This document discusses the role and procedures of an Institutional Review Board (IRB). The main points are: - The IRB is a campus committee that reviews and provides oversight of research involving human subjects to ensure ethical standards are met. - A typical IRB is composed of a diverse cross-section of faculty, staff, and community members. - The IRB classifies research into exempt, expedited or full review categories depending on the risk and nature of the research. It reviews the research design, consent process and use of vulnerable populations. - Informed consent from participants is typically required by the IRB and must outline the study purpose, risks, benefits, confidentiality and voluntary participation.

1. The IRB and
The Ethics and
Principles of
The Conduct of
Research with
Humans

2. The Institutional Review Board

3. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.

4. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.

5. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.
• IRB’s might contain faculty members from history, biology,
education, psychology, and economics, as well as one or two
members from the community who are not associated with the
institution.

6. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.

7. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.
– The IRB serves to ensure that the experimenter treats
research participants according to the established ethical
guidelines.

8. The HPU Institutional
Review Board
(IRB)

9. IRB Chair:
Dr. Ken Rossi, Financial Economics and Information Systems, College of Business
Administration
email: irbchair@hpu.edu
IRB Committee Members:
Dr. Trish Ellerson, Assistant Dean, College of Humanities and Social Sciences
Dr. Valentina Abordanado, School of Education, College of Humanities and Social
Sciences
Dr. Patricia Burrell, Chair, Graduate and Post Baccalaureate Programs, College of
Nursing and Health Sciences
Dr. Susan Watson, Department of Psychology, College of Humanities and Social
Sciences
Tammy Chung, Community Member
Vacant, Community Member
Vacant, Community Member
Teddy Snodgrass, Student Member, College of Nursing and Health Sciences
The HPU IRB

10. The HPU IRB
• Categories of Review:
–Exempt Review
–Expedited Review
–Full Review

11. The HPU IRB
• Exempt Review:
– Exempt review determines whether or not the
proposed research meets the requirements for
Exempt status or whether the project should be
submitted for review under another category.
Exempt category does not apply to any research
with children or other vulnerable subjects.
– However, research involving children under 18 years
or pregnant women or other vulnerable subjects is
not eligible for Exempt review.

12. The HPU IRB
• Exempt Review:
– Research involving educational practices and outcomes
– Data gathering as part of a classroom exercise which is intended to
familiarize students with existing instruments and procedures or to explicate
concepts presented in the classroom is not considered research.
– Research involving the use of educational tests (cognitive, diagnostic,
aptitude, attitudinal, achievement), surveys, interviews or observation of
public behavior
– Research involving the study or analysis of existing data, documents,
records, or specimens, if these are publicly available or if the information
has been recorded in such a manner that subjects cannot be identified.
– Research that has been approved by another IRB
– Occasionally, you will fit here – if your study does NOT involve human
subjects, e.g. content analysis, use of existing records or data bases, etc.

13. The HPU IRB
• Expedited Review:
– Expedited review procedures may be used for certain types of research
involving no more than minimal risk.
– The review may be carried out by the IRB Co-chair or by one or more IRB
members designated by the Co-chair. In reviewing the research, the
reviewers may exercise all of the authorities of the IRB except that the
reviewers may not disapprove the research.
– A research activity may be disapproved only after review in accordance
with the Full review procedure set forth below.
– Reviewers may also refer the proposal to a Full review by the IRB if they
believe that a full discussion is warranted.
– Expedited review can also be used for minor changes in previously
approved research during the period for which approval has been
authorized

14. The HPU IRB
• Expedited Review:
– Data collection methods that do not involve invasive procedures, deception,
or more than minimal stress.
– Research involves only noninvasive, painless, and non-disfiguring collection
of physical samples, such as hair, sweat, and excreta.
– There is no use of vulnerable subjects.
– Data are recorded using noninvasive, painless, and non-disfiguring sensors
or equipment, such as EKG, weighing scales, or voice/video recording.
– Research involving physical exertion requires only moderate levels of
exercise in healthy volunteers.
– The research does not involve ingestion of drugs or use of hazardous
devices.
– If existing data, documents, records, or specimens with identifiers are used,
procedures are in place to ensure confidentiality
– Most of your studies fit here

15. The HPU IRB
• Full Review:
– Any research not covered under the Exempt or Expedited
review categories is referred to the IRB for Full review.
– The investigator is welcome to attend the review in order to
answer any questions that may arise, and may bring others if
desired.
– The research is either approved, approved pending
modifications that must be verified by committee members,
or not approved.
– The IRB will be expeditious in its review and decision-making.
Investigators will be notified in writing about the IRB
decision.

16. The HPU IRB
• Full Review (Special Considerations):
– Children as Subjects in Research
– Research involving Fetuses, Pregnant Women, or Human In
Vitro Fertilization
– Research Involving Prisoners
– Research involving patients who have some incapacitation
– Fieldwork or Ethnographic Research
• This falls into the category of special populations that require
additional protection and oversight by the IRB.
• Fieldwork or ethnographic research commonly conducted in the field
of anthropology is a type of method in which the use of a consent
form may not be appropriate. The IRB should keep in mind the
possibility of granting a waiver of informed consent

17. The HPU IRB
• Informed Consent:
– Informed consent is a written agreement made between an
investigator and a freely participating subject, that describes
in easily understandable language:
• the subject’s role in the investigation,
• the potential risks and benefits associated with study participation,
• the confidential nature of all information obtained in the
investigation, and
• the provision for voluntary withdrawal without necessity for
explanation by the participant
• additionally, no informed consent, whether oral or written, may
include any language through which the subject or the representative
is made to waive or appear to waive any of the subject’s legal rights,
or releases or appears to release the investigator, the sponsor, the
institution or its agents from liability for negligence.

18. The HPU IRB
• The basic elements of informed consent include:
– a description of the proposed study that includes the purpose, the
procedure, and the expected duration of the subject’s participation;
– a description of foreseeable risks (i.e., physical, psychological, social,
legal) that could be associated with study participation;
– a description of benefits that could be associated with study
participation;
– a disclosure of any appropriate alternative procedures that might be
advantageous for the subject;
– a statement describing the extent to which confidentiality of records
identifying the subject will be maintained;
– a related explanation for research involving more than minimal risk that
describes whether any compensation and/or medical treatment will be
available if injury occurs and, if necessary, a description of the
compensation and/or medical treatment and information about the
associated availability;

19. The HPU IRB
• Implied Consent:
– Implied consent is used when it is not appropriate or feasible
for use of an informed consent form:
• Your research involves a survey or other data collection instrument
that is mailed, emailed or made available in some other electronic
media (web-based) to the participant ,
• Follows the same rules as the informed consent except the
participant does not sign the form,
• It is placed in front of data collection instruments or read prior to
attempting to provide input to the data collection instrument;
• Reading beyond the form implies the participant’s consent to
participating in the study and your using their data for the study
• All the same rules apply as for informed consent.
• If the participants are from a protected category (children, prisoners,
elderly, confined, etc.) the informed consent must be used.

20. • All HPU faculty and staff involved in research (with or
without human subjects) are required to register for
and to take either the online course:
• “the CITI Course in The Protection of Human Research
Subjects” at
(https://www.citiprogram.org/Default.asp ), provided
by The Collaborative Institutional Training Initiative
(CITI) or,
• National Institutes of Health Office of Extramural
Research Training Course at
http://phrp.nihtraining.com/users/login.php
• All information about the IRB can be found at the IRB
tab in Pipeline
The HPU IRB

21. IRB Procedures
• The following IRB Project documents must be
submitted to the IRB by email (.doc or .docx format
only) in order:
– IRB Project Application Form (Appendix A)
– Informed Consent Form (example at Appendix B)
– Brief Summary of the research project and instruments
for collecting information (surveys, etc.)
– Debriefing Form
– Full Grant Proposal, if applicable
– NIH Certificate (.pdf, .doc or .docx format only)
– Amendment/Modification/Renewal Form, if applicable
(Appendix C)
– Submitted as a single document with your last name and
IRB Application as the document label

22. Annual Renewal Procedures
• Thirty days before the anniversary of the last
approval date, the following should be submitted
by email to the IRB Chair:
– Human Subjects Project Amendment/ Modification/
Renewal Form (Appendix C)
– If any changes have been made, submit instruments,
the consent form(s), and written explanation of study,
with all changes highlighted and noted to the IRB Chair
by email.

23. Pau