29th Edition - January 13, 2022

With this first ORC newsletter of the New Year – may I congratulate you all for getting through 2021 and we wish everyone a healthy, enjoyable and productive 2022. We remain eager to continue to partner with you and, hopefully, we will be able to meet in-person without having to rely on a screen.

John Baumann, Ph.D., Associate Vice President for Research Compliance

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 ongoing webinar series, IU Research Integrity Office (RIO) staff 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. 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 second session in the series: The By-line and its impact

January 13, 2022, 11:30am – 1:00pm

Learn how authorship decisions can lead to research misconduct allegations, and what to do about it. Research Integrity Office staff will highlight several examples from recent cases and faculty colleagues will share best practices for determining and documenting authorship, as well as strategies for avoiding authorship disputes.

Presenters:

• Shelley Bizila, MS, Director & Research Integrity Officer, Research Integrity Office, IU Office of Research Compliance
• Victoria L. Champion, PhD, RN, FAAN, Distinguished Professor, Edward and Sarah Stam Cullipher Endowed Chair, IU School of Nursing
• Julie Manning Magid, Executive & Academic Director, Randal L. Tobias Center for Leadership Excellence, Professor of Business Law, IU Kelley School of Business

With an introduction by:

• Dr. Rick Van Kooten, Executive Dean and Professor of Physics, College of Arts & Sciences, IU Bloomington

Co-hosted by the Office of the Vice President for Research, Office of Research Compliance, and School of Medicine at Indiana University.

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

The countdown has begun for the 2022 IUB triennial animal facility and program review. The IUB IACUC, research animal community, and LAR team have begun preparations to host the site visitors, expecting to learn the exact dates in January.

You may recall that the IU School of Medicine successfully completed its re-accreditation with AAALAC International in 2021. The Office of Research Compliance appreciates faculty, staff, and facility participation in this process, especially in the midst of a pandemic.

AAALAC International became a part of the animal research landscape in 1965. At that time, researchers and veterinarians had collaborated to formulate a mission statement and assemble the private, nonprofit organization. Through its mission, AAALACi offers guidance in the enhancement of research, education, and testing by promoting responsible and humane care of research animals. This is supported further by providing institution-specific assessments (aka site visits).

In 2016, the organization ceased the use of an acronym and adopted “AAALAC International” as its legal name. This action was taken to acknowledge its evolution, from an initial focus on laboratory animals to including wildlife studies and agricultural animal research programs.

IUB is one among over 1,000 institutions that are accredited by AAALACi worldwide. Membership is voluntary and encouraged by our federal partners (e.g., NIH/OLAW, USDA). The IUB animal research partners look forward to hosting the site visitors next year and highlighting the Bloomington campus animal research community and program.

For any questions regarding the upcoming AAALACi visit, contact Susan Glowacz at sglowacz@indiana.edu.

As Requests to Rely on external IRBs have become more common, the HRPP has continued to assess our reliance processes for efficiency and to ensure appropriate oversight of reliance studies. Reliance includes research reviewed by independent IRBs, such as WIRB/WCG, Advarra, and NCI CIRB, and other academic IRBs, such as Johns Hopkins, Purdue, and University of Utah.

Effective January 2022, two policy changes have been implemented for reliance studies – the first related to Reportable Events and the second related to IU HRPP review of informed consent statements.

• The scope of the IU HRPP Reportable Events Policy has been expanded to encompass studies reviewed by external IRBs
  • For reliance studies, certain Reportable Events now require reporting to the IU HRPP. See section 2.2 of the updated Policy for the list of events requiring reporting to IU for reliance studies.
  • These events are submitted in Kuali Protocols using the existing Reportable Events form.
  • These events require reporting to IU within one month of discovery of the event and will be reviewed by the HRPP staff rather than the IU IRB.
  • This requirement does not replace any reporting that is required by the IRB of record. Thus events may require reporting both to IU and to the external IRB.
• The IU HRPP will review proposed informed consent statements for reliance studies to ensure appropriate language is included in the consent to satisfy local institutional requirements.
  • Requirement does not apply to independent IRBs with whom we have template consents on file, i.e., WIRB/WCG, Advarra, and NCI CIRB.
  • IU requirements that will be reviewed include local PI and HRPP contact information and, when applicable, compensation for injury language, payment/tax language, inclusion of Indiana state law elements of HIPAA Authorization, and return of pregnancy test results for minors.
  • The proposed consent should be included in Protocol Attachments with the Kuali Protocols Request to Rely submission. HRPP staff will insert comments in the consent indicating the language that has been reviewed and should not be revised by the reviewing IRB. HRPP staff will upload the reviewed version to Kuali Protocols for the study team to submit to the reviewing IRB.

For any questions regarding the IU reliance process, contact Danielle Giltner at droessin@iu.edu.

While IRB Reportable Event submissions require a description of the study team’s planned corrective and preventive actions, historically, the Office of Research Compliance has not followed up on these plans to ensure they were completed as planned and are effective in preventing future noncompliance. To address this gap, the HRPP has launched a CAPA follow-up program. The CAPA program will be led by CAPA Specialist Ashley Meyers and be housed in the HRPP’s Quality Improvement Office under the leadership of Neala Lane. In preparation for the program’s launch, the HRPP has drafted and published new guidance on the development and documentation of CAPA Plans.

The CAPA program will initially be focused on two categories of events, those classified as high compliance risk and moderate compliance risk. Additionally, HRPP leadership may request follow-up on other events not meeting these criteria. As is the case with human subjects audits, the CAPA program is intended to be education-focused, offering assistance to researchers regarding best practices to ensure compliance.

High risk events are protocol deviations and noncompliance that meet prompt reporting criteria, as defined by the IU HRPP Policy on Reportable Events, and are reviewed by the convened IRB. For these events:

• The CAPA Specialist will email the study team to inquire about the CAPA plan’s completion approximately two weeks after review of the event by the IRB.
• The study team will be asked to respond within two weeks providing documentation of completion of the CAPA Plan.
  • The CAPA Specialist may request documentation be uploaded to a secure Microsoft Teams folder or provided through secure email submission.
  • The CAPA Specialist will work with the study teams to determine a plan for CAPAs which are not yet completed at the time of follow-up, e.g., reconsent scheduled to occur at a study visit which has not yet occurred.
  • The CAPA Specialist may also provide education and/or assistance on how to document completion of the CAPA Plan and how to handle any revisions that may be needed to the CAPA Plan.

Moderate risk events are defined as noncompliance that meets the prompt reporting criteria, but which is determined by HRPP staff to be not apparent serious or continuing noncompliance (NASCN) and thus is not sent to the convened IRB for review. For these events:

• The CAPA Specialist will review a monthly report of reportable events determined to be NASCN.
• If the CAPA Specialist determines she may be able to provide education or offer assistance related to the CAPA Plan, she will contact the study team to offer assistance.

For any questions regarding the CAPA program, contact Ashley Meyers at 317-278-8493 or ashlmeye@iu.edu.

The FDA has recently begun to issue Preliminary Notices of Noncompliance (Pre-Notice Letters) and Notices of Noncompliance for CT.gov records that appear noncompliant with respect to registration or results reporting requirements. These letters are addressed and delivered to the record’s Responsible Party, which at IU, is the study’s Principal Investigator.

As outlined in the FDA’s August 2020 guidance, Pre-Notice letters describe the potential violation(s) and request that the Responsible Party take the necessary actions to address and correct the violation(s) within 30 days of receipt of the notice. Failure to restore the record to compliance after receipt of a Pre-Notice Letter will result in issuance of a formal Notice of Noncompliance.

A Notice of Noncompliance may result in civil monetary penalties being assessed against the Responsible Party. These penalties include up to $10,000 for all violations adjudicated in a single proceeding, and if the violation is not corrected within 30 days following the Pre-Notice Letter, an additional civil monetary penalty of up to $10,000 per day for each day the violation continues until it is corrected. If you receive a Pre-Notice or Notice of Noncompliance Letter related to ClinicalTrials.gov, please notify Neala Lane, lanen@iu.edu, or Beth Johnson, bwinnie@iu.edu, immediately so that we may assist you with updating the ct.gov record to achieve full compliance.

Pre-Notice Letters can be avoided by ensuring CT.gov records are kept up-to-date and accurate. IU staff are available to assist you with ct.gov registration and reporting requirements. Contact us at ctgov@iu.edu with questions or to request assistance.

The Kuali Conflict of Interest and Commitment (COIC) Disclosure system will be making cosmetic upgrades to the user interface on January 19th. The new COIC dashboard will make it easier for individuals to see the status of their current disclosure, review their disclosure history, and update their disclosure. 

All researchers should keep their disclosures up to date by making changes within thirty days of when significant financial interests change – simply click on the “Update Disclosure” button to be guided through the form to update your disclosure.

Contact us at coi@iu.edu with questions or assistance navigating the new COIC dashboard.

Responsible Conduct of Research spring workshops are open to all IU research community. Consists of two, 2-hour workshops offered per semester. Designed to satisfy the NIH requirements on responsible conduct of research.

The Office of Research Compliance, in collaboration with Vice Provost for Research Office, Office of Vice Provost for Graduate Education, and participating NIH Principal Investigators are pleased to continue offering the Responsible Conduct of Research (RCR) Series. If supported by National Institutes of Health (NIH) F, K, T, or Dissertation Awards, NIH requires that all eligible researchers complete an in-person (virtual given the pandemic) interactive program of RCR education of at least 8 hours.

Led by faculty researchers and representatives of Office of Research Compliance, including faculty members of compliance committees. Join us this spring for the following live virtual sessions:

February 17, 2022, 4pm-6pm: Collaborative Research, Data Management, & Research Mentoring

March 24, 2022, 4pm-6pm: Peer Review, Authorship, & Publication

Click here to register through Canvas. Contact us at rhopson@iu.edu with any questions.