UA IRB Guidelines
University of Akron Applicant Manual (Rev. 07/31/08)
Informed Consent Guidelines
- Required Elements of Informed Consent
- Sample Informed Consent Form
- Sample Parental Consent Form
- Sample Child Assent Form
BASIC CERTIFICATION REQUIREMENT FOR RESEARCHERS:
All individuals (faculty, staff, students, advisors) involved in the conduct of research involving human subjects, including research that qualifies for exemption, must take and pass the core modules under Group 1 - Social and Behavioral Researchers (SBR) in the Collaborative Institutional Training Initiative (CITI) curriculum. The certification is effective for 3 years, after which the Refresher Course, under Group 4 - Social & Behavioral Research –Refresher Course must be completed. It is the responsibility of the researcher to insure certification is current, as the IRB cannot approve a protocol unless all researchers are certified.
The CITI Social Behavioral Research (SBR) curriculum includes:
- Introduction ‘Belmont Report’
- History and Ethical Principles
- Defining Research with Human Subjects
- The Regulations and the Social Behavioral Sciences
- Assessing Risk in Social and Behavioral Sciences
- Informed Consent
- Privacy and Confidentiality
- The University of Akron module
Modules are presented in succession. An e mail verification, which certifies successful completion of the curriculum, will be sent once the last module is completed. Learners may assess their status at any time. Our office will receive the same verification.
Upon receipt of the verification, a ‘passed date’ will be displayed. Certification is valid for three years from this date. Researchers are required to monitor their status and complete the ‘Refresher’ in order to maintain their certification.
Approval for new and renewing protocols will be withheld until/unless certification is current for the PI and other personnel on the protocol, including advisors.
If applicants (or other project personnel) are currently certified through NIH, that will be acceptable in place of the UA requirement. Submit the NIH completion documentation with the IRB application.
CERTIFICATION THROUGH CITI, WHICH HAS BEEN COMPLETED AT ANOTHER INSTITUTION:
Applicants are not required to duplicate CITI certification for research, which has been completed elsewhere. Log in to the CITI site and update your affiliation to The University of Akron. Select Group 1- Social & Behavioral Researchers (SBR) from the Human Subjects Curriculum. If the Course Status is Incomplete, you can view which modules are missing by clicking on the course name. Once all required modules are completed, a completion report will be generated and our office can access your member information on CITI.
STUDENTS COMPLETING MODULES TO MEET COURSE REQUIREMENTS:
The CITI site also includes a course for students who are completing modules for a class, but not submitting a research application to the IRB. These students will complete modules under Group 2 - Students. Completion of modules in this group does not satisfy the IRB requirement for researchers submitting protocols. If students are conducting independent research with human subjects, they must complete the modules under Group 1 – SBR Researchers in order for a completion report to be sent to the IRB for our records. This is the database that the IRB uses to check on certifications. If modules have already been completed under the Student Group, update your Learner Group and select Group 1 – SBR Researchers. If the course status shows as Completed, you have completed all necessary modules and a completion report will be sent to the IRB. If the course status shows as Incomplete you can see which modules are missing by clicking on the course name. Once all modules are completed, a completion report will be generated and sent to the IRB.
If you have any questions or problems in accessing the CITI site, please contact UA's IRB.