28th Edition - September 30, 2021

Think Research Misconduct Allegations Can’t Happen to you? Think again!

Research misconduct allegations at IU continue to rise, and have a huge impact on the affected researchers, their colleagues, and their research. Falsification, fabrication, and plagiarism can happen in any discipline, on any campus, and often looks very different from the research misconduct cases in the headlines. In this new webinar series, IU Research Integrity Office (RIO) staff will join faculty members who adjudicate research misconduct cases to discuss the causes and consequences of research misconduct and share lessons learned from real cases right here at IU. You will learn what falsification, fabrication, and plagiarism look like in real life, how research misconduct allegations can affect you and your research, and approaches for preventing research misconduct, and research misconduct allegations, in your own labs and research teams.

Join us for the first session: Small mistakes, big consequences

October 6, 2021 , 12:00pm – 1:00pm

Many research misconduct allegations stem from sloppy mistakes or poor documentation practices. Research Integrity Office staff will highlight several examples from recent cases and faculty colleagues will offer potential solutions for ensuring protocol compliance.

Presenters:

• Shelley Bizila, MS, Director & Research Integrity Officer, Research Integrity Office, IU Office of Research Compliance
• Christopher M. Callahan, MD, MACP, Chief Research and Development Officer, Eskenazi Health; Professor, IU School of Medicine; Scientist, IU Center for Aging Research at Regenstrief Institute
• Matthew R. Allen, PhD, Assistant Dean, Faculty Affairs and Professional Development; Professor, Department of Anatomy, Cell Biology & Physiology; Chair, IU Institutional Animal Care and Use Committee (IACUC), IU School of Medicine; Co-Director, Workforce Development, Indiana CTSI

With introductions by:

• Fred Cate, Vice President for Research, IU, Distinguished Professor and C. Ben Dutton Professor of Law
• Tatiana Foroud, PhD, Executive Associate Dean for Research Affairs, Chair, Department of Medical and Molecular Genetics, IU School of Medicine

Click here to register and learn more about the series, including future sessions

With approval from the IU Office of the President, requirements were put in place by the Vice President for Research Office and involve disclosing and uploading professional consulting or research funding agreements, not managed by IU, that either are in effect now or will be in the future.  In September, the Kuali COIC disclosure form will be updated to include a new section and questions related to research security and inappropriate foreign influence.  (Please note that these disclosures will become part of the yearly COI/COC disclosure process – there is not a separate process for disclosing foreign influence or agreements.) 

Professional agreements may be reviewed by Research Security Office (RSO) staff to assess if there are issues related to inappropriate foreign influence that might need to be addressed.  The RSO was created by the Vice President for Research Office to address the security risks posed to the research environment at Indiana University and assist researchers with efforts to protect themselves, their research data and methodologies, publication rights, and intellectual property.  The RSO works to lower organizational risk for Indiana University researchers and the research environment.  Mitigation steps involve raising the awareness of nefarious entities who desire to acquire research data, methodologies, pre-published papers, or intellectual property unethically or illegally without proper permission.   

Please visit the Foreign Influence webpage or look for the upcoming release of the Research Security Office website (rso.iu.edu) to learn more.  Have questions?  Please contact the RSO staff at the email address: RSOhelp@iu.edu.

It can be difficult to determine whether a change to your research study requires a submission to the IRB.  The first step in determining whether an IRB Amendment is needed is the level of review for your study.  For exempt research, most changes to your study can be made without an Amendment submission.  Changes that require submission for exempt research studies include PI changes, addition of non-IU-affiliated personnel, substantive changes to study procedures, and other changes that may impact the study’s eligibility for exemption.  For more information on what changes to exempt research require submission and approval, see the “Amendments to exempt research” section of the HRPP Guidance on Exempt Research.

For expedited and full board research, all changes, no matter how minor, require prospective IRB review and approval before the change can be implemented.  The only exception is changes which are necessary to eliminate an immediate hazard to subjects.  Changes to eliminate an immediate hazard, for example, reducing the dose of study drug in response to an adverse event, can be made without IRB approval, but must be reported to the IRB via a Reportable Event submission within 5 business days. These changes are quite rare, and you are encouraged to contact the IRB to confirm your change meets this criterion before proceeding under this exception.

Changes requiring prospective IRB review and approval may be changes that impact all future subjects or may impact only a single subject.  The scope of the planned change does not determine whether IRB approval is needed.  Changes to expedited and full board research that require IRB review include, but are not limited to:

• Adding or removing study procedures or study visits,
• Shortening or extending study visit windows or the overall duration of subject participation,
• Revising IRB approved study documents, including recruitment materials, consent forms, questionnaires, phone or interview scripts,
• Modifying the plan for identifying or recruiting potential subjects,
• Revising the data points to be collected, and
• Permitting an individual subject that does not meet the eligibility criteria to participate.

Note that planned changes cannot be classified as protocol deviations in an effort to avoid prospective IRB review and approval of the change.  Protocol deviations are unplanned and generally discovered after their occurrence, which prevents the opportunity for prospective IRB approval of the change.  Rarely deviations may be known prior to their occurrence.  If known prior to occurrence, to be classified as a protocol deviation, the event must be outside the control of the investigator.  For example, the subject has notified the study team they will miss a scheduled visit due to planned travel.  In this case, the event is outside the control of the research team and the research team did not intend to deviate from the protocol.  Therefore, this event can be classified as a protocol deviation rather than a planned change requiring an Amendment. 

If an unexpected issue arises that necessitates a change to your research, the IU IRBs can often provide rapid Amendment review, particularly when the Amendment impacts only a single subject, so called “Single Patient Amendments”.  Please notify the HRPP staff upon submission of any Amendment requiring rapid review, and we will do our best to accommodate your request.  You can reach out to your usual HRPP contact or email irb@iu.edu with this request.

In addition to providing review for IU research, the IU IRBs provide review for a number of affiliated institutions.  Research conducted by an affiliate may be led by a PI who does not have or does not regularly use an IU email address.  However, in order to access the Kuali Protocols system, an IU username and password are required. 

Therefore, all individuals listed as PI on IU IRB submissions must obtain an IU email address and keep their IU email account active.  This email address is used for communications from the IRB, including automated system notifications and communication directly from the HRPP staff.  If an individual does not regularly check their IU email, they should forward their IU email to their primary email account to ensure IRB notifications are not missed.  Instructions for forwarding IU email can be found in the IU Knowledge Base.

Starting Sept. 30, IU offers the Responsible Conduct of Research workshop series to all members of the IU research community. Topics include protecting research subjects; threats to research integrity, and advice on reporting and practicing research.

The Office of Vice Provost for Graduate Education and Health Sciences, in collaboration with the Office of Research Compliance (ORC) within the Office of the Vice President for Research, is pleased to continue offering the 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. The next session will be Protection of Research Subjects and Participants to include Human Subjects Research and Research with Animals on October 28th, 2021. Find out more about the RCR series. Contact the ORC office at orcinfo@iu.edu with any questions.