IRB Review of Exempt Human Subjects
Research
Purpose
The purpose of this policy is to outline the procedure for conducting reviews of exempt human
subjects research.
Policy
Research activities that meet the categories defined by the federal regulations [45 CFR 46.101(b)
and 21 CFR 56.104(d)] may qualify for exemption.
The Charles River Campus (CRC) IRB is responsible for determining if a research activity is
exempt. An IRB member may determine that a research activity is exempt from IRB review.
Below are some examples of research activities that may qualify as exempt:
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Survey/interview research with adult subjects where disclosure of the information would
not place the subjects at risk of criminal or civil liability; or be damaging to the subjects’
financial standing, employability, or reputation
Review of existing data that is recorded by the investigator in an anonymous manner
Observation of the public behavior of subjects where there is no manipulation of the
subject
Testing or comparing curriculums/lessons
Studies that cannot be exempt:
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Research that involves prisoners
Survey or interview procedures or observations of public behavior involving children
except for research involving observation of public behavior when the investigator does
not participate in the activities being observed
FDA regulated research unless it qualifies under Category 6
Procedures
Research activities may be exempt if they are determined to not be greater than minimal
risk AND they fall into one of the exempt categories listed below:
1. Research conducted in established or commonly accepted educational settings, involving
normal education practices, such as:
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Research on regular or special educational instructional strategies, or
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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:
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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 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.
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 category (b) of this section, if:
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The human subjects are elected or appointed public officials or candidates for public
office; OR
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.
5. Research and demonstration projects which are conducted by or subject to the approval of
federal 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 or alternatives to those programs or procedures; or
Possible changes in methods or levels of payment for benefits or services under those
programs
NOTE: OHRP has determined that the following criteria (see 48 FR 9266-9270, March 4, 1983)
must be satisfied to invoke the exemption for research and demonstration projects examining
“public benefit or service programs” as specified under Department of Health and Human
Services (HHS) regulations at 45 CFR 46.101(b)(5):
1. 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).
2. The research or demonstration project must be conducted pursuant to specific federal
statutory authority.
3. There must be no statutory requirement that the project be reviewed by an Institutional
Review Board (IRB).
4. The project must not involve significant physical invasions or intrusions upon the privacy
of participants.
Some HHS funding agencies require review of exempt studies. In those instances, the institution
will consult with the HHS funding agency regarding the above conditions before invoking this
exemption.
6. Taste and food quality evaluation and consumer acceptance studies:
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If wholesome foods without additives are consumed; OR
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 FDA or approved by the Environmental Protection Agency
or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Review Process
Submission of Exempt Application
1. If the Principal Investigator (PI) believes that a study meets the criteria for exemption, the PI
must complete the Exempt Application.
2. The PI submits the Exempt Application and all applicable documents (consent/information
sheet, recruitment materials, questionnaires, surveys, etc.) to the CRC IRB for review.
Exempt Review Process
1. The Exempt Application is received by the IRB Coordinator. The Application is assigned a
study number and is entered into the IRB tracking system.
2. The IRB Coordinator assigns the Application to the appropriate IRB member for review.
3. The IRB member (Reviewer) will review the Application to determine if the study falls into
one of the exemption categories as defined in 45 CFR 46.101(b) and 21 CFR 56.104(d). In
addition, the reviewer will determine that the study meets the ethical standards of Boston
University (BU) using the falling criteria:
a. The research involves no more than minimal risk to subjects
b. If subjects will be enrolled, selection is equitable
c. If there is recording of identifiable information, there are adequate provisions to maintain the
confidentiality of the data
d. If there are interactions with subjects, there will be a consent process that will disclose such
information as:
i. The activity involves research
ii. The purpose of the research
iii. A description of the procedures
iv. The amount of time required for the research
v. Participation is voluntary
vi. Name and contact information for the Investigator
vii. Contact information for the CRC IRB
viii. There are adequate provisions to maintain the privacy interests of subjects
4. If the Reviewer requires additional information or modifications, the Reviewer will contact the
PI via e-mail. The Reviewer will review the PI’s response upon receipt. If the PI does not
respond within 60 days, the study will be closed out.
5. If the Reviewer determines that the revisions are inappropriate or insufficient, the Reviewer
may request that the PI make further revisions. This review and revision process will continue
until the research is either approved or disapproved as exempt.
6. Once the Reviewer determines that the study qualifies for exemption, a letter will be sent to
the PI notifying him/her of the exempt determination. The letter will include the specific
category of exemption.
7. If the Reviewer determines that the study does not qualify for an exemption, the study will be
referred for expedited or full board review as applicable.
8. Once a study is determined to be exempt, annual reviews are not required.
9. If the PI wants to make a change to an exempt study, the PI must submit a Clarification Form
to the IRB. An IRB member will review the change to ensure that the activities in the study still
qualify for exemption.
10. If the requested change does not fall within one of the exempt categories, the study would
need to be re-reviewed via expedited or full-board procedures prior to implementation.
11. If the PI has concerns about the IRB’s decision or recommendations, the PI may address
his/her concerns to the IRB in writing. This request should include a justification for changing
the IRB’s decision. The PI should send this request to the IRB Chair/Vice-Chair and IRB
Director.
Title
Author
Effective Date
Last Review/Update Date
Revision #
Approved
IRB Review of Exempt Human Subjects Research
Cynthia Monahan
April 1, 2013
March 19, 2013
Cynthia Monahan, IRB Director
Ara Tahmassian, PhD, Associate Vice President-Research
Compliance