Table of Contents
General
Questions about the IRB
What
is the Institutional Review Board (IRB) and what is its
purpose? The
existence of the IRB, its composition and responsibilities
are governed by the Code of Federal Regulations (45 CFR
46). The UAF IRB is made up of UAF faculty, staff and Fairbanks
community members. Members come from diverse backgrounds
including scientific and non-scientific areas. The IRB
conducts initial and continuing review of UAF research
projects in order to ensure protection of the rights, safety
and well-being of human subjects participating in the project.
How
long does the IRB review process take? All IRB Protocol applications undergo an initial administrative review by a ORI staff member. This review will be to check for completeness of your application and to determine if the project is "exempt". You will receive the results of this review within 10 business days. You should expect the reviewer to have some questions or ask for clarification on some aspect of your protocol. Once you have responded to the reviewer's questions you will be informed whether or not your application is "exempt" and has been approved, or is being sent to the IRB for further review and approval.
IRB review may be either "expedited" or "full" depending on the level of risk to the research subjects/participants. This determination is made by one of the IRB co-chairs. All protocols requiring "expedited" or "full" review are distributed to the entire IRB. The only difference is that "expedited" reviews are assigned to one or two members who may decide to either approve or approve with modifications. Expedited reviewers may not deny a protocol. If the expedited reviewer does not support approval, the protocol goes to "full" review and is placed on the agenda for the next IRB meeting.Expedited reviews are typically concluded within 10 business days. However, the reviewer(s) typically have questions they want answered or modifications that they want made before they give final approval. Once the PI responds, a final decision is typically made within 10 business days.
Action on a protocol that requires or has been referred for "full" review can only be decided by a majority vote of a quorum of IRB members at a convened meeting. If the IRB determines that there are enough questions or issues related to the protocol it will be "tabled" for reconsideration at the next meeting (provided the PI provides a response by the next meeting deadline). The PI will receive the results of the IRB review within 10 business days of the meeting date.
Note:
You may not begin your research until the IRB has given your application
full and unconditional approval.
What
does the IRB look for in an application? The
IRB needs to be assured that the research is 1) of sound
design, given the proposed use of human subjects; 2) that
there is e equitable selection of subjects; 3) that
there is a reasonable balance in the risks and benefits to
the participants; and, 4) that the informed consent process
is appropriate and comprehensive.
How
often does the IRB meet? The
IRB meets once a month during the fall and spring semesters. Meetings will be called as needed during the summer. A quorum of the IRB must be present
for decisions to be “official.” Information about
upcoming meetings is available from the IRB Homepage.
When
do applications need to be submitted in order to be reviewed
by full committee at the next meeting? IRB protocol applications are accepted at anytime. Application requiring full review must be received at least 10 business days prior to the next scheduled IRB
meeting. Information about upcoming meetings is available
on the IRB Homepage.
Note: Most IRB protocol applications at UAF are either "exempt" or are reviewed through the "expedited" process.
Where
do I submit my IRB application and what happens after I turn
it in? New
applications must be submitted electronically to the Office
of Research Integrity. The original signed signature page
must be mailed to:
University
of Alaska Fairbanks
Office of Research Integrity
212 West Ridge Research Building
P.O. Box 757270
Fairbanks, AK 99775-7270
How
do I know when my application has been approved? You
will receive written notification of the status of your application
following IRB review. The IRB will identify any required
revisions at that time. Note:
You may not begin your research until the IRB has given your
application full and unconditional approval.
How
do I modify an application that has already been approved? Any
time you need to change an approved IRB Protocol you must
submit a Modification Request (available on the Forms page
of this web site) and all new or revised instruments, measures,
consent documents, etc., as appropriate. Modifications must
be reviewed and approved by the IRB prior to their
implementation.
How
do I know the IRB will understand my proposed research? The
IRB is a standing board of at least five individuals, including
faculty, researchers and at least one member who is not affiliated with the university. Individual experiences and interests lead to a
diverse committee. When the IRB receives a protocol that requires
expertise beyond that available on the Board, it may seek
assistance from qualified persons outside its membership.
While outside experts may inform the IRB’s decision,
they do not vote on the IRB Protocol applications presented
for review.
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Protection
of Human Subjects
What
are the rights of a research subject? A
research subject has the right to read and discuss the informed
consent (containing all required elements) before participating in any research. A research
subject has the right to ask any questions regarding the
research and to have these questions answered in a satisfactory
manner. The subject’s decision whether or not to participate
in the research must be completely voluntary. The subject has the right
to withdraw from the study at any time without penalty.
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IRB
Protocol Application Pitfalls
What
mistakes are most likely to keep my IRB Protocol from being
approved? The
IRB looks at all aspects of your protocol application and
may have questions on any part of it that need to be cleared
up prior to approval. However, there are several common problems
that postpone approval. These are discussed in "Hints
on Writing a Strong IRB Protocol Application".
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Protocol
Review
Types
of Review
What
are the types of IRB review? There
are three levels of IRB review (exempt, expedited and full).
The Office of Research Integrity staff or designated member of the IRB is responsible for
determining the level of review required for each application
submitted. PIs may NOT determine the type
of review required. For more information on the types of
review refer to the IRB Procedures (available from the
Forms page of this web site).
My
project involves mailing anonymous surveys to adults to
assess their level of satisfaction with the medical care
available in the Fairbanks community, does this project
have to go to the full IRB for review? No!
There are three levels of review possible for any protocol
submitted to the IRB. Which level will be used is based
on risk assessment. If the survey is truly annonymous and the risk is minimal this project would qualify for exemption category #2 or #5 (described in 45 CFR 46).
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Review
Process
How
can I tell if the research I'm planning requires IRB approval? If
it is "research" and involves "human subjects" as defined in 45 CFR 46.102. you must submit an IRB protocol for review. If you have any questions
about the requirements, contact the Office
of Research Integrity.
What
kind of pilot study may I do before preparing an application
for IRB consideration? None.
You cannot collect data involving human subjects prior
to receiving IRB approval. If your study changes after
collecting a small amount of data, you should submit modifications
to the IRB for review and approval.
Can
I share an existing approved IRB Protocol with colleagues
working on similar projects? You may share your application with anyone you wish. However, IRB approval only covers the specific research and investigators identified in the approved protocol. Separate projects, no matter how similar, should be submitted independently.
Do
I need to list all the researchers or investigators participating
in the research project? Yes.
All researchers and investigators (faculty, staff, students,
collaborators, etc.) who will be collecting or reporting
data, have access to personally identifiable information about subjects,
or will receive credit as authors, should be included.
Do
I still have to go through the IRB even though I’m
not applying for funding for my research? Yes.
The University's Federal Wide Assurance states that all
research conducted at UAF, regardless of funding source,
will be subject to the IRB review, approval and monitoring
process in order to assure the protection of all human
research participants.
Do
I have to attend the IRB meeting when my application is
reviewed? No. However, IRB meetings are open to the public and PIs or research personnel are welcome to attend. In some cases the IRB may request that the PI be present at the review to answer questions or respond to specific concerns. When appropriate, the Research Integrity Administrator will coordinate this with the PI.
How
are multiple researchers, on one project, handled in the
application process? The
IRB will want to know the name and background of each person
on the project but only one person may be listed as the
principal investigator (PI). The PI must be a UAF person
who meets the criteria established in UAF Policy #05-003 Principal Investigator Eligibility. All correspondence from the Office of Research Integrity
and IRB will be sent to the PI. On request, the ORI will
copy correspondence to a second person on the project,
but the responsibility for responding is solely the PI's.
All forms and correspondence must be signed by the PI.
Is
it possible to extend the approval period? Yes.
Any project in good standing may be extended. IRB protocol approval is valid for a maximum of 365 days.
As a courtesy, the Office of Research Integrity will send
the PI a Continuing Review form 6 to 8 weeks prior to the
application’s expiration date. However, it is the PI's responsibility to insure that the Continuing Review
is submitted for all projects that will continue beyond
the “approval expiration” date on the most
recent approval letter. If you are also proposing changes
to your project, be sure to submit a Modification Request
including all appropriate supporting materials. Remember
that modifications must be reviewed and approved by the
IRB prior to implementation.
Do
I have to let the IRB know when my project is completed? Yes!
Keeping the IRB informed about the status of each approved
IRB protocol is the responsibility of the project PI. The
IRB requires that PIs formally close their research projects.
However, the end of data collection is not necessarily when you
should close your IRB Protocol; it should be
kept active at least through the analysis portion of the
research and often through publication. Please contact
the Office of Research Integrity for
specific questions about your project.
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Working
with Other IRBs
Do
I need approval from the UAF IRB if my project has been
approved by an IRB at another institution? Maybe.
Each situation is unique; please contact the Office of
Research Integrity for guidance on your specific project. In general,
if the money supporting the project was awarded to UAF
and/or UAF personnel are involved as part of their position
at UAF, then yes the project must be reviewed and approved
by the UAF IRB.
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IRB
Implications for International Projects
Are there other issues if my research
calls for research participants in other countries? Maybe.
The following is a recent release from OHRP to provide guidance
for IRB's and Researchers. "Recognizing the continued
growth of international research, the Office for Human Research
Protections has developed an International Compilation of
Human Subject Research Protections. The Compilation lists
the laws, regulations, and guidelines of over 50 countries
where DHHS funded or supported research is conducted.
The Compilation provides direct web links to each country's
Key Organizations and laws, whenever available. OHRP believes
this Compilation will help IRB's, researchers, and others to
meet regulatory requirements to assure that research studies
comply with applicable law.
The Compilation can be accessed on the OHRP web site: http://www.hhs.gov/ohrp/international/index.html#NatlPol .
To use the Compilation, go to page 3 and then click on the
country of interest."
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Consent
and Assent
Is
informed consent required even if the data will be collected
from my family, friends or colleagues? Yes.
All research involving human subjects requires informed consent,
regardless of your relationship with the subjects.
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Methods
Classes and Class Projects
I'm
teaching a research methods class and want my students to
do their own human subjects research project as part of the
course, do I need IRB approval? MAYBE.
This can be a complicated issue, the best thing to do is
contact the Office of Research Integrity well before the
class starts to discuss your options. The IRB will work
with you so that you are free to teach the course how you
wish and still fulfill the requirements for the protection
of human research subjects.
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Personnel
Training
I
know my IRB Protocol must be approved before I start
my research, but is there anything else I need to do with
respect to human subjects protections and the IRB? Yes.
All PIs and research team members listed on the IRB protocol application
must complete formal training in human subjects protection.
UAF's training program is available online (click the Training
link in the Navigation bar for more information) so it is available at your
convenience.
Why
is education on human subject protections required? One
of the questions every IRB asks during protocol review
is whether the people engaged in research involving human
participants are knowledgeable. In other words, do you
know what you are doing? Formal education in the protection
of human subjects is mandatory for all individuals engaged
in Public Health Service funded research involving human
subjects. Not all funding agencies specify that formal
education and documentation is mandatory; however, many
recognize that this leads to a much better and more comprehensive
human protections program at universities. For example,
the U.S. Department of Education does not specify mandatory
education requirements but strongly encourages institutions
to require it of their investigators. Regardless, demonstrated
knowledge in the protection of human participants in research
is a requirement of IRB approval for research protocols
at UAF or conducted by UAF faculty, staff, and students.
Who
has to complete a formal education program? All
Principal Investigators as well as those individuals listed
on the IRB protocol application that will have any interaction
with the research population and/or access to the identifiable human subject data.
Can
I obtain Continuing Medical Education credit? Yes.
When you register for the IRB approved training program (CITI)
you can request CME credits. The University of Miami Office
of Continuing Medical Education will provide 6 Category 1
Continuing Medical Education credits for Physicians, Physician's
Assistants, Nurse Practitioners and Psychologists. Nurses
may be eligible for credits and should call (305 243-6716)
or e-mail the UM Continuing Education Office for details.
Can
I use this training in my graduate or undergraduate courses? Yes.
You may have students in your classes enroll following
the instruction on our Training page . Please provide the Office
of Research Integrity with your name, the course name
and number, and a list of students so we may forward the
completion letters as they are reported to us.
Who
do I contact if I have questions? Please contact
the Research Integrity Administrator.
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Reporting
Requirements
Are
there specific reporting requirements once my IRB Protocol has been approved? Yes.
You must inform the IRB of any complaints from human subjects and any adverse events.
Principal Investigators must also file a Continuing Review
form at least every 365 days. Failure to return the Continuing
Review form by the deadline results in the immediate suspension of
the protocol. Such suspension requires that all activity
on the project stop, not just the enrollment of subjects
and collection of data. Research activities may not resume until you receive a new IRB approval letter.
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Regulatory
Agency Questions
What
IRB records should the principal investigator keep? The
principal investigator must maintain a protocol file. This
file must include: 1) The
original IRB application and all subsequent revision and
renewal applications; 2) All
correspondence between the investigator and the IRB, as
well as communications regarding the study from a sponsor;
3) The signed IRB approval letter(s); 4) Signed
Consent Forms obtained from all participants or information
where these documents can be found; 5) Progress
reports; and 6) Reports
of all adverse effect incidents and any follow-up to these
incidents. This file will act as the investigator’s
documentation regarding the proper performance of the study.
This file may be audited as part of the IRB's post-approval monitoring, which is conducted by the Office of Research Integrity.
What’s
the worst that can happen if I don’t request IRB approval? Aside
from potential ethical implications for the subject and for
the investigator, bypassing IRB review brings other risks:
- Funding
may be withheld: Federal sponsors, and many private sponsors,
require IRB approval as a condition of funding. Sponsors
may postpone review of proposals for which IRB review
is not complete/pending at the time of proposal submission.
Some sponsors will not release funds to the University
for the investigator’s use without IRB approval.
- Articles
may not be published: Many professional journals require
evidence of IRB approval when considering articles for
publication.
- Dissertation
or thesis work may not be accepted: Graduate students
must present to the Graduate School evidence of IRB approval
for their projects involving human subjects. Thesis or
dissertation work may not be accepted without it. Degrees
may not be awarded for work based on non-IRB-reviewed
projects.
- Credit
may be withheld: The University may, at its discretion,
refuse to grant students course credit for research conducted
without IRB approval.
- The
University will not support unapproved research: Liability
issues arising from unapproved research become the responsibility
of the investigator. Persons conducting unapproved research
are deemed to be acting outside the scope of authority
granted them by the University. The University will not,
therefore, provide an investigator of unapproved research
the resources to answer a liability complaint. The University
may also pursue disciplinary action against individuals
conducting unapproved research involving human subjects.
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Funding
Agency Questions
Grants
and Contracts is holding up my proposal because I do not have
an IRB protocol number! Why? All
Institute Business Offices and/or Grant and Contract Services
check to ensure that any proposal involving human subjects has
been reviewed and approved by the UAF IRB. Your proposal
will be held up if there is even a suggestion of human subject research and there is no indication of IRB approval.
If you believe that your proposal does not require an IRB approval
it is your responsibility to
provide the necessary information to the Office of Research Integrity. This is easily
accomplished by sending an explanation via e-mail to the Office
of Research Integrity; be sure to include the UAF proposal number!
The
agency I am submitting a proposal to has requested a letter
from the IRB. What do I do? The UAF IRB issues signed approval letters for all authorized projects; this is typically all the funding agency needs. If you need something more, contact the Office of Research Integrity for assistance.
Are
there situations when my funding agency will be notified about
problems with my IRB protocol? The
only time this will happen is if the Director of Grant & Contract
Services feels that progress on the award has been significantly
affected. For example, a PI whose IRB protocol is suspended
might miss the critical period of time when the proposed
study could be done and therefore have to wait until the
following year to complete the study. This would have to
be reported to the funding agency. Another example is if
the PI conducts an unapproved protocol.
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Definitions
What
is research? Research
is defined as a systematic investigation designed to develop
or contribute to generalized knowledge, or investigation
designed to test a hypothesis.
What
exactly qualifies as human subjects research? Any
systematic investigation (including curricular evaluation)
that is designed to develop or contribute to generalized
knowledge, and which uses living humans or identifiable
private information about living humans, qualifies as human
subjects research.
What
does “risk” mean? Risk
refers to the probability of harm or discomfort (these
can be physical, psychological, social or economic) occurring
as a result of participation in a research study. Both
the probability and the magnitude of possible harm may
vary from minimal to significant.
What
does “minimal risk” mean? A
risk is minimal when the probability and magnitude of harm
or discomfort anticipated in the proposed research are
not greater than those encountered in daily life.
What
is informed consent? Informed
consent is a person’s voluntary agreement, based
upon adequate knowledge and understanding of relevant information
(purpose of study, methods used, risks and benefits involved
from participation etc…), to participate in research.
What
does the IRB consider to be a "sensitive topic"? It
is up to the Office of Research Integrity and the IRB to
determine what qualifies as a "sensitive topic".
However, some common examples are sexual activity, domestic
or sexual violence, drug use/abuse, child abuse and other
illegal activities.
What
is a "Vulnerable Population"? The
Department of Health and Human Services (45 CFR 46.111(b))
and Food and Drug Administration (21 CFR 56.111(b)) regulations
require that additional safeguards be in place to protect
the rights and welfare of research subjects "when all
or some of the subjects are likely to be vulnerable to coercion
or undue influence". The regulations do not provide
a definitive list of vulnerable populations; they leave it
largely to the discretion of the IRB. Some populations/groups
that may be considered "vulnerable" include: persons
with an incurable disease, indigenous populations,
marginalized social groups, pregnant women,
children, prisoners, mentally challenged individuals, economically
or educationally disadvantaged individuals and groups, etc. Research that
specifically targets a vulnerable population will receive
a higher level of scrutiny than other protocols. This additional
scrutiny is to insure that individuals are not being coerced
into participation, that the consent process is culturally
appropriate, etc. It is also important to remember that vulnerability
must be considered in terms of the specific research proposed
- not all groups are vulnerable in all situations.
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