UAS INSTITUTIONAL REVIEW BOARD
The mission of the UAS Institutional Review Board (IRB) is to protect the welfare of human subjects in research projects conducted by UAS 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)
The IRB committee is an independent body that includes at least five members. One is a community member and one is a nonscientist. The committee reviews protocols—detailed descriptions of proposed research involving human subjects—and evaluates them in light of the Belmont principles. Committee members consider issues such as relative risks and benefits of research and ensure that potentially vulnerable groups, such as children or detainees, are treated fairly and not unduly burdened by research.
The UAS IRB is registered with the Office of Human Research Protections of the U.S. Department of Health and Human Services.
Required Elements of a Research Protocol
In addition to the required forms (e.g., minimally Form 1, the protocol cover sheet), your IRB submission must include a detailed 'Research Protocol' as a Word document or PDF. All research protocols must include each of the following: (click here for a printable PDF)
- Title of research project
- Name of principal investigator
- Dates of proposed research
- Subject profile
- Rationale for Research
- Hypothesis or research question
- Research methods
- Subject selection and recruitment
- Informed consent (or 'assent' for children)
- Privacy, confidentiality, and data security
Selected elements listed above are described in greater detail below.
Subject profile refers to a short description of the human subjects you plan to include in your research. Include approximate number and any inclusion or exclusion criteria. Indicate, for example, if you plan to include only women, or only individuals who identify themselves with a specific ethnic group. Inclusion and exclusion criteria may include variables such as sex, age, place of residence, health condition, etc. If your research involves children, indicate age ranges.
Rationale refers to the reasons for conducting research and is related to your research question. The rationale should indicate why the research should be conducted, e.g., its importance or significance.
Research methods refers to a relatively detailed discussion of how you plan to collect your data. Will you use observational methods? Interviews? Surveys? Questionnaires? How will you select and approach your research participants? Will you ask them to complete a written survey or will you ask them questions verbally? How long will the interview or survey take? Will participants be providing identifying information? Will they be participating in a public space or in private?
Risks refers to the probability and magnitude of harm or discomfort to human subjects. Risk involves two components: 1) Probability—how likely is the participant to be harmed or experience discomfort? If so, how will risk of harm be minimized? 2) Magnitude—how severe is the harm and of what nature? Is it permanent? Long-term? Temporary? Psychological? Physical? Legal? Financial?
All behavioral and education research involves some level of risk. Most such research involves 'no more than minimal risk'. 'Minimal risk' is defined as that level of risk encountered ordinarily in daily life or in the routine performance of physical or psychological examinations or tests.
Research protocols must clearly state whether the proposed research represents 1) 'no more than minimal risk'; or 2) 'greater than minimal risk'.
If the research presents 'greater than minimal risk', that risk must be clearly described both in the protocol narrative and in the informed consent document. The protocol narrative must describe how risk will be minimized and human subjects protected to the extent possible.
The IRB evaluates research protocols on the basis of its risk / benefit ratio; that is, are the anticipated risks reasonable relative to the anticipated benefits and importance of the knowledge that may be generated.
Benefits may accrue to either the individual research participant, to society, or both.
An individual research benefit is something that contributes in a positive way to the human subject’s health and well-being. Compensation for participation in research is not considered to be a benefit; it is remuneration for time and inconvenience.
A benefit to society is one in which the proposed research contributes to valuable and generalizable knowledge.
Research protocols must clearly state whether 1) there is an anticipated direct benefit to the individual subject; and 2) the research is likely to yield valuable, generalizable knowledge.
Selection criteria and recruitment refer to how the PI will determine who is eligible to participate in the research and how those subjects will be recruited. The research protocol must describe how the subjects will be selected and the methods by which they will be approached or contacted about participation, e.g., by a health care professional, by advertising, by flyers or posters, in a public park, on the street?
The PI must include any flyers, posters, or announcements to be used in the IRB submission. If recruitment is by phone or in person, the proposed text should be submitted to the IRB.
Selection and recruitment must be equitable; that is, participants may not be excluded on the basis of sex, gender, religion, ethnicity, level of education, etc., unless specified by the study parameters. Whenever possible, PIs should attempt to avoid burdening vulnerable populations, such as children.
Informed consent is the process of obtaining a subject’s agreement to participate in research. In all cases, consent must be voluntary and may not be coercive or use coercive language.
Informed consent is necessary in all research with human subjects. You must always obtain informed consent. However, if your research poses only minimal risk, you may not need to prepare an actual informed consent form. In such cases, please provide a proposed informed consent script that the researcher will use to obtain verbal consent.
In seeking informed consent from research participants, whether verbal or written, researchers must include the following:
- statement that the study involves research:
- explanation of the purpose of the research (e.g., "in order to better understand...");
- statement of expected duration of participation (e.g., 15 minutes, 2 hours, etc.);
- description of procedures (e.g., "ask you some questions" or "talk to you about");
- statement or description of risk; most social science research involves "no more than minimal risk";
- description of benefits to research participant (there may be no direct benefits);
- clear and unequivocal statement that participation is voluntary;
- description of the extent of confidentiality that the research will maintain with regard to the data.
Researchers may obtain informed consent verbally, but in all cases should provide research subjects with information sheets, cards, or cover letters that identify the researcher and/or faculty member (if a student researcher) and provide contact information.
For research involving children: Instead of informed consent, researchers are required to obtain 1) parental permission; and 2) the child’s assent. Protocols should include text of letters requesting parental permission as well as the script of verbal requests for a child’s assent if written forms are not being used.
Text of informed consent documents, parental permission forms, and text requesting the assent of a child must be written in straightforward, understandable language that avoids acronyms and legalese to the extent possible.
Privacy refers to access to an individual physically, behaviorally, or intellectually, whereas ‘confidentiality’ refers to access to information about a person. All protocols must address how the privacy of a subject will be maintained during the data collection and analysis processes. Issues to consider in discussing the issue of privacy in a research protocol include whether an observed behavior is public or private, how sensitive the information solicited or behavior observed is, and cultural norms.
For example, consider the different privacy expectations of individuals in a study of how children interact on a playground versus research on the psychological state of a recently bereaved spouse.
Confidentiality of personal data Generally, research protocols should be structured in a way that minimizes the amount of personal information solicited during research. Whenever possible, data should be collected anonymously. If such an approach is impractical, then personal identifiers should be removed from data sheets, etc., as soon as possible following data collection.
If it is necessary to maintain identifiable data, the PI must explain how the security of the data will be ensured. Considerations include who will have access to the data, where the data will be stored, when and how the data or data sheets will be destroyed. For example, will the data be shared? If so, under what circumstances? Will the data be kept on multiple computers? Networked? How will the data sheets be secured? Stored in a locked office? Destroyed immediately upon data entry?
If you still have questions, contact Erica Hill, IRB Chair, at 907.796.6017 / firstname.lastname@example.org
Interactive IRB Forms
Effective January 1, 2012 all Principal Investigators submitting protocols to the UAS IRB committee must complete on-line human subjects research training at www.citiprogram.org. You must complete the training and send the IRB chair your certificate of completion before you will receive IRB approval or a determination of exemption. If you have questions, please contact Erica Hill at email@example.com or 907.796.6017.
All IRB submissions must include Form 1 and an IRB protocol. Instructions for preparing a protocol may be found here.
- Form 1 - Protocol Cover Sheet (Rev. 09-11-12)
- (See next tab for information about exempt categories.)
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
If you plan to conduct research that involves people (human subjects) in any way, you need to prepare and submit a Research Protocol to the IRB.
An IRB, or Institutional Review Board, is a committee comprised of community members and faculty, both scientists and nonscientists, who have training in research ethics and who are conversant with federal regulations governing research involving human subjects.
The purpose of the IRB is to 1) review and monitor all research proposed by university students, staff and faculty that involves human subjects; 2) ensure that the welfare of human subjects is protected to the extent possible; and 3) ensure that research is compliant with federal regulations.
A Research Protocol is a document that describes the research that you propose to do with special reference to the risks and benefits to human subjects. A protocol is not the same as a research proposal submitted to a funding agency. For more information, see Required Elements of a Research Protocol.
All protocol submissions must contain the following:
• Protocol cover sheet (Form 1)
• Protocol narrative (this can be a Word document; it must include all required elements)
Most protocol submissions for anthropological, behavioral, and educational research require:
• Request for exemption (Form 2). (For more information, see the Exemption tab.)
Many protocol submissions require:
• Sample informed consent document
• Sample script or text of request for assent (for research involving children only)
• Sample text of request for parental permission (for research involving children only)
• Research involving children (Form 3)
If your research involves minimal risk, it may be considered exempt from the Federal Policy for the Protection of Human Research Subjects. Anthropological, behavioral and educational research is frequently exempt because it involves methods posing minimal risk, such as interviewing, surveys, questionnaires, and observation.
If you think your research poses minimal risk, complete Form 2, the Request for Exemption. To qualify for exemption, your research must fall under one or more exemption categories described on Form 2. See the Exemptions tab for more information.
The more complete your research protocol is, the faster the review will be. If you are applying for an exemption and your submission is complete, you may receive a letter by email in less than 48 hours.
If your submission is incomplete or the protocol narrative is unclear and confusing, you will be asked to submit a revision.
If your protocol is an Expedited protocol or if it requires full IRB review, allow a minimum of two weeks to receive a determination. Expedited protocols do not require full review, but they are more involved than Exempt protocols and so require more time for evaluation.
INSTITUTIONAL REVIEW BOARD
Board Members 2011-2012
Erica Hill, Ph.D., chair
Assistant Professor of Anthropology
Department of Social Science
Pedar Dalthorp, M.F.A.
Assistant Professor of Art
Department of Humanities
Caroline Hassler, M.L.S., M.L.A.
Associate Professor of Library Science
Library and Media Services
Carlton Heine, M.D., Ph.D.
Attending Physician, Bartlett Regional Hospital
President, Alaska Chapter of the American College of Emergency Physicians
Anne Jones, Ed.D.
Assistant Professor Education
School of Education
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 Policy & Guidance
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 AgenciesList 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
USDA National Institute of Food and Agriculture -- Assurances Regarding the Protection of Human Subjects
U.S. Department of Commerce -- Financial Assistance Standard Terms & Conditions
U.S. Department of Energy -- Protecting Human Subjects
Research Exempt from IRB ReviewExemption Categories.
Code of Federal Regulations, Title 45, Section 46.101 (45 CFR 46.101)
Research Qualifying for Expedited IRB ReviewGuidance on Expedited Review Procedures
Informed ConsentInformed Consent
Informed Consent Requirements in Emergency Research
Certificates of ConfidentialityCertificates of Confidentiality Kiosk
Certificates of Confidentiality
Research with Alaska NativesAlaska Federation of Natives, Guidelines for Research
NSF Principles for the Conduct of Research in the Arctic
Research with ChildrenSpecial 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 PopulationsOHRP Guidance on Vulnerable Populations
Prisoner Research FAQ (OHRP)
International ResearchComparison 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