IMPORTANT NOTICE: A new FDA rule will require consent forms for medical devices and drug trials to explain that data will be made public through an NIH website at http://www.ClinicalTrials.gov. This rule is effective March 7, 2011, and compliance to this rule is effective March 7, 2012. For more information about the rule, please click here.
UAA Faculty Handbook, Chapter VI: Human Subjects Research: Policy and Procedures
The majority of UAA policy and procedures regarding human subjects research can be found in the UAA Faculty Handbook, including:
IRB Noncompliance Investigation Policy
Section R-S of the Faculty Handbook, under General Ethical Principles, states:
R. The board shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the Institutional Review Board's action and shall be reported promptly to the investigator and appropriate officials.
S. If a research subject registers a complaint, the investigator shall attempt to relieve the complaint by explanation or by a change of procedure. Written approval is required for procedural changes. The investigator shall seek approval from the IRB.
Family Educational Rights and Privacy Act (FERPA) Regulations and Accessing Student Data
Student information that is not designated as directory information is protected under FERPA regulations. The following information is designated as directory information by UAA:
If you plan to collect non-directory student information such as student e-mails, grades, GPAs, or exam scores for your research, then you must seek written approval from the students prior to collecting this information for your research. Even if you plan to publish the data in aggregate form, you must seek prior approval. If you plan to collect non-directory student information from students that are no longer enrolled in a course, you must seek prior approval from the University Registrar's Office.
If you have FERPA questions or if you are requesting non-directory student information, contact Lora Volden, University Registrar, at 907-786-1560 or firstname.lastname@example.org.
Instructor Certification Form for Class Projects
Instructors/faculty of research courses that includes human subject research projects are required to fill out the Certification Form in order to act as the IRB for class projects. These projects would be for class credit only and the results would not be for publication.
Instructors/faculty send the completed form to the IRB Administrator, DPL 101R, along with their CITI IRB Training Certificate. The certification form and CITI certificate can also be e-mailed to Kelly at email@example.com. The following link is to this form: