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 (1979).

The ethical principles are:

• Respect for persons – which includes the requirement of a voluntary informed consent process
• 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 Research—Identifying Intent—Is This Project Research?

The code of federal regulations governing the protection of human subjects, known as the "Common Rule" (45 CFR 46), gives the Institutional Review Board ("IRB") 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 §46.102 of the Common Rule (45 CFR 46), "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:

1. The project involves a systematic investigation, and
2. 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." §46.102(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 include:

• 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 depletions
• Music therapy intervention to determine whether it affects pain levels in a hospital environment

Some examples of not human subjects research include:

• 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 publicly available data, such as reviewing U.S. Census data (not "human subjects" – de-identified data)

Institutional Review Board

Established pursuant to federal statute and regulations, the IRB is a committee composed of scientists, non-scientists including other professionally trained and lay individuals, as well as unaffiliated members who review all proposed human subjects research to ensure that the safety and welfare of human subjects are protected. Non-exempt as well as select exempt research involving human subjects requires review and approval by an IRB prior to conducting any human subjects research, such as for example recruiting or consenting study subjects; collecting, using, analyzing or sharing any individual's identifiable information or biospecimen for any research purpose, including data or tissue banking or repository; or involving individuals in any interaction (e.g., interviews, focus groups or surveys, regardless of mode or medium) or intervention, for a research purpose.  The FSU IRB is responsible for the review and on-going oversight of the above and other activities proposed or conducted by FSU employees (faculty, students, staff) and agents, regardless of the source of funding.

Assurance and Jurisdiction of the IRB

FSU’s Assurance with the federal government, an agreement under which as a condition of receiving federal funds and support for human research FSU agrees to abide by the terms of the Assurance, with all applicable laws (federal, state, local and international) and The Belmont Report, requires that all non-exempt and certain exempt research activities involving human subjects must be reviewed by the IRB, regardless of funding source or sponsorship. This includes:

• Research conducted by or under the direction of any FSU employee (faculty, staff, student) or agent in connection with his or her institutional responsibilities
• Research conducted by or under the direction of any FSU employee (faculty, staff, student) or agent using any property or facility of this institution
• Research involves the use of FSU’s non-public information to identify or contact human research subjects or prospective subjects, or to conduct or support human subjects research

The Office for Human Subjects Protection (OHSP)

The FSU Office of Research, through its Office for Human Subjects Protection, or OHSP, provides the requisite reviews and on-going oversight of all exempt research involving human subjects; provides the research community with consultation on and regulatory determinations for activities that may involve research or research involving human subjects but that may not require OHSP or IRB reviews under applicable law or FSU policy; performs pre-IRB review of non-exempt research involving human subjects; provides post-approval monitoring to ensure compliance with applicable laws; provides professional, technical and administrative support to the IRB, its business, meetings and documentation; maintains the electronic protocol management systems that serve to document and archive OHSP and IRB reviews and determinations; provides FSU leadership, the research community,  and the IRB with applicable law and policy information and resources; and provides or makes available initial, renewing and continuing training regarding human research regulatory requirements and related guidance. The OHSP staff also serve as a resource for investigators and IRB members, and has delegated authority to determine the initial appropriate level of review required for each research proposal submitted for IRB 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 to OHSP for IRB review. (Note: Researchers may also need approval from FSU Sponsored Research Services or from other oversight Committees, such as FSU Radiation Safety, before a research project may commence.) The categories of review are as follows:

1. Exempt review: To qualify for this category, the research must fall into one of eight exemptions at 45 CFR 46.104(d). These categories presumptively present low risk to potential subjects because they generally involve either collection of anonymous or publicly available data, or represent research for which the additional scrutiny required by federal regulations may have no added value for the protection of subjects; some exceptions apply. Examples of research that qualify as exempt are:

• Surveys for which subjects' identities cannot be readily ascertained, or if so then with limited IRB review
• Research involving normal educational practices not likely to adversely impact students or educators
• Analyses of discarded pathological specimens without personal identifiers
• Benign behavioral interventions in conjunction with collection of information from adult subjects

Important Distinction: It is the policy of FSU to review and determine whether research proposals meet the definition of “exempt.” The Principal Investigator does not make the decision whether a protocol qualifies as exempt. Only the IRB and the Office for Human Subjects Protection (OHSP) staff have the authority to determine whether a proposal meets the exempt requirements. Please utilize the informational sheet template on our Templates & Required Forms page under "Other Forms" instead of the consent template if your study has received an exempt determination.

2. Expedited review: To qualify for this category, research must fall into one of the nine federally-defined categories of research that may be reviewed through an expedited review process or that may require limited IRB review of certain exempt research. These categories involve research 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 (limits apply)
• Collection of data through noninvasive procedures routinely employed in clinical practice (excluding, however, procedures involving ionizing radiation, such as x-rays, DEXA scans and CT; other exceptions apply)
• Analysis of voice recordings
• Studies of existing pathological specimens with personal identifiers
• Exempt activities involving recording of subjects' identifiable information or secondary research involving identifiable private information or identifiable biospecimens.

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 IRB members, and the Chair.

NOTE: Reviews via the expedited process usually take approximately three to four weeks, provided that the application is complete at the time of submission and researchers have answered any questions to the IRB's satisfaction. To ensure the completeness of your application, please review our training requirements and templates/required forms.

3. Full Committee Review: This category of review is reserved for research proposals that are not eligible for expedited review; involve greater than minimal risk or a particular vulnerable population as defined in the regulations, or that may require limited IRB review of certain exempt research. Examples include:

• Invasive physiological or medical research or non-invasive research involving procedures that involve ionizing radiation, such as x-rays or DEXA scans
• Use of FDA-regulated products such as drugs (including supplements deemed as drugs) and devices that require FDA review 
• Research where a breach of confidentiality could reasonably place subjects at risk of criminal or civil liability, or be damaging to a subject’s financial standing, employability, educational advancement or reputation
• Exempt activities involving recording of subjects' identifiable information or secondary research involving identifiable private information or identifiable biospecimens.

Important Distinction: 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 committee.

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 checking Meeting Dates & Deadlines posted on this website. Protocols that require review at a convened full committee meeting must be received by the FSU OHSP prior to the posted times on each deadline day.

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. IRB members may not participate in the review and approval process of their own protocols.

NOTE: Full committee review process takes approximately four to six weeks, dependent on when a complete application is submitted and researchers have answered any questions to the IRB's satisfaction, within the deadlines.

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 valid written authorization to access their protected health information, or obtain an approval of a waiver of authorization from an IRB or Privacy Board. Use of data from the FSU Student Health Center must receive prior IRB approval. For more information, please visit our HIPAA in Research page.

Other Review Requirements: When the IRB review process is complete, you will receive 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 decision. 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 and the timeliness of submission of any requested revisions. Please note that OTHER NON-IRB REVIEWS MAY BE REQUIRED, SUCH AS RESEARCH COMPLIANCE AND/OR LEGAL REVIEWS FOR RESEARCH-RELATED AGREEMENTS, SUCH AS DATA USE AGREEMENTS, BUSINESS ASSOCIATE AGREEMENTS, AND AGREEMENTS FOR USE OR DISCLOSURE OF FERPA-PROTECTED INFORMATION. Contact us with questions or referral.

Serious Adverse Events: A serious adverse event (SAE) is a serious, undesirable, and unintended result involving risks to research participants or others. These must be promptly reported in writing to the IRB Chair. The Investigator must provide a description of the 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 re-submission of the protocol for full committee review. If the IRB 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 as required.

Amendments or Changes to the Protocol (Revisions): When an Investigator desires to amend or change a protocol, even a very small change, he or she must submit to the FSU IRB for review and approval, prior to making any change, a request for an amendment or modification. 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 IRB. A written description of proposed changes to the protocol, informed consent process and/or research instruments must be submitted to the IRB for review and approval.

Minor changes proposed to previously approved protocols (i.e. number of participants, consent language) must be reviewed by the IRB 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; even then, the IRB must be promptly informed of the change upon implementation.

Continuing Review (Renewals): With the general exception for studies under expedited review, all protocols approved by the FSU IRB 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 IRB approval, a request for the form should be made by contacting the OHSP.

If the IRB approval of a protocol expires before it has been re-reviewed and renewal approved, the protocol shall be suspended. While in a suspended status, all study activities, to include for example new subject recruitment or consenting, interactions or interventions with study subjects, and data analyses, must immediately cease. 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 IRB promptly. The suspension will be removed when and if the protocol is re-approved by the IRB.

The IRB, 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 timely track and schedule their renewal submissions and to apply for renewal prior to the expiration date of the IRB approval. The Principal Investigator will receive a written notification of the IRB'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."

NOTE: All renewals should be submitted at least two full months (60 days) prior to the study's expiration date to account for review time and any possible revisions that may be requested.

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 continuing review including the Study Closure Report Form to be received by the IRB/OHSP staff. Likewise, if a study terminates because a request for continuing review was not submitted by the Principal Investigator, the IRB will perform a termination report of all studies that have expired and contact each PI and major advisor to request completion of the FSU Study Closure Form. 

For questions about your study, check out the Staff Listing tab to the left, or contact your assigned IRB Coordinator