IRB Process Overview Ling Wang IRB Representative Graduate School of Computer and Information Sciences

12/7/20152 Agenda Introduction IRB Responsibilities Overview of the Process Steps in the Process Documentation Additional Reviews Additional Information Questions and Answers

12/7/20153 Introduction Research involving human subjects must be reviewed by Institutional Review Board (lRB) The National Research Act Public Law Title 45, Part 46 of the Code of Federal Regulations Guidelines are provided for research with human subjects to ensure their protection in the design and conduct of research University-level Board Representative from each center/school Outside representative

12/7/20154 IRB Responsibilities Review and approve any research that involves human subjects conducted by NSU faculty, staff or students, whether funded or unfunded The IRB is responsible for determining and assuring under the auspices of NSU faculty, staff, and students that: The welfare and rights of human subjects are adequately protected and informed consent given, if necessary Human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research The necessity and importance of the research outweighs the risks to the subjects The researcher(s) is/are qualified to conduct research involving human subjects.

12/7/20155 Overview of the Process (1) Does your research involve human subjects? Examples: Surveys/Questionnaires (e.g., phone, face-to- face, , snail mail, web-based forms) Interviews Review of documentation that contains identifying information

12/7/20156 Overview of the Process (2) Types of Review All research studies involving human subjects are reviewed in one of three ways: Center Level Review (previously labeled Exempt Research) Expedited Review Full Review Every research protocol begins with a complete submission to the principal investigator’s respective Center Representative. The Center Representative, not the principal investigator, is charged with reviewing the submission to determine the appropriate level of review for the study as well as assuring that all necessary documents are included.

12/7/20157 Overview of the Process (3) Types of Review Full Review Full review by the entire IRB panel (full University-level IRB) is reserved for studies that have potential risk to human subjects. The Center Representative will ask that the PI provide 23 copies (and one original) of the complete IRB submission to be reviewed at the monthly IRB meeting. Expedited Review In some circumstances, if there is no more than minimal risk, expedited review can be conducted even on studies involving minors. The Expedited Review is conducted by the IRB Chair or his/her designee. Center Level Review Research that represents no more than minimal risks to participants and does not involve special populations (such as the mentally retarded, some types of studies with children, prisoners, etc.). Does not require review by University-level IRB

12/7/20158 Steps in the Process  Approved Idea Paper  Work with your dissertation advisor to determine when it is the time to submit IRB documents  Complete and submit IRB documents to the IRB portal in the DTS:  CITI Completion Report (Who? When? How?) CITI  IRB Submission Form  Additional Documentation (as applicable):  Informed Consent forms  Data Collection Instruments (surveys, questionnaires, etc.)  Evidence of approval by cooperative IRBs at other sites  Brochure/recruitment materials  Notification of status  AFTER receipt of IRB approval, initiate research

12/7/20159 Additional Reviews Continuation/Renewal Reviews are good for one year. Continuing review of research must be conducted at intervals appropriate to the degree of risk, but not less than once per year. Revisions If there are revisions to the research protocol (e.g., changes to the informed consent form, survey instruments used, number and nature of subjects, etc.) the IRB must be notified immediately.

12/7/ Additional Information Course project involving human subjects: IRB approval not required if both conditions are met: The research is required by a course The student realizes that they can NEVER publish the results of the research outside of class. This includes a prohibition of use in dissertations. Informed Consent Form: When a waiver can be granted? Timing Useful Links

12/7/ Questions ?? Ling Wang