HIC/HSC #__________________
This decision tree may help you decide which category of exemption to apply for. The IRB
makes the final determination. This is meant as a guide only; additional requirements may need
to be met. Do not submit this page.
Are you proposing to do a study
involving the use of existing data?
NO
YES
YES
Does your research involve the use
of educational tests (cognitive,
diagnostic, aptitude, achievement),
survey procedures or interview
procedures?
Are you recording identifiers?
Are you proposing research on educational
practices?
Try Exemption
Category 4
YES
NO
NO
YES
Try Exemption
Category 1
NO
Are identifiers available as part of
publicly available data?
Are you enrolling minors?
YES
NO
NO
YES
NO
Does your project include
observations of public behavior?
YES
Project probably
cannot be exempt.
Are you collecting
identifiers?
The project probably cannot be
exempt under category 4. If you
propose to evaluate or examine
methods and procedures of public
benefit or service programs, you may
try Exemption Category 5, otherwise
the project is not exempt.
NO
YES
Does your research consist of
taste and food quality evaluation
and consumer acceptance studies?
Try Exemption Category 2
or Category 7
Would disclosure of the participant’s
responses be harmful to him or her e.g., due to criminal or civil liability,
or be damaging to that person’s
financial standing, employability, or
reputation?
NO
YES
YES
NO
Are subjects elected officials?
YES
NO
Try Exemption Category 6
Project probably cannot
be exempt.
Project probably
cannot be exempt
under category 2 but
try Exemption
Category 3.
HIC/HSC #__________________
Yale University
Human Investigation Committee/Human Subjects Committee
Request for Exemption Determination
100 FR 9 (2015-1)
A. Investigator and Project Information
Title of Project: Click here to enter text.
*Principal Investigator: Click here to enter text.
Dept: Click here to enter text. Address: Click here to enter text.
Telephone: Click here to enter text. E-mail: Click here to enter text. Fax: Click here to enter text.
PI’s Association or Status with Yale: Click here to enter text.
Faculty Advisor (if applicable): Click here to enter text.
Faculty advisors must be full-time faculty with an appointment as one of the following:
☐Professor
☐Associate Professor ☐Assistant Professor
☐Research Scientist/Scholar
☐Senior Research Scientist/Scholar
The faculty advisor must also have taken the required human subject protection training and completed the
Conflict of Interest Disclosure form
Correspondent: Click here to enter text.
Telephone: Click here to enter text. E-mail: Click here to
enter text.
Funding Source: Click here to enter text.
*Other Investigator(s): Click here to enter text.
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:Click here to enter text.
*All Yale University faculty, graduate students, post-docs and fellows and all 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.
HIC/HSC #__________________
B. Human Subject Protection Training (HSPT) and Health Insurance Portability and Accountability Act
(HIPAA) Training:
All individuals involved in the design, conduct or oversight of human research should have knowledge of the
relevant ethical principles and federal, state and institutional requirements related to such research, appropriate to
their role and obligations in human research. Human Subject Protection training is required for all researchers
listed on the exemption request. Yale human subject protection training is available at
(http://info.med.yale.edu/irbtraining/) HIPAA for researchers training (http://hipaa.yale.edu/training/index.html.)
is required for all study personnel participating in biomedical research. Training must be completed before
submission of the request to the IRB.
C. Principal Investigator
As the Principal Investigator of this research project, I certify the following:




The information provided in this application is complete and accurate.
That I assume full responsibility for the protection of human subjects and the proper conduct of the research.
That subject safety will be of paramount concern, and every effort will be made to protect subjects’ rights and
welfare.
That all members of the research team will be kept apprised of research goals.
_________________________________
Signature of PI
Date
Faculty Advisor
As Faculty Advisor, I certify that I have reviewed the application and approve it for submission. I will train the
student investigator in matters of appropriate research compliance, protection of human subjects and
proper conduct of research. I further certify that the student is competent to perform the proposed research
involving human subjects. I will oversee and take full responsibility for the conduct of the research.
____________________________________
Faculty Advisor
Date
D. YNHH Human Subject Protection Administrator Assurance Statement
Required when the study is conducted solely at YNHH by YNHH Health Care Providers
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that:
* I have read a copy of the protocol and approve its being conducted at YNHH
* I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest
* The Principal Investigator of this study is qualified to serve as PI, and has the support of the hospital for this research
project.
__________________________________________
YNHH HSPA Name (PRINT) and Signature
___________________
Date
E. Instructions:
Certain research activities may be exempt from review, if confirmed by the IRB Chair or his/her
designee 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 categories noted below. The
IRB does not exempt studies that involve the Introductory Psychology Subject Pool.
Choose one of the following exemption categories for consideration and provide the information as
requested under the corresponding category. Delete all other categories that do not apply.
Applications to Human Subjects Committee can be emailed to human.subjects@yale.edu.
HIC/HSC #__________________
F. CATEGORY OF EXEMPTION FROM COMMITTEE REVIEW
☐ (Category 1) 45 CFR 46.101(b)(1) 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.
1) Describe the purpose of the study.
Click here to enter text.
2) Describe the target population, including the expected number of subjects and expected
duration of the study.
Click here to enter text.
3) Describe the educational setting of the research and the practices that will be studied.
Click here to enter text.
4) Describe the procedures involved in the study.
Click here to enter text.
5) Describe measures in place to ensure confidentiality of the data and privacy of subjects.
Click here to enter text.
6) How will consent be secured? Attach a copy of any documents/materials given to subjects.
Click here to enter text.
7) Describe the location of the study. Click here to enter text.
a. Does this study include an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
HIC/HSC #__________________
☐ (Category 2) 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, unless the information is obtained and recorded in such a manner that the human subjects can
be identified, directly or through identifiers linked to the subjects; and 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.
This exemption regarding educational tests is applicable to minor subjects. However, this exemption for research
involving survey or interview procedures or observations of public behavior does not apply to research involving
minors, except for research involving observation of public behavior when the investigator(s) do not participate
in the activities being observed.
Note: This exempt category will require a Waiver of HIPAA Authorization whenever the researcher does not
have a direct healthcare relationship with the potential subjects and wishes to view identifiable records or
samples. The waiver, if approved by the HIC, will allow you to access Protected Health Information (PHI)
without authorization from the subjects. To request the HIPAA waiver, complete question 8.
1) Describe the purpose of the study.
Click here to enter text.
2) Describe the target population including the expected number of subjects and the expected
duration of the study.
Click here to enter text.
3) Describe the location of the study. Click here to enter text.
a. Does this study include an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
4) Describe the procedures that will be used to recruit subjects, obtain consent, research
authorization (or waiver), and conduct the research. Provide the text that will be used to recruit
subjects. Attach a copy of the written consent or research authorization form, if used. If written
consent will not be used, give the text of the verbal statement used to obtain consent/assent.
Click here to enter text.
5) Clarify whether data will be recorded with or without identifiers.
Click here to enter text.
6) Clarify whether disclosures will place the subjects at risk of criminal or civil liability or be
damaging to the subjects' financial standing, employability, or reputation.
Click here to enter text.
7) Submit the survey(s), instrument or interview questionnaire that will be used.
Click here to enter text.
8) Request for waiver of HIPAA authorization:
Click here to enter text.
Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this
data;
By signing this request for exemption, the investigator assures that the protected health
information for which a Waiver of Authorization has been requested will not be reused or
disclosed to any person or entity other than those listed in this application, except as required by
HIC/HSC #__________________
law, for authorized oversight of this research study, or as specifically approved for use in another
study by an IRB.
☐ (Category 3) 45 CFR 46.101(b)(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.
Note: This exempt category will require a Waiver of HIPAA Authorization whenever the researcher
does not have a direct healthcare relationship with the potential subjects and wishes to view
identifiable records or samples. The waiver, if approved by the HIC, will allow you to access
Protected Health Information (PHI) without authorization from the subjects. To request the HIPAA
waiver, complete question 7.
1)
Describe the purpose of the study.
Click here to enter text.
2)
Describe the target population including the expected number of subjects and the expected
duration of the study.
Click here to enter text.
3)
Describe the location of the study. Click here to enter text.
a.
Does this study include an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
4)
Describe the procedures that will be used to recruit subjects, obtain consent, research
authorization (or waiver), and conduct the research. Provide the text that will be used to recruit
subjects. Attach a copy of the written consent or research authorization form, if used. If written
consent will not be used, give the text of the verbal statement used to obtain consent/assent.
Click here to enter text.
5)
Clarify whether data will be recorded with or without identifiers.
Click here to enter text.
6)
Submit the survey(s), instrument or interview questionnaire that will be used.
Click here to enter text.
7) Request for waiver of HIPAA authorization:
Click here to enter text.
Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this
data;
By signing this request for exemption, the investigator assures that the protected health
information for which a Waiver of Authorization has been requested will not be reused or
disclosed to any person or entity other than those listed in this application, except as required by
law, for authorized oversight of this research study, or as specifically approved for use in another
study by an IRB.
HIC/HSC #__________________
☐ (Category 4) 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.
“Existing” is a key word here. It means that all the data, documents, etc. must already exist when the
study is started. Note that any use of additional research material collected after research is initiated
will disqualify the study from exempt status. This category solely applies to retrospective data collection,
or use of existing samples. Also, “identified” or “linked” are key words. The investigator may not
record identifiers.
Note: This exempt category will require a Waiver of HIPAA Authorization whenever the researcher
does not have a direct healthcare relationship with the potential subjects and wishes to view identifiable
records or samples. The waiver, if approved by the HIC, will allow you to access Protected Health
Information (PHI) without authorization from the subjects. To request the HIPAA waiver, complete
question 9.
1) Is an investigational drug or device being used to test the specimens in this research?
☐ Yes ☐ No
If you answered yes to this, under FDA regulations an exemption from IRB review cannot be given. You
must complete a full HIC application.
2) Is the data already existing?
☐ Yes ☐ No If you answered NO to this, an exemption from IRB review cannot be given. You must
complete a full HIC application.
3) Describe the purpose of the study.
Click here to enter text.
4) List the information that will be recorded. Only those items listed on this application may be
recorded. Click here to enter text.
5) Describe where the data/documents, records or specimens will be obtained from. Click here to
enter text.
a.
Does this study include data from an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
6) Describe the target population, including the expected number of subjects and expected duration
of the study.
Click here to enter text.
7)
Describe how data will be recorded so that subjects will not be identified.
Click here to enter text.
8)
Describe the procedures that will be used.
Click here to enter text.
9) Request for waiver of HIPAA authorization:
Click here to enter text.
HIC/HSC #__________________
Describe why it would be impracticable to obtain the subject’s authorization for
use/disclosure of this data;
By signing this request for exemption, the investigator assures that the protected health
information for which a Waiver of Authorization has been requested will not be reused or
disclosed to any person or entity other than those listed in this application, except as
required by law, for authorized oversight of this research study, or as specifically approved
for use in another study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject name,
purpose, date, recipients, and a description of information provided. Logs are to be forwarded to the
Deputy HIPAA Privacy Officer.
HIC/HSC #__________________
☐ (Category 5) 45 CFR 46.101(b)(5) 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. (For example, a study
of identifiable welfare data.)
NOTE: The following criteria must be satisfied to invoke the exemption for research and
demonstration projects examining “public benefit or service programs”:
 The program under study must deliver a public benefit (e.g., financial or medical benefits as
provided under the Social Security Act) or service (e.g., social, supportive, or nutrition
services as provided under the Older Americans Act).
 The research or demonstration project must be conducted pursuant to specific federal
statutory authority.
 There must be no statutory requirement that the project be reviewed by an Institutional
Review Board (IRB).
 The project must not involve significant physical invasions or intrusions upon the privacy of
participants.
1)
Describe the purpose of the study.
Click here to enter text.
2)
Describe the location of the study. Click here to enter text.
a.
Does this study include an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
3)
Describe the target population, including the expected number of subjects and expected
duration of the study.
Click here to enter text.
4)
Describe the programs, and/or benefits or services that will be studied, evaluated or
examined.
Click here to enter text.
HIC/HSC #__________________
☐(Category 6) 45 CFR 46.101(b)(6) 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.
This category applies to those studies that do not involve the consumption by the subject of any
type or volume of food that has any potential risk such as indigestion or vitamin deficiencies. This
implies that the food ingested be considered a reasonable eating pattern. A study that involves the
use of alcoholic beverages, vitamins, or supplements does not qualify as exempt from IRB review.
1)
Describe the purpose of the study.
Click here to enter text.
2)
Describe the location of the study. Click here to enter text.
a.
Does this study include an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
3)
Describe the target population, including the expected number of subjects and expected
duration of the study.
Click here to enter text.
4)
Describe the research activities that will be conducted.
Click here to enter text.
5)
Describe the food and/or food ingredient being studied.
Click here to enter text.
HIC/HSC #__________________
☐ (Category 7 –Yale University Special Exemption: Research Involving Response to NonPhysically Invasive Stimuli – for Non-federally-funded/regulated human research)
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):
Category 7: Research involving interviews, surveys, educational test or observation of public behavior
in which participant interaction includes providing a response to a non- physically 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:
☐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
☐psychology subject pool
☐receipt of an NIH issued Certificate of Confidentiality to protect identifiable research data.
1.
Describe the purpose of the study.
Click here to enter text.
2.
Describe the target population including the expected number of subjects and the expected
duration of the study.
Click here to enter text.
3.
Describe the location of the study.
Click here to enter text.
4.
a.
Does this study include an international location? ☐ Yes ☐ No
If yes, specify location: Click here to enter text.
5.
Describe the procedures that will be used to recruit subjects, obtain consent, research
authorization (or waiver), and conduct the research. Attach a copy of the written consent or
HIC/HSC #__________________
research authorization form, if used. If written consent will not be used, give the text of the verbal
statement used to obtain consent/assent.
Click here to enter text.
6.
Clarify whether data will be recorded with or without identifiers.
Click here to enter text.
7.
Clarify whether disclosures will place the subjects at risk of criminal or civil liability or be
damaging to the subjects' financial standing, employability, or reputation.
Click here to enter text.
8.
Submit the survey(s), instrument or interview questionnaire that will be used.
Click here to enter text.
9)
Request for waiver of HIPAA authorization:
Click here to enter text.
Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this
data;
By signing this request for exemption, the investigator assures that the protected health
information for which a Waiver of Authorization has been requested will not be reused or
disclosed to any person or entity other than those listed in this application, except as required by
law, for authorized oversight of this research study, or as specifically approved for use in another
study by an IRB.