Indiana University Bar
Research Compliance Quarterly 11th Edition
July 14th, 2017
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
 
 
New COI Disclosure System and Process

Beginning August, 2017 the Office of Research Compliance, Conflict of Interest (COI) Office will release a new Annual Research-Related Conflict of Interest Disclosure Form. COI disclosure information will now be entered into Kuali COI via One.IU.edu, as with other Kuali research applications. The new Kuali COI disclosure system will maintain a history of disclosures and allow investigators to make updates in the system. After submitting a disclosure in the new system, investigators will no longer have to re-enter the same financial entity information each year.

Additionally, the new disclosure process allows for a rolling annual disclosure period rather than a static date. In the past, all annual research-related COI disclosures were required to be updated each August. Investigators must still update the form in the new system within 30 days of any changes. Again, this will reset the annual disclosure renewal clock to 365 days from that update.

How Will the New System and Process Be Rolled Out?
The COI Office will initially be sending out notification emails to only a subset of researchers for the August, 2017 roll-out in request to update their annual research-related COI disclosure.

This first subset of researchers will include anyone who is funded by a PHS (DHHS) agency, NSF, or other awarding agency that requires PHS FCOI compliance. Researchers will receive an email notification from the COI office with instruction on how to complete their research-related conflict of interest disclosure in the new Kuali COI system. Additionally, researchers who have never completed a COI disclosure, or have an update to be reported, will also be able to complete their research-related conflict of interest disclosure using the new Kuali COI system. Otherwise, remaining investigators will be required to update their COI disclosure information in the new Kuali COI later in the course of the 2017-2018 year. More information will be forthcoming when the remaining investigators will be required to submit their forms. View the Who Needs to Complete a COI Disclosure flowchart for more specific information.

Future Plans
After the initial August release, there will be updates to the system in 2018 that will allow conflict of commitment disclosure information to be included in the annual disclosure process. Additional information will be sent out regarding these new features at a later date.

 
 
NIH Single IRB (sIRB) Policy - Update

The NIH single IRB (sIRB) policy, which requires all sites participating in human subjects research funded by NIH to utilize a centralized sIRB, will be effective January 2018. Previous communications indicated that the policy would be effective September 25; however, the effective date has since been extended to January 25, 2018.

New grant applications to NIH submitted on or after this date must include a plan for use of a sIRB, including identification of the sIRB, relying site agreement to utilize the sIRB, and a plan for communication between the sIRB and the relying sites. The HSO is continuing to assess the impact of the policy and to draft procedures and processes for local implementation of sIRB review, both for studies impacted by the NIH policy and studies for which sponsors and funding agencies other than NIH are requesting sIRB review.

If you are planning for an NIH proposal which will be submitted after January 25, 2018, or have questions about potential reliance on an external IRB, please contact Amy Waltz at acthurst@iu.edu.

 
 
HSO Update - Revised Common Rule

On January 19, 2017, the Department of Health and Human Services published revised regulations on the protection of human subjects in research, known as the Common Rule. View the previous announcement, including an overview of the proposed changes and HSO’s response. The revised regulations are effective January 19, 2018.

Over the past months, HSO has been taking positive steps to prepare for implementation of the revised Common Rule and has convened several working groups to obtain input from the research community during the process (see below). More specific information regarding implementation of the revised Common Rule will be available throughout the fall and winter of 2017.

HRPP Advisory Committee
The HRPP Advisory Committee is a working group comprised of over forty individuals representing a variety of research roles from three different campuses of Indiana University, Indiana University Health, Eskenazi Health, Roudebush VAMC, and Regenstrief Institute. The Committee has discussed several topics related to the revised Common Rule and provided guidance and recommendations to HSO for implementation. Recommendations will be presented to the IRB Executive Committee, comprised of Chairs and Vice Chairs from all seven IU IRBs, for final approval before HSO staff operationalize the recommendations into policy and procedure.

Consent Working Group
The Consent Working was convened with the express purpose of making recommendations in response to the new provisions surrounding informed consent. Specifically, the revised Common Rule outlines several new required elements of consent, and requires that the consent process begin with a concise and focused presentation of the key information most likely to assist a prospective subject in understanding why one would want to participate. The group has considered the new requirements carefully and drafted new informed consent language compliant with the revised regulations. The language is being incorporated into new informed consent templates specific to four different types of research. These templates will be required for use by new studies after January 19, 2018, but will likely be available for review and use in Fall 2017. Final policies regarding the new consent requirements are still being considered; however, at this time, HSO does not expect that previously-enrolled subjects will need to be reconsented using the revised templates.

 
 
IRB Approval for External Investigators and Sites

Given today’s highly collaborative research environment, the IU IRBs are often asked to provide IRB review for non-affiliated individuals or external performance sites. When the IU IRBs agree to provide approval for these individuals and/or sites, the IRBs still have to ensure the investigators fulfill our requirements and are appropriately qualified and trained to participate in the research. While utilizing a single IRB for multiple sites/investigators may increase efficiency in some areas, it doesn't change the amount of work required to obtain IRB approval for a protocol or a specific site, and additional regulatory requirements often apply as well.

Local study team responsibilities
When you ask the IU IRBs to provide IRB review for review for non-affiliated individuals or external performance sites, you agree to take on additional responsibilities. It’s important to remember that the IU PI will be considered ultimately responsible for conduct of the research by all investigators at all sites. In addition, the IU study team is responsible for collecting the required IRB information from external sites and investigators, compiling it for the IU IRB, making IRB submissions on behalf of sites and investigators, and communicating IRB decisions and approved documents back to the sites and investigators. Many study teams aren’t fully prepared to handle this level of coordination and communication, so HSO asks that you chat with the HSO reliance team before offering to utilize the IU IRBs for multiple sites.

What HSO needs to know and why?
When adding external investigators and sites, clear information about the external investigators needs to be documented in the IRB paperwork. Specifically, the local study team needs to provide the following information for all external investigators: name, role in the research or procedures they will perform, and the academic institution for whom they are conducting the research. If the individual is not associated with an institution or is not conducting the research on behalf of an organization (e.g. acting as a volunteer, student not receiving credit), this information needs to be provided as well.

This information is important, as additional regulatory requirements apply when the IU IRBs provide IRB review for non-affiliated individuals. Federal regulations require that, when an external institution agrees to accept the IRB review of another institution, the relationship be documented by a written agreement called a reliance agreement. The HSO reliance team will facilitate completion of the reliance agreement once all the information above is received; however, reliance agreements often take several weeks to complete due to the complexity and institutional officials involved. If the non-affiliated investigators are not associated with an institution or not conducting the research on behalf of an organization (e.g. acting as a volunteer, student not receiving credit), the individual must complete the Non-Affiliated Investigator Agreement available on the HSO Forms & Template Page. The form must be signed by the external investigator, the PI, and the Human Subjects Office.

How to submit
Adding non-affiliated investigators or sites can be done at any time; however, HSO strongly recommends that addition of non-affiliated investigators or sites be done via a stand-alone amendment (i.e. the only change is the addition of the non-affiliated investigators or sites) and not with initial review. As mentioned, completion of the required agreements can take several weeks so initial review may be delayed, or any additional changes made with the amendment held until the agreement is complete.

In order to add non-affiliated investigators or sites, please submit an amendment updating the following:

  • Personnel tab: Please add the non-affiliated investigators via The Address Book instructions available on the Kuali Coeus IRB Instructional Guides webpage. If you are adding multiple investigators at an external performance site, please contact the HSO prior to taking this step as an alternative may be available.
  • Questionnaire C: Update question ID 704 to "Yes", to indicate that the IU IRBs are being asked to provide IRB review for external investigators or sites. In question ID 709, please list the individuals, their roles in the research, and the institution(s) for whom they are conducting the research. If the individual is not associated with any institution or is not conducting the research on behalf of an organization (e.g. acting as a volunteer, student not receiving credit), indicate that as well.

As always, please don’t hesitate to contact a member of HSO reliance team with any questions.

 
 
KC IRB Needs Your Help!

Kuali Coeus IRB (KC IRB) will be celebrating its 4th anniversary since its implementation at IU in August, 2017. Huge improvements have been made to the system over the last four years; however, we continue to seek ways to improve the user experience by addressing the needs and concerns of the research community. HSO is looking for individuals from the research community willing to join a KC IRB User Group to provide input regarding the use and improvement of KC IRB. The User Group will serve in an advisory capacity to HSO and will:

  • Advise HSO about key aspects of the KC IRB system
  • Provide a community perspective on key considerations
  • Work towards a consensus among the User Group members on the desired goals, alternatives, improvements and release phases for KC IRB

If you are interested in helping to improve the user experience of KC IRB, please contact Lainna Cohen, Research Compliance Consultant, at larcohen@iu.edu.

 
 
CTSI: Clinical Research Monitoring Service

The Indiana CTSI now offers a Clinical Research Monitoring Service designed especially for investigator initiated trials. The monitoring program is a service to the investigator to help them meet their responsibility of ensuring proper routine monitoring. This service is meant to aid in overseeing the progress of the study at every step of the trial. The monitor serves as an extension of the study team to help ensure the trial is conducted, recorded and reported in accordance with the protocol, SOPs, good clinical practice (GCP) and the applicable regulatory requirements. For more information, visit The Clinical Research Monitoring Service or contact Shola Jhanji at sjhanji@iu.edu.

 
 
GCP - Social and Behavioral Research Best Practices for Clinical Research (New CITI Online Program Course)

The CITI Online Program now offers a new Good Clinical Practice (GCP) Social and Behavioral Research Best Practices for Clinical Research course. This course introduces GCP principles and discusses how they apply to clinical trials using behavioral interventions and social science research. Topics include:

  • Research Protocol
  • Recruitment and Retention
  • Informed Consent Communication
  • Privacy and Confidentiality
  • Participant Safety and Adverse Event Reporting
  • Quality Control and Assurance
  • Research Misconduct

To add this course to your learner account for training, simply sign in to your IU CITI account, select "Add a Course" from your My Learner Tools menu, select to add the course in question #4 of the curriculum listing and click submit to save. The course will now appear in your IU CITI account for completion.

 
 
KC IRB: Did You Know?
  • KC IRB Instructional Guides are available on our website and provide step-by-step instructions for different types of submissions. KC IRB help is also available by calling 812-856-4242.
  • To access approval documents in KC IRB, do not click through the link provided in the approval notification email. Instead, search for your protocol via the KC IRB portal in One.iu.edu. The Approval Letter and signed Protocol Summary can be accessed on the Protocol Actions page, Summary & History panel, Submission Details section, under Review Attachments. The stamped Informed Consent can be accessed on the Notes and Attachments tab or the Protocol Actions tab, under the Print panel. For additional information regarding how to access approval documents, see the KC IRB Instructional Guides and click on Retrieving Study Documents.
  • You can assist the HSO staff in ensuring the correct versions of study documents are included on the Notes & Attachments tab and are approved by the IRB by:
    • Downloading copies of all approved documents from KC IRB upon approval,
    • Starting with these versions when you revise documents to prepare an Amendment, and
    • Using the “replace” button in KC IRB when updating study documents with an Amendment or in response to HSO pre-review.
  • HSO staff is available for one-on-one help or training at request. Office hours are regularly held on the Indianapolis and Bloomington campuses. Contact HSO staff for additional information or to schedule a different time or location if needed.
 
   
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