The Mission of the FSU Human Subjects Committee is to protect the welfare of human
subjects participants by compliance with the federal regulations governing the protection
of human subjects, and facilitating the research efforts of FSU faculty, students
Research Using Human Subjects
The Florida State University is committed to the ethical principles for the protection
of human subjects in research as set forth in the Belmont Report of the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
The ethical principles are:
- Respect for persons - which includes the requirement of a voluntary informed
- Beneficence – which entails an obligation to protect persons from harm
by minimizing risks and maximizing benefits
- Justice – which requires that selection of subjects be fair and equitable
and that particular care be taken when working with populations (i.e. children,
decisionally impaired) whose status puts them in a vulnerable position.
Human Subjects Office
2010 Levy Avenue
Tallahassee, FL 32306-2742
Ph: (850) 644-7900
Fax: (850) 644-4392View Staff Listing
Human Subjects Research - Identifying Intent – Is this Project Research?
Federal regulations give the Institutional Review Board ("IRB"), also known as the
Human Subjects Committee ("HSC") the authority to oversee research involving human
subjects. The IRB has no regulatory authority or jurisdiction to oversee activities
that are legitimately classified as something other than research. Institutions
prefer to have non-research activities handled by an entity other than the IRB,
so that the IRB can focus its time and resources on managing its fundamental mission.
As defined by DHHS 45.CFR 46.102 (d), "Research" means a systematic investigation,
including research development, testing and evaluation, designed to contribute to
generalizable knowledge. When evaluating a specific project, it is helpful to focus
on two key elements:
- the project involves a systematic investigation, and
- the design – meaning the goal, purpose, or intent – of the investigation is to
develop or contribute to generalizable knowledge. Having only one of these properties
means that the activity is not “research” and should not be handled as such.
One helpful question to aid in determining whether a project is "research", is whether
the investigators desire or may desire to publish the results of their project in
a journal, or present some aspect of the project at an academic meeting. While this
is often a practical key factor in determining intent involving a project, there
is a distinction between publication that is merely educational in intent, such
as a medical journal that may contain an article that discusses information that
is not the result of a research activity versus an article that addresses results
of a research activity.
After the project has been designated "research" as defined by the federal regulations,
the next step is to determine whether the project involves "human subjects". 45
CFR 46 (f) provides:
Human Subject means a living individual about whom an investigator (whether
professional or student) conducting research obtains (1) data through intervention
or interaction with the individual, or (2) identifiable private information. Intervention
is defined as both physical procedures by which data are gathered (i.e. venipuncture)
and manipulations of the subject or the subject’s environment that are performed
for research purposes. Interaction includes communication or interpersonal
contact between an investigator and subject. Private Information must be
individually identifiable (the identity of the subject is or may be ascertained
by the investigator or associated with the information) in order for obtaining the
information to constitute research involving human subjects.
Some examples of human subjects research:
- Interviewing cancer survivors about coping techniques
- Questionnaires about dating behaviors among college students
- Surveys about shopping preferences in rural communities
- Moderate exercise activities and venipuncture of individuals to determine certain
- Music therapy intervention to determine whether it affects pain levels in a hospital
Human subjects research does not include, as examples:
- Surveys for evaluating the performance of faculty, staff, and students, or other
studies for internal institutional use only (not a "research" activity)
- Oral history of New Orleans jazz artists and memories of post-WWII era (information
is not gathered for "generalizable knowledge").
- Secondary analysis of publically availably data, such as reviewing US Census data
(not "human subjects" – de-identified data).
Institutional Review Board – The Human Subjects Committee
An Institutional Review Board ("IRB") is the formal name for a Human Subjects Committee.
Established pursuant to federal regulations, the IRB is a committee composed of
scientists and laypersons who review all proposed FSU human subjects research to
ensure that the safety and welfare of subjects are protected. All human subjects
research requires review and approval by an IRB prior to subject recruitment and
data collection, and prior to the use of extant data or private information. The
IRB at FSU is known as the Human Subjects Committee ("HSC"). The FSU HSC members
have the responsibility for reviewing all research involving human subjects conducted
by FSU faculty, students, or staff, regardless of the source of funding.
Assurance and Jurisdiction of the IRB
FSU’s assurance with the federal government specifies that all research activities
involving human subjects, and all other activities which even in part involve such
research, regardless of funding source or sponsorship, must be reviewed by the IRB
(Human Subjects Committee) if one or more of the following apply:
- the research is sponsored by FSU
- the research is conducted by or under the direction of any employee, faculty,
staff, student, or agent of FSU in connection with his or her institutional responsibilities
- the research is conducted by or under the direction of any employee, faculty,
staff or agent of FSU using any property or facility of this institution
- the research involves the use of FSU’s non-public information to identify or contact
human research subjects or prospective subjects.
The Office of Research
The FSU Office of Research provides
the professional and administrative support to the HSC. The staff members provide
support by performing recordkeeping duties, maintaining a database in order to address
research protocol and compliance issues, and providing training regarding federal
regulation requirements. The staff also serves as a resource for investigators and
HSC members, and has delegated authority to determine the initial appropriate level
of review required for each research proposal submitted for review.
The Review Process for Human Subject Studies
Federal regulations divide human subjects research into three categories according
to the level of risk posed to subjects. For all projects involving human subjects,
researchers must submit an application for HSC (IRB) review. (Note that researchers
may also need approval from FSU Sponsored Research Services or from other oversight
Committees, such as FSU Radiation Safety, before the research project may commence.)
The categories of review are as follows:
Exempt: To qualify for this category, the research must fall into one of
six exemption categories by the HSC. (http://www.hhs.gov/ohrp/humansubjects/)
These categories present the lowest amount of risk to potential subjects because
they generally involve ether collection of anonymous or publically available data,
or conduct of the least harmful research experiments. Examples of research that
qualify as exempt are:
- anonymous surveys
- research involving normal educational practices
- analyses of discarded pathological specimens without personal identifiers
Important Distinction: It is the policy of FSU to review and approve research
proposals that meet the definition of “exempt”. FSU uses the expedited review process
for exempt protocols. The Principal Investigator does not make the decision whether
a protocol qualifies as exempt; the HSC/staff has the authority to determine whether
a proposal meets the exempt requirements. Investigators are still required to document
informed consent, and undergo continuing review of exempt research protocols.
Expedited review: To qualify for this category, research must fall into one
of the nine federal defined categories of research that may be reviewed through
an expedited review process. (http://www.hhs.gov/ohrp/policy/exprev.html)
These categories involve collection of samples and data in a manner that is not
anonymous and that involves no more than minimal risks to subjects. Some examples
qualifying for expedited review are:
- Studies involving collection of hair, saliva, or dental plaque samples
- Studies of blood samples from healthy volunteers
- Analysis of voice recordings
- Studies of existing pathological specimens with personal identifiers
This type of review process involves a subset of the full committee membership,
delegated this authority by the Chair, to independently evaluate the protocol, and
when all reviewers concur, the protocol is approval. At FSU, expedited review is
performed by two HSC members, and the Chair.
Note: Reviews via the expedited process usually take approximately three
Full Committee Review: this category of review is reserved for research proposals
that involve greater than minimal risk or a particular vulnerable population as
defined in the regulations. Examples include:
Invasive physiological or medical research
Research where there is a risk that confidentiality could be violated and if breached
could result in potential criminal or civil liability or damage to a subject’s financial
standing, employability, or reputation.
Research involving prisoners
Important Distinction: It is the policy of FSU that all research involving
vulnerable populations, such as prisoners, children, decisionally impaired, pregnant
women and fetuses, neonates be reviewed by the full committee. Note that protocols
involving the deception of research subjects, or other potentially vulnerable populations
such as students or economically disadvantaged persons may be reviewed by the full
Full committee meetings are held monthly at a time and location that is subject
to change from semester to semester. Information regarding the time and place of
meetings may be obtained by contacting the HSC Office, and is posted on the website.
Protocols that require review at a convened full committee meeting must be received
in the FSU HSC office no later than 5:00 PM deadline day, which is posted on the
Principal Investigators and faculty advisors may attend the full committee
meeting if requested by the primary reviewer for a protocol, and may provide
information to the members; however, they may not be present during the final discussion
and vote. HSC members may not participate in the review and approval process of
their own protocols.
Note: Full committee review process takes approximately six weeks.
HIPAA and the Privacy Rule: the Privacy Rule of the Health Insurance Portability
and Accountability Act (HIPAA) took effect April 14, 2003. HIPAA regulates the protection
of private health information for individuals. The law’s Privacy Rule provides standards
for the use and disclosure of all individually identifiable health information obtained
from a covered entity. FSU is considered a "hybrid entity" with the FSU Thagard
Student Health Center. Health Information that contains any of the 18 identifiers
defined by HIPAA are considered to be protected health information ("PHI") subject
to HIPAA regulations. To access this information, all researchers must obtain either
an individual’s written authorization to access their protected health information,
or obtain an approval of a waiver of authorization from an IRB/HSC or Privacy Board.
Use of data from the FSU Thagard Center must receive prior HSC approval.
Other Review Requirements: When the HSC review process is complete, you will
receive written notification of the Committee’s action. Please read all correspondence
carefully because it may request additional information or describe conditions associated
with the Committee’s action. The approval period for a protocol can be for no longer
than 12 months (365 days) from the date of the review, but may be less than 12 months,
depending on the perceived risks to the research subjects.
Adverse Events: An adverse event is a serious, undesirable, and unintended
result involving risks to research participants or others. Adverse events must be
promptly reported in writing to the IRB/HSC Chair, and a form is provided on this
webpage. The Investigator must provide a description of the adverse event and state
whether or not changes are needed in the protocol and the informed consent process.
These revisions must be reviewed by the full committee. If the events are determined
to place participants at increased risks, the Chair may request resubmission of
the protocol for full committee review. If the committee determines that the research
participant may be placed at an immediate risk, the Committee has the authority
to suspend or terminate approval of a protocol, requiring the immediate cessation
of data collection from research participants. The Investigator will be notified
of the Committee action, and the Chair shall contact the appropriate University
officials, sponsors, and/or OHRP or FDA as required.
Amendments or Changes to the Protocol: When an Investigator desires to amend
or change a protocol, he or she should contact the FSU HSC prior to implementation
of any amendments or changes for review and approval. A protocol change may affect
the risks involved with a study, in addition to adverse events, unanticipated problems,
or complaints about the research – all of which should be reported to the HSC. A
written description of proposed changes to the protocol, informed consent process
and/or research instruments must be submitted to the HSC for review and approval.
Minor changes proposed to previously approved protocols ( i.e. number of participants)
must be reviewed by the HSC Chair. All other proposed modifications (major changes)
will be reviewed using the same process used for the review of the original protocol.
Only when it is necessary to eliminate apparent immediate hazards to research participants,
may, according to the federal regulations, an Investigator be permitted to modify
an approved protocol without the prior review and approval of the IRB; however,
the IRB must be promptly informed of the change upon implementation.
Continuing Review (Renewals): All protocols approved by the FSU HSC are subject
to continuing review at intervals appropriate to the degree of risk, but not less
than once in the 12 months following approval. At FSU, this is called the Renewal
process. If the Principal Investigator does not receive a form for request for continuing
review (renewal) within one month prior to the expiration date of the current FSU
HSC approval, a request for the form should be made by contacting the HSC office.
If the HSC approval of a protocol expires before it has been re-reviewed, the protocol
shall be suspended. While in a suspended status, new subject recruitment must
cease, and interventions under the research protocol must be halted. The only exception
to this requirement is when there are concerns for the safety or well-being of the
research subjects. In such a case, the Investigator must contact the HSC promptly.
The suspension will be removed when and if the protocol is re-approved by the HSC.
The HSC, as a courtesy, sends out a written reminder to the Principal Investigator
that the approval date is approaching expiration, and a renewal form is attached
to the notice. However, it is the responsibility of the Principal Investigator
to apply for renewal prior to the expiration date of the HSC approval. If the protocol
has not been re-approved, then the approval expires and data collection must cease.
The Principal Investigator will receive a written notification of the HSC’s review
and decision for continuing a research protocol when the review process is complete.
If the protocol has been re- approved, the notice will be labeled as "Re-Approval".
Closing a Study at FSU: If an Investigator desires to close or terminate
a study on or before the approval expiration date, he/she must submit a Study Closure
Report Form to be received by the IRB staff.