EXEMPT STATUS REQUEST GUIDANCE
12/01/2012
Contents
1. Introduction
2. Exempt Categories
a. Category 1: Education Practices
i. Considerations
ii. Research activities that do NOT qualify for exemption
iii. Criteria that cannot be exempt under this category
iv. Examples
b. Category 2: Educational Tests, Survey Procedures, Interview Procedures, or Observation of
Public Behavior
i. Considerations
ii. Research activities that do NOT qualify for exemption
iii. Criteria that cannot be exempt under this category
iv. Examples
c. Category 3: Educational Tests, Survey Procedures, Interview Procedures, or Observation of
Public Behavior – Public Officials
i. Considerations
ii. Criteria that cannot be exempt under this category
iii. Examples
d. Category 4: Existing Data
i. Considerations
ii. Research activities that do NOT qualify for exemption
iii. Criteria that cannot be exempt under this category
iv. Examples
e. Category 5: Research and Demonstration Project
i. Considerations
ii. Examples
f. Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies
i. Considerations
ii. Examples
3. Respect for Persons and Informed Consent
4. Modifications to Exempt Studies
5. Examples of Non-Human Subjects Research Activities
6. PI Responsibilities (including Co-PI Investigators)
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1. Introduction
Pursuant to 45 CFR 46.101(b), research activities in which the only involvement of human subjects will be in
one or more of the following categories are exempt from 45 CFR 46, Subpart A. It is the policy of the Indiana
University Institutional Review Board (IU IRB) that all human subjects research activities under its jurisdiction,
regardless of funding or funding source, under its jurisdiction be reviewed to determine whether the
research meets one or more of the exemption categories described in the federal regulations and complies
with IU ethical standards. Investigators do not have the authority to make an independent determination
regarding whether or not a research activity meets these requirements. As such, a member of the IU IRB or
authorized Human Subjects Office (HSO) staff member must make that determination. To do so, an exempt
application must be submitted to the IRB for consideration.
2. Exempt Categories (per 45 CFR 46.101(b))
a. Category 1: Educational Practices
Research conducted in established or commonly accepted educational settings, involving normal
educational practices such as:
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research on regular and special education instructional strategies; or
research on the effectiveness of, or the comparison among, instructional techniques, curricula,
or classroom management methods.
Considerations:
 Research must involve no more than minimal risk to subjects.
 Commonly accepted educational settings including, but are not limited to, K-12 schools, college
classrooms, special education programs, after-school programs, preschools, vocational schools,
alternative education programs, and other sites where educational activities regularly occur.
o If research will be conducted outside of these settings, researchers should justify in their
application why the setting is believed to be a commonly accepted education setting.
 Normal educational practices include established or innovative teaching methods, (not considered to
be experimental) curriculum and commonly accepted classroom management techniques that are
planned and implemented by the classroom teacher. Normal educational practices are activities that
would occur regardless of whether the research is conducted.
o Because research involving the use of radically new or innovative practices may not qualify
for exemption, researchers should justify in their application why the practice is believed to
be a normal educational practice that is commonly accepted. Once way to do this is to
provide a letter from an authority of the school/institution attesting to the acceptability and
use of the procedures in the normal conduct of education activities at the school/institution.
 The research study should be instructional in nature with the research procedures conducted in a
manner typical to the situation. In other words, would the teacher or instructor normally carry out
this activity or practice regardless of research intention? If so, the research may fall under this
category. However, if the research involves any activity, procedure or practice that involves a novel
approach (e.g. comparing a new study approach to an established practice) it will NOT qualify as
Exempt under this category.
 Research activities that may appear to qualify for exemption under this category may also be subject
to other regulatory requirements under the Family Educational Rights and Privacy Act (FERPA)
and/or the Protection of Pupil Rights Amendment (PPRA).
o Research activities involving access to school records (FERPA) or asking students certain
types of questions (PPRA) may not be eligible for exemption.
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 If all students will not be participating in the educational practice, you must explain what the
students who will not be participating will be doing instead. It is important that the study is designed
in such a way that does not penalize students who will not be participating.
 If the study involves research subjects under the age of 18, parental consent or notification and
student assent is needed. Signed parental permission is not required, but the IRB does recommend
that parents are notified of the research and children agree to participate.
 When describing research activities believed to fall under this exemption category, the following
should be addressed in the application:
o Will the research activities occur during class time or outside of class time?
o If implementing a novel educational method, describe how it differs from the standard
method.
o If reviewing and/or collecting student grades and/or standardized test scores, describe what
grades or scores will be reviewed and/or collected.
o If observing and/or recording data (audio/video/hand written) on teachers and/or students,
describe the activity.
o If reviewing coursework, describe what coursework will be reviewed, if t will be identifiable
and how subjects’ identities will be protected.
 If you do not normally have access to any of the above information, you may only
obtain it once the custodian of the records de-identifies the data. If you want to
collect identifiable data or data linked to identifiers for which you will have access to
the code key, the research does not qualify for exemption. FERPA states that school
officials, including teachers, can access identified records so long as there is
legitimate educational interest to be determined by that agency/institution. IU’s
policy is that the records custodian makes those determinations.
o State if the educational activity is solely related to the research or if the educational activity
occurs regardless of whether the research is conducted.
Research activities that do NOT qualify for exemption:
 Procedures that are likely to expose subjects to discomfort beyond levels encountered in daily life.
 Procedures that fall outside of normal classroom activity, such as untested educational practices
Research meeting the following criteria cannot be exempt under this category:
 Research regulated by the Food and Drug Administration (FDA)
 Research involving prisoners
 Research involving pregnant women that is conducted at or funded by the Veterans Administration
(VA)
Examples of research that may qualify for an exemption under Category 1:
 A study evaluating the effectiveness of a commonly accepted science curriculum. For the study,
researchers will observe classroom instruction and collect quizzes and class evaluations that are part
of the curriculum and normal classroom practices.
 A study comparing two curricula that are currently being implemented in a school. Researchers will
observe classrooms as well as interview instructors about their experiences implementing the
instructional materials (but not about specific students).
 An investigator at X Medical Center wants to determine the effectiveness of an interactive
anatomy/physiology DVD used to help medical students study for exams. This CD-rom is established
course material for X Medical Center.
 A research study evaluating the effects of a health literacy curriculum on first-year physician
assistant students.
 A study comparing driver’s education curricula offered by area driving schools. The researcher will
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observe classes and compare driving test scores at the end of the courses.
b. Category 2: Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public
Behavior
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior, unless both of the following
are true:
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information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects; AND
any disclosure of the subject’s responses outside the research could reasonably place the subject
at risk of criminal or civil liability or be damaging to the subject’s financial standing,
employability, insurability, or reputation.
Considerations:
 Research must involve no more than minimal risk to subjects.
 Survey procedures refer to the act of gathering data on attitudes, impressions, opinions, satisfaction,
etc. by polling a section of the population.
 Interview procedures refer to a meeting at which people talk to each other in order to ask questions
and get information.
 Public behavior refers to behavior in which the subject does not have a reasonable expectation of
privacy, e.g. a public plaza or park, a street, a building lobby. If subjects have a reasonable
expectation of privacy at the location where they researcher is conducting the observation, the
project may not be considered exempt.
 Data collected for the research may be identifiable as long as the subject would not be placed at risk
for criminal or civil liability or be damaging to the subject’s financial standing, employability,
insurability, or reputation should it be accessed by a third party. If such data could place subjects at
risk, it should be collected/recorded/stored in an unidentifiable manner.
 If you are using a private list of names for recruitment, you must have permissible access to make
initial contact yourself. If you do not have permissible access to the list, you must ask the custodian
of the record to make initial contact for you and let the potential subjects contact you if they are
interested.
 For research activities that involve survey, interview, or focus group procedures, researchers must
provide information about the study to the subjects, for example, a study information sheet.
 Audio and/or video recording is acceptable for purposes of data collection/transcription. However, if
people outside the research team will view the recordings, e.g. for a presentation, the study no
longer meets exempt review.
Research activities that do NOT qualify for exemption:
 Surveys on sensitive or personal topics which may cause stress to study subjects.
 Surveys or interviews involving children (ages 17 and younger) that is not part of their normal
educational curriculum.
 Observation of public behavior involving children when the researcher participates in the activity.
 Research involving legal matters, illegal activities, or admissions of guilt regarding illegal acts or
violations of parole.
 Techniques which expose participants to discomfort or nuisance beyond levels encountered in daily
life.
 Research involving significant physical invasions or intrusions upon the privacy of participants.
 Observation of behavior in settings where participants have a reasonable expectation of privacy.
 Audio and/or video recordings intended to be shown to others outside of the research team, e.g. for
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a presentation.
Research meeting the following criteria cannot be exempt under this category:
 Research regulated by the Food and Drug Administration (FDA)
 Research involving prisoners
 Research involving pregnant women that is conducted at or funded by the Veterans Administration
(VA)
Examples of research that may qualify for an exemption under Category 2:
 A study involving an anonymous survey regarding workplace satisfaction at areas businesses.
 An observational study of pedestrians crossing a street. The research takes notes of what occurs,
recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
 A researcher asks patients who have diabetes to participate in a focus group about their exercise
habits. The researcher does not collect any identifiable information about the participants during the
focus group.
 An investigator reviews publically available Twitter posts that include the term “smoking.” The
investigator evaluates these posts to determine what type of information Twitter users are
sharing about this topic.
 A study involving interviews with college seniors (age 18 and older) about their plans after
graduation. The answers to questions asked would present no risks to subjects if divulged outside of
the research.
 A survey of women at a local hospital regarding their knowledge and attitudes of the Human
Papillomavirus (HPV) Vaccine. The anonymous survey contains non-sensitive questions and no
personal identifiers are requested.
 A research project interviewing subjects (age 18 and older) about the influence of religion on their
health (no personal identifiers requested).
 Surveying parents regarding parental awareness and understanding of over the counter products
containing Acetaminophen (Tylenol) in children under the age of 5. The anonymous survey contains
no personal identifiers
 A researcher asks nurses from several institutions to complete three online surveys about a new
statewide mandate. The surveys include the nurses' email addresses so the surveys can be linked.
However, the researcher will not share the email addresses with anyone outside the study team and
will destroy the link after completing data collection. Note: Because the responses are linked, the
study would not qualify for exemption if the survey responses may put the nurses' employment at
risk.
c.
Category 3: Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public
Behavior – Public Officials
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
Category 2, but meets either of the following:


the subjects are elected or appointed public officials or candidates for public office; OR
federal statute(s) require(s) without exception that confidentiality of the personally identifiable
information will be maintained throughout the research and thereafter.
Considerations:
 Research must involve no more than minimal risk to subjects.
 Part a above includes research procedures described under Category 2, but holds public servants, i.e.
public officials and candidates for public office, to a different privacy standard by not requiring that
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the data be collected anonymously, and is not concerned with any risks that may result from
disclosure of the data.
Research meeting the following criteria cannot be exempt under this category:
 Research regulated by the Food and Drug Administration (FDA)
 Research involving prisoners
 Research involving pregnant women that is conducted at or funded by the Veterans Administration
(VA)
Examples of research that may qualify for an exemption under Category 3:
 A survey administered to town mayors within a county that contains questions that might expose
information that the public might not support. The PI can report the data, identifying the mayors
that participated in the study and even identify how certain mayors answered specific questions and
still qualify for exempt review. Public officials or candidates running for public office give up the
right to confidentiality in lieu of the public’s need to know.
d. Category 4: Existing Data
Research involving the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens if:


these sources are publicly available; or
the information is recorded by the investigator in such a manner that subjects cannot be
identified, directly or through identifiers linked to the subjects.
Considerations:
 To qualify for this exemption, the materials to be used in the research must be existing or “on the
shelf” at the time the research is proposed. This category does not apply to the prospective
collection of data or specimens.
 Research can qualify for exempt status if the investigators initially have access to identifiable private
information but abstract the data needed for the research in such a way that the information can no
longer be connected to the identity of the subjects. This means that the abstracted data set does
not include direct identifiers (names, social security numbers, addresses, phone numbers, etc.),
indirect identifiers (codes or pseudonyms that are linked to the subject’s identity), or the original
data.
Research activities that do NOT qualify for exemption:
 Biological or pathological specimens and/or data obtained prospectively DO NOT qualify as Exempt
under this category. For example, a research protocol calls for an investigator to receive a week later
a blood sample taken during an anonymous patient's physical exam. This does not qualify as an
existing specimen because it was collected during the research period and does not fall under
Exempt.
 Data collected from private documents, records or specimens must be used and analyzed in a
manner that subjects cannot be identified (anonymous). Research studies needing to keep a master
list of existing data for continuous access to private records may not qualify as exempt. For example,
if an investigator needs to keep a master list of patient name, date of birth and patient number for a
month in order to access their medical record, this study may not qualify as Exempt. The master list
can directly link a subject to their medical information, therefore compromising confidentiality.
 Research conducted on biological or pathological specimens obtained prospectively and taken
strictly for research purposes does not qualify for exempt review.
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Research meeting the following criteria cannot be exempt under this category:
 Research regulated by the Food and Drug Administration (FDA)
 Research involving prisoners
 Research that is conducted at or funded by the Veterans Administration (VA)
Examples of research that may qualify for an exemption under Category 4:
 A research study of treatment outcomes for a drug that involves the review of patient charts at a IUaffiliated hospital. The researcher records patient age, sex, diagnosis, and treatment outcome in
such a way that the information cannot be linked back to the patient.
 A graduate student has access to identifiable data from a study previously conducted by her faculty
advisor and records the information she needs for her research, so that the data being analyzed for
the research cannot be traced back to individual subjects.
e. Category 5: Research and Demonstration Projects
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:

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public benefit or service programs;
procedures for obtaining benefits or services under those programs;
possible changes in methods or alternatives to those programs or procedures; or
possible changes in methods or levels or payment for benefits or services under those programs.
Considerations:

Exemption Category 5 only applies to research on public benefit programs (such as Social Security)
conducted by the federal government and therefore is rarely, if ever, applied to research at IU.
Research and demonstration projects in general (e.g., state or city funded public service programs)
do not fit under this exempt category. Moreover, there must be no statutory requirement that the
project be reviewed by an IRB and the project must not involve significant physical invasions or
intrusions upon the privacy of subjects.
Examples of research that may qualify for an exemption under Category 5:
 Department of Health and Human Services wants to conduct a study analyzing the effectiveness of
various government sponsored programs in decreasing obesity in the United States.
 A researcher sponsored by the Department of Agriculture- Food and Nutrition Service wants to
compare the current use of the Supplemental Nutrition Assistance Program (i.e. food stamps) by
Americans compared to ten years ago.
 The Department of Justice wants to conduct a research study analyzing the effectiveness of their
National Public Awareness Campaign part of the Project Safe Childhood to minimize sexual predators
over the internet.
f.
Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies
Taste and food quality evaluation and consumer acceptance studies if:


wholesome foods without additives are consumed;
food is consumed that contains a food ingredient at or below the level and for use found to be
safe by the Food and Drug Administration (FDA) or approved by the Environmental Protection
Agency (EPA), or the Food Safety and Inspection Service (FSIS) of the US Department of
Agriculture (USDA); or
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food is consumed that contains 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 FSIS of the USDA.
Considerations:
 Taste and food quality evaluation studies conducted under this exempt category may not involve the
consumption of any type or volume of food that would present any risk to the subjects, and the
research should involve what would be considered reasonable eating behaviors by the subject.
 The food must be “wholesome,” meaning that the food ingredients have not been manipulated
by the investigator. Moreover, the content of the food cannot be detrimental to the health of
the research subjects. If it involves plants or animals raised for food products, the level of
chemical additives or environmental contaminants must be at or below the levels approved by
the FDA, EPA, or USDA. Studies involving the consumption of alcohol, vitamins, and other
supplements do not qualify for exempt status.
Examples of research that may qualify for an exemption under Category 6:
 A taste-testing study evaluating the differences in taste of various types of apples grown nationally.
 A taste-testing study analyzing the effects of a safe (FDA determined) additive on beef.
 The tasting effects of a low level environmental contaminant on a food product which has been
deemed safe by the FDA and EPA.
3. Respect for Persons and Informed Consent
Considerations:

The Belmont Principle of Respect for Persons generally requires that subjects be given the
opportunity to choose whether or not to participate in research. For this reason, voluntary consent
should be obtained from participants for any exempt research where the investigator will be
collecting data through interaction with the participant. If the study involves children, it may be
appropriate to inform parents of their child’s participation in the research. The IRB recommends
that researchers provide participants with, at a minimum, information listed below to enable
participants to make a voluntary decision to participate in the research and before any data
collection begins. In some cases, researchers may find it necessary or appropriate to provide more
information.
 Minimum Information to be Provided to Prospective Participants:
o The identity/affiliation and contact information of the researcher(s);
o A clear description of the study procedures;
o A statement that that the activity is research and that participation in the research is
voluntary; and
o Contact information for questions about the research.
4. Modifications to Exempt Studies
Minor modifications made to exempt studies are allowable without prior IRB/HSO review and approval given
that they do not change the nature of the research, and therefore, the validity of the exempt determination.
Examples of “minor” modifications:


Minor revisions to recruitment materials and methods. For example, change to the phone number,
addition of newspaper ad when using same language as already approved flyer.
Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of
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the original approved instruments. For example, word-smithing, additional of clarifying question(s),
deletion of question(s).
Substantive modifications needed to a research project, however, do require prior approval from the IRB
since they have the potential to change the nature of the research and therefore, the validity of the exempt
determination. In some cases, the proposed changes may disqualify the project from exempt status and
require an expedited or full Board review.
Examples of “substantive” modifications requiring submission of an amendment:

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
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


Change in Principal Investigator (PI)
Change to study purpose
Change to study procedures. For example, adding a follow-up survey, new data collection, changes
to study instruments that fall outside the scope of the original instruments.
Changes to study population. For example, adding a new population or substantively revising the
inclusion/exclusion criteria for the current population.
Receiving or viewing additional dataset(s) or adding new variables.
Changes to the identifiability of the research data you will receive or record. For example, your
exempt application states that you will not collect names with the surveys, but you want now want
to, or you know want to record identifiable data from an existing dataset, but your exempt
application states that there will be no identifiers.
Changes to the risks involved in the study.
To request approval of substantive modifications, please submit an Amendment to the IRB, along with the
revised and/or additional study documents.
Forms can be obtained at: http://researchadmin.iu.edu/HumanSubjects/hs_forms.html#forms_cate.
5. Examples of Non-Human Subjects Research Activities
 Quality assurance or improvement activities or evaluation projects designed for self-improvement or
program evaluation, not meant to contribute to “generalizable” knowledge. Quality improvement
projects are not research when designed to improve or alter the quality of care or the efficiency of
an institutional practice. If the data is to be re-examined or re-analyzed and new information
surfaces that would contribute to generalizable knowledge, an application may be submitted to the
IRB.
 Searches of existing literature or analysis of aggregate or public data that cannot be linked to a living
individual, e.g. data sets available on the web that do not require any sort of privacy/confidentiality
agreement or special request procedure, newspaper accounts, census data held in public libraries,
published school test scores. Note: If access to the data is limited to researchers, and not publicly
available, then IRB review is needed.
 Data collection for internal departmental, school, or other University administrative purposes.
Examples: teaching evaluations, customer service surveys. Service surveys issued or completed by
University personnel for the intent and purposes of improving services and programs of the
University or for developing new services or programs for students, employees, or alumni, as long as
the privacy of the subjects is protected, the confidentiality of individual responses are maintained,
and survey participation is voluntary. This would include surveys by professional societies or
University consortia. Note: If at a future date, an opportunity arose to contribute previously
collected identifiable or coded survey data to a new study producing generalizable knowledge, IRB
review may be required before the data could be released to the new project.
 Information gathering interviews and research where questions focus on processes, services, or
policies and do not gather information about living individuals. Examples: Asking teachers what
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methods are in use at their schools, asking emergency room physicians what procedures are used for
treating a particular disease.
 Single case studies in which all data already exists. If, however, this includes medical record review,
there may be obligations under the HIPAA privacy law.
6. PI Responsibilities (including Co-PI Investigators)
 When research, including recruitment, is to be conducted at an institution, organization, company,
etc., e.g. public or private schools or businesses, the PI must obtain and document permission from
the appropriate authority to allow the conduct of the research or recruitment. This documentation
must be made available to the IRB/HSO Office upon request.
 When research is to be conducted in a language other than English, the PI must provide subjects with
accurately translated study documents, e.g. study information sheet, recruitment materials, surveys,
etc. Only the English versions of these documents should be submitted to the IRB/HSO Office;
however, translations must be made available to the IRB/HSO Office upon request.
 The PI is responsible for complying with policies and procedures pertaining to the conduct of exempt
research, as well as with any policies and procedures pertaining to the institution/organizations
where the research is being conducted.
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