Transcript UW-MADISON Social & Behavioral Science IRB Human Subject

Education Research and
Social & Behavioral Science
IRB
BACKGROUND
 Nuremberg Code
 Infamous Cases 1950’s through 1970’s
 1971 - DHEW Guidelines Pamphlet
 1979 - Belmont Report
 1981 - 45 CFR 46
FWA
 Agreement between UW and DHHS which
allows for the conduct of HS research
 OHRP/Common Rule
 UW will be guided by the ethical principals of
the Belmont Report regardless of source of
funding
UW IRB WILL REVIEW IF:
 Research is sponsored (i.e. funded) by UW
 Conducted by, or under the direction of, any
UW employee
 Uses UW property or facilities
 Requires non-public UW information to
identify or contact subject
DEFINITIONS
 Research 46.102(d)
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A systematic investigation, including research
development, testing and evaluation, designed
to develop or contribute to generalizable
knowledge
 Human Subject 46.102(f)
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A living individual about whom an investigator
obtains data through intervention or private
information
RISK
 For a study to be considered “minimal risk”,
the risks associated with participating in the
study must be equal to or less than the level
of risk a participant will encounter in their
daily lives
 Acknowledgement of risk is acceptable and
expected. What the IRB wants to see is the
ways you will mitigate those risks (for
example, encrypting data, pseudonyms, etc.)
STUDENT RESEARCH
 All students conducting human subject
research must obtain IRB approval
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Senior Thesis
Hilldale Awards
Independent Study
Master’s Thesis
Doctoral Dissertation
STUDENT RESEARCH
 Class Projects
 May be research if Federal definition is met
 If the results are for course credit/class
assignment and will not be disseminated
beyond the University, IRB approval is
probably not required
 Course assignments that are not research
must be carried out ethically to protect
individuals involved
INFORMED CONSENT
 Informed consent is a process with its basis in ethical
principals – it’s not just a signature
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Written, signed consent is the default
Oral Consent
 Literacy concerns
 Cultural Norms
 Protection of Participants
Waiver of Documentation of Consent
 The only link to participants is the signed consent
document
INFORMED CONSENT
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Assent
Waiver of Consent
Waiver of Parental Consent
HIPAA Authorization
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If the researcher works for or is a member of a
HIPAA protected entity
PHI is being collected
Passive consent
ELEMENTS OF INFORMED
CONSENT
 1) Statement that the study involves research
 Identify it as a UW-Madison research project
 2) Description of any risks
 Can be emotional
 Risk of a breach of confidentiality
 3) Description of any benefits to the subject
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There are typically NO direct benefits to participating in
research
 4) Disclosure of alternative procedures
ELEMENTS OF INFORMED
CONSENT
 5) Confidentiality of records
 Use of pseudonyms
 Data encryption
 Password protected laptop
 Use of audio or video recording
 6) If more than minimal risk – steps the research will
take to mitigate those risks
 7) Contact information for answers to pertinent
questions
 8) Statement that participation is voluntary
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Participants can withdraw at any time, skip any
questions they do not wish to answer
ELEMENTS OF INFORMED
CONSENT
 Compensation – Compensation is NOT a
benefit
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Parking pass
Gift cards
Drawings, raffles
Extra credit
If cash is offered, is the amount coercive?
Use the IRB Consent Wizard
 The IRB wizard is a tool to help ensure all
federally required elements of consent are
included:
https://rcr.gradsch.wisc.edu/cfwizard/start.asp?wisc
The majority of modifications requested by the IRB
are due to consent form errors. Use the wizard to
avoid these errors.
WAIVERS OF INFORMED
CONSENT
 Waiver of documentation of informed consent
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Only document linking subject to research and
principal risk is breach of confidentiality
Minimal risk and involves no procedures for
which written consent is normally required
outside of research
WAIVERS OF INFORMED
CONSENT
 Waiver of Informed Consent
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Minimal Risk
No adverse affect to rights & welfare of
subjects
Research could not practicably be carried out
without waiver
If possible, provide subjects with additional
information after participation
EXEMPT RESERACH
 Falls within one of the six categories listed at
45 CFR 46.101(b)(1-6)
 Minimal Risk
 Is human subject research, but is “exempt”
from the regulations
 IRB - not the PI - determines exemption
 Does not require full IRB review
EXEMPT CATEGORIES
 Conducted in established or commonly
accepted educational settings, using normal
educational practices
 Educational tests, survey or interview
procedures or observation of public behavior
unless information is identifiable and sensitive
EXEMPT CATEGORIES
 Educational tests, survey or interview
procedures or public observation not exempt
under the previous item if subjects are
elected or appointed public officials or
Federal statutes require confidentiality
 Collection or study of existing data or
documents if they are publicly available or
anonymous
EXPEDITED REVIEW
 Minimal risk
 Falls within one of the categories found at 45
CFR 46.110
 All the regulations apply (unlike exempt)
 The full IRB does not review the protocol
CATEGORIES ELIGIBLE FOR
EXPEDITED REVIEW
 Research on individual or group
characteristics or behavior or employing a
survey, interview, oral history, focus group,
program evaluation, human factors
evaluation, or quality assurance
methodologies
CHILDREN AS SUBJECTS
 In most cases, children may participate only if
the research involves no more than minimal
risk
 Consent of parent or guardian
 Assent of the child
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Age appropriate language
Written assent age 11 and up
Oral assent age 10 and under
INTERNATIONAL RESEARCH
 Guidelines for International Research
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Cultural, political or economic conditions that
would increase risk to participants
Local IRB or ethics committee
Local contact for questions
Consent forms in native language of
participants
Because traveling internationally increases the
risk of a confidentiality breach, you will need to
encrypt your data.
INTERNATIONAL RESEARCH
 Consider the most appropriate method for
obtaining informed consent
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Take into account the literacy level of
participants, cultural norms and confidentiality
concerns.
 All key personnel must complete CITI
training, even if they are from outside the U.S.
 In many cases it won’t be possible to expedite
international protocols.
INTERNET RESEARCH
 Surveys administered via the internet
 How sensitive is the data
 Security
 Confidentiality
 Consent Issues
 FaceBook
 Blogs
 Chat rooms
 Expectation of privacy by the subject
 Minors
COLLABORATION WITH
OTHER INSTITUTIONS
 Must be a UW PI
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PI’s must be tenure or tenure track faculty
 Must provide evidence of approval from the
other IRB
 Must obtain approval from a UW IRB
 All key personnel must complete human
subject training
OTHER CONSIDERATIONS
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Conflict of Interest
Status Relationships
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Community-based research
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Classroom or clinic environment
Issues of engagement of the community partner
Going into homes?
Sensitive Population
Non-English speaking participants