February, 2017 - Printable Version
Message from the Director
This issue of the newsletter brings my last “Message from the Director”. I am retiring after 36 years as faculty at the UIC. As one might imagine, over this time I have experienced a number of memorable events, one of the more notable being the outpouring of support the OPRS and I received from investigators at the time of a for-cause site visit from OHRP in 2014. Specifically highlighted in the site visit report as a strength of the UIC human subject protection program (HSPP) was the atmosphere of collegiality and respect between the research community and OPRS. Having benefitted from the collaborative atmosphere on this campus for almost 4 decades as a clinical researcher, this observation was not surprising and reinforced my pride in UIC.
The last 10 years have been eventful for the UIC HSPP. The HSPP achieved accreditation and re-accreditation from AAHRPP for both UIC and the Jesse Brown VAMC, added staff dedicated to investigator training, education and outreach, established three regional central IRBs to facilitate collaboration between UIC and non-UIC investigators, provided the option for external IRB review for pharmaceutical funded clinical trials, initiated an electronic IRB submission system, and successfully weathered site visits from the U.S. FDA and OHRP. These achievements reflect the vitality of the UIC research mission and the priority the institution places on conducting ethical research. I am honored to have had the opportunity to serve as OPRS Director during this time.
I want to thank the three Vice Chancellors for Research who entrusted me with the opportunity to oversee the HSPP since 2007. I want to express my appreciation to the staff of OPRS and IRB chairs and members whose efforts are primarily responsible for all we have achieved together. If any of you happen to pass through Grayling, Michigan after February 28, please feel free to stop in at the Fischer’s Cѐili Cottage for an afternoon of fly-fishing and refreshment. The crew at Spike’s will be able to provide directions.
Wishing each of you every success in your research endeavors.
On January 17, 2017, the UIC Vice Chancellor for Research, Dr. Mitra Dutta, announced the appointment of Elaine Fluder as OPRS Director.
Elaine Fluder’s career in research began more than 25 years ago first managing a research program within the Department of Anesthesiology at Loyola, conducting both Investigator initiated and sponsor funded research. Her experience includes establishing both a research compliance and safety program and most recently a Human Subjects Protection Program (HRPP), becoming the University’s first Director for the Health Sciences Division at Loyola University Chicago. Most recently she was instrumental in achieving AAHRPP accreditation for the Human Research Protection Program (HRPP) at Loyola. In addition to her role as the Director of the HRPP at Loyola she has served as the Chair of the Conflicts of Interest in Research Committee and been a long standing member and Vice Chair of the IRB.
Ms. Fluder received her Master of Science in Nursing degree from the Marcella Niehoff School of Nursing at Loyola University Chicago.
Please join me in welcoming Ms. Fluder to OPRS.
Reflecting on her first month at UIC, Ms. Fluder commented, “UIC is a remarkably diverse and dynamic research environment. I look forward to working with the entire UIC research community to enhance human subject protections while fostering the conduct of excellent research.”
Contributed by Charles Hoehne
In the fall of 2016, the National Institutes of Health (NIH) announced a new Good Clinical Practices (GCP) training requirement with the “expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).”
As a result, all investigators and key research personnel conducting NIH-funded clinical trial research must have on file evidence of completion of an approved GCP Training course.
To help investigators meet this NIH requirement, OPRS is promoting awareness of the following courses:
Option 1: Collaborative Institutional Training Initiative (CITI) program GCP Series: https://www.citiprogram.org/
The CITI GCP series includes two distinct basic courses tailored to the different types of clinical research, along with three corresponding refresher courses that are intended to provide learners with a highlighted review of what is covered in the basic modules.
The available CITI GCP courses include:
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
Option 2: National Drug Abuse Treatment Clinical Trials Network Good Clinical Practice: https://gcp.nidatraining.org/
As per the NIDA website: The NIDA Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.
FAQ’s regarding this NIH training policy:
- What is the effective date of this policy?This NIH policy became effective January 1, 2017.
- Does this policy apply to all NIH-funded research?
No. This NIH GCP training policy applies only to those investigators and their research staff who are conducting NIH funded clinical trials. That said, it is important to understand that this policy is not limited to clinical trials utilizing a drug or device. The policy also applies to clinical investigations of behavioral interventions, surgical interventions etc.
- How does NIH define “clinical trial”?
"A clinical trial is defined by NIH 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."
- Does the GCP policy apply to personnel on grants and contracts awarded before the January 1, 2017 effective date?
The policy applies to all active grants and contracts, no matter what point they are in the life cycle of the trial.
- Is there a difference between the CITI GCP training courses and the NIDA training course?
The courses are roughly equivalent. The CITI courses are more directly relatable to clinical trial research involving investigational drugs, and biologics. The NIDA course focuses a bit more on behavioral interventions.
- Is this considered to be a new IRB requirement?
No. This training is mandated by NIH. The UIC Office for the Protection of Research Subjects (OPRS) role is to promote awareness of the requirement and to provide information to UIC investigators to help them satisfy the requirement.
- How long does it take to complete the training?
Approximately six hours, so please do not wait until the 11th hour to begin this important training requirement.
- Does the training need to be repeated?
Yes, training must be completed every three years.
- How do I obtain my completion certificate?
NIH requires investigators and key research personnel who are subject to the training requirement to maintain evidence the training has been successfully completed. It is therefore important to print the completion certificate both CITI and NIDA make available at the successful completion of the training. The completion certificates are provided by CITI and/or NIDA, not OPRS.
- Will OPRS award Investigator Continuing Education credit for completing GCP training?
Yes, in recognition of the significant time commitment required to complete the training, OPRS will award three contact hours for completion of either the CITI or NIDA courses; however, in order to receive investigator CE credit, investigators will need to email a copy of their completion certificates to email@example.com.
- Who should I contact if I have questions about this training requirement?
Please contact your NIH Program Officer for additional information.
Contributed by Patricia Fischer and Charles Hoehne
ClinicalTrials.gov is a web-based resource maintained by NIH’s National Library of Medicine (NLM). The registry was established nearly two decades ago as a mechanism for the public to access information on human subject research involving clinical trials. This effort has unfortunately been hampered by the limited amount of information submitted, lack of clarity regarding registration requirements and lack of enforcement.
In September 2016, the U.S. Department of Health and Human Services (HHS) released the Final Rule designed in part to address these shortcomings. The Final Rule went into effect on January 18, 2017 with a compliance date of April 18, 2017. A complementary policy was issued at the same time by NIH.
Important elements of the Final Rule include:
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information;
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA. While the Final Rule does not include Phase I clinical trials of FDA products and small feasibility studies of device trials, these are included in the NIH policy which also includes trials and interventions not regulated by the FDA, such as behavioral interventions.
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol;
- Requiring additional types of adverse event information; and
- Providing a list of potential legal consequences for non-compliance.
- Stipulation that the responsibility for fulfilling the requirements rests solely with the investigator and the “responsible party.”
- Financial and professional consequences for failure to comply.
OPRS will take the following steps to assist investigators/responsible parties in understanding their responsibilities in order to comply with the Final Rule include:
- Send out email notification(s)/newsletters(s) explaining the Final Rule to UIC principal investigators.
- Inform UIC Investigators of Training opportunities related to the Final Rule.
- Revise IRB submission documents to alert investigators to their responsibilities.
- Presentations will be made available electronically in the future as refresher options.
- Link to UIC’s OVCR Quality Improvement Program (QIP): http://research.uic.edu/compliance/qip
- NIH September 15, 2016 “Summary of HHS/NIH Initiatives to Enhance Availability of Clinical Trial Information: https://www.nih.gov/news-events/summary-hhs-nih-initiatives-enhance-availability-clinical-trial-information
- NIH September 16, 2016 news release: https://www.nih.gov/news-events/news-releases/hhs-take-steps-provide-more-information-about-clinical-trials-public
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-22379.pdf
Contributed by Charles Hoehne
The December 2016 OPRS newsletter included an article regarding an important Policy Change - Extension of Approval Periods for Minimal Risk Non-Federally Funded IRB-Approved Research. The article explained that beginning in spring 2017, IRB approval for most minimal risk, non-federally funded research will be extended from a maximum of one year (365 days) to a maximum of three years (1095 days). OPRS has been working to implement this exciting policy change (aka the “Flexibility Initiative”) as quickly as possible within the framework of federal research regulations.
Here is where things get interesting: On January 18, 2017, the U.S. Department of Health and Human Services (HHS) released new rules for the conduct of human subject research with an effective date of January 19, 2018. The new rules will - in most instances - eliminate the requirement for continuing review of minimal risk research and give institutions more latitude for oversight of minimal risk research. However, the revised Common Rule has been placed on a 60-legislative day hold to allow the new HHS Secretary, Tom Price, to review the new rules.
With the new rules on temporary hold, so too is the UIC Flexibility Initiative. OPRS remains committed to the Flexibility Initiative and looks forward to resume moving forward once the final rules have been released by HHS. Stay tuned!
Contributed by Charles Hoehne
- The UIC Student Research Form will be held on Monday, April 3, 2017 from 1:00pm – 5:00pm at the UIC Forum (725 West Roosevelt Road)
The Office of the Vice Chancellor for Research, in conjunction with the Office of the Vice Provost for Undergraduate Affairs, the Honors College and the Center for Student Involvement, is pleased to announce the 2017 Student Research Forum (SRF) and UIC Impact Day, which will be held on Monday, April 3, 2017. This important campus-wide event showcases undergraduate, graduate and professional student research covering a broad range of scholarship: Art/Design/Humanities; Business/Computer Science/Mathematics; Engineering/Physical Sciences; Life Sciences; and Social Sciences.
This year the Student Research Forum will include a new initiative, UIC Impact Day, as a part of this event. UIC Impact Day will provide students with an opportunity to showcase pursuits in and beyond the classroom such as service, study abroad, internships, student employment, career development, and/or leadership.
Student Research Forum Submission Deadline: Friday, March 17, 9AM
UIC Impact Day Submission Deadline: Monday, March 20, 9AM
Link for additional information: http://research.uic.edu/srf
- Coming Soon: OPRS will soon be making available a series of short (3-6 minute) videos designed to answer investigator’s frequently asked questions. Quick Tips will provide online on demand information covering such topics as how to register for OPRS Live (beta), investigator training requirements, the definition of “key research personnel” and the similarities and differences between research and evaluation. If you have any suggestions for Quick Tips topics, please email them to me (Charles Hoehne): firstname.lastname@example.org.
- As noted in this newsletter, Dr. Jim Fischer has announced his retirement from UIC effective February 28, 2017. The ten years Jim has served as OPRS Director have been remarkable and include several important accomplishments including: AAHRPP accreditation and reaccreditation, successful navigation of OHRP and FDA audits, establishment of several collaborative IRB initiatives, and the development and implementation of an electronic submission and review process.
It has also seen the birth of Jim’s three beautiful grandchildren.
That Jim is the longest tenured OPRS Director since 1997 is a testament to his fortitude and expertise. That “Vacant Office” was the previous “tenure king” demonstrates just how challenging the position is and how hard it is to find the right person for the job. The OPRS staff is grateful to Jim for his leadership. We are also appreciative of his willingness to assist with the transition to the leadership of our new Director, Elaine Fluder. We are confident Ms. Fluder will continue to move the office in positive direction to enhance the UIC Human Subject Protection Program for all.
Thank you Jim. Now go wet a line and enjoy those grandkids!