June, 2017 - Printable Version
Message from the Director
Having spent much of my first six months at UIC analyzing the Human Research Protection Program and examining ways to strengthen the program while promoting the ethical conduct of research, I am reminded of the following paradoxical quotes:
“No matter what business you're in, you can't run in place or someone will pass you by. It doesn't matter how many games you've won.” -- Jim Valvano, Hall of Fame Basketball Coach and Founder of the V Foundation, striving for victory over cancer
“We face a challenge in our time. Science and technology are rapidly changing our lives with the promise of making us much healthier, much more productive and more prosperous. But with these changes we must work harder to see that as we advance we don’t leave behind our conscience. No ground is gained and, indeed, much is lost if we lose our moral bearings in the name of progress.” -- Bill Clinton, Remarks by the President in Apology for Study Done in Tuskegee, Alabama, May 16, 1997
There is no question UIC has a winning research program. UIC ranked 65th nationally in FY2015 with federally financed expenditures of $196,010,000. In FY2016, 1,518 projects at UIC were awarded $313,280,019. UIC faculty, staff and students submit approximately 1,300 new studies for IRB review annually, along with thousands more amendments, continuing review applications, final reports, and yes, the occasional prompt report related to unanticipated problems or adverse events. UIC is a massive research entity. We are indeed “Chicago’s Public Research University.”
Our stature, however, comes with a great deal of responsibility. We must strive to conduct ethical research that benefits everyone equally. For this reason, we must have a robust Human Research Protection Program at UIC. And we do.
UIC has been accredited twice by the Association for the Accreditation of Human Research Protections Programs (AAHRPP), the gold standard for research ethics, quality and human protections. This year, we are in the process of obtaining our second five-year AAHRPP reaccreditation. We have successfully completed FDA audits and OHRP site visits. OPRS has grown from an office of six staff members in the mid-late 1990’s to an office of twenty-four. We have grown to three IRBs, each meeting twice per month. We have partnered with the Western IRB and the NCI Central IRB to review certain multi-center clinical trials. We are honored to be the IRB of record for the American Medical Association.
Most importantly, OPRS is proud to share responsibility for protecting human subjects with so many talented researchers. Together, challenges such as those related to HIPAA and federally-mandated data security requirements for Protected Health Information and other sensitive information have been managed. Together, we will navigate over the next several months the challenging process of enacting the much anticipated revisions to the Common Rule.
As President Clinton predicted, the past twenty years has seen tremendous change in the way research is conducted. For example, technology has significantly altered the way we gather, share, and analyze data. Today, we can access enormous amounts of data with just a few keystrokes. Genetic and DNA research has helped develop personalized treatment options for patients facing daunting medical conditions. It is a brave and complex new research world. As Jim Valvano noted, if we do not adapt, we will fall behind. In this newsletter, we will highlight some of the recent ways the UIC Human Research Protection Program has evolved and is evolving to meet new research demands and methodologies while still maintaining high ethical standards.
To all of you that I have gotten to know during my first six months at UIC, it is an honor to share responsibility for the protection of research participants with you. To those whom I have not had the opportunity to meet, I very much look forward to working with you as well.
I wish each of you every success in your research endeavors.
Contributed by Charles Hoehne
“I think if you look at exactly where you are, you can't really focus without looking back and forward at the same time.” -- Bill Laswell, Musician
First, a look back: The U.S. system for human research protections is based upon the Belmont Report. Written in 1979, the Belmont Report details three basic ethical principles for the conduct of human subject research: Respect for Persons, Beneficence and Justice.
These ethical principles serve as the foundation upon which all U.S. human research protection programs are built. If you have not read the Belmont Report – and applied it to your human subject research projects – please do so. The importance of having a solid ethical foundation for the conduct of research cannot be overstated.
In 1991, the Federal Policy for the Protection of Human Subjects (“Common Rule”) was published and codified (45 CFR 46) by 15 Federal departments and agencies. The Common Rule outlines the requirements for IRBs, informed consent and Assurances of Compliance. In short, because UIC receives federal human subject research funding, we are required to have a Human Research Protection Program consistent with the Common Rule.
Now, a look at today: The Common Rule has been in place for over a quarter of a century and has served human subject research well. Although updated in 2009, the Common Rule has not been significantly revised since 1991. However, as OPRS Director Elaine Fluder noted in her introduction to this newsletter, the nature of research has evolved significantly during the life of the Common Rule. It is time for the Common Rule to get a new set of tires.
In 2015, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) seeking comment on proposed revision of the Common Rule to enhance research protections while facilitating the conduct of research in today’s world. The common sense approach of the NPRM is to reduce regulatory requirements for minimal risk research, which will enable IRBs to focus efforts on research involving greater than minimal risk such as clinical trials and research involving investigational drugs and devices.
On January 19, 2017, after receiving significant public feedback to the NPRM, HHS released final revisions to the Common Rule with an implementation date of January 19, 2018. As per HHS, highlights of the final revisions include:
- The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement. Because of the complexities associated with enactment of this requirement, the compliance and effective date for this change will not occur until January 20, 2020.
- For studies utilizing stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. The use of de-identified data and/or biospecimens will, as under the current rule, be exempt from the regulations and in most instances informed consent will not be necessary.
- The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects, including studies that qualify for expedited review.
- Requirement that consent forms for certain federally funded clinical trials be posted on a public website.
On January 20, 2017 (Inauguration Day), the final revisions to the Common Rule were placed on hold to allow the new administration time to evaluate the revisions. Results of that evaluation are pending. As a result, it is unclear if the final revisions of the Common Rule will be implemented as is (most likely), revised (perhaps) or dropped altogether (very unlikely).
This uncertainty puts all Human Research Protection Programs – including UIC’s - in an awkward position. For example, as part of its Flexibility Initiative, OPRS was in the process of implementing three-year approval periods for non-federally funded minimal risk studies; however, if the revised Common Rule entirely eliminates the requirement for continuing review for minimal risk studies, implementing three-year approval periods is counter-productive. On the other hand, if the revised Common Rule requires annual continuing review for all research regardless of funding or risk level, then implementing a three-year approval period will potentially set investigators up for non-compliance with the revised Common Rule.
Now, a look forward: So, where do we go from here? National experts have read their tea leaves and believe the revised Common Rule will be implemented as proposed on – and not before - January 19, 2018. Based on this assessment, OPRS is actively working on changes to the UIC Human Research Protection Program policies and procedures to accommodate the revised rule. These changes, however, cannot be implemented until January 19, 2018.
OPRS will send out news blasts and additional newsletters as details emerge. In the meantime, please understand that there is a vast amount of work being done “behind the scenes” to prepare for a lot of exciting and much-needed change in human research protections.
Contributed by Charles Hoehne
The UIC Vice Chancellor for Research, Dr. Mitra Dutta, and the Office for the Protection of Research Subjects (OPRS) are pleased to inform the campus of a significant revision of the Initial Review Application for Social and Behavioral Sciences.
Highlights of the revised Initial Review Application: Social and Behavioral Sciences include:
- Incorporation of the necessary elements of a research protocol into the Initial Review application, thereby eliminating the need for a separate protocol document. It is hoped that problematic inconsistencies between the research protocol and application will no longer be an issue for researchers and the IRB.
- Substantial revisions to the Initial Review application that have reduced the length of the document from 28 pages (+ protocol) to 11 pages total!
- Significantly less duplication of effort for Social-Behavioral-Educational investigators submitting an application for initial IRB review.
- Investigators will no longer be required to make several regulatory determinations in the application such as selecting expedited review categories or requesting and justifying waivers/alterations of informed consent.
Simply put, less is more. The revised Initial Review Application for Social and Behavioral Sciences is 60% shorter than the previous version and will also serve as the research protocol. These changes will help streamline the submission and review processes, while promoting the ethical conduct of human subject research at UIC.
- Similar revisions of the Initial Review Application: Health and Biological Sciences are in development; however, because of the nature of Health and Biological Sciences research, a separate research protocol will continue to be required.
- Investigators should always utilize the current version of documents available through OPRS Live (beta) or download the documents from the Forms page of the OPRS website.
As always, if you have any questions regarding the UIC Human Research Protection Program – including revisions of the Initial Review Social and Behavioral Sciences application – please contact OPRS at 312-996-1711 or firstname.lastname@example.org.
Association for the Accreditation of Human Research Protection Programs (AAHRPP) Re-Accreditation Update
Contributed by Charles Hoehne
“Do right. Do your best. Treat others as you want to be treated.” -- Lou Holtz, Football Coach
While Lou Holtz’s quote is not directly related to human research protections, it does help explain why AAHRPP accreditation is so important to the UIC Human Research Protection Program. While the primary purpose of AAHRPP accreditation is to strengthen protections for research participants (do right), accreditation advances that objective (do your best) and helps build public trust and confidence in research (treat others as you want to be treated).
In other words, AAHRPP accreditation is the smart and right thing to do. Here is why:
AAHRPP-accredited institutions (http://www.aahrpp.org/learn/considering-accreditation/value-of-accreditation):
- Earn the respect and meet the expectations of their peers. Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Increasingly, organizations that have not earned AAHRPP accreditation are being asked, “Why not?”
- Play a leadership role in collaborative efforts. AAHRPP accreditation instills trust among research partners and, therefore, is becoming a requirement for collaboration. AAHRPP-accredited organizations often insist that accreditation status be a determining factor in decisions on external IRB review.
- Gain a competitive edge with sponsors and other funders, who recognize that AAHRPP-accredited organizations have more efficient operations, provide more comprehensive protections, and produce high-quality data. Virtually all sponsors require independent IRBs to be AAHRPP accredited. Some sponsors also consider accreditation status when choosing investigative sites.
- Reduce the risk of non-compliance. AAHRPP accreditation signifies that an organization has built the necessary infrastructure for a quality human research protection program (HRPP). AAHRPP-accredited organizations tend to have more streamlined, effective policies and procedures. These organizations also typically keep better records and are more likely to avoid costly shutdowns and problematic inspections.
- Enhance their standing with U.S. federal agencies, which are more likely to target non-accredited organizations for inspections. Federal agencies have begun seeking AAHRPP accreditation for their own HRPPs. The central IRB of the National Cancer Institute earned AAHRPP accreditation in December 2012.
- Benefit from a common commitment to continuous quality improvement. AAHRPP-accredited organizations share innovative practices and collect data to help establish benchmarks and assess quality improvement. AAHRPP compiles and distributes these data to aid organizations, sponsors, government agencies, and participants in identifying and promoting high-quality practices.
UIC became the first non-VA Chicagoland institution to gain AAHRPP accreditation on March 12, 2010. UIC obtained reaccreditation for a full five years on September 13, 2013. We are now in the process of obtaining our second reaccreditation.
Reaccreditation involves four key steps:
- Application preparation: The first step in earning accreditation is to conduct a self-assessment, to evaluate the Human Research Protection Program and make improvements. An application includes a seven-page application form, a program overview (seven-page maximum) and copies of documents used by the HRPP.
UIC completed this step in the spring of 2017.
- On-Site Evaluation: A team of experts reviews the materials and schedules an on-site visit. During the visit, the team evaluates the program's performance with respect to the AAHRPP Accreditation Standards.
UIC is in the process of scheduling the site visit with AAHRPP. It is expected that the site visit will occur in late 2017 or early 2018.
- Council Review: AAHRPP's Council on Accreditation reviews the application, Draft Site Visit Report, and determines accreditation status.
- Notification of Accreditation Status.
It is important to understand that AAHRPP doesn’t just accredit IRBs. Instead, AAHRPP evaluates the entire Human Research Protection Program. The site visit will therefore involve not only the IRB and OPRS staff, but also faculty, staff and student researchers as well as administrative personnel.
OPRS will provide more detail and additional information in preparation for the site visit. Please stay tuned.
Contributed by Brandi Drumgole
The December 2016 OPRS Newsletter (http://research.uic.edu/dec2016#new) included an article detailing a new NIH policy for NIH-funded studies involving non-exempt human subject research. Effective January 25, 2018, a single Institutional Review Board (sIRB) will be used to conduct the ethical review required by the Department of Health and Human Services (DHHS) regulations for the protection of human subjects. Yes, this date differs from the revised Common Rule requirement. The date for compliance for all other multi-institutional research studies is January 20, 2020.
In response to the new NIH policy, OPRS has developed internal policies and procedures (“Registration of a Protocol, Continuing Review, Amendment, and Study Closure by an External IRB or Central IRB”) designed to facilitate this requirement.
Additionally, to help investigators subject to this NIH requirement navigate the sIRB process, an FAQ has been developed and can be found on the OPRS website: http://research.uic.edu/irb/investigators-research-staff/preparation-submission.
Please note the following:
- The FAQs provide a brief overview of what this new process involves, although certain aspects are still under review and development.
- This process is specific to NIH funded research only, where UIC will cede IRB review and rely on the reviewing IRB.
- New forms have been created that are specific to this new process and are currently under review by associates who are a part of the SMART IRB (see below for additional information regarding the SMART IRB). Once these forms have been finalized, they will be made available on the OPRS website and will be integrated into OPRS Live.
NIH Single IRB mandate and the SMART IRB
OPRS has received several questions regarding the new NIH Single IRB mandate and its relationship to the SMART IRB.
The SMART IRB is a Streamlined, Multisite, Accelerated Resource, a Trials Reliance platform, designed to harmonize and streamline the IRB review process for multisite studies. UIC is a participating institution under the SMART IRB Master Agreement. SMART IRB has developed an Online Reliance System that can be used to request, track, and document reliance agreements for participating institutions. It is important to note that SMART IRB is not an IRB and does not review research proposals. The platform is a mechanism whereby institutions can establish relationships for identifying an IRB of record for multi-site research.
Joining and using the SMART platform is free; however, UIC does have a fee schedule for coordination and oversight of the research associated with the use of an external IRB.
For additional information regarding SMART IRB, visit the following website: https://smartirb.org/
For additional information regarding the Single IRB, refer to the FAQ located on the OPRS website: http://research.uic.edu/irb/investigators-research-staff/preparation-submission.
If you have any questions regarding the NIH single IRB mandate and/or SMART IRB, please contact me, Brandi Drumgole, at 312-996-0548 or email@example.com.
Contributed by Charles Hoehne
- OPRS is in the process of updating the UIC Unanticipated Problems and Other Events Requiring Prompt Reporting Policy. Highlights of the revised policy will include:
- Investigators will be required to determine whether the unanticipated problem is related to the research.
- Two (2) types of events will be moved from reporting within 15 business days to 5 business days:
- New information indicating an unexpected change to the risks or benefits of the research (i.e., an unanticipated problem)
- External adverse events that are i) unanticipated, ii) indicate research associated with a greater risk of harm to participants or others than previously known, and iii) more likely than not to have been caused by the procedures associated with or subject’s participation in the research. An analysis from the sponsor, coordinating center, or DSMB/DMC supporting that the event or problem meets the three (3) criteria above must be included.
- Removal of the VA Collaborative IRB (IRB #4). Addition of CHAIRb
- The OPRS offices are undergoing a massive remodeling project. Construction is expected to last at least through the remainder of the year. OPRS is, however, open for business, and construction is not expected to significantly impact OPRS daily operations. OPRS is still located in AOB Suite 203. Follow the signs, pardon our dust!
- OPRS staff has heard from some investigators that they fear the electronic submission process, OPRS Live, will impede direct communications between OPRS staff and faculty, staff and student researchers. OPRS Live should not in any way make it more difficult to contact and communicate with OPRS staff:
- For non-IRB specific questions, please either call OPRS at 312-996-1711 or send an email to us at firstname.lastname@example.org.
- For IRB-specific questions, please contact OPRS staff supporting the IRB. Link to OPRS Directory (http://research.uic.edu/directory?display=unit&unit=34&first=&last=&search=1).
- For questions related to a “Request for Modifications and/or Additional Information” letter, please contact the OPRS staff member who sent the letter. Contact information is provided on the last page of the letter.
- For technical questions related to OPRS Live: email@example.com
- General, non-technical questions about OPRS Live can be sent to firstname.lastname@example.org.
- Personnel on protocols can see a summary of protocol information in the myResearch Portal. UIC users that are personnel on a protocol and have access to OPRSLive will now see summary data for their IRB protocols displayed in the myResearch Portal. For more information about this update, view it and other updates here https://web.uillinois.edu/start_myresearch/portal_updates/