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IRB for HumanistsNaomi E. Coll, MPH, CPH, CIP
Manager of Research Integrity
Grace Caskie, Ph.D.
Associate Professor – Counseling Psychology
IRB co-chair
Patti Manz, Ph.D.
Associate Professor – School Psychology
IRB co-chair
Today’s Agenda
1. What is the IRB?
2. Defining Human Subjects Research
3. Informed Consent
4. Submitting IRB applications
5. IRB review
6. Upcoming changes to the regulations
7. FAQs and your questions
What is the IRB?
• Institutional Review Board – independent
committee.
• Review, approve, monitor research with human
subjects.
– Scientific validity
– Ethical review – protect human subjects
• Composition requirements:
– Diverse, at least 5 members, scientists, non-scientists, at
least 1 member not affiliated with the University
Belmont Report - 1979
• Foundation for today’s IRB system.
• Outlines ethical research principles:
1. Respect for persons = informed consent
2. Beneficence = favorable risk/benefit
assessment
3. Justice = selection of subjects
What is human subjects research?
Research = a systematic investigation
designed to develop or contribute to
generalizable knowledge.
• Systematic = system, method, plan.
• Generalizable = universally or widely
accepted.*
*Note – does not apply to student research at LU
What is human subjects research?
Human subjects = living individuals about
whom an investigator conducting research
obtains either:
1. Identifiable private information
OR
2. Data through intervention or interaction
Identifiable Information
Individual identities can be readily
ascertained or associated with the
information.
Private Information
1. Information about a behavior that occurs in
a context in which an individual can
reasonably expect that no observation or
recording is taking place.
OR
2. Information provided for a specific purpose
in which the individual can reasonably expect
that it will not be made public.
Intervention• Physical procedures.
• Manipulation of the individual or their
environment for research purposes.
*Interaction*• Communication or interpersonal contact
with individuals.
Interaction – most common for
research in the humanities
• Surveys/questionnaires
• Interviews
• Focus groups
Minimal risk
“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 exams or tests”
Informed Consent
• Central to the protection of participants.
• Both a process and a procedure:
• Process = exchange of information – before,
during, after
• Procedure = developing an informed consent
document and having the participant sign
8 Required Elements of Informed
1. Activities involve “research”, the purpose,
duration, procedures, and which procedures
are experimental
2. Foreseeable risks/benefits
3. Appropriate alternatives
4. Extent to which confidentiality will be
maintained
8 Required Elements of Informed
Consent (continued)
5. [research which may result in injury – does not
apply]
6. IRB contact information
7. Participation is voluntary, refusal to participate
will involve no penalty or loss of benefits, and
subject is free to withdraw any time
8. Additional elements as appropriate
Informed Consent
• Templates that include all elements of
informed consent are posted on the IRB
website.
Waiving or Altering Informed Consent
• Some or all of the 8 elements may be waived
or altered.
• Must meet regulatory criteria listed in IRB
policy.
• Must be approved in advance by IRB.
Waiving Written Documentation of
Informed Consent
• Some studies may be approved to waive
documentation of informed consent (i.e. no signed
consent document).
• Must meet regulatory criteria listed in IRB policy.
• Must be approved in advance by IRB.
• IRB may require the investigator to provide
subjects with a written statement regarding the
research.
Vulnerable Populations
Regulatory and consent implications:
• Adults who are unable to consent
• Infants, teenagers, children
• Pregnant women
• Prisoners
Must be indicated in your inclusion criteria.
Must be approved in advance by the IRB.
Submitting an application to the IRB
• Must have advanced approval of the IRB.
• Submit at least six weeks in advance.
• Guidance, worksheets, FAQs, policy on IRB
website.
• IRBNet - tutorials on IRB website.
Submitting an application to the IRB
• All investigators must complete NIH
“Protecting Human Research Participants”
online tutorial.
• All investigators must sign IRBNet package
prior to submission to IRB.
• Faculty must serve as PI and lead the
process.
Submitting an application to the IRB
A new protocol application includes:
• Protocol application form
• NIH certificates (for faculty first time, for students
each time)
• Consent documents
• Recruitment materials (flyers, email, etc.)
• Letters of permission for research in schools
or similar institutions
IRB Review
Three levels:
1. Exempt
2. Expedited
3. Full committee
IRB Review – Exempt Review
Six categories of research are eligible for
exempt review.
Three categories are the most common
for humanists…
IRB Review – Exempt Review
“Educational tests, survey procedures, interview
procedures, observation of public behavior, unless:
• Information is recorded in such a manner that subjects
can be identified, and
• Identification could place subjects at reasonable risk of
criminal or civil liability or be damaging to their
reputation, financial standing, or employability.”
* If children – only applies for observation of public
behavior if investigator not participating in activities being
observed or use of educational tests
IRB Review – Exempt Review
“Research using educational tests, surveys,
interviews, or observation of public behavior
not exempt under cat. 2, if subjects are elected
or appointed public officials or candidates for
office, or federal statutes require without
exception that confidentiality will be
maintained.”
IRB Review – Exempt Review
“Collection or study of existing data,
documents, records, pathological specimens,
or diagnostic specimens, if sources are
publically available and information is
recorded so that subjects cannot be directly or
indirectly identified. “
Additional requirements for exempt research:
• No more than minimal risk.
• Equitable subject selection.
• If recording identifiable information – must be
adequate provisions to maintain confidentiality.
• If interacting with subjects - must be a consent process
that includes:
– Disclosure that the activities involve research
– Procedures
– Participation is voluntary
– Name and contact info for investigator
– Adequate protection of privacy
IRB Review – Expedited Review
• Minimal risk only.
• Apply to all ages, except where noted.
• May not be used when identification of subjects
can be damaging to their financial standing,
employability, insurability, reputation or be
stigmatizing, unless protections are
implemented so risk of confidentiality breach is
no greater than minimal.
IRB Review – Expedited Review
Nine categories of research are eligible
for expedited review.
Three categories are the most common
for humanists…
IRB Review – Expedited Review
• “Research involving materials (data,
documents, records, specimens) that
have been collected or will be collected
for research purposes.”
IRB Review – Expedited Review
• “Collection of data from voice, video,
digital, or image recordings made for
research purposes.”
IRB Review – Expedited Review
• “Research on individual or group
characteristics or behavior, or research
employing survey, interview, oral
history, focus group, program
evaluation, human factors evaluation,
or quality assurance methods.”
IRB Review – Full Committee
Review
• Protocols that are not qualified for exempt or
expedited review are referred for full
committee review.
• Must be submitted at least four weeks in
advance of the IRB meeting date.
• IRB meetings - second Tuesday of each
month.
IRB Review – Determinations• Approved
• Modifications Required to Secure Approval
– A response submission must be submitted in
IRBNet
– If conditions are met, approval is issued
• Disapproved (rare)
Do not proceed with any aspect of your
research without approval in hand!
Investigator’s Post-Approval
Obligations• Continuing Review – for expedited and full
review protocols.
• Modifications – for all protocols (exempt,
expedited, full review).
• Submit reportable events as required to the
IRB.
• Conduct research according to IRB-
approved protocol.
Upcoming changes to the
regulations
• Changes to the “Common Rule” (federal
regulations) were finalized at end of
Obama’s term.
• Take effect 2018/2019.
• Fairly likely that they will not be signed into
law under the current administration.
FAQs1. My protocol meets the ‘exempt’ review
criteria, do I have to submit an application
to the IRB?
FAQsYes – IRB must make the exempt
determination.
FAQs
2. I’m not collecting any identifiable
information, do I need to submit an
application to the IRB?
FAQs
Yes – if you are actively collecting any data,
even de-identified, through intervention or
interaction. If you are using existing data
(e.g. secondary datasets, biological
specimens), you may not require review. You
must contact the IRB first.
FAQs
3. When can I begin recruiting?
FAQs
You must have official IRB approval (i.e.
approval notice on IRB letterhead) prior to
any interaction with subjects, including
recruiting, data collection, etc.
FAQs
4. Can the IRB approve a project
‘retroactively’?
FAQs
No – federal regulations do not allow
retroactive approval.
FAQs
5. How does informed consent for online
research (e.g. surveys) work?
FAQs
“Implied consent” – by knowingly
participating, i.e. completing the survey, the
subject is providing consent.
This is a form of waiving documentation of
informed consent. Must meet criteria for
approval.
FAQs6. When do I have to submit a Modification for
my IRB-approved project?
FAQsYou must submit an amendment when the
study design, informed consent procedures,
or research personnel changes.
Submit it in advance of making the change.
Wait for approval *exception – remove
immediate hazard (must submit report to
IRB afterwards).
Questions?
Naomi E. Coll, MPH, CPH, CIP
8-2985
http://research.cc.lehigh.edu/irb
