**IMPORTANT ANNOUNCEMENT** The U.S. Department of Health and Human Services has proposed major revisions to the "Common Rule". The Common Rule is the groundwork on which IRB reviews of human subject research is built. The revisions include changes to the definition of human subject research where activities with stored biological specimens are involved, changes to the informed consent process, new and revised categories of Exempt research, and new categories of research excluded from IRB review. To view the proposed revisions and find out how to submit formal comments to DHHS regarding the changes, please visit the announcement on the DHHS web site. They will accept comments until December 7, 2015.**
To view webinars on each of the major changes to the Common Rule, you can visit OHRP's website here: http://www.hhs.gov/ohrp/education/training/nprmwebinars.html
About the IRB
Applied Research Ethics
Protecting human participants in research involves, first and foremost, adherence to the basic ethical principles for the conduct of research. Everyone engaged in human subjects research is expected to read and understand the Belmont Report (click on the Professional Standards) and apply these principles to every aspect of their work. The three core principles identified in the Belmont Report form the basis for the federal regulations protecting research participants and provides the framework for IRB protocol review.
- Respect for persons (autonomy)
All individuals working on a UAF IRB Protocol must have a demonstrated knowledge of human subject protections. To learn about human subject protections and to document that you have completed a formal educational program please enroll and complete the rerequired modules in the CITI Educational Program (click on the Training button). The IRB requires that the Principal Investigator and, if the work will be included in a graduate degree, the graduate student whose project it is complete the training requirement for all exempt research projects. The entire research team must successfully complete the required CITI training for projects requiring expedited or full board review; final approval wiil not be issued until all training requirements have been completed.
Click HERE for a list of references and resources that are useful for stimulating discussion about the ethical conduct of research involving human subjects, participants or co-researchers.
The UAF Institutional Review Board is an independent body comprised of scientists, non-scientists, and members who are not affiliated with the university in any way. This body reviews all UAF research projects involving human subjects by applying the three ethical principles mentioned above. This review process is quite different from peer review; therefore, to assist you in your application the IRB has developed a form that you must complete and submit (click on Forms and Instructions). Although this is different from a peer review process the IRB requires that you clearly state your research objectives and methodology because it is an integral component of evaluating risk versus benefit. If the research is funded by the U.S. Public Health Service it is required that a copy of the grant be included with the IRB Protocol application.
Understanding the Program
This web site provides the basic information and guidance for UAF faculty, staff and students conducting or planning to conduct human subjects research (a.k.a. research with human participants). The first step the Office of Research Integrity takes when reviewing proposed work is to determine whether or not it constitutes "research" as defined in 45 CFR 46.102(d) and, if it is research, whether or not it involves "human subjects" as defined in 45 CFR 46.102(f).
Many activities that involve interaction with living human beings and considered to be "research" within a specific discipline do not constitute research with human subjects under 45 CFR 46. This is not a judgement as to the validity and value of these activities! It simply means that these activities are not subject to this particular set of Federal regulations; for example, interviews conducted for journalistic (web, print, radio or television) purposes are not subject to 45 CFR 46 despite the fact that they may be considered "research" for an article or feature. Many program assessment activities, although similar in format to research, are also not subject to 45 CFR 46 if they are conducted solely to improve or evaluate an existing program and no identifiable personal information is being collected. If you have specific questions whether the work proposed is "research" or "program assessment", quality assurance or quality improvement, review the guidance document. Note: At UAF only the Office of Research Integrity has the authority to determine whether or not an activity is human subject research.
If you have any questions, concerns or suggestions be sure to contact the staff in the Office of Research Integrity at 907-474-7800.
Winter/Spring IRB Meetings:
- Generally the first Wednesday of each month
- Location: 210 WRRB
- Time: 9:00am to 10:00am
- Submission Deadline: Two weeks prior to each meeting date @ 5:00 P.M. (ADT)
Note: All submissions for IRB review must be made through IRBNet!
All researchers will projects to be reviewed by the full board are welcome to attend. Please let us know if you plan to attend at x7800.