Volume 3, Issue 9
In this issue:
- Regulatory Changes-Revised Common Rule
- NIH Single IRB Policy
Winter Break Closure
The University will be closed from Monday, December 25, 2017 through Tuesday, January 2, 2018. Our office will be working diligently until Winter Break to ensure IRB reviews are completed in a timely manner. We want to take this opportunity to alert you to changes in our office, update you on the upcoming changes to federal requirements and wish everyone a safe an enjoyable break.
Meet our Assistant IRB Compliance Officers
Please join us in welcoming our two new Assistant IRB Compliance Officers.
Sara Mulville, MA, was promoted to the position of Assistant IRB Compliance Officer in August. Many of you already know Sara who joined the HRPP as an IRB Compliance Specialist in July 2015. Prior to that she was a public health educator with the Knoxville County Health Department. Sara has done an outstanding job during her time with our office and we are confident in her continued success in this new role.
Jennifer Engle, Ph.D., joined the HRPP as an Assistant IRB Compliance Officer in September and has prior experience in both social behavioral research and clinical research. Jennifer comes to UT from Thompson Cancer Survival Center where she worked as a Clinical Trials Regulatory Compliance Specialist. Prior to that she was a Research Project Manager at Vanderbilt University Medical Center. Before that Jennifer conducted social behavioral research for seven years providing her a with a wide range of research experience. Jennifer holds a doctorate in Human Development and Family Studies.
“Who is my IRB Liason?”
Due to the recent reorganization of our office, colleges are now assigned to one of three in-office staff members instead of two. Additionally, the contact information below lists your first point of contact based on topic.
Who to Contact
Examples include submission status, completing IRB/iMedRIS Forms, CITI training, application requirements, meeting deadlines, iMedRIS user support, etc.
|Contact: HRPP/IRB Office
|Study or Research-Specific Questions
Examples include IRB review required?, responding
IRB Liaison by College or Unit:
|Contact: Your IRB Liaison|
|Agricultural Sciences & Natural Resources
Arts & Sciences
Communications & Information
|Contact: Sara Mulville
|Architecture & Design
Education, Health & Human Sciences
University-wide Units (Student Life, Libraries,
NIMBioS, Athletics, etc.)
|Contact: Jennifer Engle
|Audiology & Speech Pathology
|Contact: Kristine Hershberger
|Reportable New Information
Examples include unanticipated problems/adverse
events, complaints, concerns about participant
welfare or safety, etc.
|Contact: Colleen Gilrane
Examples include departmental training, classroom
|Contact: Colleen Gilrane
|Reliance Agreements/Single IRB
& Collaborative Research
|Contact: Kristine Hershberger
|Clinicaltrials.gov||Contact: Kristine Hershberger
Regulatory Changes-Revised Common Rule
Most of the changes to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, are scheduled to go into effect on January 19, 2018. In early October the HHS Office for Human Research Protections submitted a request for a one-year delay in the implementation of these changes to the U.S. Office of Management and Budget (OMB). OMB has yet to respond to this request making the actual implementation date of these changes uncertain.
Overview of Major Changes
Below is an overview of the major changes scheduled to go into effect next month. Other changes related to collaborative research will go into effect in 2020.
New and Revised Definitions – The definition of who is a human subject has been
expanded to encompass “obtaining, using, studying or analyzing” as well as include both identifiable data and identifiable biospecimens.Clarification of activities that do not meet the definition of “research”. An explicit definition of clinical trial has been added. “Clinical trial means 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 the interventions on biomedical or behavioral health-related outcomes.” This is the same definition used by NIH.
New and Revised Exemption Categories – The revised regulations modify the
existing categories, adds new categories and also adds limited IRB review to some
categories. For example:
• Secondary research involving identifiable private information that is protected by
HIPAA can be reviewed at the exempt-level, while currently it must be reviewed
at least the expedited-level.
• Some research involving brief benign behavioral interventions with adults.
Changes to Informed Consent
• Re-organization of consent documents to begin with a concise and focused
presentation of the key information that is most likely to assist in understanding
the reasons why one might or might not want to participate in the research.
• New elements of informed consent related to future use of
information/biospecimens, disclosure (if applicable) of profit from commercial
use, return of research results and information related to genome sequencing.
• Posting consent forms on a designated public website in for some clinical trials
Continuing Review – Elimination of continuing review for some minimal risk
Single IRB Review – The revised Common Rule mandates single IRB review for
most federally funded collaborative research projects conducted in the U.S. beginning
January 20, 2020. However the NIH Single IRB Policy goes into effect on January 25,
2018 (all competing grant applications for due dates on or after January 25, 2018).
What to Expect
Though it is possible that the federal government could choose to take action to delay the implementation of these changes, we may not learn about that decision until January 18, 2018. Due to this uncertainty, the UT IRB plans to implement the necessary changes scheduled to go into effect on January 19th. Should changes occur, we will announce them as soon as they are known.
• IRB application changes on or before January 18th.
• New informed consent templates posted on the IRB website in early January.
• Guidance and instructions posted on the IRB website in early January.
• Throughout January and into the new year, a training video and education materials willbe provided.
Interested in Learning More?
Science: What do revised U.S. rules mean for human research?
Council on Governmental Relations: Common Rule Summary Table
Association for Psychological Science: Revision to the Common Rule: Implications for Behavioral and Social Sciences Research
NIH Single IRB Policy
The NIH Single IRB policy goes into effect on January 25, 2018. This policy requires that certain types of NIH-funded research involving multiple institutions to use a single IRB (sIRB) for the research conducted at all of the study sites. Use of an sIRB avoids duplicative review by multiple institutional review boards. This policy applies to research studies that are:
• Funded by grants (new, renewal, revision, or resubmission), cooperative agreements or contracts submitted to NIH on or after January 25, 2018, and
• Involve non-exempt human subjects research, and
• Research conducted domestically, and
• Involve multiple study sites, all of which are conducting the same protocol. This includes multi-site studies where most sites are conducting the same protocol but one or a few sites are responsible solely for overall study coordination, laboratory services, statistical services, or other study support functions.
This policy does not apply to research studies that are:
• Funded to institutions outside of the U.S., or
• Conducted at foreign sites (though domestic sites of the same study must be reviewed by sIRB), or
• Funded through career development, research training or fellowship awards, or
• Where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy, or
• Collaborative projects involving multiple sites, but the different sites complete different parts of the study, or
• Granted an exception to this policy by NIH due to a compelling justification. These exceptions are expected to be granted infrequently.
We anticipate that most research studies subject to these requirements will be clinical trials, but keep in mind that the definition of “clinical trial” has been expanded.
What to Expect
Look for additional information in early January. We plan to send additional notifications to you via email and post more detailed guidance on our website. Throughout January and into the new year, education materials and trainings will be rolled out.
For More Information
Implementation of the sIRB policy FAQ
Scenarios illustrating the use of direct and indirect costs for single IRB review
FAQ on Costs
NIH Announces Revisions to Policies and Guidelines
Recently the National Institutes of Health (NIH) announced it is amending NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research to require recipients conducting applicable clinical trials ensure results of valid analyses by sex/gender, race, and/or ethnicity are submitted to Clinicaltrials.gov. The agency also announced plans to revise the NIH Policy and Guidelines on the Inclusion of Children.