Policies
 

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.

 
 
IRB Policies

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:

  • General Ethical Principles Regarding Research with Human Subjects
  • General Procedures for Submitting an IRB Proposal
  • Levels of IRB Review
  • Instructions for the Preparation of an Informed Consent Form

    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:

  • Names of students 
  • Dates of attendance at UAA 
  • Program/major fields of study
  • Degrees and certificates received including dates
  • Participation in officially recognized University activities
  • Academic and co-curricular awards, honors, and scholarships received and dates received
  • Weight and height of students on athletic teams
  • Students' electronic mail addresses 
  • Hometown; city and state

    • 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 llvolden@uaa.alaska.edu.

    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 kamclain@uaa.alaska.edu. The following link is to this form:

  • Certification Form for Course Instructors/Faculty