Federal regulations and institutional policy require an IRB Full
Board Review for applications where the research involves more than
minimal risk to human subjects or has been referred to the
committee by an expedited reviewer or the Chair.
Research can be approved as “exempt” if it is no more than
“minimal risk” and fits one of the exempt review categories as
defined by federal regulation 45 CFR 46. Studies that may qualify
for “Exempt” must be submitted to the IRB for review. Exempt
reviews are conducted by a member of IRB staff.
Types of IRB Review
The TCNJ Institutional Review Board (IRB) goals are to protect
human subjects and support the design and conduct of sound research
by reviewing for approval IRB submissions: new applications,
amendments to approved studies, and continuing reviews.
All projects that meet the federal definition of research with
human subjects (45 CFR 46.102 ) must be reviewed and approved, or
receive an exempt determination, by an IRB prior
to beginning the research. The IRB staff initially screens
submissions to determine the completeness and the appropriate type
of review. Submissions may be returned to the study team for
changes before the review type is assigned. The review type may be
reassessed at any time during the review process.
IRB must review all projects that meet the definition of
research and that involve human subjects prior to any data
collection to determine the appropriate level of review, and, as
appropriate, approve them. There are three major types of review:
Exempt, Expedited, and Full.
Exempt Review
Studies that receive an exemption determination from IRB are
exempt from the specific regulations and requirements in Title 45,
Part 46 of the Code of Federal Regulations. Please note, however,
that they are still considered human subject research.
If the proposed research involves no greater than minimal risk
to participants and involves any of the following, it may qualify
for exempt status in accordance with the revised Common Rule
(effective January 21, 2019):
- Research, conducted in established or commonly accepted
educational settings that specifically involves normal educational
practices that are not likely to adversely impact students’
opportunity to learn required educational content or the assessment
of educators who provide instruction. This includes most research
on regular and special education instructional strategies, and
research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management
methods.
- Research that only includes interactions involving educational
tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior
(including visual or auditory recording) if at least one of the
following criteria is met:
- The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects cannot
readily be ascertained, directly or through identifiers linked to
the subjects;
- Any disclosure of the human subjects’ responses outside the
research would not reasonably place the subjects at risk of
criminal or civil liability or be damaging to the subjects’
financial standing, employability, educational advancement, or
reputation; or
- The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects can readily
be ascertained, directly or through identifiers linked to the
subjects, and an IRB conducts a limited IRB review to make the
determination that there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of
data.
- Research involving benign behavioral interventions in
conjunction with the collection of information from an adult
subject through verbal or written responses (including data entry)
or audiovisual recording if the subject prospectively agrees to the
intervention and information collection and at least one of the
following criteria is met:
- The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects cannot
readily be ascertained, directly or through identifiers linked to
the subjects;
- Any disclosure of the human subjects’ responses outside the
research would not reasonably place the subjects at risk of
criminal or civil liability or be damaging to the subjects’
financial standing, employability, educational advancement, or
reputation; or
- The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects can readily
be ascertained, directly or through identifiers linked to the
subjects, and an IRB conducts a limited IRB review to make the
determination that there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of
data.
- Secondary research uses of identifiable private information or
identifiable biospecimens, if at least one of the following
criteria is met:
- The identifiable private information or identifiable
biospecimens are publicly available;
- Information, which may include information about biospecimens,
is recorded by the investigator in such a manner that the identity
of the human subjects cannot readily be ascertained directly or
through identifiers linked to the subjects, the investigator does
not contact the subjects, and the investigator will not re-identify
subjects;
- The research involves only information collection and analysis
involving the investigator’s use of identifiable health information
when that use is regulated under HIPAA as “health care operations,”
“research” or “public health”; or
- The research is conducted by, or on behalf of, a Federal
department or agency using government-generated or
government-collected information obtained for nonresearch
activities and the information is subject to federal privacy
standards and other requirements specified in the exemption [Refer
to 45 CFR 46.104(d)(4) of the revised Common Rule]
- Research and demonstration projects that are conducted or
supported by a Federal department or agency, or otherwise subject
to the approval of department or agency heads (or the approval of
the heads of bureaus or other subordinate agencies that have been
delegated authority to conduct the research and demonstration
projects), and that are designed to study, evaluate, improve, or
otherwise examine public benefit or service programs, including
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.
- Taste and food quality evaluation and consumer acceptance
studies.
- Storage or maintenance of identifiable private information or
identifiable biospecimens for potential secondary research use. The
exemption can only be used when there is broad consent from the
subjects for the storage, maintenance, and secondary research use
of their identifiable materials. [Refer to 45 CFR 46.104(d)(7),
46.111(a)(8), and 46.116(d) of the revised Common Rule.]
- Research involving the use of identifiable private information
or identifiable biospecimens for secondary research use, if the
following criteria are met:
- Broad consent is obtained from the subjects for the secondary
research use of their identifiable materials,
- Documentation or waiver of documentation of informed consent is
obtained,
- An IRB conducts a limited review to make certain determinations
relating to privacy and confidentiality protections and broad
consent, and
- The investigator does not include returning individual research
results to subjects as part of the study plan. [Refer to sections
45 CFR 46.104(d)(8), 111(a)(7) and 46.116(d) of the revised Common
Rule]
Full Review
If the proposed research does not qualify for Exempt or
Expedited Review as defined above, it will be subject to a Full
Review. In addition, if the proposed research involves any of the
following, it will be subject to Full Review.
- Children under the age of 18
- Prisoners
- Individuals with impaired decision-making capacity
- Economically or educationally disadvantaged persons
- Procedures that might cause physical harm.
- Procedures that might cause significant psychological/emotional
distress.
- Collection of information about highly sensitive topics.
- Collection of information about illegal behavior.
- Collection of information that could seriously harm the
participant legally, socially, financially etc. if other people
could identify them.