34th Edition - March 30, 2023

Did you know that you’re responsible for disclosing your outside activities to the university? How does the university review disclosures after submission? How are potential conflicts evaluated by the COI Committee?

Federal regulations and university policy require that anyone responsible for the design, conduct, or reporting of research or sponsored programs at Indiana University, including principal investigators, project directors, consultants, students, non-paid volunteers, complete an annual disclosure form and update it within 30 days of a change in outside activities. The university has a process in place to evaluate the disclosures and ensure compliance with federal regulations. The Vice President of Research and the Office of Research Compliance invite you to attend a research webinar on research conflict of interest, your responsibility to disclose, and the disclosure review process.

In this webinar session, IU Conflict of Interest Office (COI) staff join faculty members who are Research Conflict of Interest Committee members to discuss the responsibilities of disclosing, what happens with disclosures, the causes and consequences of not disclosing, and share lessons learned from examples at IU. Learn what must be disclosed and when you need to make those disclosures, why reach conflict of interest matters, how this impacts your research and what happens after submitting a disclosure.

Join us for this research best practice webinar: Demystifying the COI Process: Researcher Responsibilities and the Review of Disclosures

April 12, 2023, 12:00pm-1:00pm

Presenters:

• Mark Kelley, PhD, Betty and Earl Herr Professor of Pediatric Oncology Research, IU School of Medicine, Indiana University
• Eric Swank, Executive Director, Office of Research Compliance, Office for the Vice President of Research, Indiana University
• David Wild, Professor of Informatics and Computing; Director, Crisis Technologies Innovation Lab (CTIL); Director, Integrative Data Science Lab (IDSL) Luddy School of Informatics, Computing, and Engineering

With an introduction by:
Fred Cate, JD, Vice President for Research, Distinguished Professor and C. Ben Dutton Professor of Law, Adjust Professor of Informatics and Computing, Indiana University

Attendance is free but registration is required. Register to learn more about this webinar. If you have questions or want more information on the conflict of interest submission system or review process, please contact coi@iu.edu.

Kuali Protocols (KP) is integrated with IU training platforms to automatically pull in required training records. Most training records will update when a new submission is created in KP and throughout the review process until the submission has been approved.

When an in progress submission is opened in KP the training records may take a few moments to load. You will see a spinning circle in the personnel section over training records if they are not fully loaded yet. Also, training completion records may take up to 48 hours to display correctly as the integration is not a real-time feed of training data into KP.

If an individual does not have the required training or it is expired, you will still be able to make edits to the protocol submission and submit/resubmit however the IRB and IBC will be unable to approve the submission until the required training either shows as complete in KP or completion has been confirmed by IRB/IBC staff.

If you believe you have completed training and it is still showing as incomplete in KP after 48 hours please reach out the office that will be reviewing your submission. Contact the IRB at irb@iu.edu or IBC at ibc@iu.edu and we will provide further assistance.

The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information requires that clinical trials register and submit results on ClinicalTrials.gov. Registration must occur within 21 calendar days after the first participant is consented, and results must be submitted within one year of the trial’s completion dates.

Recent enhancements to the eRA Commons system have allowed NIH to more easily identify trials that appear to be noncompliant with either the registration or results reporting requirement when a Research Performance Progress Report (RPPR) is submitted. In response to identified errors, NIH has begun to issue Notices of Noncompliance. As compliance with the NIH Policy is a condition of the award, these Noncompliance letters are typically addressed and delivered to the institution’s Research Administration office.

Noncompliance Notices require that the noncompliance be corrected within 30 calendar days. Failure to correct the noncompliance within the allotted timeframe may result in the withholding of the next year’s funding, suspension, or termination of the award and/or withholding of funding for future awards. NIH has further indicated that awards to other PIs at the institution may be jeopardized for failure to correct CT.gov noncompliance.

The IU HRPP is coordinating IU’s response to NIH Noncompliance Notices. If you receive a Notice of Noncompliance Letter related to ClinicalTrials.gov, please notify Neala Lane (lanen@iu.edu) and Beth Johnson (bwinnie@iu.edu) immediately so that we may assist you with updating the CT.gov record to achieve full compliance.

NIH Notices of Noncompliance can be avoided by ensuring CT.gov records are kept up-to-date and accurate, particularly with regard to anticipated completion dates. Primary and Study Completion dates are defined by each trial’s data collection plan for primary and secondary outcome measures respectively and occur when the last subject is evaluated for the purposes of generating data towards these outcomes. The data must be analyzed and results posted within one year of those evaluations being completed. No additional time is provided for extraction of data from other systems, sample analysis, or to accommodate the drafting of publications. Additionally, if a trial is terminated early, due to insufficient enrollment or other issues, the completion dates retrospectively apply to the last subject enrolled and their participation. More information on how to calculate completion dates can be found by expanding the Results Reporting section of the Complying with ClinicalTrials.gov page on our website.

Projects that may face extenuating circumstances with regard to the one year deadline for results reporting may be eligible to apply for a good-cause extension; however, such extensions must be requested and granted prior to the results being due. Examples of good cause requests may include trials that are dependent on release of data from another state or federal agency for analysis after direct subject participation ends; trials in which the pace of enrollment has been slow and which are nearing one year since the last participant was enrolled but for which there is an intent to continue subject enrollment in the future; and studies in which a data collection site was impacted by a natural disaster or catastrophic event. IU staff are available to assist you with CT.gov registration and reporting requirements, including evaluating potential eligibility for good cause results reporting extensions and application instructions. Contact us at ctgov@iu.edu with questions or to request assistance.

The Office of Research Compliance shares research-related news and updates from IU research partners. Please see the latest updates on VA Collaborative Research.

When is human, non-human, bench laboratory, or animal research considered “collaborative” with VA, and what special requirements are there when VA is involved in collaborative research?

Collaborative research between VA and non-VA institutions is like a Venn Diagram. The point where the VA and Non-VA institutions overlap is how they form a collaboration and interact for the research. A few examples, not all inclusive, of VA/non-VA collaborative research regarding sharing of data, resources, and property include:

• A VA paid investigator has been awarded a VA grant for live animal and bench laboratory research, utilizing an IU bench laboratory to conduct a portion of the VA funded research. This is collaborative research.
• A VA investigator who receives data void of the 18 HIPAA identifiers and with no way to reassociate the data back to the individual requests a non-VA investigator to consult, review the data, and provide input on analysis and development of a future protocol. This is collaborative research.
• Research in which a VA and non-VA (possibly IU, IUH, Regenstrief, or Eskenazi) investigator are each enrolling participants separately under one protocol and agree to pool all data together for analysis at one of the institutions. If only one institution is enrolling participants and the other institution analyzes the data for the first institution, then the sharing of data between the institutions/investigators is collaborative research.
• A non-VA investigator (let’s say IU) has received a non-VA grant which could benefit Veterans. A VA paid investigator agrees to collaborate, enroll, and conduct visits at the VA as one of the sites. However, the VA doesn’t have the specific MRI equipment that IU/IUH has and is required for the protocol. The VA recruited participants will be VA consented and VA HIPAA authorized participants. The VA participants will also become non-VA participants at IU for the MRI procedure, consenting yet again on the non-VA consent and non-VA HIPAA Authorization in this collaborative study.

When conducting VA Collaborative research, a number of additional requirements apply, such as:

1. VA Human Collaborative form or a Non-Human Collaborative form
2. VA Research Data Ownership RDOA form, listing VA PI expectations
3. VA Information Security Officer form (ERDSP)
4. VA Privacy Officer form #10-250 (only for human research)
5. Agreements for collaborative research:
   1. For bench research conducted outside the VA or NHSR, an RDOA is required.
   2. For live animal research, this is covered by the existing MOU & Contract between the VA and the IU animal housing facility (LARC).
   3. For human research and often NHSR projects a data use agreement is required, or a proper VA HIPAA Authorization must be signed and there must be IRB submission & approval of VA as a site, including completion of the VA section in the Kuali Protocols form specifying the research is collaborative (question #0347) and sharing of data outside the VA (question #0349).
6. The VA R&DC board approval is required for all VA research. The VA R&DC board will approve only the activities that are specifically documented as part of the VA portion of the collaborations.
7. All VA research data collected must be stored on the VA network. A separate COPY of VA data can be shared (using VA approved methods to transfer data) with the non-VA institution when there is an agreement as described in item #5.
8. Additional requirements may apply.

For additional Information related to VA research contact any of the following: marta.sears@va.gov, angela.harris11@va.gov, bridget.fultz@va.gov, or IndVAResCompliance@va.gov.