31st Edition - June 30, 2022

In recent years, Research Integrity Office staff have observed an increasing number of comments via the online forum, PubPeer. PubPeer is an online journal club for researchers and scientists designed to, according to the website, “improve the quality of scientific research by enabling innovative approaches for community interaction.” PubPeer provides an online discussion forum about scientific research where individuals can comment, positively or negatively, on scientific publications, highlighting fundamental problems with data and prompting discussions about research and its conclusions. Comments are posted anonymously and authors are immediately alerted of new comments via email from PubPeer. Authors can then respond to the comments, clarifying interpretations and uploading data and images.

What to do if you receive a notification from PubPeer?

If you receive a notification from PubPeer that one of your articles has received comments, PubPeer provides an author registration that allows you to respond to any concerns as the author (instead of posting an anonymous reply). PubPeer encourages authors to respond and to share original data and images to help clarify your response.

Sharing your perspective and engaging in constructive dialogue with other researchers about your work is valuable to the scientific community, but please consider the following before you comment:

• Discuss your response with the other authors of the publication before posting. A thoughtful, coordinated response is more likely to satisfy any concerns raised.
• Comments and responses are permanent. PubPeer’s Frequently Asked Questions indicate that “in most cases we will not consider removing comments, even if the authors apparently provide a convincing reply or explanation.”
• Keep responses factual and polite, and focused on the questions raised.
• Ask a colleague or co-author to proofread your response before posting.

RIO review of PubPeer comments

PubPeer comments are increasingly focused on concerns related to image duplication and manipulation, which in some cases can signify potential falsification or fabrication. Allegations of potential falsification and fabrication are facilitated by the IU Research Integrity Office (RIO) under the IU Policy on Research Misconduct . The RIO receives notification of all PubPeer comments related to publications including IU authors in order to ensure potential allegations are addressed appropriately. When notifications are received, RIO staff evaluates each one carefully in conjunction with a member of the Research Integrity Standing Committee to determine whether the comments raise credible concerns of potential research misconduct. If so, research misconduct proceedings may be initiated. If not, RIO staff may forward the notification to the authors to address at their discretion.

RIO staff are available to provide guidance when possible. Please feel free to contact the Research Integrity Officer at sbizila@iu.edu or rio@iu.edu if you’d like to discuss concerns a PubPeer comment or response.

The HRPP has made updates to guidance and policy effective July 1, 2022. A summary of updated information is provided below.

• A new Transnational Research Guidance has been published to the HRPP website
• Updates have been made to the HRPP Policy on Reportable Events. Changes include:
  • Clarification regarding when data security incidents require prompt reporting to the IRB. The following incidents require prompt reporting – Disclosure or release of identifiable subject data outside the research team, which:
    • May place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, educational advancement, or reputation, and/or
    • Is determined by the appropriate covered entity’s HIPAA Privacy Officer, after review, to be a breach as such term is defined in the HIPAA Privacy Rule
  • A number of minor clarifications regarding when consent, assent, and authorization errors require prompt reporting. We recommend you review the Policy before reporting any such events to ensure prompt reporting is required under the revised policy.
• The Kuali Protocols application form has been updated, specifically in the Transnational Research and Reportable Events forms, to reflect the above changes. A number of additional minor wording revisions have also been made to the form. These changes will not impact items previously submitted to the IRB for review, only those that are submitted on or after July 1, 2022.

Please contact the HRPP with any questions regarding these changes at irb@iu.edu.

The IBC is saying goodbye to Word document protocol submissions and is moving to an online protocol submission system called Kuali Protocols in August 2022. Kuali Protocols is designed to be user-friendly and will ease the IBC submission process, paving the way for quicker review, turnaround, and approval. Kuali Protocols is already used for IRB submissions and will also be used for IACUC submissions starting in 2023.

To prepare for the transition, the IBC has designated submission cut-off dates, after which submissions to the IBC will be suspended until Kuali Protocols is live.

• New Protocols & Major Amendments: Submission cut-off date was June 17, 2022*
• Minor Amendments: Submissions must be received by July 18, 2022*

*The IBC will consider urgent submissions on a case-by-case basis.

Please contact the IBC with any comments or questions about the transition to Kuali Protocols at IBC@iu.edu or visit the website created to communicate the progress of this transition.