Sep, 2017 - Printable Version
Message from the Director
AAHRPP is coming to UIC! It seems that we blinked and summer has past us by. Students have returned to the classroom, the weather has a chill in the air, and it is time to prepare for our Association for the Accreditation of Human Research Protection Programs (AAHRPP) re-accreditation site visit, which will occur November 13 and 14, 2017. As you may recall, the June 2017 Newsletter included an article about AAHRPP; however, as we prepare for the site visit it will be important for research Faculty and Staff to become more familiar with this process.
What is AAHRPP?
AAHRPP is an independent not for profit accrediting body that evaluates human subject (or research) protection programs (HSPP or HRPP) to determine whether the HSPP meets their high standards. AAHRPP promotes high-quality ethically sound research.
Why is AAHRPP Accreditation important?
Institutions that are AAHRPP accredited are able to provide an assurance to research subjects, investigators, the general public, sponsors, and governmental regulatory agencies that the HSPP not only follows the required rules and regulations set before them but goes above those minimum requirements with a goal of demonstrated commitment to scientifically and ethically sound research.
I’m an investigator, why should I care?
As an investigator, you may be asked to attend an interview to describe your interactions with the rest of the HSPP. The site visitors may review your protocol file within the OPRS or your grant/contract may be reviewed in ORS. The AAHRPP accreditation process affects the entire HSPP including (but not limited to) investigators, key research personnel, IRB members, OPRS, the Institutional Official, the Conflict of Interest Office, the Investigational Drug Service, the Institutional Biosafety Committee, ORS, University Counsel, and more. Our research does not occur in silos, neither does our HSPP.
You have my attention, now what?
When we receive the draft agenda from AAHRPP, we will reach out to the selected interviewees to schedule a meeting or two to help prepare you for the site visit. We will also release additional information via the OPRS website, emails, and/or additional newsletters. If you have any questions or would like additional information, please contact Barbara Corpus at 3-8457 or email@example.com and she will be happy to answer any questions regarding the accreditation process and site visit with you.
In this newsletter you will find exciting news about changes that OPRS has recently implemented to help streamline the submission and review process.
I wish each of you every success in your research endeavors.
Contributed By Charles Hoehne and Barbara Corpus
The UIC Vice Chancellor for Research, Dr. Mitra Dutta, and the Office for the Protection of Research Subjects (OPRS) are pleased to introduce a new and improved Health and Biological Sciences Initial Review Application. The application has been revised to remove some of the duplicative information that is found within the protocol document and, thus, removed the potential for inconsistencies.
Please note that the requirement to include a separate protocol document has not changed.
It is hoped that this and the other changes listed below will promote efficiencies for the user, OPRS and the IRB.
- The application has been reduced in length from 28 to 12 pages!
- The layout has been revised to group questions of a similar nature and to follow a more logical progression.
- The lay summary has been removed and questions regarding data collection, data storage and security, and data sharing have been revised.
- Questions regarding the Expedited Review Categories have been removed as the IRB will determine which category/categories apply to the research.
- The informed consent and HIPAA compliance sections have been completely revised and the justifications for waivers have been removed. The IRB will determine which waivers/alterations may apply, based on a detailed description of the consent process.
When submitting your Initial Review proposal, download the application and applicable appendices from OPRS Live to ensure that you are completing and uploading the current versions for review. Applicable documents are available for download in the “Attachments” tab in OPRS Live after completing the Smart Form screening questionnaire. Submissions will be returned if the current version of forms are not submitted for review.
The revised Initial Review Application for Health and Biological Sciences is significantly shorter than the previous version. These changes should help streamline the submission and review processes, while promoting the ethical conduct of human subjects research at UIC.
As always, if you have any questions regarding the UIC Human Subjects Protection Program – including revisions of the Initial Review Health and Biological Sciences application – please contact OPRS at 312-996-1711 or firstname.lastname@example.org.
Contributed by Barbara Corpus and Teresa Johnston
Department Head approval will no longer be required for the following OPRS Live submissions:
- Continuing Review Applications
- Final Reports
- Amendments involving a change in Principal Investigator
- Claim of Exemption Applications
OPRS has revised its policy with respect to the signatory requirements for these submission types in an effort to streamline the submission process and remove unnecessary administrative burden.
Department Head sign-off will continue to be required for all Initial Review submissions. All other submission types will now be routed directly to the OPRS front desk. It is important to note that student submissions will still require Faculty Sponsor approval.
- Any in que submissions may still require Department Head sign-off before being routed to OPRS.
- Department Heads will continue to be copied on most OPRS letters to investigators, to help keep them aware of the departmental research activities.
As always, if you have any questions regarding the UIC Human Subjects Protection Program – including this OPRS policy update – please contact OPRS at 312-996-1711 or email@example.com.
Contributed by Charles Hoehne
OPRS is pleased to announce the following enhancements of the OPRS electronic submissions system, OPRS Live.
1. IRB-Approved Stamped Documents are now available online through OPRS Live:
After receiving notification of IRB approval via email, the Principal Investigator (PI), along with designated key research personnel, will be able to access the stamped IRB approved recruitment and consent documents via OPRS Live. Stamped documents uploaded to OPRS Live can be accessed by investigators using the following steps:
- Go to Active Protocols
- Click on the protocol number from the list of active studies
- Click on the “Approved Documents” tab in the dark blue band
- Documents will be available for download
While stamped documents will no longer be emailed to the PI, OPRS believes this much requested enhancement will make the documents readily available to members of the research team as designated by the PI throughout the life of the protocol.
- To facilitate this enhancement, investigators should upload supporting documents such as recruitment and consent documents individually rather than embedding them into other documents such as the research protocol (Health and Biological Sciences) and/or merging multiple documents into one upload. Tips for formatting file names for OPRS attachments are available via this link: http://research.uic.edu/formatting-file-names-oprs-live-attachments
- By definition, exempt research is not subject to the Common Rule approval requirements as defined under 45 CFR 46.111 and 45 CFR 46.116. OPRS, therefore, does not stamp exempt research documents as being IRB approved.
2. Merged Documents Enhancement:
In response to Faculty Sponsor, Department Head and IRB Member feedback, OPRS Live now includes an option for uploaded documents to be opened and viewed as one merged PDF document. While documents downloaded into OPRS Live by the PI or designee can still be viewed individually, all uploaded documents can now also be viewed together with a click of the “Download Merged PDF” button. Once the merged PDF document has been downloaded, bookmarks are available to help viewers navigate between the documents.
3. OPRS Live Enhancement: New PDF forms format
Historically, OPRS has sent IRB communications to investigators via email as RTF documents. Several investigators (primarily Mac users), however, have difficulty opening such documents. As a result, OPRS will soon send all IRB communications via email as PDF documents. This change will eliminate the RTF document issue while continuing to allow investigators to copy and paste the content of the letters into a Word document when responding to IRB requests for modifications and/or additional information.
Contributed by Charles Hoehne
As per institutional policy, the Principal Investigator is ultimately responsible to ensure that all individuals involved in the research receive both adequate training, including human subjects protection training, and oversight in accordance to the roles these individuals perform in the research. The goal of this article is to help Principal Investigators manage this responsibility.
OPRS requires the following UIC Investigator Training:
Initial Investigator Training (Investigator 101):
- Should be completed online through CITI. The following course is completed online: CITI Human Subjects Research (HSR) BASIC Course
- Biomedical (Biomed) Basic HSR Course; or
- Social-Behavioral-Education (SBE) Basic HSR Course
- The CITI Human Subjects Research (HSR) Basic Courses are the ONLY beginning programs that qualify.
- Current Language Availability: English, French, Khmer, Korean, Portuguese, Russian, Spanish, Tamil, Vietnamese
- One of the key advantages of CITI training is that it is generally accepted at other institutions. If the CITI HSR Basic Course was completed at a non-UIC site, please forward a copy of the completion certificate to OPRS so that it can be evaluated for consistency with UIC Investigator Training requirements: firstname.lastname@example.org.
HIPAA HSPP Training:
- Is ONLY required for investigators and key research personnel who handle UIC protected health information (PHI).
- HIPAA taken at University of Illinois Hospital & Health Sciences System (UI Health) or at other institutions WILL NOT qualify.
- Investigators must complete the following online HIPAA course: CITI Information Privacy and Security (IPS) Health Privacy (HIPAA) Basic Course
- Current Language Availability: English, Korean
Continuing Investigator Education:
- Continuing Education requirements for UIC Investigators have recently been revised:
- Previous Requirement: Two hours of continuing education every two years.
- Current Requirement: Two hours of continuing education every three years.
- OPRS awards two hours of continuing education credit for completion of one of the following CITI Human Subjects Research (HSR) REFRESHER courses:
- CITI Human Subjects Research (HSR) Biomedical (Biomed) Refresher Course
- CITI Human Subjects Research (HSR) Social-Behavioral-Education (SBE) Refresher Course
- Language Availability: English, French, Khmer, Korean, Portuguese, Russian, Spanish, Tamil, Vietnamese
Online Training Tips:
- To view your training records (Initial, HIPAA HSPP, and Continuing Education), log in to OPRS Live (https://oprslive.ovcr.uic.edu/), and click on the Educational Status tab to view your record.
- Link to CITI Homepage: https://about.citiprogram.org/en/homepage/
- When registering for CITI courses, you must indicate you are affiliated with “University of Illinois, Chicago.”
- There is no individual fee for users completing CITI courses to satisfy UIC Investigator Training requirements.
- When registering for and completing CITI training, please use your UIC email address. If you utilize your personal email address (e.g., Gmail, Hotmail, or similar), and then register in OPRS Live utilizing your UIC email address, the electronic system may not be able to match your training record to your role at UIC. If this occurs, there will be a delay in your ability to access OPRS Live and/or conduct human subjects research at UIC.
- CITI sends batched completion reports to OPRS overnight. The completion reports are then automatically uploaded into the OPRS database. While not immediate, this process is significantly faster and more accurate than manual updates.
- For purposes of consistency and efficiency, OPRS will eliminate Learning Management System (LMS) online investigator training courses effective October 2, 2017. If you have registered for an LMS course, you must complete the course prior to October 2, 2017.
Additional information regarding UIC Investigator Training requirements is available on the OPRS website: http://research.uic.edu/compliance/irb/education-training
As always, if you have any questions regarding the UIC Human Subjects Protection Program – including Investigator Training requirements – please contact OPRS at 312-996-1711 or email@example.com.
Contributed by OVCR
For those of you new to UIC, or for those of you who would like a refresher on the resources offered by OVCR to the research community, Dr. Dutta would like to give you the opportunity to meet with staff from OVCR. We have set up the following brown bag lunches and encourage you to attend as many as you like. OVCR will provide beverages and we encourage you to bring your lunch to these informal discussions. Each session will consist of a brief presentation followed by the opportunity to ask questions and discuss issues. In order to help us plan, we ask that you RSVP for each session at http://research.uic.edu/brownbagRSVP .
- OVCR Overview - Meet with Dr. Mitra Dutta, Vice Chancellor for Research:
Wednesday, September 20, 12:00-1:00 p.m., 307C AOB
- OVCR Overview - Meet with Dr. Mitra Dutta, Vice Chancellor for Research:
Thursday, September 21, 12:00-1:00 p.m., 1043 ERF
- Research Involving Animals, rDNA and Infectious Agents - Meet with Mary Bowman, Director, to learn more about policies and procedures and training needed to begin your research:
Wednesday, September 27, 12:00-1:00 p.m., 307C AOB
- Research Integrity - Meet with Mark Grabiner, Research Integrity Office to discuss research integrity policies and procedures related to research and publication:
Wednesday, October 4, 12:00-1:00 p.m., 307C AOB
- Research Involving Human Subjects - Meet with staff from the Office for the Protection of Human Subjects to learn more about policies, OPRS Live and training needed to begin your research:
Wednesday, October 11, 12:00-1:00 p.m., 307C AOB
- Research Development Services - Meet with Sarah O’Brien and Mary Frances Miley to discuss RDS, Limited Competitions and finding funding:
Wednesday, October 18, 12:00-1:00 p.m., 1043 ERF
- Conflict of Interest - Meet with Jacquelyn Jancius, Director to discuss RNUA, FCOI and other topics related to Conflict of Interest:
Tuesday, October 31, 12:00-1:00 p.m., 1043 ERF
- Office of Research Services - Meet with staff from ORS to learn more about pre-award and non-financial post-award activities:
Wednesday, November 8, 12:00-1:00 p.m., 1043 ERF
- Grants and Contracts - Meet with Karen McCormack, Interim Director to discuss post-award activities including financial questions:
Wednesday, November 15, 12:00-1:00 p.m., 307C AOB
Contributed by Charles Hoehne
Consistent with federal mandates and research best practices for human subjects research, OPRS has implemented a plan to assess and improve the quality, effectiveness, and compliance within the Human Subject Protections Program (HSPP). One component of the Quality Improvement Program (QIP) is the QIP-Toolbox. The QIP Toolbox includes logs, checklists and guidance to assist with the documentation of clinical research activities in a GCP compliant manner. Information about the QIP and the QIP Toolbox is available online: http://research.uic.edu/compliance/qip.
For additional information about the QIP and related policies, please contact the following OPRS staff:
Associate Director of Research Compliance
Assistant Director of Research Compliance
- The NIH sIRB effective date is January 25, 2018: The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board of Record for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46.
- The OHRP sIRB effective date is January 20, 2020: For all other multi-site non-exempt cooperative research the compliance date [revised common rule- 45 CFR 46.114 (b)] is January 20, 2020.
Help with the sIRB process is available to UIC investigators through SMART IRB. The SMART IRB is a Streamlined, Multisite, Accelerated Resource for Trials Reliance platform, designed to harmonize and streamline the IRB review process for multisite studies. However, SMART IRB is not an IRB or ethics review board. In addition, SMART IRB has developed an Online Reliance System that can be used to request, track, and document reliance agreements for participating institutions. UIC is a participating institution under the SMART IRB Master Agreement. For additional information:
- OPRS has created a new tab entitled, “What is SMART IRB?”: http://research.uic.edu/irb/investigators-research-staff/preparation-submission
- Link to the SMART IRB website: https://smartirb.org/
- If you have any questions or would like additional information, please contact Brandi Drumgole at 312-996-0548 or firstname.lastname@example.org and she will be happy to answer any questions regarding sIRB’s or SMART IRB.