/ FORM: Request for Exemption
Request for Exemption Form
Submit this completed form (with original PI signature) to the IRB office (Box 817 or 15 Kneeland St, 1st floor)
This form must be typed. Only the IRB may make the determination that a study is exempt; an investigator must not make this determination. Complete this form in its entirety to apply to the IRB for an exemption. This form is to serve as your protocol and a separate protocol document is not required.
Some research qualifies for exemption from the code of federal regulations (CFR) that govern human subjects research (45 CFR 46). Research must be “minimal risk” and meet certain defined categories in order to qualify for exempt status per 45 CFR 46.101(b).
Research involving the following categories of subjects does not qualify for exemption: Prisoners, fetuses and/or neonates, pregnant women, human in vitro fertilization, substance abusers, or individuals with psychiatric, cognitive, or developmental disorders.
IRB Number: or Pending (no IRB # assigned) / Study Title:
Principal Investigator: / PI Telephone:
PI Email:
Research Coordinator: / Research Coordinator Telephone:
Research Coordinator Email:
Institution: / Department/Division:
Mailing Address or Box #:
A.  Mandatory Human Subject Protection Education
PLEASE NOTE: If additional spaces are needed in this section, please attach an additional piece of paper
List the PI and Research Team Members
This includes those responsible for the design, conduct, or reporting of the research, such as the PI & Co-Is, research nurses and coordinators, project managers, etc. / Individual’s Role
(For example, list PI, Co-I,
Research Coordinator. Do not list any research team member as a “Co-PI;” only one person may be listed as PI for a study.) / Institutional Affiliation
(For example, Tufts MC, TUSM, HNRCA, outside institution) / Current CITI Certification:
(Indicate the expiration
date of each individual’s CITI certification)
B.  Funding Source
State funding source, if any; (If no funding source, state “None”):
Is this project supported by a federally funded grant? Yes (submit copy of grant) No
Specify the primary award recipient of the grant:
C.  Location of Research Study
1.  Specify and describe the location of the research procedures:
1.  Other Institutions (specify institutions & attach a copy of each current IRB approval):
List other institutions only when Tufts is the Sponsor, primary grant recipient, or coordinating site, otherwise indicate not applicable “N/A”.
2.  International Sites (specify sites & attach a copy of each current IRB approval):
List international sites only when Tufts is engaged in research at those sites OR is the Sponsor, primary grant recipient, or coordinating site, otherwise indicate not applicable “N/A”.
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D.  Exemption Categories
Check all applicable boxes below. If research falls into one or more of the following categories, it may be granted exemption.
Category
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.
2 / 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.
Note: Research involving survey or interview procedures or observation of public behavior does not qualify for exemption category 2 when participants are minors, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
3 / Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, 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.
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.
Note: If the research solely consists of retrospective review of existing data/records and/or specimens, please submit a Form 7. Do not submit a separate protocol or a Request for Exemption Form.
5 / Research and demonstration projects that 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.
6 / Taste and food quality evaluation and consumer acceptance studies,
i) If wholesome foods without additives are consumed, or
ii)  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.
E.  Recruitment
Will human subjects be recruited for this study? Yes No
If Yes, describe the following:
1.  The study population (e.g. number to be enrolled, age range, minors, students/employees, etc.):
2.  The methods by which potential subjects will be identified and contacted (e.g., contact letters, emails, advertisements recruitment materials must be submitted with this application):
If No, explain involvement of human subjects in your research:
F.  Informed Consent
Although formal informed consent is not required by federal regulations for studies exempt from IRB review [45 CFR 46.101(b)], Tufts Medical Center and Tufts University institutional standards require researchers to uphold the ethical principle of respect for persons. Therefore, whenever possible and appropriate, researchers must provide potential research subjects with information that satisfies the basic elements of informed consent which include all statements below (some research may require additional elements of consent):
·  A statement that the study involves research and that participation is voluntary. Subjects may stop participating at any time without penalty.
·  An explanation of the purpose of the research and the procedures to be followed
·  The expected duration of the subject's participation
·  A description of any reasonably foreseeable risks (i.e. risk of loss of confidentiality) and discomforts to the subject
·  A description of any expected benefits to the subject or to others. If none, state none.
·  A statement specifying if subjects will receive any payment/incentive for participation. If none, state none.
·  A statement about the alternatives to participation (i.e. not participating in the survey, not having your data collected for the course included in this study)
·  A statement explaining how long the procedure will take.
·  A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
·  A statement that the study has been reviewed by the Tufts Health Sciences IRB
·  Provide study team contact information for whom to contact for answers to pertinent questions about the research.
1.  Detail your plan on how you will consent subjects to assure their voluntary consent to participate in this research:
2.  If subjects will not be consented or there is no human subjects involved for this research, specify why:
G.  Protocol*
Provide a detailed protocol summary and ensure that the following elements are discussed in detail below:
1.  Background:
2.  Aim and Hypothesis:
3.  Procedures:
4.  Risks:
5.  Benefits:
6.  Payments:
7.  Costs (to subjects):
*A separate Tufts protocol is not required and all relevant information should be included in this form. If a separate protocol has already been created by the investigator at Tufts or another collaborating institution, or by the sponsor, you may submit it; however, this Request for Exemption form should then be used to document any site-specific information/procedures for Tufts.
H.  Confidentiality
1.  Describe how subject privacy and confidentiality will be maintained. Detail what identifiers will be collected (if any) and explain how the data/records will be coded and stored.
2.  If data/records will be sent outside Tufts Medical Center/Tufts University, describe the nature of the data/records (contains identifiers, coded, de-identified) and explain how the data/records will be shared securely. Check with research administration to determine if a data agreement is required:
I.  Health Insurance Portability and Accountability Act (HIPAA)
Accessing and utilizing de-identified data (as defined by HIPAA) only
Waiver or alteration of research authorization request (attach form)
Limited data set (attach Data Use Form)
HIPAA does not apply – Protected Health Information (PHI) will not be collected
HIPAA does not apply – Research will not be conducted in a covered entity
J.  Submit the following study documents, if applicable:
Questionnaire(s)/Survey(s)/Interview Script(s)
Advertisement(s) and other recruitment material(s)/contact letter(s)
Letter(s) of support (from head of applicable department/division and/or offsite where research will take place) for recruitment of students/employees, hosting the study or providing records/samples, etc.
Consent statement(s)/Information Sheet(s) for subjects
K.  Conflict of Interest (COI)*
Check to confirm the PI and each research team member have completed the Research COI form and copies of the completed
forms have been retained in the study files.
Check to confirm that the following COI forms have been included in this submission to the Tufts IRB office:
1.  The PI’s completed COI form (whether or not a conflict was indicated).
2.  COI forms from research team members on which a conflict was indicated by a “YES” response in any field.
*Contact the Tufts MC Office of the Vice President of Research or the TUHS Office of the Vice Provost with questions regarding this policy.
L.  Investigator Acknowledgment
I certify that the information provided in this application is complete and accurate. As Principal Investigator, I have ultimate responsibility for the accuracy of the information that has been provided, the conduct of this research study, its ethical performance, and the protection of the rights and welfare of human subjects. I will conduct this research in compliance with the information included in this form, institutional policies including Tufts Health Sciences IRB policies, Investigator Post-Approval Responsibilities and the requirements in the INVESTIGATOR MANUAL (HRP-103), regulations including 45 CFR 46, applicable federal and state laws, and the principles of research ethics set forth in The Belmont Report. I understand that research studies that are granted exemption are not subject to annual continuing review. After initial approval, if any modifications to are made to this research, I will submit the revisions to the IRB office for approval prior to initiating any change.
Principal Investigator (type name):
Principal Investigator’s signature: / Date:
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