The Institutional Review Board's - Frequently Asked Questions (FAQs)

1. What is the University's policy for the use of human subjects in research?
2. What is the Institutional Review Board (IRB)?
3. What are the responsibilities of the IRB?
4. How does the IRB function?
5. Does my project involve human subjects?
6. What is research?
7. What are some examples of research with human subjects conducted at the PBA?
8. What is the difference between practice and research?
9. What is the difference between anonymous and confidential?
10. Can the Board stop me from conducting my research?
11. Does the IRB serve as a scientific review panel?
12. My research with human subjects is not funded. Do I still have to submit an application to the IRB?
13. Do student research projects have to be Submitted to the IRB?
14. Is anyone available to speak to classes and/or groups about the IRB process?
15. Who is responsible for reporting any problems that may occur during the conduct of approved Human Subject Activities?
16. What should I do if I know of research that has violated ethics?
17. What is considered minimal risk?
18. How can an investigator obtain further information or advice regarding the use of human subjects?
19. What materials should I submit to the IRB Office?
20. Where can I get an application?
21. How long does the approval process take?
22. May I call about my study?
23. Will the Human Subjects Office personnel help researchers complete the applications?
24. What about meeting the Chairperson of the IRB?
25. What kinds of activities are considered "normal educational practice"?
26. May deception or misrepresentation be used in studies with human subjects?
27. May I begin my Human Subject Activity  before I receive IRB approval?
28. Do I need IRB approval if my Human Subjects Activities will be conducted someplace other than the University campus? Do I need IRB approval if my protocol is already approved by another IRB?
29. If I make changes in my protocol does the IRB have to review and approve again?
30. What is an identifier?
31. Are any special steps required to protect data collected on film, photographs, and audio or videotape?
32. How can I speed my proposal through the IRB?
33. When do projects require consent?
34. Does the project require written consent?
35. Is it necessary to explain to the subjects ahead of time how data from the study will be used?
36. What consent materials are required for research with minors?
37. What is assent?
38. Is assent always required?
39. What do I do with the consent forms once they are signed?

1. What is Palm Beach Atlantic University's policy for the use of human subjects in research? The University Policy on activities involving Human Subjects is to fully comply with regulations and follow guidelines defined by the Federal Office for Human Research Protections and to implement principles first outlined in the Belmont Report. Any research activity that involves human subjects, whether such activity is undertaken on a large or small scale, whether it is preliminary or fully designed, whether it is conducted by students or faculty, whether it is externally funded or not, and whether it involves minimal risk or more than minimal risk, is subject to the IRB review.

2. What is the Institutional Review Board (IRB)? The IRB is the Palm Beach Atlantic committee that reviews and approves protocols for the use of human subjects in research. Federal regulations require that the IRB membership represent a variety of backgrounds, training, and experiences. At least one IRB member must have no formal or family connection with the University. At least one member must be a non-scientist.

3. What are the responsibilities of the IRB? The IRB reviews research protocols to ensure that the rights and welfare of subjects are protected and that the proposed use of human subjects is in compliance with Federal regulations, the laws of the State of Florida, and the policies associated with Palm Beach Atlantic University.

4. How does the IRB function? Once it has been determined that a research project falls under the purview of the Institutional Review Board, it is reviewed under one of three categories, Category I (Exempt), Category II (Expedited Review) or Category II (Full Review). Category I projects are reviewed by the IRB chair and one-to-two IRB members, depending on the complexity of the research methodology and sensitivity of the research topic.

Principal investigators are notified in writing the review results at the completion of the review process. The review process for Category II takes anywhere from 3 days to 2 weeks, depending upon the individual project and the workload of the IRB. Category III review may take 4 to 6 weeks. The review generates one of three results:

            1) Approved

            2) Approved with Comments (i.e., modifications) or

            3) Denied.

5. Does my project involve human subjects? Human Subject refers to an individual, living or dead, about whom a researcher obtains data through intervention or interaction with the individual, or Identifiable private information. Intervention includes both physical procedures, by which data are gathered (for example, collection of saliva or venipuncture), and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between researchers and subjects.

Private information includes information about behavior that occurs in a context, in which an individual can reasonably expect that no observation or recording is taking place, and information, which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, client or medical records or information obtained in an interview).

6. What is research? Research is defined as a systematic investigation that contributes to the larger body of knowledge of any given discipline. This includes collection of scholarly materials for theses and dissertations done by students, and investigations carried out by faculty and staff for publication and/or presentation.

7. What are some examples of research with human subjects conducted at the Palm Beach Atlantic University? Examples include psychological experiments, educational and behavioral testing, in-person and telephone surveys, questionnaires, interviews and focus groups, review of medical or other records, observation of public or private behavior, including classroom observations, and taste tests.

8. What is the difference between research and practice? The term Research is designed to test hypotheses, permit conclusions to be drawn and thereby develop or contribute to the larger body of knowledge. The term Practice consists of interventions designed to enhance the well being of a patient or client. Research and practice are not mutually-exclusive and can be carried out together. However, if there is any element of human subject research in an activity, then it would be advisable to describe the activity in an application for submission to the IRB.

9. What is the difference between anonymous and confidential? Anonymous the IRB means that the researcher cannot link the data to the participant. Confidential means that the researcher may be able to identify a participant’s data but will not reveal the participant’s identity to anyone else. For example, face-to-face are never anonymous.

10. Can the Board stop me from conducting my research? Yes, it can! The IRB has the authority to disapprove, suspend or terminate research that is not carried out according to its requirements or may be associated with unexpected serious harm to subjects. Any such step shall include a statement of the IRB's reasons for its action and will be reported promptly to the principal investigator, Palm Beach Atlantic's Attorney, and the funding agency (if applicable).

11. Does the IRB serve as a scientific review panel? No. However, if a proposed project appears to lack scientific merit or rigor, or duplicate existing work with more than minimal risk to subjects, the Board is required to consider whether the benefits to individual subjects and society outweigh the potential for harm to them.

12. My research with human subjects is not funded by Quality Initiative (QI) grants or other source of funding. Do I still have to submit an application to the IRB? Yes. All research that involves human subjects/participants must be reviewed and approved by the IRB. For more information on Palm Beach Atlantic University policy and procedures for research with human subjects/participants read the IRB Guidelines.

13. Do student research projects have to be submitted to the IRB? Yes. Student research projects involving human subjects must be reviewed by the IRB for human subject protection.

14. Is anyone available to speak to classes and/or groups about the IRB process? Yes. The IRB is available to discuss the importance of protecting human subjects/ participants and the procedures with any group on campus.

15. Who is responsible for reporting any problems that may occur during the conduct of approved Human Subject Activities? Researchers are responsible for reporting promptly to the IRB any serious or continuing noncompliance with federal regulations, or university policies, or injuries to subjects, unanticipated problems, and changes proposed in research activities. Research related problems should be reported to the IRB Chair at (561) 803-2463 or e-mail at david_Compton@pba.edu .

16. What should I do if I know of research that has violated ethics? You should notify the chair of the department and/or the Office of Legal Affairs. If you have any concerns or are uncertain about what constitutes a violation, please contact the Office of Legal Affairs at (561) 803-2051 or e-mail gene_fant@pba.edu.

17. What is considered minimal risk? Minimal risk means that the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

18. How can an investigator obtain further information or advice regarding the use of human subjects? Contact the IRB Office at (561) 803-2463 or e-mail David Compton.

19. What materials should I submit to the IRB Office?

Submittal and Review Procedures

            --An original, fully completed application. Each researcher must sign the application, and for students, the signature of a faculty advisor is
                 also required.

            --All applicable attachments, including consent forms, surveys, interview guides, instruments, recruitment flyers, and letters of authorization
                from each institution involved other than Palm Beach Atlantic University.

            --One additional copy of the application and all attachments is also required.

            --For more information, contact the IRB Office at (561) 803-2463 or e-mail David Compton.

20. Where can I get an application? Application forms are available on the web. If you are unable to download the application from the web please notify David Compton.

21. How long does the approval process take? The review process takes anywhere from 3 days to 6 weeks, depending upon the individual project, level of review, and the workload of the IRB.

22. May I call about my study?  Yes, you may call the IRB Office at (561) 803-2463 to learn the status of your application after you have submitted an application. You may learn where your proposal is in the review process. Your study can only be approved after all the changes have been made and submitted. When your study is approved you will receive written notification from the IRB. Do not begin data collection until you receive written approval from the IRB. If you do not hear from the IRB, it is your responsibility to inquire about the status of your application before you begin your data collection. For more information, see the IRB forms webpage or the IRB Checklist.

23. Will the IRB personnel help researchers complete the applications? Yes, the IRB personnel are pleased to give advice and guidance. You will not be penalized for incomplete or incorrect answers on your application; you will be asked to correct them. For more information, see the IRB forms webpage.

24. What about meeting the Chairperson of the IRB? The IRB Chairperson will be pleased to meet with you, but we recommend that you make an appointment. Please call (561) 803-2463 for an appointment.

25. What kinds of activities are considered "normal educational practice"? Generally, normal educational practice means activities that would occur in a given educational setting regardless of whether or not a study was being conducted. Such activities must not be disruptive to the normal classroom routine and do not require students to undertake any tasks specifically designed for a particular project.

26. May deception or misrepresentation be used in studies with human subjects? Yes, if the benefits outweigh the risks to the subjects for participating in such a study and if the researcher provides a compelling scientific justification for such experimental manipulation. For research where deception or misrepresentation is involved, the subjects must receive an explanation (a debriefing) about the nature of the experiment and why such manipulation was critical to its success. Such a form should be included with the materials submitted for IRB review and approval.

27. May I begin my human subject activity before I receive IRB approval? No. All research must be approved by the IRB before the research can be conducted.

28. Do I need IRB approval if my Human Subjects Activities will be conducted someplace other than the University campus? Do I need IRB approval if my protocol is already approved by another IRB? Yes. To ensure that the Palm Beach Atlantic University researchers comply with federal and university regulations, it is important that the University, through the IRB, be aware of where and by whom such activities are being done, even if conducted in a foreign country. In many cases the researcher must provide written authorization from that location.

29. If I make changes in my protocol does the IRB have to review and approve again? Yes. Any changes to your protocol must be reviewed and approved by the Board. In most cases, however, this can be done quickly through an expedited review by the IRB chair and/or selected members of the Board.

30. What is an identifier? The term Identifier refers to any information that could be used to match the data with the individual subject. Some examples are the subject's full or partial name, initials, social security number, and phone number.

31. Are any special steps required to protect data collected on film, photographs, and audio or videotape? Yes. The subject must be informed that the data is being collected through such recordings unless approval for deception has been granted by the IRB. Consent forms must describe specifically who will use these recordings, how they will be used, for what purposes, how long they will be stored, and how they will be disposed of at the end of the study. Use of such data for other purposes must be disclosed and permission obtained for subsequent use in a special part of the consent.

32. How can I speed my proposal through the IRB?

The IRB is responsible for reviewing and approving your application to use human subjects, but is not responsible for meeting research deadlines and cannot predict or guarantee approval dates. Fill out forms accurately and completely, and submit an original plus one copy of all materials as early as possible to meet your deadlines.

CAREFULLY read all of the Guidelines for Researchers.

Complete each section of the application form fully and accurately. Leave no blanks in your application; type and answer all questions. If a question is not applicable, answer "not applicable." This includes the question concerning funding. If the IRB must call or write for additional information, or wait for a second copy of your application, approval of your study will be delayed. Be sure the phone number and/or e-mail address you provide on the application form is one where you can be reached during the day or a message can be left for you. If you do not understand an item in the application form, please contact the IRB Office at (561) 803-2463.

Carefully write your consent form(s) or cover letter(s). Tell the research participants as much as possible depending on their level of understanding and without compromising your study. If you cannot give them all the details, let them know you are withholding certain information, and that you will provide a full explanation at the end of the study. Do not make your final copies until the IRB has approved your research.

Don't forget to sign the application form. All researchers must sign the application cover sheet, not just the Primary Investigator (PI). If you are a student or non-faculty, it is necessary that a Palm Beach Atlantic University faculty member supervises the research and sign in the space designated for faculty oversight.

The IRB and its staff work very hard to approve your projects as quickly as possible. However, there are instances when they are unable to reach you to discuss some point in your study. If you do not receive some word from the IRB Office within a reasonable period of time (3-4 weeks), call the office at 803-2463 to learn the status of your study.

33. When do projects require consent? Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. In some cases, the IRB may waive consent if the project involves no more than minimal risk, the waiver doesn't adversely affect subjects, the research couldn't practicably carried out without the waiver, and, where appropriate, subjects are given information about the project afterwards. The researcher must provide adequate justification if a waiver is desired. Otherwise, consent must be obtained.

34. Does the project require written consent? The IRB may waive written consent if:

                    •The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained outside of the
                         research context Or
                    •Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality.

35. Is it necessary to explain to the subjects ahead of time how data from the study will be used? Yes. If data obtained will be made available to any person or organization other than the subject, the researcher, and the researcher’s staff, the informed consent must disclose:

                •the person or agencies to whom information will be furnished,
                •the purpose of the disclosure, and
                •the nature of the information to be furnished.

36. What consent materials are required for research with minors? Human Subject Activities with minors require completion of a parental Consent Form and an Assent Form.

37. What is assent? Assent refers to agreement by a minor or incompetent adult to participate in Human Subject Activities. Assent must be accompanied by consent form a parent or guardian. The assent form must be written in the simplest terms possible.


38. Is assent always required? Assent must be sought from the child unless:

                • the child is incapable of providing assent (due to age or condition), or
                •the intervention holds out the prospect of direct benefit to the child and the intervention is available only in the context of the study.

In these two situations, consent from parent(s) or guardian(s) is considered sufficient.

39. What do I do with the consent forms once they are signed? You must keep the signed consent forms in a secure location. These consent forms must be retained for a period of 3 years after the study is complete. For some disciplines the forms and data must be kept longer. For example, the American Psychological Association requires forms and data be kept for 6 years. Some fields require that the information is kept for a period of 7 years.