25th Edition - February 11, 2021

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 this spring.

February 18, 2021, 4-6 pm

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

March 18, 2021, 4 - 6 pm

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 offer 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 contact Research Integrity Office staff at rio@iu.edu.

The Association of the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, Intl.) conducts 3-year site visits of the IU School of Medicine animal care program.  The School of Medicine Animal Care and Use program’s next site visit will be in the summer of 2021.  

In preparation for this site visit, all laboratories using vertebrate animals must be prepared to participate by having knowledgeable representatives available to answer questions about their lab’s animal-related research. This representative will be need to be available to show the site visitors the lab areas involved with animal housing, procedures, surgery, and euthanasia.  Medical records (e.g., surgical monitoring and documentation of analgesic dosing) should also be available for review.  Of course, due to the increased use of remote communications, there may be adjustments to this process when compared to prior years.

Additional information for lab preparation and scheduling details will be sent when the plans AAALAC site visit dates are finalized.  For additional question, please contact the IACUC office at somiacuc@iu.edu.

On January 19, 2021, the new IRB system, Kuali Protocols was implemented. The transition has gone smoothly with nearly 400 submissions approved in the first two weeks of use of the new system. While a few software bugs have been discovered, those are being addressed by Kuali as quickly as possible and have not impacted the IRB or HRPP's ability to review and approve submissions. Thank you for your patience, understanding, and flexibility during the development and implementation process!

The latest information on Kuali Protocols, including links to training guides and videos, can be found on the Kuali Protocols webhub. The webhub was recently updated. Please visit to review the latest information on differences between KC IRB and Kuali Protocols and for answers to frequently asked questions. Additionally, you can reach out to HRPP staff at irb@iu.edu with any questions regarding use of the new system.

The Manage Protocols screen in Kuali Protocols allows you to search for IRB Protocols in the Kuali Protocols system.  The page has a set of default columns that display when you conduct a search.  However, the page can be customized to display the information that is most useful for you.

The HRPP strongly recommends that you replace “Continuing Review Date” in the default view with “Expiration Date”.  In Kuali Protocols, Continuing Review Date is used for studies that do not expire and do not require annual renewal.  The Continuing Review Date is used to trigger an annual notification reminding you of the IU HRPP Policies applicable to your study.  Studies with a Continuing Review Date do not require submission of a Renewal.  In contrast, Expiration Date is used for studies that require Renewal.  A Renewal must be submitted and IRB approved prior to the Expiration Date or all research activities must stop.

To customize the columns that display on the Manage Protocols screen, click on Manage Columns near the upper right side of the page.  Uncheck Continuing Review Date and check Expiration Date.  Other changes to customize your view can also be made.  However, do not remove Title as this field has the embedded link which allows you to open the IRB Protocol record in Kuali Protocols.  Click save in the lower right corner of screen and your view should automatically update.

The HRPP, in collaboration, with the IU HIPAA Privacy Office, is pleased to offer a new combined consent/authorization template that can be used for human subjects research subject to HIPAA.  The new Biomedical Informed Consent template, incorporating Authorization language, is available on the IRB Forms & Templates page. 

Study teams who prefer to combine the research consent and Authorization into a single document can utilize this new template.  Sponsor templates incorporating Authorization language will also be accepted provided the document includes all of the federal and Indiana state law required elements of Authorization.  Indiana state law requirements include the subject’s address and an expiration date or event.  Date of birth is not required.  The standalone Authorization is still available and can be used by study teams who prefer to keep these documents separate.  Additionally, a separate Authorization will continue to be required for VA research.

The IU HRPP Policies were updated, effective January 19, 2021, to incorporate changes related to the implementation of Kuali Protocols.  With these updates, additional changes were made that may impact your processes.  Major changes are highlighted below.  We encourage you to review the updated policies on the Office of Research Compliance website.

New Requirement for Translation of Consent Documents after use of Short Form

Short form consents in various languages are available on the IU HRPP website.  These documents can be used to document informed consent when a subject who does not speak or read English is unexpectedly encountered.  When consent is documented via a short form consent, it is generally expected that, thereafter, the full consent form will be translated to the subject’s language and the subject will be re-consented using the full consent form in their language.  Translation and re-consent will not be required for research that is minimal risk or where research interventions are short term and will be completed before the full consent could be translated.  At annual Renewal, any use of a short form must be reported.  If the full consent was not translated and the subject was not re-consented, justification will need to be provided.  Please review the IU HRPP Policy on Informed Consent for additional information.

Additionally, when a witness is required to document the consent process for a subject who cannot read English, that witness must be an adult.  A minor child of the subject is not permitted to serve as a witness.

Elimination of Requirement to Report Certain Minor Noncompliance Promptly

Minor noncompliance is noncompliance that does not require prompt reporting to the IRB.  Examples include minor errors in the consent documentation process and use of outdated study documents that did not substantively differ from the IRB-approved versions.  Previously, the occurrence of ten (10) or more instances of minor noncompliance triggered prompt reporting, regardless of how minor the noncompliance.  This has been removed from IU HRPP Policy.  Going forward, minor noncompliance is reportable at next Renewal or study closure, whichever comes first, regardless of the number of instances.  Major noncompliance continues to require prompt reporting to the IRB.  For details regarding whether an issue is minor or major noncompliance, see the IU HRPP Policy on Reportable Events.

Responsibility for Ensuring Completion of CITI Training

For Other Research Staff, CITI training is only required if the individual is interacting with subjects. Because Kuali Protocols does not collect information about whether research personnel are interacting with subjects, the HRPP will no longer verify CITI training completion for Other Research Staff. The PI, or their designee, is required to ensure CITI training is complete and up to date for all Other Research Staff interacting with subjects. Documentation of CITI completion for these personnel should be maintained in your research records.  Additional information on training requirements can be found in the IU HRPP Policy on Research Personnel Responsibilities.