-Introduction and Overview -What the IRB Is and Isn't -Basic Responsibilities of the Institutional Review Board -Organization of the Institutional Review Board -E-mail the Chair of the IRB  Frequently Asked Questions

-Review Process -Research Project Categories -Forms -IACUC -Palm Beach Atlantic University Title 45 CFR, Part 46, revised June 23, 2005

Palm Beach Atlantic University faculty, students, and researchers are required follow all guidelines specified by the Department of Health and Human Services (DHHS) policy on Protection of Human Subjects (Title 45 CFR, Part 46, revised June 23, 2005) and the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research April 18, 1979) in all research activities requiring human subjects. This includes all projects regardless of whether the funding is internal or external. All research projects involving human subjects will be reviewed and monitored by the Institutional Review Board (IRB) in accordance with the above mentioned policies. Strict adherence to all regulations is required by law.

Research involving the use of humans as research participants falls under the supervision of the Palm Beach Atlantic University Institutional Review Board (IRB). Here, research is restricted to the systematic investigation of questions designed to develop or contribute to generalizable knowledge, involving the collection of data from or about living human beings. The IRB does not review research utilizing published or publicly available documents or research on elected or appointed public officials or candidates for public office. Research involving the use of animals as research participants falls under the review of the Institutional Animal Care and Use Committee (IACUC).

Responsibilities of the IRB include but are not limited to:

• Review and approve, require modifications in (to secure approval), or disapprove proposals for all research activities covered by this policy.
  
  Require information given to subjects as part of informed consent is in accordance with Par. 46.116 of Title 45 CFR Part 46. The IRB may require that information, in addition to that specifically mentioned in Par. 46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
  
  Require documentation of informed consent or may waive documentation accordance with Par. 46.117.
  
  Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
  
  Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

All research activities that involve the use of humans as research participants must submit the IRB Approval Form and appropriate Cover Form to the Institutional Review Board. If the research activity is a proposal to an outside agency (e.g., National Institutes of Health), the review form and proposals must be submitted to the Institutional Review Board before the proposal is mailed to the sponsoring agency. The review form can be obtained here or from the Office of the Institutional Review Board, Gregory Hall, Room 456.

The Chair of the Institutional Review Board determines whether the research qualifies for an expedited review (see below) or must receive a full review by the committee. If the research project does quality, the Chair of the Institutional Review Board will process the proposal and forward the proposal to one or two members of the board for review. Typically, this process takes 2 to 5 working days. Category II reviews can take up to 6 weeks so please plan ahead.  Verbal notification of the approval can be forwarded to the principle investigator if needed. If the research project does not qualify for an expedited review, the Chair of the Institutional Review Board will convene Institutional Review Board for a full review of the research proposal.

Please note that, in order to receive a full review, all Research Proposals must be submitted a minimum of three weeks prior to the scheduled date to begin the project.

Incomplete proposals will be returned for correction and will not be reviewed!

Once it has been determined that a research project falls under the purview of the Institutional Review Board, it is reviewed under one of two categories, Category I (Expedited Review) and Category II (Full Review). The review procedures for each of these are described below. Each researcher should make the initial determination regarding the appropriate category of review, although the Institutional Review Board may require review under another category. The researcher can always request a higher level of review than that required.

Project categories, along with examples of the types of projects included in each category are as follows:

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  Project Category I (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 I 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.

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•  Project Category II (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 II review are as follows:

  1. Research which might put subjects at risk
  2. Research involving psychological or physiological intervention
  3. Non curricular, interactive research in schools
  4. Research involving deception that might have adverse effects on the subjects
  5. Interviews or surveys on sensitive topics
  6. Research on special populations; e.g. minors, prisoners, and the mentally incompetent
  7. Research conducted outside the United States, regardless of the procedures involved

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  • Project Category III (Class-related assignment). Please note that only the "Instructor Exemption for Class Projects" form, along with a class roll, should be submitted to the IRB for review.

  1. 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.

  Forms

  

  Or You May Go to the Quick Checklist and Forms Page

  

   ©2009 Faculty, Students, & Staff of Palm Beach Atlantic University
  & David M. Compton, PhD.
  Comments or suggestions, please contact David M. Compton

  last update: 13 October, 2009

  Last update: 3 October, 2009lasdddt