Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB) Dr. Jason Eberl, IRB Chair Dr. Sam Pope, Biomedical Subcommittee Chair Dr. Karen Spear, Social/Behavioral Subcommittee Chair

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Purpose of the Institutional Review Board Committee within an institution that reviews and oversees all research using human subjects. Governed by 45 CFR 46: the “Common Rule.”45 CFR 46: the “Common Rule.” Scientific review: To ensure study is scientifically valid and addresses an important problem. Informed consent review: To ensure informed consent form is readable and understandable, contains no potentially coercive language, informs prospective subjects about risks and benefits, and addresses subjects’ rights and privacy.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Two Essential Protections for Human Subjects Independent review of research to assess risks and potential benefits An opportunity for people to voluntarily and knowl- edgeably decide whether to participate in a partic- ular research protocol

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Basic Informed Consent Requirements Provide sufficient information to fully inform the subject Written in a language understandable to the subject population

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Basic Informed Consent Requirements (cont’d) Contain NO exculpatory language: 45 CFR 36/FDA 21 CFR 50.20: “No informed consent, whether oral or written, may include any exculpatory 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”

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Basic Informed Consent Elements Explain: Research Purpose Procedures (specifying those which are experimental) Reasonably foreseeable risks or discomforts Reasonably expected benefits to the subject or others Compensation (for research with more than minimal risk) Available medical treatments if injury occurs Alternative procedures or courses of treatment Confidentiality (noting possibility of FDA inspection)

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Basic Informed Consent Elements (cont’d) Other Elements: Contacts regarding research questions, subjects’ rights, and to report a research-related injury. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Definition of Human Subjects Research Definition of “Research” “a systematic investigation... designed to develop or contribute to generalizable knowledge.” (45 CFR d) Final goal: To disseminate findings via publication What is not research Classroom practice exercises Not intended as generalized knowledge or to contribute to body of knowledge and/or not intended for publication. Data gathered to evaluate program without intent to publish findings.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Definition of Human Subjects Research Definition of “Human Subject” “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.” (45 CFR f)

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Vulnerable Populations Pregnant Women, Human Fetuses, and Neonates See Subpart B of the “Common Rule”Subpart B Prisoners See Subpart C of the “Common Rule”Subpart C Children (especially in educational research) See Subpart D of the “Common Rule”Subpart D

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. How do I know if I need to submit my research study for IRB review? Are you using “human subjects”? Will you present data from your research beyond your classroom as contributing to generalizable knowledge? Will you present or publish your results?

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. What Do I Do First to Start the IRB Process? Fill out and submit Marian University IRB Form 1 Available on the IRB website: Submit to Bev Day, Admin Asst for the IRB: Within 14 days, the IRB Chair will respond with guidance about how to proceed.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Levels of Review Exempt – No application is required No risk or minimal risk Expedited – Application is required No more than minimal risk Full – Application is required More than minimal risk See “Common Rule” (45 CFR 46) for more details on“Common Rule” (45 CFR 46) review criteria. Also available on IRB website (

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. How do I submit an application to the Marian University IRB? Upon request from the IRB Chair, complete the application. Application is available online at Application must include: The study protocol (including how data will be collected and analyzed). An informed consent form or script. Any surveys or questionnaires. Any other materials that will aid in review of the application.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. How do I submit an application to the Marian University IRB? (cont’d) Submit your application electronically to Bev Day, Admin Asst for the IRB: Send/mail one hard copy to Bev Day, Mail Marian Hall mailroom

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. When is the application due? Biomedical Subcommittee 2 months prior to submission of grant and/or start of subject recruitment. Social/Behavioral Subcommittee Applications for expedited studies may be submitted at any time. Applications for full review are due by the 1 st day of the month.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. When can I expect to receive approval? Exempt or Expedited studies will be approved within approximately 2 weeks (assuming the application is complete and there are no serious problems). Full review requires the entire IRB committee to meet and may take up to approximately 1 month.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Questions? IRB Chair Dr. Jason Eberl: ; Biomedical Subcommittee Chair Dr. Sam Pope: ; Social/Behavior Subcommittee Chair Dr. Karen Spear: ; IRB Administrative Assistant Bev Day: ;