22nd Edition - April 17, 2020

It has now been over a month since what we never imagined possible became not just possible, but all too real – going to work and going about the activities of our everyday lives threatened our health as well as that of our families and our communities. There is so much to be said about this whole experience, but I want to take advantage of the soap box to which I have access to specifically call out the fine, responsible, and ethical manner by which the IU research community responded to these unique circumstances. 

What could easily have developed into rampant chaos marked by indiscriminate shutdowns or immoral non-action, selfish competition for potentially limited resources, and protectionism of what's mine DID NOT.  Instead, our community of researchers came together to protect the integrity of IU's research writ large – the science, the human subjects, the research animals, the data, and our fellow researchers. Some research could safely and appropriate proceed while other research needed to be altered or even suspended – and when asked to make this assessment of their own research, IU researchers did so openly and willingly, albeit not without regrets and concerns. And for this, we, the staff of the Office of Research Compliance, tip our hats to commend, thank and show our appreciation and respect to the IU community of researchers.

All offices and operations of ORC have continued throughout this time without interruption – more details can be found below. Staff are all working remotely and committees and meetings are being conducted virtually. So, I will take this opportunity to brag about the leaders and staff of ORC. When faced with these unique challenges, the ORC leaders and staff recognized their vital mission was both unchanged and, at the same time, changed. They responded beautifully – with commitment, with integrity, and with respect. Unchanged was their primary mission of collaborating with IU researchers to ensure that IU conducts its research activities in a manner that is consistent with regulatory and organizational requirements and is of the highest integrity. What was changed very dramatically, however, was the context and to some extent the stakes in carrying out this mission – and how they can best support their mission and IU's researchers while their own lives were upended by the pandemic and the needs of their families. I am so proud to say that these are my colleagues.

Please stay safe and healthy. Thank you all for your efforts and please show appreciation to the "essential" workers in health care, transportation, food services, and other areas who continue to work to make things better for us. And, the same for the "non-essential" workers (hate that term) who are struggling during the pandemic.

This message is from John R. Baumann, Ph.D., Associate Vice President for Research Compliance

As announced on 23 March: To protect the health and safety of the university community and our state, and to comply fully with Gov. Holcomb's executive order, all in-person research activities on IU campuses will be limited to Essential Research Activities.

Essential Research Activities may be continued, provided that they can otherwise comply with university policies, including IACUC, IRB, and IBC protocols and lab safety policies; state law; and CDC guidelines.

IMPORTANT: To qualify for the Essential Research Activities exemption, the PI or his or her designee must complete a brief Essential Research Activities online form. This will allow us to maintain an ongoing record of essential research activities.

All areas of the Human Research Protections Program (HRPP) remain fully operational despite COVID-19 restrictions.  Staff are working remotely, and IRB meetings are occurring remotely.  While we have seen a large influx of COVID-related submissions, our staff have been working hard to ensure you still receive prompt responses to inquiries and your submissions, both COVID and non-COVID related, are reviewed as quickly as possible.  Additionally, our auditing staff are continuing their activities, reaching out to study teams to inquire about the feasibility of conducting remote audits and offering additional educational opportunities to the research community. 

If we can assist you in any way or if you have a special request, such as a submission that needs priority review, you can contact us, as always, at irb@iu.edu and we would be happy to help.

Radiation Safety, Institutional Biosafety Committees, Institutional Animal Care and Use Committees, Conflict of Interest, and Export Control (RIICE) continues to be fully operational and support our stakeholders.

RIICE staff are using technology to work remotely and, like everyone, finding a way to continue forward during this unusual period.  We are grateful for the flexibility and understanding shown by the researchers we support.  Like the rest of ORC, our committees are continuing to review and process protocols and we are prepared to conduct IACUC, IBC, Radiation Safety, and COI meetings remotely.

In order to avoid any delay at the resumption of normal activity, protocols will continue to be reviewed in the interim period, even for non-essential research.  The IBCs in Indianapolis and Bloomington have held emergency ad hoc meetings in order to rapidly review and approve work related directly related to Covid-19.

The Indiana Biobank has been designated as the central resource coordinating COVID-19 research specimen collection for the School of Medicine.  Researchers submitting sample collection protocols to the IRB may be requested to collaborate with the Indiana Biobank rather than approaching patients individually for specimen collection.  Through its current infrastructure, the Indiana Biobank is providing a resource supporting sample collection and banking to researchers who are leading the way in developing diagnostic tools and treatments for COVID-19.  This infrastructure includes a kit production core that provides sample collection kits for a wide range of sample types. It also includes receiving, processing, storing and distributing samples, providing centralization of these services. Database and IT support are also provided.  The Indiana Biobank’s collection protocol allows for the collection of a variety of de-identified samples, linked to the electronic medical record, which can be distributed for broad research use to approved researchers.  We are happy to provide letters of support and other documentation for grant applications as well.  

For additional information about the Indiana Biobank, please contact Indiana Biobank Manager, Brooke Patz, at bpatz@iu.edu.  For questions or concerns regarding how this may impact IRB review of your protocol, please contact HRPP Director, Beth Johnson, at bwinnie@iu.edu. 

In recently released guidance, NIH confirmed the importance of providing accurate and up-to-date information to the public through ClinicalTrials.gov, particularly related to Overall Recruitment Status and Individual Site Status.  While such updates are important, they should only be undertaken when clinical duties and other essential research duties allow.  The NIH guidance acknowledges that delayed updates and corrections may be unavoidable during this time, and encourages investigators to retain documentation to justify delays.

“Individual Site Status” is defined as “the recruitment status of each participating facility in a clinical study” and is located within each participating site’s facility information in the CT.gov study record.  The “Overall Recruitment Status” field is defined as the recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting."  

As staff availability permits during the COVID-19 pandemic, consideration should be made both to individual site status and to the study’s overall recruitment status.  For multi-center research, it should be noted that participating sites may be handling COVID-19 restrictions differently.  If IU is serving as the lead site, confirmation of participating site status may be necessary in order to update the CT.gov record accurately.

Individual Site Status and Overall Recruitment Status may be set to any of the following pre-defined conditions:

• Not yet recruiting: Participants are not yet being recruited

May be the most appropriate option to remain for newly approved studies that plan to delay enrollment of the first subject until after COVID-19 restrictions are lifted.

• Recruiting: Participants are currently being recruited, whether or not any participants have yet been enrolled
• Enrolling by invitation: Participants are being (or will be) selected from a predetermined population
• Active, not recruiting: Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled

May be the most appropriate option for studies that have voluntarily and temporarily elected to discontinue new enrollment during COVID-19 restrictions, but are continuing to conduct study visits – even remotely – with previously enrolled subjects. Status may be revised to “Recruiting” upon removal of COVID-19 restrictions and resuming of new subject enrollment.

• Completed: The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred)
• Suspended*: Study halted prematurely but potentially will resume

May be the most appropriate option for studies that have discontinued all study interventions at this time, but which plan to resume study procedures (and data collection) following the removal of COVID-19 restrictions.

• Terminated*: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

May be the most appropriate option for studies that have discontinued participation of all previously enrolled subjects with no intention to resume data collection post COVID-19. Please note that a status of “terminated” will initiate the timeline for anticipated results reporting.  Trials required to report results must do so within one year after the study’s termination date for all data collected prior to study termination.

• Withdrawn*: Study halted prematurely, prior to enrollment of first participant

*Of note, selection of a status of “Suspended,” “Terminated,” or “Withdrawn” prior to the planned completion date will require a brief explanation of why the study was stopped.

If any additional information about the study’s status is provided in the “Detailed Description” field, the NIH has requested that the date of the added information be included.  Please note that upon the removal of COVID-19 restrictions, recruitment statuses should again be updated to reflect both site(s) and overall trial conditions.

The NIH guidance “Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19)” can be found on the Support Materials page, within the Data Elements Definitions, Templates, and Checklists section.

In the last edition of the newsletter, we shared the exciting news that the Human Research Protections Program (HRPP) is working on implementation of Kuali Protocols, an electronic IRB submission system to replace KC IRB.  Although COVID-19 has impacted us in many ways, the HRPP is still on schedule for implementation of Kuali Protocols at the end of 2020 or beginning of 2021.  The HRPP will continue to provide updates and are in the process of developing a new web hub where information about the implementation will be compiled.

All active studies in KC IRB will be transitioned into Kuali Protocols.  In order to transition studies, all KC Questionnaires must be updated to the most current versions. HRPP staff have already started updating KC Questionnaires with Amendment and Renewal submissions.  Efforts will continue in the coming months to update KC Questionnaires for all active studies.  HRPP staff will update KC Questionnaires on their own when possible; however, in some cases we may need to reach out to you for additional information.

Closed studies will not be transitioned into the new system.  If you have completed your research and are able to close your study, we ask that you do so as soon as possible.  For information about when and how a study can be closed, please visit our website.

For questions or assistance, please contact the HRPP office at irb@iu.edu.

Responsible Conduct of Research (RCR) education has transitioned to remote opportunities. RCR education is an important aspect of IU’s curriculum, and is required for investigators conducting research supported by NIH, NSF, and PHS. During IU’s stay-at-home guidance, RCR training will continue to be available in the following formats:

• The IU Bloomington RCR seminar series will continue with one-hour Zoom sessions in May and June. Stay tuned for details.
• RCR courses at the IU School of Medicine are offered by the Bioethics and Subject Advocacy Program. All courses will continue to meet virtually through the remainder of the semester.
• Online RCR modules are available via CITI.

Information about responsible conduct of research training can be located on the research integrity office website.

If you were unable to attend the Joint Public Lecture with AAMC Heather Pierce on March 3^rd, you can now watch it from home.

As part of the ORC Joint Public Lecture Series, ORC with Indiana CTSI collaborated to host Heather Pierce, Senior Director for Science Policy and Regulatory Counsel for the Association of American Medical Colleges (AAMC). At AAMC, Heather Pierce is the subject matter expert for issues related to regulation of science and research, as well as interactions between industry, academia, and government. 

The Office of Research Compliance in collaboration with academic units throughout IU, hosts a Joint Lecture Series on key topics in research compliance. Contact rhopson@iu.edu with collaboration interests or questions.

Have you heard from a colleague who did not receive recent announcements  from the Office of Research Compliance?  Perhaps you want to share this newsletter with a new coworker or research team member.  We do our best to ensure that researchers with active compliance approvals are continually on our distribution list; additionally anyone may complete our online subscription form  to receive the quarterly newsletter, announcements, changes to policies and procedures, and important compliance updates for research at IU. 

We also welcome feedback and suggestions  at researchcompliance@iu.edu regarding our communication content and timing.