The Institutional Review Board
Chris McCarty
PHC6716
July 13, 2010
Purpose of the IRB
• To protect the rights of human subjects in research
• To ensure human subjects are informed of their
rights as participants and understand the
consequences of the research
• The IRB is not charged with evaluating or modifying
the science of a research project beyond protecting
the rights of human subjects
Abusive and unethical research led
to the creation of the IRB
• Tuskegee Syphilis Study (1932-1972)
• Nazi experimentation during WWII
• Thalidomide (1950s)
Legal structure
• 1974 -- The National Research Act (Public Law 93-348) created
the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
• 1979 -- Belmont Report outlined principles of ethical
treatment of respondents
• 1991 -- The Common Rule (Code of Federal Regulations Title
45, Part 46) adopted by multiple agencies
• This covers all institutions receiving funding from or
operating on behalf of the Federal government
• In practice, all research involving human subjects is
reviewed by the IRB, whether it is federally funded or not
CFR Title 45 Part 46
• (a) Except as provided in paragraph (b) of this section,
this policy applies to all research involving human
subjects conducted, supported or otherwise subject to
regulation by any federal department or agency which
takes appropriate administrative action to make the
policy applicable to such research. This includes
research conducted by federal civilian employees or
military personnel, except that each department or
agency head may adopt such procedural modifications
as may be appropriate from an administrative
standpoint. It also includes research conducted,
supported, or otherwise subject to regulation by the
federal government outside the United States.
Exemptions
1. Research on educational practices or for
educational purposes
2. Educational tests and surveys of subjects cannot be
identified
3. Educational tests and surveys of public officials
4. Research on existing data if it is public or
deidentified
5. Quality assurance and evaluation
6. Taste and food quality evaluation and consumer
acceptance studies (these are covered by the FDA)
How do you know if it is exempt?
• If it is not research it is exempt
• What is research?
– "systematic investigation ... designed to develop or
contribute to generalized knowledge.“ (Code of Federal
Regulations)
– If you will publish from the data it qualifies as research
• The IRB prefers to decide
– The process of applying for an exemption is very similar to
applying for IRB approval
– Most research done by the UFSRC is not ever published
Types of Review
• Exemptions – See above
• Expedited Review
– Review by chair, vice-chair or external reviewer
– Does not involve vulnerable population
– Typically takes 2-3 weeks
– Interaction between reviewer and PI
• Full Board Review
– Board meets monthly
– Only when protocol is not straightforward
• Indefinite plans
– Instruments not yet developed
– Funding not secured
– Allows proposal submission to go through
Where IRB fits in UF Organization
How is IRB submission policed?
• Within university research $$ monitored at
Division of Sponsored Research
– DSR 1 form has a field asking if human subjects
are involved
– If field is yes then disbursement will not be
released without independent approval from IRB
– PI is responsible for making this happen
• Externally, federal research funding tied to
proper IRB implementation
The consequences of IRB failures
(Why it is a big deal)
• Johns Hopkins
– June 2, 2001 – Ellen Roche died in a Hopkins asthma study
– July 19, 2001 -- Office for Human Research Protections
suspended all human subjects research at Johns Hopkins
funded by the federal government until all protocols were
reviewed again
• Duke
– Routine site visit in December, 1998 uncovered 22
administrative deficiencies (including inadequate
documentation)
– All NIH-funded activities were suspended until the
deficiencies were addressed
When do you need to submit an IRB
protocol?
• For collection of data from human subjects that will (or may)
be used for publication or other research purposes
– PI submitting a proposal
– PI getting approval for work to be completed as part of a
funded grant
• This will often involve many submissions as one part of
research feeds into others
– Graduate or undergraduate student submitting proposal
for thesis or dissertation data collection
– Anyone using existing data in a way not covered under
original protocol
Process
• Fill out IRB form
– Example 1 – Brief submission
– Example 2 – Long submission
– Example 3 -- Revision
Informed Consent
• Written consent
– Example
• Verbal consent (over the phone)
– The University is conducting research about economic
conditions and other issues in Florida and we would like
your opinion. Your phone number was selected at random
by computer, and only your first name will be used to
ensure confidentiality. You do not have to answer any
question you do not wish to answer and I want you to
know this call may be recorded for quality control
purposes.
Red Flags that may trigger a full board
review
• Issues relating to potential for coercion
• Working with children
• Working with prisoners
• Working with mentally challenged
• Offering excessive incentives
Tips for IRB submission of a survey
• Refer to prior protocols that were approved
• Refrain from providing excessive documentation
• Providing questionnaire is customary, but IRB should not suggest changes
to question wording, only to IRB language prior to the survey
• It is best to ask permission to interview slightly larger sample than you
think you will need just in case. Also ask for more time than you think,
although the UF IRB typically gives a year.
• It’s easier to get a revision than a new IRB
• Keep copies of IRB approval
IRB position on web surveys
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Confidentiaility, and Anonymous On-Line Surveys
Many studies are making use of third-party software to implement online surveys and other forms
of data collection. In cases where sensitive information is being obtained from individuals, the
protocol should be explicit about what software system or vendor is being used to implement the
study (e.g., SurveyMonkey), and explain that system's privacy protections. For example, are IP
addresses of respondents collected, then destroyed, or not monitored at all?
It is often the case that data saved on vendor's servers is not as secure as you might hope, or they
might claim. Data should be removed from the vendor's server as soon after collection as possible;
if there is some need to maintain the data on the remote server, this should be explained in the
protocol.
On-line surveys can be administered anonymously given that the following precautions are taken:
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confirm that the service provider for the web-based survey does not, or cannot, collect IP addresses of
respondents in any way that could be connected with their participation or their data.
no questions asking for identifying information, including e-mail address, should be sought in any of the
online surveys.
ensure that any code connecting responses at multiple occasions is participant generated and not tracable
back to the participant. These can be unique, and easily and reliably generated by participants, and usually
involve some combination of parts of family first names, letters of hometowns, etc.
IRBs at UF
• IRB-01 (Health Science Center)
– All protocols from Health Science Center
– All protocols involving use or collection of Personal Health
Information (PHI)
• What qualifies as PHI is somewhat ambiguous
• The IRB will err on the side of caution
• IRB-02 (Behavioral/Non-medical)
– All protocols coming from the rest of campus, unless they
involve the collection of PHI
– http://irb.ufl.edu/irb02/index.html
• IRB-03
– All protocols originating at the Jacksonville campus
IRB when collaborating
• When collaborating across institutions you will need IRB
approval from each institution
– Example – Fibromyalgia study
• IRBs in other agencies (government and private)
– Florida Department of Health has its own IRB
– IRB has been used as a reason not to get a contract
• IRBs in other countries
– Not all countries have the equivalent of the IRB
– WHO adopted similar policy as the U.S., but there is no
real leverage for enforcement
IRBs at other universities
• While the guidelines for the creation of the IRBs are
the same, the way they evolve across institutions,
and even within institutions, can vary
• Examples
– UCLA did not allow social network projects where
respondents reported about people they knew
– The University of Cincinnatti at one time gave
blanket approval for survey projects to be
reviewed at the end of the year
Independent IRBs
• Some IRBs exist outside of institutions
– Western IRB
• Typically used when conducting research
across institutions
• Many universities will not allow this as a
substitute
UF Privacy Office
• The privacy office is not the same thing as the
IRB
• The IRB used to handle privacy issues, but
now these activities are separated
• http://privacy.ufl.edu/
Interesting questions
• Can different practices of IRBs at different universities create
comparative advantages?
– Be careful when negotiating with the IRB on certain points as they may
become policy at that institution
• Do journalists need to get IRB approval for investigative
stories?
• How are qualitative approaches handled by IRBs when the
data collection is by definition open-ended?
• Does it make sense to treat social science research the same
as bio-medical research?