24th Edition - October 22, 2020

Anyone responsible for the design, conduct, or reporting of research or sponsored projects at Indiana University – including principal investigators, project directors, consultants, students, non-paid volunteers, and others – must complete an annual disclosure in the Kuali COI disclosure system each year or within 30 days of a change in outside interests. Based on your responsibilities at the university you may also need to select the role of university employee.

The following new features are available in Kuali COI disclosure system:

1. Delegate feature

This new feature allows users to assign delegates to aid in completion of their disclosure form. Delegates can answer the questions in the form however delegates can not submit the form on behalf of someone else. Each individual must log into the system to review the responses entered by their delegate(s) to ensure accuracy and must take the final submit action.

2. Request disclosure send back

Previously if your disclosure form was in a submitted for approval status you could not update your form until it was approved by the Research Conflict of Interest (COI) Office. Now if your form is in a submitted for approval status you will see a ribbon at the top of your form with the option to request send back. This will send a message to the Research COI office that you need to make updates to your form and they will send your form back to you within the system. If you inadvertently select the send back form button there is an option in the same ribbon to cancel send back request.

3. New Questions

There is a new Research COI question and additional outside activity checkbox in the General Form regarding membership in a foreign government’s talent program. Please see the foreign influence article in this newsletter for more information.

4. Removal of External Flag on System-Generated Notifications

The system-generated notifications from Kuali COI will no longer have the [External] flag added to the beginning of the email subject line as the email is now listed on the IU trusted email list. We encourage you to follow safe practices of not following links from unknown or suspicious sources, and will continue to provide instructions on how to navigate to your disclosure should you prefer to avoid using direct links in the system-generated emails.

If you have any questions about the new features or how to answer the new questions on the disclosure form please contact us at coi@iu.edu.

Successful international collaborations are critical to the teaching, research, and service missions of Indiana University.  However, when engaging in these relationships, representatives of the university must be mindful of disclosure requirements and other legal restrictions that may apply.  The Director of the National Institutes of Health (NIH), Francis Collins, M.D., Ph.D., has issued a “Foreign Influence Letter to Grantees”. He offered a reminder to “disclose all forms of other support and financial interests, including support coming from foreign governments or other foreign entities...in accordance with the NIH Grants Policy Statement, [on] all applications and progress reports.” Keep in mind when engaged in international projects:

• Beginning today, the Kuali COI disclosure form now includes a specific question requiring disclosures of involvement with a foreign government talent program. As always, you must disclose any outside professional activities and financial relationships, whether compensated or uncompensated, through the Conflict of Interest/Commitment.
• Journals and professional organizations have various, often broader, standards for financial interest disclosure than the university. Review those standards for each relevant journal or organization and disclose appropriately.
• Ensure compliance with U.S. export control regulations when doing any of the following: accepting publication restrictions on research; traveling internationally and attending conferences; participating in international collaborations; working with international staff and students; hosting international visitors; shipping materials internationally; and engaging in other international transactions. Learn more about export control at IU and, if needed, contact IU’s Export Control Office at export@iu.edu within the Office of Research Compliance.

Effective June 29, 2020, many exports to China, Russia and Venezuela that were previously exempted will now require an Electronic Export Information (EEI) to be filed with the US government, regardless of the value of the item being exported.  When required, the EEI filing must include a correct Export Control Classification Number (ECCN) for the item(s) being shipped.

Certain limited exceptions still apply for the following exports:

• An export consisting only of items classified as EAR99;
• An export eligible for License Exception “GOV” or another exception in the Export Administration Regulations and Foreign Trade Regulations.

Contact Export Control (export@iu.edu) for assistance with these new requirements on shipments to China, Russia or Venezuela and with all international shipments.

The HRPP continues work toward implementation of Kuali Protocols, the replacement system for KC IRB.  Development and testing of the new, more streamlined application form has been completed.  Testing of the process for migrating existing studies from KC IRB to Kuali Protocols is ongoing.  Additionally, Kuali continues to develop and deliver new system features necessary for system implementation at IU.  The project remains on track for go-live in very early 2021.

We are excited to implement this more user-friendly system for IRB submissions and look forward to sharing more details with the research community soon.  Watch for HRPP announcements in the coming months regarding the go-live date, training opportunities, and important information you need to know about processing of submissions during the cutover period.  As a reminder, the latest updates regarding Kuali Protocols can always be found on the Kuali Protocols webhub.

The HRPP has added an FAQ related to obtaining electronic signatures on consents and authorizations to the ORC Research Restart page.  Please see the FAQ for more information regarding use of RedCap to obtain electronic signatures.  Note that IU RedCap is not validated as Part 11 compliant, therefore, it should not be used to obtain consent signatures for FDA regulated studies.  The HRPP is not aware of any University-provided systems that have been validated as Part 11 compliant for purposes of electronic informed consent.  However, some sponsors may provide e-consent systems that can be used for FDA-regulated research.

An auditing program dedicated to the review of minimal risk research was initiated by the Quality Improvement Office (QIO) in 2019.  This program was developed in response to the revised Common Rule’s removal of the requirement for continuing review by the IRB.  However, it also provided an avenue to provide focused education to investigators and study teams conducting minimal risk research. The primary goal of the IU auditing programs is to provide compliance education and to help bring studies or teams who may be unaware of compliance issues, back into compliance as quickly and as efficiently as possible. 

The minimal risk audit program was designed to function remotely, by requesting researchers to upload a narrow scope of study documents into a web portal for auditor review.  Following the auditor’s review, an audit report is provided to the study team that includes guidance on scenarios, policy, and best practices specific to the study under review and to the noted observations.  The minimal risk auditing program has been well received by the research community with several researchers and study teams noting the usefulness of the education provided by the auditor throughout the process.  Feedback from investigators who are selected for audit is welcome and is included in the regular analysis of the program to identify areas for improvement.

Twenty-six minimal risk studies were reviewed in the inaugural year, about two-thirds of which were from social/behavioral/educational research disciplines.   The most common audit observations included implementation of changes without IRB approval, use of a non-IRB approved or non-watermarked version of the consent document, and minor deviations from the IRB approved study plan.  More significant observations – those considered to meet IU’s prompt reporting criteria – included the implementation of substantive changes to recruitment documents without IRB approval, failure to obtain subject signatures on consent or authorization documents, and performing study procedures prior to obtaining consent.  These observations are consistent with those seen in audits of greater than minimal risk research.

Studies conducted by Principal Investigators who have never undergone a QIO audit, or whose previous audit was more than 5 years ago, are the primary focus for routine audit selection at this time.  Additionally, investigators and study teams may request an audit of a particular study, or a portfolio of studies, by contacting the QIO Associate Director, Neala Lane, at lanen@iu.edu.

Before a clinical research study can begin to accrue subjects, the study must be submitted to a number of offices who complete varying level of reviews and approvals. The HRPP and the Office of Clinical Research Coverage Analysis Team (CAT) review many of the same documents, with a different focus. The HRPP focuses on human subject protections and IRB compliance, where the CAT is focused on clinical research billing and finance compliance.

CAT Process and Responsibilities

When a study is submitted for entry into OnCore (the Clinical Research Management System required by IU since 2016), the CAT receives the information provided and focuses on reviewing the billing plan and financial responsibility language within the budget, contract or award, and informed consent documents.

When reviewing the billing plan and budget, the CAT is responsible for documenting the separation of allowable costs and validating that all procedures planned as billable to the patient/patient insurance are allowable by Medicare standards and regulations. In some cases, this is confirmed by reviewing Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), national treatment guidelines (NCCN, AHA, etc.) and peer reviewed journals to help determine if the procedure is part of the nationally recognized routine treatment for the condition indicated in the protocol. This review is documented in OnCore under the ‘Coverage Analysis Console,’ inside the Billing Grid, and is used to inform hospital billing in the OnCore Research Billing Process, which expands to all departments beginning December 1, 2020.

The CAT also completes a document alignment review to ensure that the financial responsibility language is consistent across study documents and complies with regulations governing clinical research billing compliance, such as NCD 310.1 and Medicare’s Secondary Payer rules. Financial responsibility language can include the costs of care, subject stipends and reimbursements, and also subject injury language. Since subject injury language should also be addressed within the contract or research agreement, the CAT is also assisted by the Office of Clinical Research Contracts Team, who review the subject injury language within the informed consent in order to negotiate proper language into the contracts with industry sponsored studies.

It is best to submit for entry into OnCore and start the Coverage Analysis Review as early as possible. Ideally, the CAT reviews should take place with draft documents. Reviewing the draft documents will allow the CAT to provide feedback and direction on how to negotiate the documents, and allow for changes to take place prior to finalizing, and removing the need to amend the documents after approval.

IRB Process and HRPP Responsibilities

Compared to the CAT process, the IRB review process has more breadth but less depth.  The IRB’s primary role is protection of human subjects.  To this end, the IRB reviews risks and benefits, recruitment procedures, consent forms and processes, safety monitoring, and protection for vulnerable populations, among other details.  The IRB’s review of billing information is limited.  The IRB does not review the CAT’s determinations regarding who will be billed for clinical procedures conducted during the course of a research study nor does the IRB compare billing information to the budget or the contract.  Those responsibilities are managed solely by the CAT.  The IRB’s role is limited to ensuring the informed consent is clear and understandable regarding what costs the subject may incur as a result of participating in the research. 

When an external (non-IU) IRB is used, the study must still be submitted in KC IRB, but typically, the HRPP does not review the consent form.  Responsibility for review of the consent form is deferred to the reviewing (external) IRB.   In these cases, any request by the CAT to revise language in the consent to align to the coverage analysis, budget, or contract language must be submitted to the external IRB for review and approval.  The HRPP is always willing to assist in communications with the external IRB regarding these types of changes.

Summary

While the IRB and CAT provide review and approval based upon different areas of focus and responsibility, these two offices have worked closely to ensure the IU studies meet the highest standard of compliance. While your study is undergoing review by each of these offices, it is important to remember that approvals do need to come from each office prior to a study opening to accrual, and keeping open communication during the reviews will be of the utmost importance to get your study opened in a timely manner.

Responsible conduct of research (RCR) training is an important aspect of IU’s curriculum, and is required for investigators conducting research supported by NIH, NSF, and PHS. The 2020-2021 RCR Webinar Series is designed to satisfy the NIH RCR in-person education requirement and is open to all members of the IU research community. Join us virtually for the two remaining sessions in Spring 2021.

2020-2021 RCR Webinar Series

February 18, 2021, 4-6pm

Reporting/Reviewing Research, including discussion of the peer review process and responsible publication and authorship practices

March 18, 2021, 4-6pm

The Practice of Research, including data acquisition, management, sharing, and ownership, collaborative science, and mentor/trainee responsibilities

Click here to enroll.

Speakers for the spring sessions are still needed

The Office of Research Compliance is looking for faculty members with expertise in publication and peer review, authorship, data management, collaborative science, and mentor/trainee responsibilities to help lead spring RCR webinar sessions. Most sessions include at least two speakers and involve sharing your knowledge through didactic and interactive discussion with junior researchers. Please contact rio@iu.edu to volunteer, or to recommend a colleague or professor.

IU offers two additional opportunities for meeting RCR training requirements:

• Collaborative Institutional Training Initiative (CITI) RCR modules offers training on a variety of RCR topics including Research Misconduct, Data Management, Authorship, Peer Review, Mentoring, Conflicts of Interest, Collaborative Research, Financial Responsibility, Using Animal Subjects in Research, and Research Involving Human Subjects.
• RCR courses at the IU School of Medicine, offered by the Center for Bioethics, continue in accordance with campus requirements regarding COVID-19 protections.

For more information about responsible conduct of research training during the COVID-19 pandemic, see the FAQs related to restart of research on research integrity, or view RCR requirements. You may also contact Research Integrity Office staff at rio@iu.edu.