Message from the Director
Spring time! The weather is finally warming up (well, sort of), the Cubs and Sox are back on the field, and playoffs have taken center stage. It is a great time of the year to be in Chicago.
This is particularly true at UIC where it is graduation season. To all of our graduates - On behalf of the Vice Chancellor for Research, Dr. Mitra Dutta, the IRBs and the entire OPRS staff, we offer our heartfelt congratulations! By fulfilling the requirements for graduation, you have proven your resolve to accomplish a tremendous goal. At OPRS, we want to help ensure a successful transition to your next academic and/or professional stage.
We therefore would like to remind you of the following:
- All investigators conducting human subject research must formally close out their research protocols by submitting a Final Report to OPRS. Failing to close out a research study represents non-compliance with federal regulations and institutional policy.
- Research data should not be transferred or removed from UIC without proper IRB and departmental approval. If you have any questions regarding how to proceed with a transfer of research data from UIC to another institution, please contact OPRS at 312-996-1711 or firstname.lastname@example.org.
As we move forward, it is my pleasure to inform UIC investigators that the campus will begin transitioning to an electronic process for submitting research protocols for IRB review. Details regarding this transition are included in this newsletter.
Research data security is always a fundamental concern for investigators conducting human subject research, and Phil Reiter, Executive Director of IT for the College of Pharmacy, has contributed an article regarding best practices for Email recruitment of research subjects.
Finally, federal research funding serves as the foundation for the UIC human subject research enterprise. In this newsletter, Charles Hoehne, OPRS Assistant Director for Education and Training, has provided an overview for how to appropriately handle any changes in scope of research for federally funded research.
We hope the newsletter is helpful and informative.
Contributed by Charles Hoehne
As OPRS Assistant Director for Education and Training, it is my pleasure to conduct numerous Investigator Training sessions around campus. There is little doubt which question I am asked the most frequently: “When will we be able to submit applications to the IRB electronically?” OPRS is pleased to announce that electronic submission of research protocols for UIC IRB review will soon be a reality! The OVCR IT Team has been working on a system enabling Investigators to finally go paperless. OPRS Live will soon be available to our investigators.
Please understand, however, that converting from a paper to an electronic submission process is a monumental task involving a fairly steep learning curve. In preparation, OPRS has begun a reduced service schedule for accepting walk-in (paper) submissions in order to accommodate the processing of electronic submissions. OPRS is open for walk-in submissions (including convened submissions) on Mondays, Wednesdays, and Fridays from 8:30am to 4:30pm. OPRS will be closed to walk-in submissions on Tuesdays and Thursdays.
As always, the OPRS staff is available to answer investigator questions Monday – Friday, 8:30am – 5:00pm.
OPRS will provide additional information on the exact roll out dates for OPRS Live when they become available. Stay tuned!!!
Contributed by Phil Reiter
One of the most important components of any human subject research study is recruiting participants that meet the study criteria you are evaluating. In today’s day and age, recruitment undoubtedly involves technology, and we must be sensitive to enabling research and recruitment while balancing the need for the security and protection of research participants.
It is understood that you will need to use technology to recruit, and offer these tips to help you recruit participants through electronic means safely:
- If email must be used for recruitment, be certain to inform potential participants to not respond with personal health information (PHI) in a response which they wish to remain private.
- If possible, offer a solution which allows encrypted communication between the PI and potential participant.
- Inform participants of the risks inherent with their electronic response, offer alternative options such as telephone to contact you if any response may include private or confidential information or PHI.
- Consider using a University-recommended survey tool such as REDCap or Qualtrics to securely recruit participants using a secured survey. You can even reduce risk by sending the email directly from the survey to get input directly back into the survey, with encryption in both directions.
Link to REDCap: http://www.ccts.uic.edu/repository/redcap-research-electronic-data-capture
Link to Qualtrics via ACCC: http://accc.uic.edu/tag/qualtrics
Additionally, use caution to avoid products and services that do not have a business associate agreement (BAA) in place to protect information, or end-to-end encryption. One common example of a service to avoid is a non-UIC email account, such as a free email account. Those accounts do not have a formal agreement or BAA in place with the University and may not offer the security and protection needed for research participants.
Contributed by Charles Hoehne
As per NIH Grants Policy Statement (10/13):
“Before changing the scope of your research, you need approval from your grants management specialist. In general, the Principal Investigator may make changes in the methodology, approach, or other aspects of the project objectives. However, the grantee must obtain prior approval from the NIH awarding institute/center for a change in scope. A change in scope is a change in the direction, aims, objectives, purposes, or type of research training, identified in the approved project. The grantee must make the initial determination of the significance of a change and should consult with the Grants Management Officer/Specialist as necessary.”
Potential indicators of a change in scope include, but are not limited to, the following:
- Change in the specific aims approved at the time of award.
- Change from the approved involvement of human subjects that would result in an increased risk. This includes:
- An addition or change that would result in changing the overall human subjects or clinical trial designation of the award from No to Yes;
- The new inclusion of subject populations that are covered by additional regulatory protections under 45 CFR 46;
- Any change to the study protocol that would increase the risk level for subjects;
- New information indicating a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment.
- Shift of the research emphasis from one disease area to another.
- A clinical hold by FDA under a study involving an IND or an IDE.
- Application of a new technology, e.g., changing assays from those approved to a different type of assay.
- Change in other senior/key personnel not specifically named in the Notice of Award.
- Significant rebudgeting, whether or not the particular expenditure(s) require prior approval.
- Incurrence of research patient care costs if costs in that category were not previously approved by NIH or if a grantee desires to rebudget additional funds beyond those approved into or rebudget funds out of the research patient care category.
Additional examples of change in scope of research, as well as the entire policy (Subpart A: General – File 6 of 6, section 126.96.36.199), are available via the following link: http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch8.htm
Related Procedures at UIC:
- The PI must obtain approval from the grants management specialist before making changes in scope of research.
- The IRB requires submission of written approval by grants management specialist in order to consider review of amendments involving a change in scope.
FAQ’s related to the Change in Scope of Research Policy:
Q1: Does this policy apply to all research?
A1: No. This policy only applies to federally funded research.
Q2: Is approval from the grants management specialist always required prior to submitting an amendment to federally funded research to OPRS for IRB review?
A2: No. In general, the PI may make changes in the methodology, approach, or other aspects of the project objectives. However, the grantee must obtain prior approval from the NIH awarding entity for a change in scope.
Q3: What if I am not sure if an amendment represents a change in scope of research?
A3: When in doubt, contact your grants management specialist.
Q4: So, as long as my grants management specialist approves the change in scope of research, I don’t need IRB approval?
A4: No! Prospective IRB approval of all amendments is required, regardless of the nature of the amendment. For changes in scope of federally funded research, prospective approval from the grants management specialist is required in addition to the need for prospective IRB approval.
Contributed by Charles Hoehne
- …Pilot and feasibility studies, regardless of the number of subjects, require the same scrutiny as full-scale research projects and must be submitted for IRB review and approval. Pilot and feasibility studies should be identified as such in the IRB application. Investigators should obtain informed consent utilizing the IRB-approved consent process and document. The consent document must indicate the study is a pilot.
2. …UIC has a a campus-wide Information Technology Security Program:
“The purpose of this Program is to inform all campus members of their responsibilities for securing University informational assets and maintaining safe access to them. One could consider this Program as being similar to the “Rules of the Road” for all drivers, cyclists, and pedestrians. Just as we all have responsibilities when we use the roads, we also have responsibilities when we are accessing, storing, and transmitting data in the course of our jobs.”
The Program, which includes rquirements for safeguarding all UIC data including data collected for research purposes, has been approved by the UIC Information Technology Governance Council (ITGC) – Infrasec Committee, the UIC Deans Council, the UIC Chancellor and Vice Chancellor Committee, and the UIC Faculty Senate. The UIC IT Security Program was enacted effective July 1, 2014.
To help UIC faculty, staff and students comply with the Program, each college has designated an IT Admininstrator to serve as a liason to the ITGC. Your IT admininstrator is available to help secure your data and to help you develop a data security plan for your research studies.
Link to the Information Technology Security Program Policies: http://security.publish.uic.edu/policies/
3. …The number of submissions OPRS received during the 2014 calendar year?
- Initial Review Applications: 1247
- Continuing Review Applications: 1811
- Amendments: 2707
- Final Reports: 464
- Responses to requests for modifications: 2154
- Responses to IRB deferrals: 88
- Unanticipated Events: 643
- Total submissions: 9114
4. …OPRS submission deadline dates apply only to protocols being submitted for convened review by the full IRB. There are no deadline dates for exempt and expedited applications. Despite this fact, many investigators race to submit exempt and expedited applications to OPRS on “deadline” days. Because OPRS receives about 100 new and 750 total applications monthly, deadline days at OPRS can resemble rush hour on the Eisenhower. By avoiding deadline days for exempt and expedited applications, you can save yourself time and help OPRS process all submissions efficiently.