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Indiana University
Research Compliance Quarterly 5th Edition
January 8th, 2016
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
 
 
Accreditation Site Visit - February 23-25, 2016

The Association for Accreditation of Human Research Protection Programs (AAHRPP) will be conducting a site visit from February 23 – 25.

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. Indiana University has been accredited by AAHRPP since 2005. Accreditation is renewed every 5 years, and IU is currently due for reaccreditation. The IU Human Subjects Office (HSO) has completed the first step in obtaining reaccreditation, which involved a self-assessment of the HRPP and a comprehensive application to AAHRPP. The second step involves an on-site visit with a team of experts from AAHRPP, who will conduct interviews and review materials.

HSO has contacted the individuals with whom AAHRPP has requested to interview - Researchers, IRB members and Staff, Grants and Contracts Staff, and other Compliance Committee Staff. If you have been contacted for an interview, please provide HSO with your availability as soon as possible so the site visit agenda may be finalized. The HSO is available to answer any questions in regards to preparations for the site visit. Please contact Shawn Axe, saxe@iu.edu, with your questions.

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. Thank you for supporting this important endeavor!

 
 
Helpful Hints for Your Next IRB Submission

Everybody hopes for a smooth IRB review and approval process. Here are a few tips to help you navigate KC IRB and other administrative aspects to your IRB submission:

    ➺ AMENDMENTS

  • Help the IRB understand exactly what you are amending by providing a detailed response to question 169 in the amendment questionnaire "List and describe the proposed changes with this amendment."
  • While you may refer to a supplemental document that outlines the changes, please refrain from brief responses such as ‘See protocol’ or ‘Various updates.’ Additionally, in lieu of repeating the response in question 169, please offer a meaningful answer to question 177 "State the rationale or justification for the proposed changes."
  • Providing specific information in each of these responses will assist the IRB reviewer in understanding the nature of and reason for the changes and will assist in eliminating confusion or the potential to miss important details.

  • Before creating the amendment and making changes to approved documents, make sure you are applying the changes to the correct, IRB-approved versions of the documents to be amended. First, download the documents to be amended from the Notes & Attachments tab of the approved KC IRB study. Then, make revisions to those downloaded documents.

  • Replace existing documents on the Notes & Attachments tab,
    don’t add versions of the same document.

    ➺ PERMISSIONS

  • The ‘Permissions’ tab in KC IRB is unlocked and may be manipulated at any time – without an amendment or other IRB submission – so that study staff may manage access to the KC IRB entry. The Permissions tab dictates who may view and edit protocol information, and who receives notifications.
  • For more information, review the Permissions Training Guide.

    ➺ RESPONDING TO HSO STAFF REVIEW

  • Prior to IRB review, the HSO staff perform a ‘pre-review’ of your submission. This pre-review may result in requests for adjustments or supplements to your submission. If changes are required, you will receive an automated notification from KC IRB with ‘Pre-Review’ in the subject line.
  • To retrieve the staff comments, search for the study submission in KC IRB and choose to edit. Then, click on the Protocol Actions tab, Summary & History → Submission Details → Review Attachments. Please note that you must download the attachment in order to view the comments.
  • To submit your response to the comments, first edit the KC entry and/or attachments as requested. If editing attachments, be sure to REPLACE documents versus adding versions of the same attachment, and also update the version date on the document and in the Description field in KC. Once all requests have been satisfied, on the Protocol Actions tab, Request an Action → Submit for Review.

    ➺ CITI

  • Did you know? You can request administrator-level access to the CITI program so that you may check CITI completion of researchers directly within the CITI program.
  • To request this access, please email irb@iu.edu and put ‘CITI administrator access request’ in the subject line.
  • DO NOT create a new study in KC IRB just to check on CITI completion of investigators.
 
 
RIO Awarded ORI/DHHS Grant - Hosting Conference

The IU Research Integrity Office (RIO) is hosting a free conference titled, “Sequestration Analysis: Collaborative Institutional Approaches & White Collar Concerns” on March 30, 31, and April 1 of 2016 on the Indianapolis campus.

The conference is the result of an Office of Research Integrity (ORI), Department of Health & Human Services (DHHS) grant. The goal of the conference is to enhance the research integrity community’s understanding of the importance and effects of the role of sequestration in research misconduct allegations while providing practical tools and resources to successfully implement what is learned from this conference.

The conference will include a multi-disciplinary approach to involve not only national subject matter experts, but also to analyze the entire sequestration process from every angle. This collaboration will include research integrity officers and staff, general counsel and legal representatives, IT forensic specialists, and compliance personnel.

The outcome will include a best practice guidance document to be disseminated to the research integrity community, along with video vignettes to further illustrate the importance and ramifications of effective versus ineffective sequestrations.

Click here for registration and specific information about this free conference.

 
 
ClinicalTrials.gov Questionnaire, KC IRB Update

The ClinicalTrials.gov questionnaire in KC IRB (questionnaire M) was updated on January 5, 2016 to include clarified clinical trial definitions. Previously completed ClinicalTrials.gov questionnaires in KC IRB do not require a modification based solely on this update.

To review the recent update and current content of the ClinicalTrials.gov questionnaire, please review the KC IRB Crosswalk.

 
 
ClinicalTrials.gov Training

The Office of Research Compliance, along with the Clinical and Translational Sciences Institute (CTSI), is offering training on the ClinicalTrials.gov, Protocol Registration and Results system.

Please reserve your spot by visiting the University-wide Research Education Sessions & Registration class schedule. To view training opportunities, select "Quality Improvement Office" in the "List classes for Area" drop-down.


Course Name: ClinicalTrials.gov Registration Module Training
Focus: System navigation, initial record registration
Date: 1/15/2016
Time: 12-1:30 PM
Location: Indianapolis, Lockefield (LV) 3301

Course Name: ClinicalTrials.gov Record Maintenance Training
Focus: Record updates, regulatory and institutional requirements for record maintenance
Date: 1/28/2016
Time: 1-2:00 PM
Location: Indianapolis, Lockefield (LV) 3301

Date: 2/23/2016
Time: 3-4:00 PM
Location: Indianapolis, Lockefield (LV) 3301

Course Name: ClinicalTrials.gov Results Module Training
Focus: Preparing for results reporting, results reporting entry
Date: 3/14/2016
Time: 9-11:00 AM
Location: Indianapolis, Lockefield (LV) 3301

Date: 4/14/2016
Time: 2-4:00 PM
Location: Indianapolis, Lockefield (LV) 3301

 
   
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