Yale University
Human Subjects Committee
REQUEST FOR HSC DETERMINATION OF EXEMPT STATUS
100 FR 10
Title of Project:
Investigator:
Position:
___Undergraduate Student—Year of Graduation:
___Graduate Student
___Postdoctoral Fellow
___Faculty Member
____Research Scientist
Department:
Address, Phone Number, e-mail address:
Study Correspondent: (this person, in addition to the Investigator, will receive communications
from the HSC)
ALL Other Research Personnel, including name, position and department:
Does the principal investigator, co-investigator, or any other responsible research team member, or
any of their family members (spouse, child, domestic partner) have an incentive or interest, financial
or otherwise, that may be viewed as affecting the protection of the human subjects involved in this
project, the scientific objectivity of the research or its integrity? See Disclosures and Management of
Personal Interests in Human Research http://www.yale.edu/hrpp/policies/index.html#COI
Yes
No
If yes, list names of the investigator or responsible person:
All Yale University and Yale New Haven Hospital individuals listed as co-investigators must have a
current financial disclosure form on file with the University’s Conflict of Interest Office. If this has
not been done, the individual(s) should follow this link to the COI Office Website to complete the
form: http://www.yale.edu/coi/
NOTE: The requirement for maintaining a current disclosure form on file with the University’s
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital
personnel. Whether or not they are required to maintain a disclosure form with the
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise
responsible by the PI who are listed on the protocol are required to disclose to the PI any
interests that are specific to this protocol.
106739838.1
Form Approved/Revised:
3/13
Project Period:
Name of external sponsoring agencies providing funding for the study and contact name, if
known.
Include proposal title, if different from project title:
Research Site:
Where will the data be collected?
Do you have an affiliation or relationship with this research site?
Yes
No
If yes, please describe in protocol.
INSTRUCTIONS TO INVESTIGATOR
At the discretion of the Committee, certain research activities may be exempt from
review. Research involving human subjects may not start until the HSC has granted
either IRB approval or has notified the investigator that the project qualifies for
exemption from further review.
The types of research which may be exempt are described in the attached list. It is
important to note that studies involving minors cannot be exempt under category 2
below. Additionally, the HSC does not exempt studies that involve the Introductory
Psychology Subject Pool.
If you believe that your research constitutes one of the types of research which may be
exempt from review, please attach:
_____ a description of the research project
_____ the manner in which all subject materials will be identified to the researchers and
in all records made by the researchers
_____ the written consent form(s) or verbal statement to be given to the subjects
regarding consent/assent
_____ copies of surveys or questionnaires which the participants will receive
_____ sample recruitment letter or advertisement
106739838.1
Form Approved/Revised:
3/13
EXEMPTION FROM REVIEW
Certain research activities may be exempt from review, if approved by an authorized
Committee member and confirmed in writing to the Investigator. Research may be
exempt from review when the only involvement of human subjects in the research falls
into one of the following categories:
Research conducted in established or commonly accepted educational settings,
involving normal educational practices such as (i) research on regular and special
education instructional strategies, or (ii) research on the effectiveness of or the
comparison among instructional techniques, curricula, or classroom management
methods. 45 CFR 46.101(b)(1)
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior
unless: (i) information obtained is recorded in such a manner that human subjects can
be identified, directly or through identifiers linked to the subjects; and (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. 45 CFR 46.101(b)(2)
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
that is not otherwise exempt if: (i) The human subjects are elected or appointed public
officials or candidates for public office; or (ii) federal statute(s) require(s) without
exception that the confidentiality of the personally identifiable information will be
maintained throughout the research and thereafter. 45 CFR 46.101(b)(3)
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. 45 CFR 46.101(b)(4)
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: (i) Public benefit or service programs; (ii) procedures for obtaining
benefits or services under those programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible changes in methods or levels of payment
for benefits or services under those programs. 45 CFR 46.101(b)(5)
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome
foods without additives are consumed or (ii) 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. 45 CFR 46.101(b)(6)
106739838.1
Form Approved/Revised:
3/13
Yale University Special Exemption Category 7: Research Involving Response to
Non-Physically Invasive Stimuli
In addition to the six federal exemption categories above, the University grants
exemptions under the following seventh category for research that meets the criteria
described. This category is an extension of the above category b(2) and does not exist in
the federal regulations under 45 CFR 46.101(b):
Research involving interviews, surveys, educational test or observation of public
behavior in which participant interaction includes providing a response to a nonphysically invasive stimulus or behavioral activities commonly performed outside the
research context(e.g., reading/writing tasks, minimal risk non-invasive physical activities
such as walking, talking and sitting, computer tasks, video games, viewing media,
internet searches, holding warm or cold items, etc.) may be determined by the IRB to be
exempt if the following criteria are met:
 The research falls under the purview of the Yale University IRB,

The research poses no more than minimal risk to participants, and

The research does not include any of the following:
1.
2.
3.
4.
5.
6.
7.
8.
federal funding or federal training grants
FDA regulated components
procedures that would be considered biomedical based
sponsor or other contractual restrictions
clinical interventions
prisoners as subjects
children as subjects
receipt of an NIH issued Certificate of Confidentiality to protect
identifiable research data.
106739838.1
Form Approved/Revised:
3/13