Indiana University Bar
Research Compliance Quarterly 10th Edition
April 28th, 2017
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
New IRB Procedure for Study Closure

The Human Subjects Office (HSO) has released new procedures for study closure. As of April 27, 2017, the previously-used Study Closure Report form will no longer be accepted, and study closure must be reported via KC IRB.

To view specific instructions for reporting a study closure to the IRB, including step-by-step KC IRB instructions, see Human Subjects Study Closure.

Please note, it is very important the instructions be followed carefully to ensure proper submission to the IRB. Specifically, any attachments submitted with the closeout submission must be attached LAST , just prior to completing the “submit” action.

Closure of studies involving greater than minimal risk research (i.e. full board) and FDA-regulated research MUST be reported to the IRB. These studies cannot be allowed to expire, and failure to report study closure prior to expiration will be considered noncompliance.

Study closure of minimal risk research may also be reported via KC IRB; however, failure to submit closure information for these studies is not required and will not be considered noncompliance. Researchers may allow minimal risk, non-FDA regulated studies to expire, and the expiration will be treated as a study closure.

NIH Single IRB Policy – Update

The National Institutes of Health (NIH) single IRB (sIRB) policy, which requires all sites participating in human subjects research funded by the NIH to utilize a centralized sIRB, will be effective Fall 2017. Previous communications indicated the policy would be in effect on May 25, 2017; however, the new effective date has since been extended to September 25, 2017.

New grant applications to the NIH submitted on or after this date must include a plan for use of an 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 September 25, 2017, or have questions about potential reliance on an external IRB, contact Amy Waltz.

Revised Common Rule – Update

On January 19, 2017, the Department of Health and Human Services (HHS) published revised regulations on the protection of human subjects in research, known as the Common Rule. The HSO published an announcement, Revised Federal Policy on Human Subjects Research (Common Rule) on the same date, which included details of the revisions and the HSO’s response.

In the previous communication, the HSO noted the potential for repeal of the revised regulations by the new presidential administration, as well as the need for response from additional oversight agencies including the U.S. Food and Drug Administration (FDA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP). To date, there has been no action to overturn the regulations and, while both the FDA and AAHRPP are reportedly working on updates, no official action has occurred.

The revised regulations will be effective January 19, 2018. HSO is 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. Over the next months, we will continue to provide regular communications about our progress and expect to begin education in Fall 2017.

IRB Reporting of Determinations to OHRP, the FDA, and the VA

When the Institutional Review Board (IRB) reviews an FYI (Reportable Events) submission, they are required to determine whether or not the event or issue represents serious or continuing noncompliance or an unanticipated problem involving risks to subjects or others (UPIRTSO). If your research is federally-funded, FDA regulated, or subject to Veterans Administration (VA) regulations and the IRB makes a determination of serious or continuing noncompliance, UPIRTSO, suspension, or termination, federal regulations require reporting of the determination to the Office for Human Research Protections (OHRP), the FDA, and/or the VA, as applicable.

The IRB meets this requirement by drafting a reporting letter which is sent to OHRP, the FDA, and/or the VA. Principle Investigators (PI's) and department chairs will be sent a copy of the reporting letter for their files. Reporting is not a punitive measure; rather, the federal agencies encourage reporting and view it as evidence of a healthy, compliant human research protection program.

If you have any questions regarding federal reporting, please contact the HSO.

HSO Staffing Update

The HSO welcomes a new Research Compliance Associate to our team!

Natalie Phillips joined the HSO in late January. Natalie has a wide range of experiences in the nonprofit sector, including drafting state and federal grant proposals and reporting grant outcomes. Natalie predominantly reviews full board submissions. Please join us in welcoming her to Research Compliance! Protocol Registration and Results System (PRS):
Final Rule Updates

The Protocol Registration and Results System (PRS) was updated on April 18, 2017 to require the data elements described in the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). These new requirements apply to registration information when the Study Start Date is on or after January 18, 2017 and for results information when the Primary Completion Date is on or after January 18, 2017.

The Final Rule Information Page was also updated to include information on the submission of protocol and statistical analysis plan documents, the quality control review criteria and process, and extensions for good cause.

See the Quality Improvement Office's Compliance Program page for more information on the IU Compliance Program.

Questions and/or requests for training may be sent to

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