HPU IRB Presentation
- 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