27th Edition - July 22, 2021

As we begin the 2021-2022 academic year, we are looking at something sort of but not exactly like that we experienced in August of 2019 or 2020.  Time will tell if it is some compromise between these two beginnings or something completely different.  But, and let me emphasize this, what has not changed is ORC’s commitment to continuing our goal of being a supportive, committed, and sound collaborator with the IU research community.  While how we go about this collaboration may be different than in the past years, our commitment to working together to achieve the highest ethical standards and best practices remains constant. 

While we never considered it to become the norm, prior to March 2020 many of the ORC staff already worked some to mostly remotely and a few of the compliance committees met virtually. As everyone is well aware, after March all staff worked entirely remotely and all committee meetings went virtual.  As we approach the new academic year, ORC office structure and operations can best be characterized as fully hybrid

• Staff
  • Some will work entirely remotely except when required to be in the office
  • Some will regularly split their work week between remote and on site
  • Some will regularly be working in the office
• Committee Meetings
  • Some will remain virtual
  • Some will return to in-person – everyone sharing the same space (seems like such an exotic practice now)

But regardless of how we carry out this mission, our commitment to you – researchers, research subjects, auxiliary staff – remains the same: to join you in the conduct of research that meets the highest professional standards of integrity and scientific soundness.  We are looking forward to beginning this new academic year together.

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

In the coming months the Kuali COIC disclosure form will be updated to include new section and questions related to research security and inappropriate foreign influence.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has granted Indiana University full reaccreditation status. 

AAHRPP is an independent, non-profit accrediting body which uses a voluntary, peer-driven, educational model to ensure HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence - through policies, procedures, and practices - of their commitment to scientifically and ethically sound research and to continuous improvement.

The IU HRPP has been continuously accredited since 2005.  On March 30th and 31st, AAHRPP conducted its fifth reaccreditation site visit, but for the first time, the site visit was conducted virtually.  During the visit, site visitors interviewed numerous researchers, IRB members and staff, other research compliance staff, and grants and contracts staff.  Both in advance of and during the site visit, they also reviewed numerous research studies and thoroughly reviewed IU HRPP policies and procedures. 

AAHRPP accreditation is an important step in strengthening protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research at IU. The HRPP offers their sincere thanks to those who participated in the site visit for supporting this important endeavor!

The IU HRPP Policies were updated, effective July 1, 2021, to make a number of changes.  In addition to minor, administrative changes, certain substantive changes were made to the Reportable Events Policy that all researchers should be aware of.  These changes result in new categories of reportable events that will require prompt reporting to the IRB. 

• Definition of major protocol deviation updated. Protocol deviations are considered major, and require reporting to the IRB within five (5) business days of discovery, if the event:
  • Placed subjects at great risk of harm,
  • Caused actual harm to subjects or others, OR
  • For greater than minimal risk research, compromised the integrity of the study data such that the subject’s data can no longer be used in analysis of study outcomes
• Additional categories of consent-related promptly reportable events added. The following require reporting to the IRB within five (5) business days of discovery:
  • In research enrolling children who have turned 18 during study participation: failure to obtain consent from the now-adult subject prior to direct interaction with the subject
  • In research enrolling individuals who lack consent capacity and regain capacity during study participation: failure to obtain consent from the subject prior to direct interaction after capacity is regained
  • Failure to use a witness or obtain witness signature (when required by IU HRPP Policy on Informed Consent)
  • For research subject to the IU Office of Clinical Research policies on research billing compliance: failure to record subject consent in OnCore within the required policy timeframe

As always, consult the IU HRPP Policies on the ORC website for the current policy requirements.  Additionally, HRPP Guidance documents were updated with minor revisions and a new Guidance document has been published regarding Certificates of Confidentiality. 

In addition to the Policy and Guidance changes, new Informed Consent templates have been published on the HRPP forms webpage.  Language changes have been made in a number of sections of the template.  Please be sure to download the latest copies to use with your next new study submission.

For any questions regarding changes, please contact the HRPP at irb@iu.edu.

Historically, the Office of Research Compliance monitored research billing compliance for human subjects research conducted in clinical settings.  Compliance activities have been paused in recent years while the Office of Clinical Research (OCR) developed centralized policies and procedures around coverage analysis and research billing.  Because centralized policies and procedures are now in place, the Office of Research Compliance will resume research billing compliance activities.

Rather than conducting dedicated billing audits, however, the billing review will instead be incorporated into the existing not-for-cause and for-cause audits conducted by the Quality Improvement Office (QIO).  During these audits, QIO auditors will review billing-related actions for which the study team is responsible. 

The audit process will include confirmation of the following key elements:

• The study was registered in OnCore and submitted for coverage analysis as required;
• Applicable protocol amendment documents were provided to the Office of Clinical Research (OCR) for the purposes of study calendar and billing grid updates;
• Unit and OCR sign off were completed prior to enrollment of the first subject;
• Subjects were registered in OnCore as consented within one day of consent being obtained;
• Subject visit dates were accurately recorded on the OnCore protocol calendar within one day of visit occurrence; and
• Other subject statuses, specifically withdrawn, not eligible, and off study, were entered in OnCore within one day of occurrence.

Only studies that are subject to the OCR/IU Health research billing policies, and for which initial IRB approval was granted December 1, 2020 or later, will be reviewed for compliance.