Welcome to eIRB
This is the online protocol submission and review system for the Institutional Review Board (IRB) at Wake Forest University. eIRB provides a collaboration workspace for the IRB and the Human Subjects Research community and is the location for IRB review activities. Principal Investigators and their study teams can initiate new study applications, make amendments to existing studies, submit continuing review applications and report safety events through this site.
If you are new to eIRB, please make sure to reference the FAQ section and User Support section for help.
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NEW Information 3/18/2020
COVID-I9 Research Changes
This guidance will be in effect from Wednesday, March 18, 2020 through at least Wednesday, April 15, 2020. We will continue to monitor COVID-19 status in the community to provide updates and further guidance as appropriate.
We are continuing to closely monitor the COVID-19 outbreak with a consistent focus on assuring the health and well-being of our patients, research participants, research staff and the greater Wake Forest community. As you are aware, a state of emergency has been put in place by the state of North Carolina and many local municipalities. We are also preparing for the possibility of a “community quarantine” similar to what is currently in effect in Italy, France and Spain. Pertinent to our research staffing, in an effort to support social distancing, we are implementing the following policy that is designed to protect the health of our teams by limiting our on-site workforce to the absolute minimum needed while positioning us to effectively re-start our research enterprise at a later point in time.
Pause all in-person clinical research activities not linked directly to the health of the research participant.
Reduce on-site staffing for animal and mechanistic research by focusing on activities directly linked to essential functions, such as maintaining the health of animals involved in research studies.
Clinical Research
We are now imposing a pauseon in-person research visits that are not linked to the direct health or well-being of the participants. We ask Principal Investigators to carefully determine if their research is essential for the direct support and care of participants. Also, we ask all investigators to consider the risk implications for studies recruiting or following high-risk groups (i.e. older, with comorbid conditions, immunocompromised participants, etc.). This pause also includes research studies conducted in non-clinic settings (e.g., community focus groups, home visits, etc.). Participant research visits should be performed remotely (e.g., by phone, email, WebEx, or other means) whenever possible.
If you determine that a research protocol should continue bringing participants for on-site research visits, please request approval by emailing a brief rationale to Selvin Ohene (sohene@wakehealth.edu) in the Office of Clinical Research and Joseph Andrews (jandrews@wakehealth.edu) in the Office of Regulatory Affairs and Research Integrity.
In the rare instances when clinical research will continue to bring participants on-site, we are requiring the following precautionary measures:
All research staff must administer the following screening questions on both a reminder telephone call (24 hrs. prior to the scheduled visit) and immediately when the participant arrives for an on-site clinic visit:
Screening Questions:
Have you been in contact with someone who was sick in the last 14 days?
Do you have a fever, cough, shortness of breath or difficulty breathing?
Have you traveled internationally in the last month?
All study personnel (faculty and staff) should receive appropriate training regarding proper research participant screening (e.g., masking protocols) and participant triage, should a research participant be deemed at risk for COVID-19 infection during an in-person research visit screening. Participants should be provided with information prior to the visit regarding the current COVID-19 epidemic and how best to reduce their risk of infection.
If the participant responds negatively to the questions above, you may proceed with the visit. Assist all participants reporting active symptoms following institutional recommendations.
Clinic visit suggestions: wipe down the tables, chairs, beds, writing utensils, keyboards, tablets, equipment and other surfaces prior to the participant’s arrival. Use hand sanitizer at the start of every visit. At the end of the visit, wipe everything down again while wearing gloves, then remove gloves and wash hands.
Continued Diligence for Clinical Study Teams:
Maximize social distancing for our research staff by reducing the number of staff required to be on-site to the minimum required for essential activities.
Establish contingency plans for your teams should a “community quarantine” occur.
Determine and communicate how essential activities will be performed with a smaller staff footprint, allowing more people to work remotely.
Revisit whether in-person visits can be replaced with virtual visits or by sending study medications by mail.
Implement communication strategies to prepare for either quarantining of individual team members or a “community quarantine.”
As always, continue to weigh the risk and benefit of each research study, keeping in mind the welfare of populations most vulnerable to COVID-19.
Animal and Mechanistic Research
COVID-19 Implementation Plan for Animal and Mechanistic Research
Similar to clinical research teams, we are now asking basic science teams to implement their contingency plans to limit research to include only essential activities. During this time, the Animal Resources Program will continue to provide care to animals while pausing all non-essential functions, including procedures that are not mandatory for the health of animals. We will also pause animal procurement during this time. In addition, we ask that you immediately implement the following activities.
Maximize social distancing for our research staff by minimizing the number of staff required to be on-site to the minimum required to maintain care and essential activities.
Develop strategies to allow more team members to work off-site (e.g., telecommuting, web-based work, job sharing, etc.).
Work closely with Animal Resources Program colleagues to coordinate animal care activities with the study team members.
Cross-train staff to perform essential tasks in regard to animal care or lab safety.
Implement communication strategies, such as creating a shared cell and emergency phone number list, to be prepared for either quarantining of individual team members or a “community quarantine.”
Other Issues
As per the CDC, regardless of specific exposure risks, it is always a good practice to:
Frequently wash your hands with soap and water for at least 20 seconds. When soap and running water are unavailable, use an alcohol-based hand sanitizer with at least 60% alcohol.
Avoid touching your eyes, nose or mouth with unwashed hands.
Avoid close contact with people who are sick.
We understand that these policies may impact ongoing research activities, but our primary responsibility remains to protect the health of our researchers and our communities. We look forward to the opportunity to return to our regular research routines in the near future. Below please find links to pertinent COVID-19 policies from the NIH outlining administrative flexibilities that will apply to NIH applicants and recipients.
