14th Edition - April 27, 2018

On April 4, 2018, IU's Office of the Vice President for Research and IU Communications launched the new and improved research.iu.edu website.

The goal of the new website and its redesign is to make searching for research information and opportunities at IU more intuitive and streamlined.

In the new design, more than 2,600 IU research-related website pages previously housed on separate university research websites have been combined to provide single-source searching for all research-related resources at IU. The new design will save time and better facilitate the work of those currently involved in or interested in research at IU.

Below are just a few of the new website's features:

• Research compliance & research training requirements organized in one spot.
• Quick access to research newsletters and announcements.
• Comprehensive/searchable list of internal funding opportunities.
• Proposal development/preparation tips and tools.
• Streamlined grants processing/management information.

Please visit the new website to update any commonly used bookmarks to research pages. Should you have questions concerning where previously bookmarked content is located on the new site or are unable to locate resources when searching, please contact us at researchcompliance@iu.edu.

If you have suggestions on how the new site pages might be further developed, feel free to contact research@iu.edu.

The Office of Research Compliance has partnered with the University Compliance Office to build a single portal for capturing and updating conflicts of interest disclosures. IU School of Medicine faculty, as well as certain staff, should have received a message last month directing them to complete the new online Kuali Conflicts of Interest and Commitment (COI-C) Disclosure Form. Anyone engaged in design, conduct, and reporting of research must have an updated disclosure on file. The consolidated form is being rolled out to other areas of the university over the next several months.

All researchers are now required to have a completed disclosure in the Kuali System. If you have not completed a disclosure in the new system, please do so as soon as possible so your research submissions are not delayed. Information on how to access the new Kuali COI-C Disclosure Form can be found on the new Research website's Complete a Conflict Disclosure page.

Tips for Successful Research-Related COI Disclosure:

It is important that all applicable roles are selected when completing the form. For example, if a faculty physician is a researcher and also employed by IU Health, then the roles of university employee, researcher, and IU Health should all be selected in order for the proper questions to populate and the annual disclosure requirements to be met.

Those who are completing the form at the direction of the Human Subjects Office or the Office of Research Administration (“ORA”), must mark the researcher-specific role in order to be presented the research-specific questions and for the form to register as completed for purposes of IRB studies and proposals and awards processed by ORA.

After a national search, Bethany Johnson, CIP, has been named University Director, Human Research Protection Program and now leads both the Human Subjects Office and Quality Improvement Office. Bethany joined the Human Subjects Office in 2010, and most recently served as the Associate Director for Operations.

Neala Lane, MS, CCRC has been promoted to Associate Director, Quality Improvement Office. Neala previously served as the Human Subjects Research Auditing Manager and will be responsible for human subjects auditing, CT.gov compliance, and clinical research billing compliance in her new role. Neala has been with IU since 2014.

Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) were expected to go into effect on January 19, 2018; however, last-minute government action has delayed implementation until at least July 19, 2018. While we continue to prepare for the new Common Rule, the HSO has taken steps to allow research that is not federally funded and not subject to FDA or VA regulation to take advantage of certain burden-reducing provisions. Effective March 29, 2018, these changes reduce administrative burden for research that is not federally funded and not subject to FDA or VA regulation.

• New studies should utilize the revised informed consent document template currently available on the HSO website. The new template includes a summary section of important information, where appropriate, and additional elements of informed consent, both of which provide value to human subjects.
• New expanded categories for exempt research are available for research that is not federally funded and not subject to FDA or VA regulation.
• Renewal is no longer required for the following research:
  • Expedited research that is not federally funded and not subject to FDA or VA regulation
  • Full Board research that is not federally funded and not subject to FDA or VA regulation AND for which research procedures are limited to clinical follow-up (i.e. accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care) or data analysis only
• Research which is federally funded or subject to FDA or VA regulations will continue to require renewal as scheduled.

For details about the changes, read the full Changes to Review of Human Subjects Research, Including New Exempt Categories & Changes to Renewal Requirements announcement.

Do you need to find information from a previous submission or Questionnaire? Perhaps you are completing a Renewal Questionnaire and need to retrieve the previous year’s subject numbers?

Follow these instructions to access previous submissions:

1. Access the Base Protocol in KC IRB.
2. Navigate to the Protocol Actions tab.
3. Click ►show on the Summary & History tab to expand that section.
4. Click ►show on the History section. This section will display the history of all actions taken on the Protocol.
5. Locate the approved submission you are looking for and select ►show next to the Notifications section associated with that submission.
   
6. Inside the message of the notification, right-click on the protocol number and select Open Link in New Tab. This will open up the approved submission in a new page. You will know you are in the approved submission because the header will look similar to this:
   
7. To view the submission (or other) Questionnaire, click on the Questionnaire tab. You can also view other areas of the submission, e.g. Notes & Attachments, if needed.
8. To retrieve approval documentation, i.e., signed Protocol Summary, for the submission, navigate to the Protocol Actions tab.
9. Click ►show on the Summary & History tab to expand that section.
10. Click ►show on the Submission Details section.
11. Click ►show on the Review Attachments section. You will find your approval documentation. Click [view] to view and download the signed Protocol Summary.
    

We would like to thank everyone for their outstanding preparation for, and time spent with, the representatives of AAALAC during their recent site visit to the IUPUI School of Medicine. The site visit came together very well, and the site visitors were very impressed with the LAR, as well as PI labs and personnel. The visitors commented that everyone they met was knowledgeable and able to answer their questions and that the IUSM animal use program was a highly functioning program of which everyone could be very proud.

As a result, the AAALAC team is recommending “Continued Full Accreditation” to the AAALAC Council. These site visits, which occur every three years, are part of our institutional commitment to maintaining a high quality animal care and use program. Thank you to everyone again!

Do you ignore your own feelings?
Does caring hurt too much?
Do you feel you can’t talk to others about your job?
Do you feel there is nothing to show for all your work?

If you answered "Yes" to any of these questions, come help June 26 - 29, 2018

Anneke Keizer, co-owner and founder of CopePlus, will be working with the IU School of Medicine IACUC and LARC staff on developing a Compassion Fatigue Support Program for people who work with laboratory animals.

If interested in taking part in the development of our program and talking to Anneke, please contact either Megan Losh via email at meglosh@iu.edu, Jessica Peveler via email at jpeveler@iupui.edu or feel free to call 317-278-1826.

What are export controls and how do they affect you?

Export controls are US laws and regulations that govern the transfer of items (commodities, software and technology), information, services, or money to non-US destinations, persons (including foreign nationals working in or visiting the US), or entities (including universities). Export control laws apply whenever these transfers are limited for reasons of national security, foreign policy or US economic objectives.

To assist with understanding how Export Controls affect you and IU, please contact the Export Control Specialist and the Office of Research Compliance at export@iu.edu or visit the Export Control website, particularly when:

1. Traveling outside of the US on university business with IU equipment.
2. Traveling outside of the US to a country/region with comprehensive sanctions. Currently, these include:
   1. Crimea Region of the Ukraine
   2. Cuba
   3. Iran
   4. North Korea
   5. Syria
3. Hosting foreign persons from sanctioned or embargoed countries.
4. Collaborating with a researcher or institution outside of the US, especially when that collaboration involves individuals or institutions from a sanctioned country or when sensitive information or equipment may be shared.
5. Exporting/shipping items internationally.
6. Involved in a project/research with restrictions or limitations on publication, dissemination, proprietary information (e.g., confidentiality or non-disclosure agreements), or foreign person participation. For example, if a project required that participants be US citizens or that all foreign persons be screened and approved by a non-IU entity.
7. Involved in a project/research related to military; space related information; nuclear, chemical and/or biological weaponry; missiles; unmanned vehicles; encryption technologies or other items listed on the International Traffic in Arms Regulations (ITAR) US Munitions List (USML).
8. Performing work under an RFP/Agreement/Contract that is marked "Export Controlled" or includes export control provisions.
9. You suspect a violation of export control laws or regulations has occurred.

The IU Office of Research Compliance (ORC) is committed to the education and training of members of the university community and offers training opportunities about export controls.

ORC can provide training to individuals or groups interested in an overview of export control laws, regulations, and best practices. ORC can also provide training for specific areas of export controls such as shipping.

To schedule training please contact the Export Control Specialist or the ORC at export@iu.edu.