Frequently Asked Questions
Below
are some of HSD's most frequently
asked questions:
General FAQs
Consent FAQs
Federal Wide Assurance (FWA)
FAQs
HIPAA FAQs
Research Participant FAQs
Confidentiality Agreement FAQs
Does my research require review?
If you are a faculty or staff member, or a student at
the University of Washington, and your research1 involves
the use of human subjects2 (either directly or through
records or other data such as specimens or autopsy materials),
your research requires human subjects review.
1 "Research" means a systematic investigation
designed to develop or contribute to generalizable knowledge. Activities
which meet this definition constitute "research" for
the purposes of these regulations, whether or not they are supported
or funded under a program which is considered research for other
purposes. For example, some "demonstration" and "service" programs
may include research activities.
University of Washington Human Subjects Manual Part II.A.,
(from Department of Health and Human Services Regulations, Code
of Federal Regulations 46.102, Definitions).
2 "Human subjects" are individuals whose physiologic
or behavioral characteristics and responses are the object of study
in research. Under the federal regulations, human subjects are
defined as: living individual(s) about whom an investigator conducting
research obtains: (1) data through intervention or interaction
with the individual; or (2) identifiable private information [Federal
Policy • 45
CFR 46.I 02(f)]. In Washington state, individuals who have died
are still considered to be human subjects.
Why does the IRB need to review my research?
Federal, state and university regulations require that the use of
human subjects in research be reviewed and approved by an Institutional
Review Board (IRB). The IRB Committees review the proposed purpose,
procedures, and subject populations to be used and determine if the
benefits of the activity outweigh the risks to subjects. Issues considered
in this analysis include:
- how subjects are approached to participate,
- what measures are used to protect subjects' privacy,
- what physical and psycho-social risks, stresses, and discomforts
subjects will be asked to endure.
The scientific merit of the activity is considered only if
it has an impact on the risk-benefit analysis. For example,
will the number of subjects proposed allow the results obtained
to be statistically significant? Is there a less risky way
to achieve the same results?
The Committees also evaluate advertisements, approach letters,
consent/assent forms or information statements, telephone scripts,
and debriefing statements to determine if they are accurate,
explanatory, and written in simple, lay language appropriate
for the intended subjects.
A Committee may decide that there is insufficient information
to approve or disapprove an application. In such a case, the
Committee defers consideration and asks the researcher to provide
additional information. When the Committee receives the information,
the application is reconsidered.
Very rarely, a Committee will determine that the risks of a
proposed activity outweigh the benefits and will withhold approval.
Usually, the researcher and the Committee can work out a compromise
to reduce the risks and gain permission to carry out the research.
If a researcher disagrees with a Committee's disapproval, the
decision may be appealed.
What is the IRB review process?
The “Life Cycle” of a Human Subjects Application can
be described as having six phases:
- Researcher Preparation
- Department Review and Approval
- IRB Review and Approval
- Conduct of Research and Reporting
- Continuing Review
- Ending the Study
A diagram of the
Human
Subjects Application Life Cycle describes
what happens within each phase.
Once you have decided how you want to use human subjects in your
research, begin the process by completing a Human Subjects Review
Committee application form (UW 13-11) and submit it to the Human
Subjects Division, Box 355752 – including all relevant
information (grant proposals, drug or device information, consent
forms, questionnaires, test instruments, advertisements, debriefing
statements, contact letters, etc.).
Federal, state and university regulations require that the use
of human subjects in research be reviewed and approved by an
Institutional Review Board (IRB). At the University of Washington,
seven IRB Committees carry out this function:
- Three review Biomedical research – Committees A,
B, and D.
- Three review Behavioral research – Committees C,
G, and H.
- One reviews Veterans Administration research – Committee
V.
The Human Subjects Division (HSD), Office of Research (OR), provides
administrative support to each of these Committees. The Human Subjects
Division also:
- Reviews proposals and provides certifications of review
to funding agencies.
- Reviews modifications to existing approvals.
- Receives reports of adverse effects resulting from research
with human subjects.
- Monitors complaints from human subjects.
- Advises researchers and departments on human subjects review.
Does all research go through the same review process?
No. There are three types of research, each of which receives
a different level of review.
- Exempt Research
Research falling into exempt categories is reviewed by your department. These
categories are defined in the Human Subjects Manual and on the back of
the Certificate of Exemption form. A Certificate of Exemption must be reviewed
and approved by your Chair. Send a copy of the form to the Human
Subjects Division and keep a copy for yourself. Approval is valid for five
years as of the date of the Chair's signature.
- Minimal Risk Research
Research falling into minimal risk categories is reviewed by a subcommittee
of the IRB (use form UW
13-11). You may also hear the term “expedited review” used
in conjunction with the review of minimal risk research; describing the
ability of the research to be reviewed by a subcommittee – not that
the review process is necessarily faster.
- More than Minimal Risk Research
Research falling into categories considered to be of more than minimal risk
requires review by the full Committee (use form UW
13-11).
How long does this process take?
HSD has identified goals for turn-around time from receipt of
an application to the time it receives approval by type of application
and level of review:
- Exemptions – Goal: One to two week turn-around
at HSD.
- Minimal Risk – Goal: Four to six week turn-around.
- Full IRB Review – Goal: Six to eight week turn-around.
Multiple factors can impact the time it takes an application
to go from “researcher preparation” to “approved,” including:
departmental and other peer review requirements, additional committee
reviews (i.e., Radiation), and time in revision and/or clarification.
Each new application is screened by HSD staff for completeness
when it is received. If the application is complete, it will be
assigned to a Committee. Each IRB Committee meets every two weeks
and the agenda is sent to Committee members one week before the
meeting. This means that an application and all related materials
must be received at least two weeks prior to a meeting date to
have the potential for review at a particular meeting. However,
receipt of materials at least two weeks in advance does not guarantee
review at a specific meeting. Due to the high volume of application
submissions, applications can wait longer before they are able
to be assigned to a meeting agenda. The absence of necessary information
can also significantly delay the processing of an application.
You can expect to receive a letter from the Committee after the
meeting at which the application is reviewed, requesting any additional
information and consent form revisions necessary before full approval
can be given. Once a full response to the Committee's requests
has been received by HSD, you can typically expect approval unless
further questions arise.
How long is approval valid?
Approval is generally valid for one year from the date of Committee
approval.
Two months before expiration, the Human Subjects Division will
send an e-mail alerting you to the need to submit a Status Report (Renewal or Closeout) Form - 05/30/08 (doc) 220 kb for annual
review. If you want to make substantial changes that affect human
subjects, you must typically take one of two actions:
Typically, changes to an application that are within the initial
scope of the study will be appropriately met by use of a Modification.
However, changes that alter the overall scope or focus of the study
may require preparation of a new application. If you don't want
to renew your application, submit the Status Report Form to close
out the study and as a final report.
Certificates of Exemption are valid for five years, and may not
be modified.
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