23rd Edition - July 15, 2020

The HRPP is continuing work on the Kuali Protocols implementation project.  Kuali Protocols will replace KC IRB as the electronic submission system for all IRB submissions.  Important updates since our last newsletter include:

• Implementation is tentatively planned for January 2021. A specific date for the system cutover will be announced in the last quarter of 2020 after confirmation that all required system functionality has been developed and delivered by Kuali.
• For approximately one week prior to the cutover to Kuali Protocols, we will not accept any IRB submissions. This submission freeze is necessary to allow HRPP staff to complete review of pending submissions prior to the system cutover and to allow migration of all active studies from KC IRB to Kuali Protocols.  We will provide additional details regarding the submission freeze in late 2020.
• We’ve launched the Kuali Protocols Web Hub as a central source for details, updates, FAQs, and training opportunities. We’ll be adding content to the Web Hub regularly over the next six months.  Please consider bookmarking the page and checking it regularly to be sure you stay up to date on the latest developments.

In case you missed it in our prior newsletters, here’s what you need to know and do:

• Active studies will be transitioned from KC IRB to Kuali Protocols.
• Some studies may require updates before they can be migrated. HRPP staff are currently making these updates as administrative amendments. In most cases, we can complete the action without requiring any action from you in KC IRB.  You will be notified via email if your study is updated by HRPP staff during this process (in addition to receiving the usual KC IRB notifications).  If we need any information from you to complete the update, we’ll let you know.
• Please review your list of open studies in KC IRB, and close any studies you have completed. This will assist us in the data migration process.

As always, email HRPP staff at irb@iu.edu if you have questions or concerns.

The University has announced the retirement of IU Box and migration of data currently housed in Box to Microsoft at IU or Google at IU. More information on the retirement of IU Box can be found on the Knowledge Base. 

If you have noted in your IRB submission that data will be stored in a Box Entrusted or Box Health account, there is no need to submit an Amendment notifying the IRB that your data will now be transitioned to Microsoft at IU Secure Storage or Google at IU Secure Storage. We will maintain documentation of the University’s transition from Box to Microsoft and Google Storage Services. Individual documentation of this transition in your IRB study record is not required. Please direct any IRB-related questions regarding data storage to irb@iu.edu.

The revised Common Rule, effective in January 2019, added a requirement that consent forms include a statement regarding whether clinically relevant research results will be returned to participants.  For the last year, HRPP staff, IRB members, researchers, and clinicians have participated in a working group designed to identify and recommend ethical principles, policy, and guidance for the IU research community around this new requirement.  The goals of the working group were to ensure the IU research community is meeting research subject expectations for return of research results, offer clarify and consistency, and provide a framework for IRB review of return of research results.  The working group drafted a comprehensive guidance document addressing these topics which is now available on our website.

Beginning this month, new study submissions for research which is anticipated to generate clinically-relevant research results must include a statement regarding whether the results will be returned in the Informed Consent Statement.  The IU Informed Consent Statement templates have been updated with instructions and sample language that can be used for this purpose.

The HRPP is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  Every five years, the HRPP applies for re-accreditation, which involves a thorough review of all policies and procedures and offers an opportunity for HRPP staff to assess whether any program improvements or updates should be made.  The HRPP completed their Step 1 application for re-accreditation in June.  A number of updates to HRPP Policies, guidance documents, and templates were made during this process.  While most of the changes were administrative in nature and do not impact the day-to-day conduct of human subjects research, nearly all Policies were updated with a new effective date of July 1, 2020.  Policies are always available on our website, however, if you have copies of any Policies downloaded or saved locally, please be sure to update your files with the current versions.

All changes are effective July 1, 2020.  Changes you may want to be aware of include:

• CITI Training extended:
  • Biomedical Researcher and Social/Behavioral Researcher courses will now be required every five years (rather than every three)
• Informed Consent Template revisions:
  • Statement regarding whether research results will be returned to subject is now required for new studies which may generate clinically relevant research results
  • Conflict of interest language revised to provide more detail to subjects
• New process for reporting of certain IRB determinations to the PI’s department chair or division chief, as appropriate
  • Determinations include serious or continuing noncompliance, unanticipated problem involving risks to subjects or others, suspensions, and terminations
  • Previously these were only reported to leadership if the study was federally funded or FDA-regulated. Effective July 1, these determinations will be reported regardless of the study’s funding source/applicable regulations.
• Guidance regarding Children in Research updated:
  • Considerations added to guide the IRB in determining when contraceptives may be required for minor females enrolled in clinical research

Since March, the Institutional Biosafety Committee (IBC) has received an influx of COVID-19 related research proposals and the IBC Office has been working closely with PIs and reviewers to ensure quick turnaround times while maintaining compliance. The IBC reviews all work with recombinant DNA or synthetic nucleic acid molecules, as well as any work with Biosafety Level 2 or greater non-recombinant biological materials, including infectious agents and biohazards, such as human tissues and fluids. The IBC Office has facilitated the creation of a Biosafety Level 3 facility at the IU School of Medicine in Indianapolis to enable research with SARS-CoV-2 (the virus that causes COVID-19) and has formed a new subcommittee that reviews these proposals and oversees the training of personnel. This space should be up and running by the end of July.

For more information about the Biosafety Level 3 facility and COVID-19 research overseen by the IBC, please visit the ORC Research Restart FAQs. You may also contact staff at IBC@iu.edu. The all-hands-on-deck approach and tireless efforts of our committee members, biosafety officers, and office administrators to ensure that this research can begin safely and swiftly has brought a lot of gratitude from the research community and we are very happy to be able to support this essential work.

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. During the COVID-19 pandemic, requirements for in-person instruction of RCR training have been suspended, and training may be completed online.

IU offers several 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.
• IU Bloomington RCR seminar series will continue via Zoom in Fall 2020. Specifics will be provided online and via email shortly.
• RCR courses at the IU School of Medicine, offered by the Center for Bioethics, will continue in Fall 2020 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.