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THE INSTITUTIONAL REVIEW BOARD

The mission of Institutional Review Boards (IRB) is to protect the welfare of human subjects in research projects conducted by university faculty, staff and students. IRB committee members receive training in federal regulations governing research involving human subjects; they are also conversant with The Belmont Report, which outlines the ethical principles that provide the foundation for all IRB work. Those principles are:

• Respect for persons (protecting personal autonomy by providing subjects with information about the planned research)

• Beneficence (ensuring that the proposed research maximizes benefits relative to risks)

• Justice (ensuring that research is conducted in a way that is fair and non-exploitative)

Protocols for Human Subjects Research (HSR) conducted by UAS faculty, staff, and students is reviewed by the IRB at UAF.


All protocols must be submitted for review using IRBnet.

Submit a Protocol via IRBnet

All protocols and supporting documentation (consent forms, questionnaires, etc.) must be submitted via IRBnet at https://www.irbnet.org.

For instructions on IRBnet: http://www.uaf.edu/irb/irbnet-(e-file)/

New users can create an IRBNet account by clicking on the New User Registration link located just under the log-in fields in the upper right-hand corner of the page.  This link will walk you through the steps to create your account. Make sure you select University of Alaska Fairbanks as your organization.  Once you have created your account you will receive an activation email, be sure to click on the link in the email to activate your account.

Required Training

All PIs, student researchers, and associated study personnel must complete human subjects research training via the Collaborative Institutional Training Initiative (CITI) before approval of their proposed research.

 You must create an account at CITI by clicking “Register.” Select “University of Alaska Fairbanks” as your organization and proceed with registration. (All UAS faculty, staff and students should affiliate with UAF during CITI registration.)

 For further instructions, visit:  http://www.uaf.edu/irb/training/

IRB Exemption Categories

To qualify for exemption, research must fall under at least one category of exemption. Most anthropological, behavioral and educational research qualifies for exemption categories 1 and/or 2. If you are applying for exemption, you must include Form 2 in your protocol submission.

1.  Educational Research
This exemption category includes research in educational settings, such as schools or universities, and involves 'normal' educational practices. Such research may study or compare curricula or the effectiveness of different instructional approaches or classroom management methods.

2. Research involving surveys, interviews, observation, or educational tests
This exemption category includes surveys, interviews, observation of public behavior, and administration of educational tests (cognitive, diagnostic, aptitude, or achievement). To qualify for the exemption, no data may be recorded that identifies the subjects (e.g., names, ID numbers, social security numbers; . Numerical or alphabetical identifiers may be used as long as they are disassociated with personal identifying information.

• This exemption category includes surveys, interviews, observation of public behavior, and administration of educational tests (cognitive, diagnostic, aptitude, or achievement).

• For research involving children, this exemption may only be used for educational tests (e.g., not for surveys or interviews with children) and / or when observations of public behavior are being conducted and the investigator is not involved in the activity being observed.

3. Research involving public officials or candidates for office

4. Research involving existing data
This exemption category refers to samples, data, documents, or specimens in existence before the research begins. This category applies if the materials are publicly available and / or if the data is recorded by the PI in a way that ensures that the research subjects cannot be identified.

5. Research evaluating public benefit and service programs

6. Research on taste and food quality

Ethical Principles

The era of modern human subjects’ protection began with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captured many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, first adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and subsequently revised in 1975, 1989, and 2000. The 1964 Declaration of Helsinki further distinguished therapeutic from non-therapeutic research and introduced an institutional mechanism to ensure that its principles were followed.

External Resources: Policies and Guidance

Office for Human Research Protections (Department of Health and Human Services)

The Office for Human Research Protections (OHRP) provides leadership in the protection of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP policies provide a model adopted by most other federal agencies funding research. OHRP provides Federalwide Assurances (FWAs) and a registration process for Institutional Review Boards.

OHRP Home Page

OHRP Compliance Oversight Activities: Determinations of Noncompliance

Code of Federal Regulations, Title 45, Part 46 (45 CFR 46). Protection of Human Subjects

Guidance and Regulation for Other Federal Agencies

List of Agencies and Departments signed onto the Common Rule
U.S. Department of Education -- Protection of Human Subjects in Research
National Science Foundation (NSF) -- Human Subjects Policy

U.S. Department of Commerce -- Financial Assistance Standard Terms & Conditions
U.S. Department of Energy -- Protecting Human Subjects

Research Exempt from IRB Review

Exemption Categories.
Code of Federal Regulations, Title 45, Section 46.101 (45 CFR 46.101)

Research Qualifying for Expedited IRB Review

Guidance on Expedited Review Procedures

Informed Consent


Informed Consent Requirements in Emergency Research

Certificates of Confidentiality

Certificates of Confidentiality Kiosk
Certificates of Confidentiality

Research with Alaska Natives

Alaska Federation of Natives, Guidelines for Research
NSF Principles for the Conduct of Research in the Arctic

Research with Children

Special Protections for Children as Research Subjects
Research with Children FAQs
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process
Family Educational Rights And Privacy Act (FERPA)
Protection of Pupil Rights Amendment (PPRA)
Family Policy Compliance Office

Research with Other Vulnerable Populations


Prisoner Research FAQ (OHRP)

International Research

Comparison of International Guidelines for Research Involving Humans
International Conference on Harmonisation: Good Clinical Practice: Consolidated Guidance
Council for International Organizations of Medical Sciences (CIOMS) Home Page
International Ethical Guidelines for Biomedical Research Involving Human Subjects
International Ethical Guidelines for Biomedical Research Involving Human Subjects
Canadian Institutes of Health Research
National Council on Ethics in Human Research-Canada

For questions regarding Human Subjects Research or protocol submission, contact UAF Office of Research Integrity at:

uaf-ori@alaska.edu

907-474-7800

907-474-7832