The IRB Process Decision Tree

The questions that follow will help you determine if your research project falls under one of the categories classified as human subjects research as defined by Federal regulations or exempt and, therefore, not subject to IRB oversight and review. All of the activities that your study will employ must fall into one or more of the exempt categories in order for the project to be classified as exempt. Please contact the IRB at (561) 803-2463 or david_compton@pba.edu if you are unsure or have additional questions.

1. Is your planned research activity a systematic investigation designed to develop or contribute to generalizable knowledge? A systematic approach involves a plan to study a specific topic, answer a specific question or set of questions, test a specific hypothesis or hypotheses, or develop a theory. It incorporates the collection of qualitative and/or quantitative data, or specimens, and analysis. Generalized knowledge is knowledge gained from an investigation that may be applied to populations beyond the specific study group, inform policy, or to generalize results.

IRB review and approval is not required.

2. Does your research investigation involve interaction or an intervention with, collection of information about, or collection of specimens from living human beings?

This research does not involve human subjects. IRB review is not required and nothing needs to be submitted to the IRB.

3. Does your research investigation involve an intervention or interaction with these living human beings?

IRB review is required. Please review the Exemption Screening Checklist on the IRB web site to determine which of the three types of IRB review is required for your project.

4. Does your research investigation involve accessing information that is individually identifiable (e.g., the identity of theparticpants  is or may easily be determined by the investigator or associated with the information.)

This research does not involve human subjects. IRB review is not required and nothing needs to be submitted to the IRB.

5. Does the research investigation involve what is normally considered private information (e.g., behaviors that occur in a context in which an individual can reasonably expect that no observation or recording is taking place, or provided for specific purposes by an individual and which the individual can reasonably expect will not be made public including things protected by Federal law such as medical or school records)?

This research does not involve human subjects. IRB review is not required and nothing needs to be submitted to the IRB.

IRB Exemption Screening Checklist

The following questions will help you determine which type of IRB review is required for your project. The three types of review include:

Project Category I (Class-related assignment & Exempt Reviews). Research involves no more than minimal risk to participants. Exempt review consists of an initial IRB review, and following classification as exempt, the study is exempted from continuing annual IRB oversight. Please note that all future proposed revisions to an exempted study must be reviewed by the IRB prior to implementation to ensure the study remains exempt. A study is classified as exempt when it falls under one or more of the six categories of exempt research (see below).
  Instructor Exemption for Class Projects Form
The course instructors are responsible for completing the Instructor Exemption for Class Projects form and forwarding this, together with the class roll, to the IRB, Gregory Hall, room 456. The exemption is valid only for the academic semester during which the class project will be conducted.

Approval for Classroom Activity Course instructors should review and approve the Approval for Classroom Activity form for each student, and should maintain a copy of this form in their class records. These applications are only for the use of the instructors - the IRB does not review them. 

Class-related Informed Consent Letter (sample)   Instructors must review and approve the informed consent procedures for all class-related projects. A sample consent form is provided to assist instructors with this process.   
ProjectCategory II (Expedited Review) This research generally does not require written documentation of informed consent, but oral consent is required for all research involving direct interaction with subjects. All research in public and private schools primary and secondary schools requires written permission of the school district.
Some relevant examples of research that involves a Category II review are as follows:
 
  • Anonymous, mail or telephone surveys on innocuous topics
    Anonymous, non-interactive, non-participating observation of public behavior
  • Secondary analysis of existing data
    Educational research involving no interaction with students; e.g., regular classroom activity
  • Research involving the use of educational tests such as cognitive, diagnostic, personality, aptitude, and achievement tests.
  • Research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that subjects cannot be identified
  • Research on individual or group behavior of normal adults where there is no psychological intervention, physiological intervention or deception
  • Interviews and interactive surveys on non-sensitive topics (i.e. taste and food quality evaluation and consumer acceptance studies)

  • The Institutional Review Board may require full review of any research submitted or approved under expedited review.
    3. Project Category III (Full Review) For all research involving human participants who have been determined to be "at risk," written documentation of legally effective informed consent is required. Research on minors or subjects incompetent to give consent (e.g., certain clinical populations) requires permission by a parent or legal guardian. Deception research will only be approved if it meets certain conditions (e.g., debriefing). Some relevant examples of research that involves a Category III review are as follows:
     
  • Research which might put subjects at risk
  • Research involving psychological or physiological intervention
  • Non curricular, interactive research in schools
  • Research involving deception that might have adverse effects on the subjects
  • Interviews or surveys on sensitive topics
  • Research on special populations; e.g. minors, prisoners, and the mentally incompetent
  • Research conducted outside the United States, regardless of the procedures involved
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    1. Are you using existing data only and will have no contact with subjects?

    2. Does this research involve the use of any drug, device or invasive procedure that would place participants at risk for bodily injury or involve them in risky behavior?

    3. Does your research target pregnant women or fetuses (and put the pregnancy or fetus at risk), prisoners, including individuals on probation or otherwise involved in the criminal justice system, or individuals with impaired decision-making capacity?

    4. Is the research conducted in established or commonly accepted educational settings? “Accepted educational settings” include but are not limited to schools and colleges and may include other sites where educational activities regularly occur.

    4a. Does the research involve normal educational practices only (such as research on regular or special education instructional strategies, research on effectiveness of or comparison among instructional techniques, curricula, or classroom management methods) and involve no extraordinary educational or non-educational activity?

    Note: If your project involves surveys or interviews of minors under 18 years of age, it cannot be classified as exempt.

    Submit IRB Exemption Request under Category 1

    5. Does your research involve the administration of standard educational tests (e.g., cognitive, diagnostic, aptitude, achievement) only?

    Submit IRB Exemption Request under Category 2

    Note: Research conducted in schools, even if exempted by the IRB under Category 1 or 2, must follow any guidelines/restrictions imposed by the school(s) or district(s). You should submit evidence of approval from any school in which the research will take place. The IRB may require parental consent even if the school does not.

    6. Does the research involve observation of public behavior in which the investigator does not participate in the activity being observed?

    Submit IRB Exemption Request under Category 2

    7. Does your research involve the collection of data through surveys, questionnaires, interviews or focus groups, or observation of public behavior in which the investigator interacts with the subjects being observed?

    7a. Are any of your subjects under the age of 18?

    Note: If your project involves surveys or interviews of minors under 18 years of age, it cannot be classified as exempt.

    7b. Could the data collected reveal damaging or sensitive financial or personal information, or expose criminal activity about your subjects, or persons they know?

    Submit IRB Exemption Request under Category 2

    You must also answer YES to 7c, 7d, OR 7e to qualify for an exemption

    7c. Are data collected anonymously so that no link ever exists between the research records and the participant’s identity?

    Submit IRB Exemption Request under Category 2

    7d. Are your subjects elected officials or candidates for public office?

    Submit IRB Exemption Request under Category 3

    7e. Does any federal statute, without exception, require that the confidentiality of the personally identifiable data be maintained throughout the research and thereafter?

    Submit IRB Exemption Request under Category 3

    Note: If you did not answer “YES” to 7c, 7d, OR 7e, you must submit an IRB Approval Request.

    8. Is the research conducted or approved by a federal department or agency head and involves only the study, evaluation, or examination of a public benefit or service program; e.g., Social Security, Medicaid, etc.?

    Submit IRB Exemption Request under Category 5

    9. Is this a study of food preference or quality assessment to determine consumer acceptance of wholesome foods containing either no additives or additives at levels found to be safe by the Food and Drug Administration or approved for consumption by the Environmental Protection Agency or the U.S. Department of Agriculture?

    Submit IRB Exemption Request under Category 6

    Questions 10a through 10c are for studies involving access to secondary data only with no direct interaction or involvement with human subjects.

    10. Are the subjects who provided the data individually identifiable?

    Your research does not meet the Federal definition of “research on human subjects” and therefore no IRB action is required.

    10a. Will all data, documents, records, or specimens be in existence at the time of IRB review and approval of the project?

    10b. Is the archive, database, or record collection publicly available?

    Submit IRB Exemption Request under Category 4

    10c. Will any identifying information that may link your project data to individuals in the database/archive be included in your research records; i.e., will you create a coded list for follow-up purposes or to compare data from multiple sources?

    IRB Exemption Categories [from the OHRP Exempt Categories 45 CFR 46.101(b) - (WORKSHEET: HRP-312)]

    Category 1: Educational Purposes Only

    Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Examples include but are not limited to (1) evaluating the use of accepted or revised standardized tests, (2) testing or comparing a curriculum or lesson and, (3) a program evaluation of pharmacy continuing education

    Category 2: Surveys, Interviews, Public Observation, Educational Tests

    Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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. Examples include but are not limited to (1) surveys of teachers, nurses, or doctors about a technique or an outcome, (2) interviews with managers about a management style or best practices, and (3) conducting a focus group about an experience or an opinion of a community program in West Palm Beach.
    Note: The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.

    Category 3: Elected or 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 appropriate Florida state sunshine laws, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. An example would be an interview of a public official about a local or global issue.

    Category 4: Research with 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 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. An example would be analyzing existing tissue samples, publically available gene sequences, or a dataset which are recorded by the investigator without identifiers.

    *Note: "Existing" means existing before the research is proposed to the institutional review board to determine whether the research is exempt.

    Category 5: Public Benefit or Service Programs

    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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
    See OHRP's guidance regarding this category

    Category 6: Taste Tests

    (See also FDA’s Exempt Category) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.