To: Primary Investigators and Study Coordinators
From: Kevin Brown, Chair, CSUEB IRB
Date: March 17, 2020
As the COVID-19 coronavirus outbreak continues, the risk/benefit ratio for human subjects research participation must be carefully assessed. Both the ethical principles of research delineated in the Belmont Report and federal regulations for the protection of research participants dictate that we ensure the risk/benefit ratio be acceptable at all times. Universities such as Columbia have already paused certain types of human subjects research activities underway at their institutions and others such as the University of California system are considering their next steps. While we do not believe that such research at CSUEB should be brought to a halt at this time, we do strongly recommend that investigators take steps to decrease the likelihood that they will put themselves, members of their study teams, or their study participants at risk of becoming infected with or spreading the disease. Below are guidelines to follow with respect to overall planning and data collection activities
Establish Formal Plans
All investigators engaging in human subjects research should develop concrete and actionable plans for:
Review Data Collection Procedures
As part of planning, investigators and study teams should revisit data collection procedures as well as the extent to which or circumstances under which data collection should be brought to a halt, either temporarily or permanently. Suggestions are provided here:
If an investigator or study team needs to alter data collection activities by shifting to phone or online, or another change needs to be made to a study protocol in order to protect participants or study personnel, a modification request should be submitted for approval prior to making the change. If an investigator needs to make a change to research plans and is unable to submit an amendment (e.g., immediate hazard or risk to research participants exists), these changes can be made and then reported to the IRB within 5 days, as a reportable event. Eliminating immediate hazards may include actions that reduce potential exposure to COVID-19 in regards to activities which are ongoing. A modification request must also be submitted with the event report. The CSUEB IRB encourages sponsors and investigators to take such steps as necessary to eliminate apparent additional risks to participants.
At the current time, the CSUEB IRBs will continue to review and approve research protocols that have been or will be submitted. However, any research team that has not yet begun research activities should ensure that doing so will not jeopardize members of the research team or participants. In addition, should the COVID-19 landscape change significantly, there may come a point when research activities including human research subjects will be restricted and application reviews might be paused in the interest of individual and public health.
CSUEB will be moving to an electronic IRB management system beginning Spring semester, 2020. This system, offered by Cayuse, will allow all initial research protocol submissions, modification and renewal requests, and approvals to be handled electronically. Configuration and deployment will be completed by the end of Fall semester, 2019. Training materials for the Cayuse system will be posted on the IRB website, and in-person training sessions will be held beginning in Spring 2020.
Faculty research protocols may be submitted to the IRB via the Cayuse system from the beginning of Spring semester 2020, and the IRB encourages faculty to do so. Faculty research protocols must be submitted via the Cayuse system beginning March 1, 2020.
Student research protocols may continue to be submitted via email or hard copy until the beginning of Summer session 2020, after which, all protocols must be submitted via the Cayuse system.
As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multisite career development (K) and fellowship (F) awards.
The Common Rule, the set of regulations which have governed human subjects research in the U.S. since 1991, was replaced with the Final Rule on January 21, 2019. For more information, please read below.Notice Update: Delay of the Revisions to the Final Common Rule Revisions Effective July 19, 2018
Starting Fall 2008, researchers doing non-exempt research were required to complete a course in conducting research using Human Subjects before their research protocols could be approved by the IRB. The IRB also strongly encourages researchers doing exempt research using human subjects to complete a course. This requirement was approved by the Academic Senate in 2007-2008. After submission of a research protocol, the IRB will make the determination as to the exempt status of the protocol and notify the researcher.
The training requirement must be fulfilled by taking the CITI (Collaborative Integrative Training Initiative) research training course in human subjects research ethics. A certificate, valid for 3 years, will be issued on completion of the CITI courses. (An up-to-date NIH course completion certificate is also acceptable as proof of human subjects research training.) The ORSP will maintain a database of the researchers who have completed the training.
Researchers working with human subjects must take either the social/behavioral/educational module, or in appropriate cases, the biomedical module of the CITI course. Each module contains 9-10 required sections needed to complete the course, along with optional sections for special interests. Elective sections include HIPAA, international research, and research with prisoners, among others. Instructors may demo the course from the home page.
To register for the courses go to CITI Program. Go directly to “New Users Register Here.” You will choose the human subjects courses in the process of registration.