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Indiana University
Research Compliance Quarterly 3rd Edition
July 9th, 2015
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
Human Subjects Office update to policies, procedures, and processes - Effective July 9

Beginning today, the HSO will implement a series of changes to policies, procedures, and processes. These changes will decrease burden on the HSO and the research community, and ensure HRPP processes are aligned with accreditation standards.

  • New electronic stamp. Approval stamps on informed consent documents will be automatically applied by KC IRB and will take on a watermark format. The electronic approval stamp will no longer contain approval or expiration dates, and will not be applied to assent documents. More information about the new stamp is available on the HSO website.
  • Expanded exempt review. Research which would previously have been reviewed under expedited categories 6 and 7 and is NOT subject to federal oversight (i.e. not federally funded, or subject to HIPAA, FDA, or VA regulations) may be reviewed via exempt procedures. As part of the exempt review, these studies will undergo an abbreviated application process and will not be required to submit annual review. Eligible studies include: collection of data from voice, video, digital, or image recordings made for research purposes; and research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. More information is available via the HSO website.
  • Conflicts of Interest disclosure requirements harmonized. Non-key investigators are no longer required to submit the annual Conflicts of Interest disclosure in order to receive IRB approval. The IU Policy on Financial Conflicts of Interest in Research has not changed; this change simply harmonizes IRB requirements with the current policy.
  • Changes for VA research. The recently-released VHA Handbooks 1058.01 and 1200.05 make several clarifications for research-related processes and decreases burden on investigators. Revisions to the handbook, including changes to required reporting of adverse events and serious problems, have been integrated into HSO SOPs and KC IRB questionnaires.
  • Revised SOPs, guidance documents, and KC IRB questionnaires. IU's human research protection program is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and will be preparing for reaccreditation for the remainder of 2015. As part of the process, SOPs, guidance documents, KC IRB questionnaires, and website are being revised to align with accreditation standards. Revised versions are available via the HSO website.
Transition of regional IRB activities to HSO

As of July 1, 2015, review of human subjects research at all eight IU campuses is facilitated by the IU HSO, resulting in a University-wide human research protection program. Investigators at all campuses make submissions via the KC IRB system and HSO staff serves all IU investigators regardless of campus location. Transition information has been shared directly with researchers on each campus and is available via the IRB websites of the individual campuses. Regional investigators working with HSO for the first time are encouraged to review the Introduction to HSO and may contact Amy Waltz (acthurst@iu.edu) with any questions or concerns.

ClinicalTrials.gov compliance program

The ClinicalTrials.gov Compliance program, an initiative aimed at mitigating risks associated with record registration and maintenance in ClinicalTrials.gov, was initiated on January 1, 2015. The IU Office of Research Compliance, Quality Improvement Office manages the ClinicalTrials.gov Compliance program.

The ClinicalTrials.gov questionnaire in KC IRB that was released on December 4, 2014 obtains information on the type of clinical trial being conducted and the current registration status of the record in ClinicalTrials.gov. The ClinicalTrials.gov questionnaire responses are utilized by the ClinicalTrials.gov administrator in assessing Applicable Clinical Trial determinations and identifying required actions in ClinicalTrials.gov. The ClinicalTrials.gov administrator may be in contact with researchers and study teams as required actions in ClinicalTrials.gov are identified.

The ClinicalTrials.gov questionnaire in KC IRB is required for the following:

  1. Expedited New Study
  2. Full Board New Study
  3. Renewal for FDA-regulated protocol

To complete the ClinicalTrials.gov questionnaire on an existing protocol when submitting a Renewal or Amendment, take the following actions:

  1. After creating the Renewal or Amendment in KC IRB, in the Protocol Actions tab, Request an Action panel, Modify Amendment Sections section, check the box next to the ClinicalTrials.gov questionnaire
  2. In the Questionnaire tab, complete the ClinicalTrials.gov questionnaire

A modification to the former ClinicalTrials.gov structure at IU includes Responsible Party identification. When IU is identified as the Responsible Party, that role is delegated to the qualified Principal Investigator. All new and existing ClincalTrials.gov records that identify IU as the Responsible Party will require a modification to identify the Principal Investigator as the Responsible Party.

Compliance program documentation and guidance can be found on the ClinicalTrials.gov Compliance program website. Video instructions on actions required by Principal Investigators identified as the Responsible Party in ClinialTrials.gov can be found in the Education section of ClinicalTrials.gov Compliance program website.

For other questions about the ClinicalTrials.gov questionnaire and the ClinicalTrials.gov Compliance program, email ctgov@iu.edu.

CITI update and renewal process

Beginning this month, all IU Collaborative Institutional Training Initiative (CITI) accounts will be merged into one account - Indiana University/IU Health. Individuals completing CITI to meet an IU requirement, such as the IRB investigator requirements, should affiliate with this account. All previous IU accounts (i.e. Indiana University Health, IU regional campus accounts) will be automatically merged to affiliate with the new, single IU account.

(CITI) will be sending automated reminder emails for the Biomedical Researchers and Social/Behavioral Researchers courses starting in July 2015. Currently, the expiration notifications for the human subjects courses are sent from the Human Subjects Office (HSO), irb@iu.edu. Now they will come directly from CITI, citiprogram-noreply@med.miami.edu. Please be sure to update your preferences to make CITI a trusted sender so the notices do not go into junk mail. The reminder emails will be sent in the same time intervals as is currently done; 90-, 60-, 30-days from expiration date.

In the CITI reminder email you will be guided to log in using the Single Sign-On portal, using your IU credentials. To renew your certification, click on the link in the reminder email and click on "Log in via SSO" in the section titled Log in through my institution. Find Indiana University/IU Health from the drop down list. Please note: if you do not have an IU username and password then you will log in using the CITI username and password you used in the past.

CITI educational modules for human subjects research must be renewed every three years.

Please contact the Human Subjects Office with any questions at irb@iu.edu or 317.274.8289 or 812.856.4242.

OneStart retirement: October 2015

OneStart, the IU portal which provides investigators access to KC IRB and KC Grants (among other things) will be retired on October 21, 2015. At that time, investigators will access IU online services via One.IU, an app-based search function. For more information about the transition, visit the Making the move to One.IU and see the October edition of Research Compliance Quarterly for more information about accessing KC IRB via One.IU.

Next in Research Compliance Quarterly

Beginning with the next edition, Research Compliance Quarterly will return to its planned quarterly publication schedule. Watch for our first Investigator Spotlight in our upcoming October edition. If you know an investigator whose research should be highlighted, or if you'd like to share about your own research, please contact Shani Stiles at sestiles@iu.edu.

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