human subjects research (irb)
attention: please see covid-19 guidance for human subjects research
not sure where to get started? please see the hsr roadmap
page for an intro to relevant concepts and first steps.
human subjects research ethics
the university of alaska anchorage is committed to protecting the interests of research subjects and promoting the responsible conduct of human subjects research.
core principles, as described by the belmont report for responsible research involving human subjects research and their applications, are:
- respect for persons: informed consent of subjects to the degree that they are capable
- beneficence: minimization of risks to subjects
- justice: equitable selection of subjects and distribution of benefits
the irb at uaa is responsible irb for fulfilling the requirements of the federal regulations at title 45 part 46 of the code of federal regulations(45 cfr 46), and uaa assures the department of health and human services, office of human research protections, that it will meet all of the requirements of 45 cfr 46.
for determining whether a given project or activities constitute human subjects research (hsr), uaa has created the hsr roadmap page as a starting point, and additionally two hsr determination forms are located in the irbnet forms and templates library. one form is for researchers to document their not-hsr self-determination, and the other is for researchers to submit an hsr determination request. these requests are reviewed by the irb chair, and a formal determination is made that either informs the researcher they need to submit an application package for review, or else documents that the proposed activities do not constitute human subjects research and thus, do not require any formal oversight as such. instructions for filling out and submitting the forms are included within each form. please see irbnet resources for instructions on how to access irbnet and uaa's forms and templates.
responsibilities of researchers
the primary responsibility for ensuring that the research is conducted in the appropriate manner rests with the researcher. to this end, the researcher is responsible for:
- ensuring that the subjects meet selection and eligibility requirements.
- the research is approved by the irb and conducted according to the protocol.
- subjects' informed consent is appropriately obtained.
- the study is properly designed and scientifically valid.
the role of the institutional review board (irb)
the irb was established by the provost and office of academic affairs to protect the interests of research subjects. the main role of the irb is the review of all human subjects research conducted at uaa to ensure that the research fulfills the requirements of the federal regulations.
the irb reviews research proposals according to the following criteria:
- are the risks to subjects minimized?
- are the risks reasonable in relation to anticipated benefits?
- is the selection of subjects equitable?
the university of alaska anchorage holds a federal wide assurance, fwa no. 00000184. under this assurance, the irb at uaa is recognized as the responsible irb for fulfilling the requirements of the federal regulations at title 45 part 46 of the code of federal regulations (45 cfr 46), and uaa assures the department of health and human services, office of human research protections, that it will meet all of the requirements of 45 cfr 46 regardless of sponsorship.
i need to...
- contact irb staff with an immediate question
- complete irb training for a course or to submit an irb study for review
- register with irbnet to electronically submit an irb study
- submit a separate irb application the alaska area irb for review
i would like to know more about...