COVID-19 & Research Restart

OVCR Research-Related Updates Regarding COVID-19 Emergency and Research Restart

COVID-19 OPRS/IRB Archives

Date Updates
June 10, 2020 FAQ: Is it possible to obtain informed consent remotely due to the COVID-19 Public Health Emergency? In an effort to maintain social distancing during the COVID-19 Public Health Emergency, face-to-face informed consent procedures are limited to therapeutic clinical trials.   As a means of offering flexibility and minimizing non-essential contact, investigators conducting therapeutic trials may utilize a remote consent process for the purpose of screening potential research participants during this public health emergency.   The remote consent process may be used to conduct screening procedures related to therapeutic clinical trials. This allows the investigator/designee and potential subject/legally authorized representative (LAR) to engage in the informed consent process via telephone, conference call, videoconference, telemedicine, or other method that has been prospectively approved by the UIC IRB.   The remote consent process cannot be used for research that involves administration of drugs, biologics, or devices without an in-person clinic visit (e.g., research in which study drugs would be prescribed and sent to the subject without any physical assessments). Research subjects will still need to sign the full consent form prior to receiving any of the above therapeutic intervention.   It is important to note that the plan to utilize a remote consent process must be prospectively reviewed and approved by the IRB at the time of initial review or via an amendment for studies already approved by the IRB. The submission must clearly describe the method (e.g., teleconference, videoconference, etc.) that will be used to conduct the remote consent process, request an alteration of consent to conduct the consent process in this manner, and confirm that the following procedures will be followed.   The procedures for the remote consent process are as below:
  • The informed consent document must be sent (e.g., via email, mail, fax) to the potential subject/LAR in advance of the remote consent process. The conversation may not occur if the potential subject has not received the consent document, as they will need to refer to the document during the discussion.
  • After verifying that they are speaking with the correct individual, the investigator/designee discusses the study with the potential subject either via telephone or video conferencing (e.g., telephone, conference call, videoconference, telemedicine, etc.).
    1. The conversation must include a witness. The rationale for the witness is to ensure that a third party has heard both sides of the conversation and observed the potential subject consenting to participating in the research. Since the witness does not need to be impartial and to ensure that the witness is present for the full conversation, it is preferred that the witness be someone selected by the person obtaining informed consent rather than a member of the potential subject’s household.
    2. The investigator/designee must document the conversation, including (at a minimum): the date and time the conversation occurred, how it occurred (e.g., telephone, video conference), the name of the witness and any other participants, confirmation that the subject/LAR received the informed consent document, and confirmation of verbal informed consent to conduct the screening.
  • When the subject arrives at the clinic/hospital for the research intervention, consent must be re-affirmed and signatures of the subject/LAR and investigator/designee be obtained.
  • The final informed consent document must be filed in the designated investigator/research file location.
  • No therapeutic interventions may occur until all steps of the informed consent process are complete.
  For all FAQs, please go to FAQs: Coronavirus (COVID-19) and Human Subjects Research at UIC.
June 3, 2020 FAQ: Is it possible to obtain informed consent remotely due to the COVID-19 Public Health Emergency? (June 3, 2020) In an effort to maintain social distancing during the COVID-19 Public Health Emergency, face-to-face informed consent procedures are limited to therapeutic clinical trials. As a means of offering flexibility and minimizing non-essential contact, investigators conducting therapeutic trials may utilize a remote consent process for the purpose of screening potential research participants during this public health emergency. This allows the investigator/designee and potential subject/legally authorized representative (LAR) to engage in the informed consent process via telephone, conference call, videoconference, telemedicine, or other method that has been prospectively approved by the UIC IRB. The remote consent process cannot be used for research that involves administration of drugs, biologics, or devices without an in-person clinic visit (e.g., research in which study drugs would be prescribed and sent to the subject without any physical assessments). Research subjects will need to sign the full consent form prior to receiving any of the above therapeutic interventions. It is important to note that the plan to utilize a remote consent process must be prospectively reviewed and approved by the IRB at the time of initial review or for via an amendment for studies already approved by the IRB. The submission must clearly describe the method (e.g., teleconference, videoconference, etc.) that will be used to conduct the remote consent process. For any questions about this process please contact the OPRS. For all FAQs, please go to FAQs: Coronavirus (COVID-19) and Human Subjects Research at UIC.
May 29, 2020 Information provided on April 7, 2020 remains current
May 22, 2020 Information provided on April 7, 2020 remains current
May 14, 2020 Information provided on April 7, 2020 remains current
May 8, 2020 Information provided on April 7, 2020 remains current
May 1, 2020 Information provided on April 7, 2020 remains current
April 24, 2020 Information provided on April 7, 2020 remains current
April 17, 2020 Information provided on April 7, 2020 remains current
April 10, 2020 Information provided on April 7, 2020 remains current
April 7, 2020 COVID-19 Clinical Research Projects A COVID-19 Research Advisory Committee has been established to help investigators address the operational needs of UI Health and clinical research protocol feasibility during the COVID-19 epidemic. The review committee will assess studies balancing research significance and the potential for immediate clinical benefit, feasibility of completion, potentially competing trials in UI Health settings, and the proposed protocol’s operational feasibility for UI Health (eg, burden on nursing, physicians, PPE, etc) during emergency operations. The COVID Research Advisory Committee will make recommendations to approve, modify or disapprove research protocols to the UI Health Chief Medical Officer, and UI Health Incident Command, who have final authority over research study implementation at UI Health. The rapid COVID-19 Research Advisory Committee review process will start when investigators submit or inquire about submission of COVID-19-related studies for IRB review. IRB review of protocols will be separate but coordinated to maintain rapid reviews. The committee first met April 6th, 2020 and will meet weekly or as needed to facilitate rapid implementation of COVID-19-related interventions. Contact (Acting) Associate Vice Chancellor for Research Jonathan Klein at jonklein@uic.edu for questions.
March 31, 2020, 10am FAQs: Coronavirus (COVID-19) and Human Subjects Research at UIC
March 20, 2020 Information provided on March 20, 2020 remains current
March 20, 2020 FAQs: Coronavirus (COVID-19) and Human Subjects Research at UIC
March 17, 2020 Human subjects research studies that are necessary for clinical patient care may continue according to UI Health policies and recommendations https://hospital.uillinois.edu/news/covid-19. Other human subjects’ research activities are on hold until further notice, unless such activities can be conducted remotely, without in-person visits. The Office for the Protection of Research Subjects (OPRS) is triaging submissions through OPRS Live to prioritize emergency research (e.g., compassionate use protocols), amendments to protocols impacting staff and subject safety and continuing reviews necessary to keep projects open. PIs should maintain a log of studies/activities placed on hold and report these to the IRB at the next Continuing Review. Temporary modification of study procedures may be made at the PI’s discretion and a Prompt Reporting form should be submitted through OPRS Live. PIs must continue to follow all UI Health and University data security policies, and submit prospective amendments to the IRB for any requests to change their current IRB-approved data security plan. See the latest OPRS FAQs for more information.
March 16, 2020 Clinical research protocols that use patient care areas within UI Health facilities MUST also comply with all restrictions for patient care area access. Personal protective equipment is in short supply and will only be available for clinical care delivery; any research affecting therapies will need to be closely coordinated with patient’s care needs. The UIC Office for the Protection of Research Subjects (OPRS) has developed FAQs for COVID19 and research studies to help Principal Investigators modify study procedures to mitigate any real or apparent harm to research subjects and study personnel. When possible, a request for change in protocols or protocol deviation requests should be prospectively submitted to the IRB. However, IRB response to requests may be slowed by reduced IRB staffing and by the volume of requests. In all cases, investigators are reminded that UIC policy allows changes necessary to eliminate apparent immediate hazards to subjects and others may be made without prior approval of the IRB. PIs should keep a log of changes made, brief written justifications for any changes, including whether the change was at the request of the study sponsor, the PI at the prime if UIC is a subaward, and the date the PI notified the study funder, the PI at the prime, and the IRB. Contact OPRS with any research protocol questions at 312-996-1711, or via email at uicirb@uic.edu. FAQs regarding human subjects research are posted on the OPRS website and will be updated as needed.