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Project
dates must reflect when the actual interaction with research
participants will occur. The start date CANNOT be a date prior to submission date. IRB protocols must remain open as long as you are using human subject data; this includes data analysis.
The
abstract and methods sections MUST be written in
layman's terms. Though
the committee is diverse and well educated both formally
and informally, it is possible that they are not familiar
with the particular research that is being reviewed. Avoid the use of technical or field specific jargon and acronyms whenever possible. If you absolutely need to use jargon or acronyms, define them the first time each is used.
The
Principal Investigator MUST read and sign the PI Assurance
on the first page. This
a binding commitment from the PI that human subject protection
is a cornerstone of the research being proposed. The
original (first page only) with signature must be sent to
the Office of Research Integrity.
Tenured,
tenure-track and emeritus faculty
may serve as a PI. Other University
personnel may serve as the PI as specified in the PI
eligibility policy. Doctoral
and Graduate students may not be Pis, but must be listed
in the personnel and qualifications section of the application if they will have access to identifiable human subjects' data.
When
completing the personnel & qualification section provide
the Board with information that validates expertise to
conduct the type of research being proposed. A
medical doctor that specializes in the care of children
would not be considered qualified to conduct open heart
surgery on a adult or even a child for that matter unless
the doctor had successfully attained that level of expertise
and specialization. It would be very appropriate for the
doctor to have a cardiac specialist on the care team if
the child had heart problems. Although it is not typically a life or death issue for social research, the IRB has similar expectations in that at least one person with expertise in the subject area or with the community that is the subject of the research should be included on the research team.
When
providing the IRB with information about the literature
review, remember the IRB is looking for information related to process or methodolgies to be used in the proposed
research. The Board is interested in knowing
that the techniques to be used are up to date as well as
that the work does not unnecessarily duplicate prior work and that the research is a good use of the research participants
time (i.e. that the potential benefits outweight the costs/risks of participating in the research).
If
the research population includes participants
under 18 years of age you must discuss why this is important or necessary. The human subjects regulations require special protections/considerations for research participants under the are of 18 years old. If all of the research participants will be adults (18 years of age or older) you must explicitly state that minors will be
excluded from the proposed research.
If the intended participants may not speak English fluently or speak English as second
language you must state how you will address challenges related to language comprehension, whether written, oral, or both. You must identify
in the IRB protocol application how you will deal with survey/interview
and informed consent issues that may be encountered. The IRB may require that you obtain
the services of a translator or have the participant information
available in the native language of the participants to insure consent is truly informed and voluntary. Alternatively, you may elect to limit participation to individuals who are fluent in English.
If
there is concern about literacy of the research population
a plan to address the needs for informed consent and validation
of proposed research tools needs to be fully discussed
in the application. For example, it may be appropriate
to utilize an oral consent process or one that combines
an oral disclosure/discussion with a written summary. Likewise, use of written or web-based survey tools may be inappropriate.
If
the research is to be conducted in a private residence
or place of business be sure to discuss fully why this
is appropriate and necessary. While the primary
function of the IRB is the protection of research participants
the Board also remains aware of safety issues for the researchers
as well, particularly student researchers.
Consent
/ Assent forms must be written at an age appropriate
level, however, the level should not exceed an eighth grade reading level unless it is specifically justified in the protocol.
The
average adult population reads at between an 6th and 8th
grade reading level. The spelling and grammar check feature in most word
processing packages will provide a rudimentary assessment
of a document's reading level. However, please be aware that these features provide a fairly crude evaluation and therefore should be used as a guide only. The IRB recognizes that occasionally researchers need to use words or phrases that exceed the recommended reading level; when this occurs you must specify which words or phrases are responsible. Defining "problem" words the first time they are used may eliminate potential comprehesion difficulties; but in other cases, the IRB may find that the use of the "problem" words or phrases cannot be avoided and is appropriate given the nature of the research.
Consent
/ Assent forms that will be used for projects subject to expedited or full board review must contain the core components outlined
in the consent examples. However, the IRB may waive some or all of the informed consent components or the requirement for written documentation in specific circumstances. If you would like more information on when this is an option, please contact the Office of Research Integrity. Research that is "exempt" does not have the same informed consent requirements and may be handled in a simplified fashion, for example, a survey that is mailed to participants and does not require any identifying information may simply have a statement at the top stating why the survey is being conducted and that participation is voluntary. However, the Office of Research Integrity encourages all researchers to provide their contact information (official UAF contacts are stronly recommended) and that of the IRB so that participants can ask questions, report concerns, etc.
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