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IRB News & Updates
Reminder of the Summary of Pre-and Post-Common Rule Expiration Dates:
- The federal regulations for human subject protections changed in 2019 to the post-2018 Revised Common Rule.
- Pre-2018 all IRB protocols expired in 1 year (or less if an IRB made the expiration earlier).
- Revised Common Rule: Only IRB Protocols requiring full-board review expire in 1 year or less.
- In all cases Principal Investigators are responsible for knowing when and if their protocol expires, for submitting an annual report prior to expiration when they are requesting a continuation, and for submitting their continuation request prior to expiration if needed.
- When an IRB protocol expires it is no longer valid and a new protocol is required.
- For all approved IRB protocols, Principal Investigators are responsible for submitting protocol modification requests when their data collection or data handling research team members change, participant numbers change significantly, or their methodology or other protocol details change, and for submitting requests to close out the protocol when their data collection or study is complete and their protocol is no longer needed.
DHHS Human Protection Research Training
The DHHS has created short ~30 min training videos for IRB reviewers and researchers.
Human Subjects Research at CSUEB and Coronavirus Concerns
As the COVID-19 coronavirus outbreak evolved it became essential that the risk/benefit ratio for human subjects research participation was even more 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.
Investigators should continue to 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 disease. Below are guidelines to follow with respect to overall planning and data collection activities
All investigators engaging in human subjects research should develop concrete and actionable plans for following all CDC, state, and local guidance.
Review Data Collection Procedures
As part of planning, investigators and study teams should revisit data collection procedures to ensure safety and compliance.
- Ensure that that the research staff is healthy and check with study sites to determine whether there have been any identified cases or if anyone at the site is or has been quarantined when collecting data from populations at higher risk of suffering severe health consequences if they contract COVID-19 (e.g., older adults or those designated at higher risk by the CDC) or in settings that bring large groups of people together in contained spaces (e.g., K-12 schools, close proximity living spaces).
- Avoid or minimize bringing groups of people together for data collection activities (e.g., focus groups, whole group interventions), and if they are brought together follow on federal, state, and local guidance.
- Moving face-to-face data collections (e.g., interviews, surveys administered in person, some forms of observation) to telephone or online (e.g., Zoom) formats is still prudent.
- If research was paused, determine whether it is feasible to restart, and follow the latest governmental guidance and university guidance.
When 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. (email@example.com). 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.
Electronic IRB System
CSUEB moved to an electronic IRB management system beginning Spring semester, 2020. This system, offered by Cayuse, allows all initial research protocol submissions, modification and renewal requests, approvals, and protocol closures to be handled electronically. Training materials for the Cayuse system are posted on the IRB website.
Final Rule Provision
As of January 20, 2020, studies involving multiple institutions 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.
Final Rule News
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
Federal Register Announcement
Human Subjects Research Training Required for Researchers doing Non-Exempt Research
Researchers doing non-exempt research are required to complete a course in conducting research using Human Subjects before their research protocols can be approved by the IRB. The IRB also strongly encourages researchers doing exempt research using human subjects to complete a course. 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.
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.