and study teams will be notified of any actions they need to take and relevant information they need to be aware of.  In the meantime, if you have any questions about the merger, please contact Ryan Ballard at rcballar@iu.edu or Beth Johnson at bwinnie@iu.edu.

Beginning in July 2019, the IRB will increase the number of biomedical IRB meetings from the current schedule of four meetings per month to twelve meetings per month.  Meetings will be shorter, with fewer IRB members in attendance, and fewer protocols reviewed at each convened meeting.  The goal of this restructuring is to increase engagement of IRB members and improve the IRB membership experience.  You may notice very minor changes in your IRB approval documents and our processes after the merger, but the transition should be seamless.  If you are interested in joining the IRB as a reviewer under this new structure, please contact Danielle Giltner at droessin@iu.edu.

HSO is happy to announce new functionality available to researchers! This
functionality, known as "Compare to," provides better visibility of the
changes made to the KC Questionnaires.

How does the "Compare to" functionality work?

• Go to the Questionnaire tab or to Print > Questionnaires on the Protocol
  Actions tab, and you will see the option to "compare to previous."
• From the BASE protocol (the "base" is the currently approved protocol and
  documents):  You can compare the currently approved questionnaires to previously approved
  questionnaires.
• From a submission (i.e. AXXX or RXXX):  You can compare the questionnaires being revised to the base OR a previously submitted version (if any).

We hope this functionality helps bring clarity to any modifications that are
made and provides additional ability for research staff to appropriately
track amendments.