Navigating the IRB Process

1. Navigating theIRB Process University Institutional Review Board California State University, Stanislaus

2. History & Purpose • Bio-medical and Social Sciences • Protection of human subjects and the researcher(s) • The IRB process • CSU, Stanislaus safeguards the rights and welfare of human subjects involved in all research projects conducted by an employee, student or agent of this institution in connection with his or her institutional responsibilities. This responsibility is guided by the ethical principles set forth by the national Commission for the Protection of Human Subjects of Biomedical and Behavior Research in its report, Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research (commonly known as the Belmont Report). The Belmont Report sets forth three basic ethical principles for conduct of human subjects research… Prepared by ORSP Fall 2014

3. Basic Ethical Principles • Respect for Persons • Respect individual autonomy • Protect individuals with reduced autonomy • Informed consent • Protecting privacy and maintaining confidentiality • Additional safeguards for protection of subjects likely to be vulnerable to coercion or undue influence • Beneficence • Maximize benefits and minimize harms • IRB assessment of risk/benefit analysis including study design • Ensure that risks to subjects are minimized • Risk justified by benefits of the research • Justice • Equitable distribution of research burdens and benefits • Ensure that selection of subjects is equitable Prepared by ORSP Fall 2014

4. Human Subjects • A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. • If you are conducting research using secondary publicly-available data with no individual identifiers, this does not require IRB approval. • A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. If you are conducting research using secondary publicly-available data with no individual identifiers, this does not require IRB approval. • If an activity involves obtaining information about a living person by manipulating that person or that person’s environment, as might occur when a new instructional technique is tested, or by communicating or interacting with the individual, as occurs with surveys and interviews, the definition of human subject is met. Prepared by ORSP Fall 2014

5. Research • A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. Prepared by ORSP Fall 2014

6. Steps for Submitting 1. Submit your research protocol 2. Obtain approval 3. Receive approval letter Prepared by ORSP Fall 2014

7. Research Protocol 1. Title 2. Hypothesis, Purpose 3. Methods, Procedures, Subjects 4. Risks to Subjects and Precautions Taken 5. Informed Consent Letters 6. Instruments to be Used 7. Letters of Support Prepared by ORSP Fall 2014

8. Informed Consent • Follow model provided by UIRB • Describe the study • State the risks/benefits • Participation is voluntary • Contact information • Protect yourself and do not include personal information • Signature of participant Prepared by ORSP Fall 2014

9. Levels of Review • Full Board: The research requires a full board review before approval can be given. • Expedited: The research is approved and is authorized to proceed for one year. • Exempt: The research is exempt from further review and is authorized to proceed for one year. • Beyond the Purview: The research does not involve human subjects, but the researcher needs confirming documentation for special procedural reasons. Prepared by ORSP Fall 2014

10. Exempt Review • Low or no known risk to participants • Normal educational practices, standard surveys, interviews, observations of public behavior • Collection or study of existing data, documents, or records where the subject cannot be identified • The research does not need further review beyond the initial UIRB board member’s review. • This is not to be confused with the research being exempt from any review at all. Prepared by ORSP Fall 2014

11. Expedited • Minimal risk to the subject(s) • Standard non-invasive physical recording, use of existing documents or records where the subject can be identified, standard laboratory procedures • Certain projects disqualified from Exempt Review conditions • Reviewed by one member of IRB Prepared by ORSP Fall 2014

12. Full Board • Requires entire IRB committee review • Any activity qualifying as human subjects research that does not meet the criteria for Exempt or Expedited Review • More than minimal risk to the subject(s) • Vulnerable participants such as minors and/or persons at risk of psychological harm, including harm if confidentiality were violated or deception involved Prepared by ORSP Fall 2014

13. Research Subjects • Vulnerable Populations : children, pregnant women, ethnic minorities, prisoners, mentally disabled persons, economically or educationally disadvantaged persons, students in the classroom, or employees in their workplace Prepared by ORSP Fall 2014

14. UIRB contact • Website • www.csustan.edu/uirb • Full Board meeting schedule • www.csustan.edu/office-research-sponsored-programs/UIRB/meeting-calendar • Forms, additional information • www.csustan.edu/office-research-sponsored-programs/UIRB/forms-publications Prepared by ORSP Fall 2014