Transcript Introduction to Human Subjects Research: Policies & Procedures

The Care and Feeding of
Your IRB Application
Laura A. Moll, M.A., CIP
IRB Administrator
Hugh D. Spitler, Ph.D.
IRB Chair
Office of Research Compliance (ORC)
864-656-6460, [email protected]
Overview of Workshop
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IRB Review Process
Basic definitions in human subjects research
IRB Review of Exempt Research
IRB Review of Expedited / Full Research
Defining members of the research team
Required training
Materials available on Clemson’s IRB website
Workshop Learning Objectives
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Have a familiarity with the IRB review process
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Have a familiarity with basic definitions in
human subjects research
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Understand basics of why a protocol might
require Exempt / Expedited / Full Review
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Understand decisions re: who is a research
team member
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#1 Lesson – Contact us with questions 
Institutional Review Board (IRB)
…Here and Elsewhere
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Differences in policies and procedures across
institutions
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Federalwide Assurance (FWA) with Office
for Human Research Protections (OHRP)
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Institutional policies
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Local interpretations
IRB Review Process
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Researcher develops research project
Researcher completes IRB training
Researcher completes IRB application form
Form and attachments submitted to IRB
Pre-screen by Office of Research Compliance
Committee / Committee member review
Decision in writing (sometimes via email)
What Is Research?
45 CFR 46.102(d)
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Research means a systematic investigation,
including research development, testing and
evaluation, designed to develop or contribute to
generalizable knowledge. Activities which meet
this definition constitute research for purposes of
this policy, whether or not they are conducted or
supported under a program which is considered
research for other purposes. For example, some
demonstration and service programs may include
research activities.
What Are Human Subjects?
45 CFR 46.102(f)
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Human subject means a living individual about
whom an investigator (whether professional or
student) conducting research obtains
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(1) Data through intervention or interaction
with the individual, or
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(2) Identifiable private information.
Human Subjects or Not?
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The owners of businesses complete surveys regarding
the number of employees, the percentage of hourly
paid vs. salaried, company policies re: family leave,
whether any complaints have been filed against the
company by employees, etc.
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A colleague, who is drawing blood from patients for
medical purposes, collects an extra 4 mls of blood for
your research project (with informed consent from the
patients), and gives it to you with sex, age, height and
weight, but no other individually identifying information.
Determining Review Category –
Which Application to Use
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Applications at
www.clemson.edu/research/compliance/irb/forms.html
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Exempt / Expedited status determined according to 45
CFR 46 (Exempt ≈ 80%; Expedited ≈ 20%)
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Full board review (< 1%)
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Entire protocol is reviewed at one level, highest level of
review required based on research activities
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Determinations made by IRB or ORC
IRB Exemption
Exempt means
“exempt from continuing review”
NOT
“exempt from any review”
Exemptions
45 CFR 46.101(b)
(1) Research conducted in established or
commonly accepted educational settings,
involving normal educational practices, such as
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(i) research on regular and special education
instructional strategies, or
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(ii) research on the effectiveness of or the
comparison among instructional techniques,
curricula, or classroom management methods.
Exempt or Not?
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Research in a middle school, using journaling
entries, test scores, homework assignments,
and interviews with students to determine
whether different parenting styles have an
effect on school performance.
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Research in a workshop on preparing grant
proposals, using audiorecorded small-group
discussions and workshop evaluations to
assess the effectiveness of the workshop.
Exemptions
45 CFR 46.101(b), cont.
(2) Research involving the use of educational
tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview
procedures or observation of public behavior,
unless:
Exemptions
45 CFR 46.101(b)(2), cont.
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(i) information obtained is recorded in such a
manner that human subjects can be identified,
directly or through identifiers linked to the
subjects;
AND
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(ii) any disclosure of the human subjects'
responses outside the research could reasonably
place the subjects at risk of criminal or civil
liability or be damaging to the subjects' financial
standing, employability, or reputation.
Exempt or Not?
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Participant observation and interviews about
their job duties with employees of the office in
which the researcher works.
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Observing and taking notes on the interactions
between children who appear to be of different
ethnic backgrounds at a public park.
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Interviewing teachers about the management
style of their principal and its effects on them.
Exemptions
45 CFR 46.101(b), cont.
(6) Taste and food quality evaluation and
consumer acceptance studies,
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if wholesome foods without additives are
consumed, OR
If a food is consumed that contains a food
ingredient at or below the level and for a use
found to be safe, or agricultural chemical or
environmental contaminant at or below the level
found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food
Safety and Inspection Service of the U.S. Department of Agriculture
Exempt or Not?
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Asking participants to evaluate the freshness
of raw meat packaged in a new plastic wrap,
when the meat varies from having been
packaged one day to one month ago.
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Asking participants to taste a newly
developed snack containing commercially
sold dill pickles, peanut butter, and fresh
cherries.
Expedited vs. Full Review
45 CFR 46.110
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Expedited review procedures for certain kinds of
research involving no more than minimal risk.
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45 CFR 46.102(i) Minimal risk means that the
probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily
life or during the performance of routine physical or
psychological examinations or tests.
Expedited Categories
45 CFR 46.110
(5) Research involving materials (data, documents,
records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes
(such as medical treatment or diagnosis).
(6) Collection of data from voice, video, digital, or
image recordings made for research purposes.
Expedited Categories
45 CFR 46.110, cont.
(7) Research on individual or group
characteristics or behavior (including, but not
limited to, research on perception, cognition,
motivation, identity, language, communication,
cultural beliefs or practices, and social behavior)
or research employing survey, interview, oral
history, focus group, program evaluation, human
factors evaluation, or quality assurance
methodologies.
Expedited or Full?
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Interviewing adults about their personal and family
medical histories.
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Videorecording interviews with pregnant women
about their experiences with back pain during
pregnancy.
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Interviewing adults with mental illness who are
recovering from drug addictions. The interviews
include questions on their childhood experiences,
their mental illness, and their drug use.
Who Is Part of the
Research Team?
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Anyone who intervenes or interacts with living
individuals for research purposes; or obtains
individually identifiable private information for
research purposes [45 CFR 46.102(f)]
Who Is Part of the
Research Team?, cont.
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interacting with living individuals for research
purposes (e.g., engaging in protocol-dictated
communication or interpersonal contact;
conducting research interviews; obtaining informed
consent)
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obtaining, receiving, or possessing private
information that is individually identifiable (either
directly or indirectly through coding systems) for
research purposes (e.g., obtaining private
information from medical records in an individually
identifiable form)
Engaged in Research or Not?
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Secretary who retrieves individual school
records off the fax machine and places them in
the researcher’s mailbox.
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Community partner who provides informed
consent form to potential participant and
answers any questions they may have.
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Professor who distributes informed consent
forms and receives signed / unsigned forms
back from students in sealed envelopes.
What Training Is Needed for the
Research Team?
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CITI Course in the Protection of Human
Research Subjects (Social / Behavioral
Science Research, Biomedical Research,
HIPAA only, IRB Reference Resource)
www.citiprogram.org
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Continuing Education requirement – all team
members, every two years
IRB Forms for Investigators
Exempt and Expedited / Full Applications
www.clemson.edu/research/compliance/irb/forms.html
Continuing Review form
Amendment Request form
Adverse Event / Unanticipated Problem form
Developmental Approval form
Final Summary Report
HSSC IRB Request for Cooperative Review – Initial
HSSC IRB Request for Cooperative Review – Post-Approval
Informed Consent Information
www.clemson.edu/research/compliance/irb/forms.html
Templates:
Informational Letter (no signature)
Adult Consent Form
Parental Permission Form
Minor Assent Form
Federally-Defined Criteria for:
Waiver of Documentation of Consent (Signature)
Waiver of (Elements of) Consent
IRB Guidance
www.clemson.edu/research/compliance/irb/regulations.html
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Advertising for Research Participants
HSSC IRB Collaborative Review
PI / Research Team Member Responsibilities
Post-Approval Monitoring
Research Site Letters
Submitting Research Protocols to GHS
Use of Audio / Videorecording
Use of Deception or Concealment
Use of Human Cell Lines
Use of Students as Research Participants
Coming Features
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New and improved forms
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New and improved website organization
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Informed consent templates specific to either
exempt or expedited / full requirements
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More information and guidance, organized in a userfriendly way!
Contact Information
Telephone: (864) 656-6460
Email: [email protected]
Office: 223 Brackett Hall
www.clemson.edu/research/compliance/irb/