Indiana University
Research Compliance Quarterly 9th Edition
January 6th, 2017
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
 
 
NIH Policy on Good Clinical Practice (GCP) Training Required Beginning January 1, 2017

The NIH recently issued a Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.

While IU has an existing training requirement with regard to Good Clinical Practices on the Human Subjects Investigator Requirements webpage (under CITI Completion), the NIH requirement does differ slightly in regards to scope, affected personnel, and training mechanism.

IU has elected to enforce the NIH training requirement as a condition of IRB approval. Consequently, the IU Human Subjects Office (HSO) will be verifying GCP training completion for applicable personnel on NIH-funded clinical trials during the IRB review process.

Important points:

  • The NIH has defined a clinical trial as: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See the NIH's Notice of Revised NIH Definition of Clinical Trial.
  • If you are not conducting a clinical trial, neither the NIH nor the IU policy applies. Note that some behavioral research does meet the definition of a clinical trial.
  • If your clinical trial does not receive NIH funding, the NIH policy does not apply, but the IU policy may apply (if the trial is considered interventional).
  • If you have completed the CITI GCP modules to satisfy the IU training requirement, these will also satisfy the NIH training requirement.
  • IU requires the CITI GCP training course to satisfy the IU requirement, whereas the NIH requirement may be fulfilled via other training mechanisms, with appropriate documentation.

 
 
New ClinicalTrials.gov Compliance Regulatory and Policy Changes Take Effect January 18, 2017

Changes to ClinicalTrials.gov compliance for both the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) take effect on January 18, 2017.

The FDA requires completion of new registration data elements for all clinical trials meeting the Applicable Clinical Trial definition with a Study Start Date on or after January 18, 2017. Completion of new results reporting data elements is required for Applicable Clinical Trials with a Primary Completion Date on or after January 18, 2017. All Applicable Clinical Trials with a Primary Completion Date on or after January 18, 2017 will be required to complete results reporting regardless of the drug, biologic or device status with the FDA.

The NIH requires registration and results reporting for NIH funded clinical trials meeting the NIH clinical trial definition. NIH clinical trials funded by the NIH Intramural Program and initiated on or after January 18, 2017 are required to comply with the NIH policy. NIH clinical trials funded by the NIH Extramural Program with an application for funding submitted on or after January 18, 2017 and initiated on or after January 18, 2017 are required to comply with the NIH policy.

NIH clinical trials covered by the NIH policy are required to include a word-for-word statement regarding ClincalTrials.gov registration in the Informed Consent documentation.

A description of this clinical trial will be available on ClinicalTrials.gov. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

As a part of the grant process, an applicant seeking funding for an NIH clinical trial covered by the NIH policy is required to provide a plan describing how the expectations of the NIH policy will be met. Meeting the expectations of the NIH policy is considered a term and condition of the award. The cost of complying with the NIH policy can be covered by the grant. Progress report forms will require a certification that the expectations of the NIH policy have been met and the completion of required actions in ClinicalTrials.gov will be reviewed prior to the release of remaining or future funding.

Several key changes to the IU ClinicalTrials.gov Compliance Program are being implemented to address these requirements including a revised Kuali Coeus (KC) IRB questionnaire. Key changes will be communicated through the Research Compliance Quarterly Newsletter and updates can be reviewed on the IU ClinicalTrials.gov Compliance Program webpage.

For more information, please review the NIH News Release on the FDA final rule and the NIH policy.

For questions, concerns or to request a departmental training session, please email ctgov@iu.edu.

 
 
New Two-Step Login Procedure to Access KC IRB – Action Required for IU Affiliates!

IU University Information Technology Services (UITS) has announced a new authentication procedure for accessing all IU applications via the IU Central Authentication Service (CAS), including KC IRB.

Effective February 2, 2017 all student employees, faculty, staff and affiliates will be required to perform a two-step (Duo Authentication) login process when logging into CAS. This new requirement is in response to increased email phishing and online scams targeting several universities, including IU. The process will add a second layer of security when logging into the IUIE secure system and help prevent anyone but you from logging in.

  • If you are IU faculty, staff, or student – the Duo authentication will apply to any/all CAS-secured IU systems. You should have already received communications directly from UITS with regard to establishing a Duo login.
  • If you are an affiliate of IU – (e.g., IU Health, Eskenazi, Roudebush VA, Regenstrief employee) who has been granted an IU affiliate account for the purposes of accessing KC IRB or serving as an IRB member, please note you will need to take steps to establish a Duo login:
 
 
Changes Coming Soon to IRB Procedures; KC IRB

The Human Subjects Office (HSO) will be implementing several new procedures, releasing new guidance documents, and revising the KC IRB application effective February 23, 2016. These initiatives are the result of discussions with the research community and IRB members and are intended to streamline the IRB process by better utilizing the KC IRB system and clarifying IRB requirements. More specific communication and training will be available in the coming weeks.

Changes will include:

  • Simplified requirements for notifying the IRB of reportable events (e.g. serious adverse events, protocol deviations, noncompliance) including: revised procedures, new guidance (previously available for public comment), new KC IRB questionnaire for reportable events, retirement of the current Prompt Reporting Form and Noncompliance Form.
  • Revised process for closure of IRB studies, including a closeout procedure in KC IRB and retirement of the current Closeout Form.
  • Revision of several KC IRB questionnaires to clarify language and incorporate recent requirements from oversight agencies.
  • New guidance for research with individuals lacking consent capacity (previously available for public comment).
  • Revised guidance on utilizing external IRBs.
 
 
Holding Enrollment in Ongoing Studies when New Risks Have Been Identified

When a newly discovered risk related to study participation is identified in an ongoing human subject research study, study teams must take immediate steps to halt enrollment in the study. Enrollment may resume once a revised Informed Consent Statement (ICS), inclusive of language explaining the new risk, is reviewed and approved by the IRB.

Suspending enrollment until an updated and accurate ICS is available fulfills the regulatory requirement of informing subjects of all reasonably foreseeable risks at the time of their enrollment in the study. Verbally explaining newly discovered risks is not an adequate substitute for revising the consent document. IU has received communication from federal oversight agencies that outlines this expectation.

If the study team does not voluntarily hold enrollment in such situations, the IRB is obligated to formally suspend enrollment upon receipt of new risk information, pending review and approval of a revised ICS.

For questions regarding this requirement, contact the HSO staff at irb@iu.edu.


 
 
Human Subjects Office (HSO) Staffing Updates

The HSO welcomes two new Research Compliance Associates to our team!
Jill Wallace and Milissa Maric will join the HSO in early January.

Jill most recently worked at Purdue University in the Sponsored Programs Office. She also worked in the IRB office at Purdue for three years and has her Certified IRB Professional (CIP) credential.

Milissa has experience in the health care reimbursement services industry and held the position of Compliance Officer for her prior employer’s Medicaid contract.

 
 
Did You Know?

➺ The HSO publishes IRB metrics each quarter, including turnaround times and volume data. Access this data publicly on the HSO Data & Reports page.

➺ IU does not make its IRB rosters public. Here’s what you can provide to sponsors or monitors requesting a roster instead: Statement of Compliance.

➺ The HSO encourages study teams to contact their assigned departmental staff member directly (see HSO Support Teams), and publishes direct contact information for each of its staff members on the website:

  1. Please visit the ORC Staff Directory Search page;
  2. Select ‘Research Compliance’ in the Offices dropdown;
  3. Then select ‘Human Subjects Office Team’ in the Teams dropdown and click 'Search'.

In addition, the HSO has a general office phone (317.274.8289) and email (irb@iu.edu), as well as a KC IRB help line (812.856.4242) which are monitored during normal business hours.

We want to help, and look forward to hearing from you!.

 
   
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