IRB News & Updates

缅北禁地 Institutional Review Board Recruitment

The 缅北禁地 (CSUEB) Institutional Review Board (IRB) is charged with protecting the rights of human subjects who participate in research on or through this campus. This includes research conducted by all CSUEB faculty, staff and student investigators, and also research by investigators from other institutions or agencies who are working in conjunction with CSUEB in any capacity. The IRB is responsible for ensuring that human subjects are informed about and protected from any unnecessary risks that may be associated with participating in research. 

The , enforced by the Office of Human Rights Protection, details the regulations surrounding research with human subjects. The outlines the history of human subjects protection.

 

 

Institutional Review Board Seeking Members

The Institutional Review Board (IRB) at 缅北禁地 East Bay provides the important function of safeguarding human subjects in research projects.

The IRB depends upon its members, a group of faculty and community members, who volunteer their services in this effort.

IRB members serve a three-year term and, with knowledge in their specialized fields, actively participate in carefully reviewing human subject research protocols.

We are now seeking volunteers to fill vacancies for primary and alternate IRB members. Alternates assist with protocol review and act as a back-up for a primary member when a primary member cannot attend an IRB meeting. IRB meetings are scheduled to occur at least twice a semester. We are specifically interested in these areas of study, but encourage anyone interested to apply:

  • Nursing
  • Psychology
  • Public Health
  • Social Work
  • Unaffiliated Community Member

For further information on the IRB, please visit the IRB online at IRB.

If you are interested in serving on the IRB please fill out this or email the IRB Coordinator at irb@csueastbay.edu.  Your self-nomination will be reviewed and we will notify you if we are able to appoint you to an opening or to the waitlist for future openings

Thank you for your consideration. This appointment will count towards service to the University.

  

IRB Office Hours:

If you need assistance with the IRB process Tina Avilla, IRB Coordinator, is available:

 

 

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
  • 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.

Topics include, "" and.

 

 

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. (irb@csueastbay.edu). 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.





 

Human Subjects Research Training Requirement

Researchers are required to complete a course in conducting research using Human Subjects before their research protocols can be approved by the IRB. 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 . Go directly to “New Users Register Here.” You will choose the human subjects courses in the process of registration.