Human Subjects Research and the Marian University Institutional

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 IRB • Committee within an institution that reviews and oversees all research using human subjects. • Governed by 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 • Opportunity for people to voluntarily and knowledgeably decide whether to participate in a particular 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 • Contain NO exculpatory language 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) • 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 46. 102 d) • Final goal: To disseminate findings via publication or professional presentation • Examples of 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 an educational program without intent to present or 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 46. 102 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” • Prisoners • See Subpart C of the “Common Rule” • Children (especially in educational research) • See Subpart D of the “Common Rule” 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.

Structure of the Marian University IRB • IRB Chair: Dr. Jason Eberl • Two Subcommittees: • Biomedical Research: Dr. Sam Pope, chair • Social/Behavioral: Dr. Karen Spear, chair Marian University is sponsored by the Sisters of St. Francis, Oldenburg.

Starting the IRB Process • Fill out and submit Marian University IRB Form 1 • Available on the IRB website: http: //www. marian. edu/academics/institutional-review-board • Submit to either Beverly Day, Admin Asst for the Social/Behavioral Subcom (bday@marian. edu), or Jeanmarie Cairns, Admin Asst for the Biomedical Research Subcom (jcairns@marian. edu) • 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 • Determined by IRB chair and appropriate subcom chair • Expedited – Application is required • No more than minimal risk • Reviewed by one or more subcom members • Full – Application is required • More than minimal risk • Reviewed at a meeting of the entire subcom Marian University is sponsored by the Sisters of St. Francis, Oldenburg.

Definition of “Minimal Risk” "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. " ([45 CFR 46. 102(i)] and [21 CFR Part 56. 102(i)]) Marian University is sponsored by the Sisters of St. Francis, Oldenburg.

IRB Application • For non-exempt studies (i. e. , subject to either expedited or full review), PIs must fill out and submit the appropriate application form, which will be sent to them by the subcom chair. • Application must include: • Study protocol (incl. data collection & analysis procedure) • Informed consent form or script • Any surveys or questionnaires • Any other materials that will aid in review of the application • CITI training completion certificates for all PIs (incl. faculty mentors for student projects) Marian University is sponsored by the Sisters of St. Francis, Oldenburg.

IRB Application • Submit to either Beverly Day, Admin Asst for the Social/Behavioral Subcom (bday@marian. edu), or Jeanmarie Cairns, Admin Asst for the Biomedical Research Subcom (jcairns@marian. edu) • Applications are due 2 months prior to submission of grant and/or start of subject recruitment. • IMPORTANT: No studies requiring IRB review can begin recruitment prior to receiving IRB approval– including student projects. Marian University is sponsored by the Sisters of St. Francis, Oldenburg.

When can I expect to receive approval? • Initial Form 1 review will be completed within 14 days of receipt by the IRB Chair. • Expedited reviews will be completed 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 a month to complete. Marian University is sponsored by the Sisters of St. Francis, Oldenburg.

Questions? • IRB Chair • Dr. Jason Eberl: 317 -955 -6601; jeberl@marian. edu • Biomedical Subcommittee • Dr. Sam Pope: 317 -955 -6275; spope@marian. edu • Jeanmarie Cairns: 317 -955 -6295; jcairns@marian. edu • Social/Behavior Subcommittee • Dr. Karen Spear: 317 -955 -6115; kspear@marian. edu • Beverly Day: 317 -955 -6176; bday@marian. edu Marian University is sponsored by the Sisters of St. Francis, Oldenburg.