New version of eResearch Portal for IRB Rolls Out Mid-March
A new version of the eResearch Portal for IRB, used for submission of human subjects research protocols, will be rolled out for university-wide use in mid-March.
The process for submission, review and approval of human research (IRB) projects went paperless in the early summer of 2013. Improvements based on users’ feedback and experience during the past two years include:
- New look and user interface
- New forms for developmental review, reliance on an external IRB, and human research determination
- Automated validation of CITI IRB training
- Streamlined application and revised form questions
- Additional Help menus
If questions arise, please email or call the IRB Office (firstname.lastname@example.org or 706-542-3199) and the IRB staff will be available to assist you.
The Human Subjects Office (HSO) assists UGA faculty, staff, and students in meeting the highest ethical and professional standards when conducting research with human subjects.
HSO performs professional and administrative functions in support of the Institutional Review Board (IRB), the research oversight committee charged with ensuring that human subjects research is conducted in compliance with the applicable federal, state, and institutional policies and procedures.
Full Board Human Subjects (IRB) Protocols to be Externally Reviewed
Beginning in January, the review of human subjects protocols that typically require review by the convened UGA IRB (Full Board) will be delegated to Western IRB (WIRB), a commercial IRB. This review arrangement is temporary and will last for the next four to six months.
Very few studies will be affected by this change since only about 3 percent of IRB protocols require Full Board review.
The OVPR has engaged WIRB review services to allow the IRB to advance major initiatives that will strengthen the University’s human subjects protections program. These initiatives include enhancing the e-Research Portal for IRB, training two new employees, developing policies and procedures, and taking definitive steps to achieve accreditation of the human subjects protection program. Since Full Board reviews are lengthy, rigorous and time-consuming, this review arrangement will enable the IRB to focus on these initiatives and, more importantly, ensure the review of the majority of the submissions is done expeditiously.
Please contact the Human Subjects Office at email@example.com or 706-542-3199 for questions or WIRB submission details.
The University Policy on activities involving Human Subjects is to fully comply with regulations and follow guidelines defined by the Office for Human Research Protections and to implement principles outlined in the Belmont Report. Any research activity that involves human subjects, whether such activity is undertaken on a large or small scale, whether it is preliminary or fully designed, whether it is conducted by students or faculty, whether it is externally funded or not, and whether it involves minimal risk or more than minimal risk, is subject to the IRB review.
Sample Consent Documents:
Consent Form with Signature
Consent Form for Use of Data Already Collected (Artifacts)
Consent Cover Letter (no signature)
Parental Permission Form Guidance and Template
Minor Assent Script/Form
Telephone Eligibility Screening Consent Script
Debriefing Form Template (for Deception or Incomplete Disclosure
HIPAA Authorization Form Template
How Do I Report an Adverse Event?
The Principal Investigator (PI) bears direct responsibility for the implementation of the research and for ensuring the protection of human research participants. The PI must promptly report any unanticipated problems or incidents involving risks to subjects or others to the IRB.
Reportable events include any harm or injury (physical, psychological, social or economic) or other unexpected events occurring as a result of participation in a research study. Such events, unless considered serious (see below), must be reported to the IRB by contacting the Human Subjects Office at (706) 542-3199 or by e-mail to firstname.lastname@example.org within 72 hours of any member of the investigative team becoming aware of the event. You also should notify the chair of the department.
If you have any concerns or are uncertain about what constitutes a violation, please contact the HSO at 542-3199 For more information read Responsibility of the Principal Investigator, Section V of the Guidelines.