20th Edition - October 9, 2019

Have you taken your required CITI modules but still show as not complete in KC IRB?

This might be the reason why:

KC IRB uses your IU email address to find your CITI training. This means, if you have used another email address in your CITI profile, then KC IRB cannot find your training.

To allow KC IRB to recognize your CITI completion, you will need to change your email address in CITI.

1. Log in to your CITI account:
2. Once you’re logged in, in the upper right hand corner find your name and select the down arrow and select "Profiles"
3. Under "Member Profile" select "Edit Profile." You will be taken to a page where you can find a box where you can enter your "Preferred Email." This is where you should replace your current email with your IU email address.  Scroll to the bottom of the page and select "Update."

If you have additional questions about your Human Subjects Research CITI training, please feel free to contact kcirb@iu.edu.

For additional information, see Accessing CITI training at IU.

If you are helping someone submit an IRB protocol and need to verify whether or not the PI, Co-PI, and key personnel have completed their COI-C disclosure forms, here is a new tool to help you do that!

The MyRA Lookup Tool has been replaced with a new COI-C Disclosure Lookup Tool.  Alternatively, you can search One.IU by entering COI in the search box, and select the Lookup-Conflict of Interest and Commitment (COI-C) icon.  Please note: the lookup tool reflects only those disclosers with an IU username and email address.

With an option of searching by name or username, the new lookup tool returns the date of last disclosure submitted, as well as the roles the user disclosed in completing the COI-C disclosure form.  The disclosure expires one year after date of submission shown (the date will show in red if expired).

Tips & Tricks:  Only disclosures showing the ‘Researcher’ role are reflected in KC IRB and KC Grants.  If you or one of your researchers is not showing up in KC IRB or KC Grants as having completed their disclosure, but you do not see ‘Researcher’ listed under ‘Roles’ in the lookup tool, instruction should be given to update the form and select the ‘Researcher’ role to complete the disclosure as a researcher.

Research Integrity Office staff recently attended a presentation given by Brandon Snell, founder of PubPeer (https://pubpeer.com/) at the Association of Research Integrity Officers 2019 National Conference (Atlanta, GA, September 16-18, 2019). PubPeer is an online journal club for researchers and scientists that, according to Snell, seeks to 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 and their conclusions. Snell believes that PubPeer provides a platform to highlight fundamental problems with data, prompting discussions that highlight underlying themes that might not otherwise be discovered. Comments are posted anonymously and should be factual descriptions of problems or concerns raised by the publication and must contain publically verifiable information.

When an article is uploaded to PubPeer and comments added, authors are immediately alerted via email from PubPeer. Authors can then respond to the comments, clarifying interpretations and uploading data and images. 

According to Snell, PubPeer has collected 80,000 comments on 14,000 articles in 2,300 journals since its creation in 2012. 

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.

PubPeer is intended to spark dialogue between researchers. Comments on PubPeer are not considered allegations of research misconduct, and the IU Research Integrity Office is not currently monitoring PubPeer for comments and concerns regarding IU researchers. We 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 about a PubPeer comment or response.

It is becoming more and more common for multi-site studies to use a single IRB.  The IU HRPP is very supportive of reliance on external IRBs!  However, even when IU-affiliated investigators are relying on another IRB, there are still some types of information that must be submitted locally via KC IRB.  The following submissions are required locally for studies using an outside IRB:

• Initial Reliance Request
  • IU approval of Reliance Request and reviewing IRB approval of your local site must both be obtained before you can initiate your study
• Amendments:
  • Personnel updates, including change in PI or any other key or non-key personnel
  • Any changes to the HIPAA Authorization form
  • Any changes to related financial conflicts of interest for any IU-affiliated personnel
• Study closure

Note that reliance generally is not an option for exempt research.  Each institution collaborating on exempt research will need their own local IRB submission.

If you have any questions about whether an item requires review locally, contact the Reliance Team at irb@iu.edu.

The HRPP welcomes Kanti Crain (back) to IU!  Kanti previously worked in the IRB office as a logistics coordinator and screener before leaving IU to gain additional experience at another institution.  We are thrilled to announce that Kanti has rejoined our team as the Assistant Director for the Biomedical Expedited/Exempt team. 

Please feel free to reach out to Kanti at kwcrain@iu.edu with any IRB-related questions about your minimal risk biomedical research.

Export Control is pleased to announce that Julie DeVoe will be joining the Office of Research Compliance as the Export Control Specialist.  Julie taught in many different countries abroad before completing her J.D. at the IU McKinney School of Law.  Most recently she worked as a fellow in the IU Office of General Counsel handling a wide variety of legal matters, but specializing in international issues.  For support on export control issues or if you have any questions, email Julie at export@iu.edu.