Human Investigation Committee
2013
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Is It Research?
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Is It Human Subjects Research?
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Is It Human Subjects Research that requires
IRB review?
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A federally designated category
Describes certain kinds of research
Means that the research is determined to be
exempt from continuing IRB review
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At Yale, the IRB decides whether or not a
study qualifies for one of the exemption
categories
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Category 1
◦ Research conducted in established or commonly
accepted educational settings, involving normal
educational practices
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Category 2
◦ Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or
observation of public behavior
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Category 1
◦ An assessment of an educational technique, e.g.,
you introduce a new model for teaching how to set
broken bones. You have students complete a pre
and post—model test of skill
◦ You survey all the medical schools in the Northeast
to determine the amount of time spent teaching
contraceptive techniques to residents
◦ Note: If you’re doing a study with a school system,
there may be other regulatory requirements.
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Category 2
◦ You survey a group of adult mental health patients
and family members to determine their basic
understanding of available mental health services.
You keep track of who attended, so you can contact
them later.
◦ You then hold focus groups of some of the people
you surveyed to identify their most common
concerns regarding access to care.
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To qualify, the information collected has to be
anonymous, or, if identifiers are kept, the
information cannot pose a risk of criminal or civil
liability or be potentially damaging to the
participants’ financial standing, employability or
reputation if the information is disclosed. If it’s
particularly sensitive information the IRB may not
grant exemption.
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Studies regulated by the FDA cannot qualify
as exempt
Even if it’s otherwise exempt, if it involves
children (unless you meet the public
behavior or the educational tests criteria), it
doesn’t qualify.
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Example
◦ You’re identifying the group you will invite to your
focus group from the medical records of the Eye
Center. You yourself are part of the Cancer Center,
so these are not your patients.
◦ You’ll need to request a Waiver of HIPAA
Authorization
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Category 3
◦ Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement),
survey procedures, or observation of public
behavior that is not exempt under item (2) above; if
the human subjects are elected or appointed public
officials or candidates for public office; or federal
statute(s) require without exception that the
confidentiality of the personally identifiable
information will be maintained throughout the
research and thereafter.
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45 CFR 46.101(b)(4)Research involving the
collection or study of existing data,
documents, records, pathological specimens,
or diagnostic specimens, if these sources are
publicly available or if the information is
recorded by the investigator in such a manner
that subjects cannot be identified, directly or
through identifiers linked to the subjects.
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All the data or the specimens have to be
existing at the time you request exemption
You can’t record identifiers
◦ This means, you can’t decide that you’ll just record
the medical record number for a while, until you
match one set of information to another.
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If this relates to an investigational drug or device,
the study cannot be exempt, per FDA regulations.
Cannot involve prisoners, cannot have been
collected from individual while they were
imprisoned or individual known to be currently
imprisoned.
A HIPAA waiver will be required if you don’t have a
direct healthcare relationship to the potential
subjects.
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You are going to search a medical records
database for all subjects who had an allergic
response to an anesthetic used in the OR
from January 2011 through December 2011.
You are going to record only:
◦ Their gender
◦ Their age
◦ Their treatment
-- The type of surgery
-- Their post-op LOS
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Research and demonstration projects which
are conducted by or subject to the approval
of department or agency heads, and which
are designed to study, evaluate, or otherwise
examine methods and procedures of public
benefit or service programs.
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A community agency you know has received a
grant from SAMHSA to initiate an innovative
service model for its publically funded clients.
Part of the SAMHSA grant requires an
evaluation of the program.
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Has to deliver a public benefit (e.g., Medicare)
or a service (e.g., example above)
Has to be conducted pursuant to specific
federal statutory authority
Has to have no statutory requirement for IRB
review
Must not involve significant physical
invasions or intrusions on the privacy of
participants.
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Cannot propose to collect any data in
addition to that which is necessary for the
study, evaluation or examination of the
program
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Cannot be regulated by the FDA
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Cannot involve prisoners.
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Taste and food quality evaluation and
consumer acceptance studies, if wholesome
foods without additives are consumed, or a
food is consumed that contains a food
ingredient at or below the level and for a use
found to be safe, or an agricultural chemical
or environmental contaminant at or below the
level found to be safe, by the FDA or
approved by the EPA or the USDA.
Research Involving Response to Non-Physically
Invasive Stimuli
Research that involves participant interaction
including providing a response to a non-physically
invasive stimulus such as:
* reading/writing tasks
* computer tasks
* video games
* viewing media
* internet searches
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No more than minimal risk to subjects
No federal funding
No FDA regulated components
No procedures that would be considered biomedically based
No sponsor or other contractual restrictions
No clinical interventions
No prisoners as subjects
No children as subjects
No need for an NIH certificate of confidentiality
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A study can qualify for more than one
exemption category.
For example, you might do a survey and also
look at related data. This is a category 2 and
4 submission. But take care: you can have
identifiable surveys, but if you’re then
checking a medical record, you can’t record
the identifiable information from the med
record.
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You still need to get consent
◦ But you won’t use an HIC validated consent form.
You’ll use an information sheet, possibly coupled
with language on the survey itself, for example. Or
you may have written consent, but without an HIC
validation box.
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You still need to tell subjects that this is
research
You still need to protect the subject’s privacy
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For all requests, fill out the HIC Request for
Exemption form.
DELETE the categories that do no apply to
your request.
Submit ONLY the request and the related
documents. No extra copies.
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Any recruitment material you will use, for
example, the email message. Or the flyer or
poster
If it’s a survey, the survey.
If it’s a focus group, the questions you are
planning to ask
The information sheet or consent form
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Is: obtaining data or specimens for research
that
◦ Were not collected for the purpose of this study
◦ Are not identifiable
◦ If coded, this PI has no link to the code
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Can be retrospective or prospective
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Might be
◦ Data about health facilities, businesses or
organizations that are not individuals
◦ Data on deceased persons
◦ Deidentified human data or specimens
◦ Data or specimens with limited HIPAA identifiers,
such as dates and zip codes
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For School of Medicine/School of Nursing
research, if data or specimens included
limited direct HIPAA identifiers, a Data Use
Agreement must be in place.
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Exemption 4 can never be prospective
◦ NHSR can be retrospective or prospective
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In Exemption 4, you are gathering the data
◦ In NHSR, the data is coming to you from another
source.
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You are getting 3,000 de-identified data files
from a national database that collects and
then de-identifies the data.
◦ The files were collected for a broader reason than
your study
◦ They have limited HIPAA identifiers, but you have a
data use agreement in place with the national
database.
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Amendments (changes) to exempt studies
should be submitted to the IRB for review
Why?
◦ The change may make the research no longer
exempt
◦ Example: An exemption was granted under
Category 4 and the researchers now want to collect
date of birth
The HIC Exemption and Not Human Subjects
applications
 The HRPP Procedure (100PR 3) for
Exemptions
 The HRPP Checklist for Exemption (100 GD9)
These are on the HRPP website,
http://www.yale.edu/hrpp/
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Call the HRPP main number
◦ 785-4688
◦ Or email us at hrpp@yale.edu; ysmhic@yale.edu;
human.subjects@yale.edu