AMITA HEALTH POLICY TITLE: Institutional Review Board (IRB) Initial Review NUMBER: 203 EFFECTIVE DATE: 10/1/2015 REVISION DATE: PAGE: 1 OF 7 PURPOSE To describe the AMITA Health Institutional Review Board’s (IRB) initial review process and define minimum criteria that must be met before research can be approved. POLICY 1. Definitions and Determination of Risks 1.1 Definition 1.1.1 Significant Risk (SR) in an investigational study is defined as one that presents a potential for serious harm to the health, safety or welfare of the subject. 1.1.2 Non-Significant Risk (NSR) is defined as one that does not pose significant risk for serious harm to the health, safety or welfare of the subject. 1.1.3 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) 1.1.4 Minor modifications: Any change(s) to the study materials and/or clarifications requested by the IRB that do not affect the IRB’s assessment of risks and benefits to subjects. Changes or clarifications that would assist the IRB in its initial assessment of risks and benefits to subjects are not considered minor. 1.1.5 Medical Device 1.1.5.1 A medical device is defined as a diagnostic or therapeutic article that does not achieve its principal intended 203-1 IRB Initial Review #203 1.1.5.2 1.1.5.3 1.2 purpose through a chemical action or by being metabolized within or on the body. Examples of medical devices are: surgical lasers, sutures, pacemakers, vascular grafts, intraocular lenses, orthopedic pins, and diagnostic aids such as reagents and test kits for in-vitro diagnosis of disease. A Significant Risk (SR) device is defined as an investigational medical device which presents a potential for serious harm to the health, safety or welfare of the subject, and (a) is intended as an implant used in supporting or sustaining human life, or (b) is of substantial importance in diagnosing, curing, mitigating or treating disease, or (c) otherwise presents a potential for serious harm to the health, safety or welfare of the subject. A Non-Significant Risk (NSR) medical device is defined as a device that does not pose significant risk for serious harm to the health, safety or welfare of the subject. Determination of Risk 1.2.1 The sponsor initially assesses the risk level of a device or drug study. The sponsor will provide the IRB an explanation of its determination with supporting documentation, and any other information that may assist the IRB in evaluating the risk of the study. 1.2.2 If an investigator proposes the initiation of a claimed NSR investigation to the IRB, and if the IRB agrees that the study is NSR and approves the study, the investigation may begin at the institution immediately. 1.2.3 If the IRB determines that an investigation for the use of a claimed NSR study is of significant risk, it will notify the investigator and, where appropriate, the sponsor. 2. The IRB will conduct a full board review of all research involving more than minimal risk to human subjects. Specifically, this will include all research not described in the categories for exempt or expedited review [See related AMITA Health policies, “Expedited Review” and “Exempt Review”] 3. Minimal Criteria for Approval of Research 3.1 In order for a research project to be approved, the IRB must find that: 3.1.1 Risks to subjects are minimized. For example, the IRB evaluates whether procedures to be performed on subjects are consistent with sound research design and do not unnecessarily expose 203-2 IRB Initial Review #203 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 4. subjects to risk, and whether they are already being performed for diagnostic or treatment purposes. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. Selection of subjects is equitable, taking into account the purposes of the research study and the setting in which it will be conducted and being particularly cognizant of the special problems of research involving vulnerable populations. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by appropriate state and federal regulations. [See related AMITA Health policy “Informed Consent”] Informed consent will be appropriately documented as required by state and federal regulations. When appropriate, the research study makes adequate provision for monitoring the data collected to ensure the safety of subjects. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Appropriate additional safeguards have been included to protect the rights and welfare of subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons). Additional Criteria for Approval of Research Involving Children 4.1 The IRB may approve a research study involving children only if it falls into one of the following four categories: 4.1.1 Research involving no greater than minimal risk; 4.1.2 Research involving greater than minimal risk but presenting the prospect of direct benefit to an individual subject, provided that the risk is justified by the anticipated benefit to the subject and the relationship of risk to the anticipated benefit is at least as favorable to the subject as that presented by available alternative approaches; 203-3 IRB Initial Review #203 4.2 5. 4.1.3 Research involving more than minimal risk with no prospect of direct benefit for the individual subject, including a monitoring procedure that is not likely to contribute to the well-being of the subject, provided that the risk represents a minor increase over minimal risk, the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations, and the intervention or procedure is likely to yield generalizable knowledge about the subject’s disorder or condition that is of vital importance for the understanding or amelioration of the subject’s disorder or condition; or 4.1.4 Research that is not otherwise approvable but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children and the Secretary of the Department of Health and Human Services (only required if the study is directly or indirectly funded by DHHS) and/or the FDA Commissioner (if applicable) determines that the research in fact satisfies one of the three conditions above or that the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles. In addition, the study must include adequate provisions for soliciting the assent of children and the permission of their parents (or legally authorized representative). [See related AMITA Health policies “Informed Consent” and “Assent”] Primary Reviewer System 5.1 This policy authorizes the use of a “Primary Reviewer System.” Under this system, studies will be assigned in advance to two IRB members who shall conduct a full review of all materials. Primary reviewers shall receive: 5.1.1 Full protocol; 5.1.2 Proposed informed consent document; 5.1.3 IRB application 5.1.4 Any relevant grant applications(s); 5.1.5 Investigator brochure or Instructions for Use (if one exists); and 5.1.6 Any recruitment materials, including advertisements and websites intended to be seen or heard by potential subjects. 5.2 Members who are not assigned primary reviewer responsibility will receive, at a minimum: 5.2.1 Protocol summary; 5.2.2 Proposed informed consent document; and 203-4 IRB Initial Review #203 5.3 5.4 5.2.3 Any recruitment materials, including advertisements and websites intended to be seen or heard by potential subjects. Complete documentation will be available to all IRB members upon request. At the next convened IRB meeting, the primary reviewers will present their findings, and after a discussion by all IRB members, a vote will be taken. [See “IRB Voting” policy] 6. Physicians wishing to perform clinical investigations of drugs or devices, or wishing to perform behavioral research within AMITA Health must submit an initial application (See Application to Conduct Clinical Investigation at AMITA Health form) to the IRB along with the following supplementary material: 6.1 The name of the principal investigator and current curricula vitae (CV) or other document describing the investigator’s professional qualifications to perform the research. 6.2 A list of all proposed sub-investigators and their CVs. 6.3 A copy of the investigative protocol complete with background information on any animal or human studies demonstrating safety and efficacy of the product, the proposed investigation, attendant laboratory, radiologic and other diagnostic procedures involved in the use of the investigative drug or device, and any known adverse reactions or side effects to the use of the device or product or from participation in the behavioral research. 6.4 A copy of the proposed Informed Consent document. 6.5 A completed copy of the Informed Consent Element Checklist 6.6 Any relevant grant application(s). 6.7 Investigator Brochure (if available) or Instructions for Use (if one exists). 6.8 Any recruitment materials, including advertisements and websites intended to be seen or heard by potential subjects. 7. All members of the research team as listed on the application who are involved in the design, conduct, or reporting of the research are required to complete training in human subject protections. Certificates or other evidence of completion of training must be submitted before final approval by the IRB. The following websites are potential resources to fulfill this requirement: NIH (National Institute of Health): http://cancer.gov/clinicaltrials/learning/page2 (Protecting Human Research Participants) The Collaborative Institutional Training Initiative website: https://www.citiprogram.org/ (Human Subjects Research Basic Course: Biomedical Module or Social-Behavioral-Educational Module) 203-5 IRB Initial Review #203 Note that there may be additional requirements from research sponsors, institutions or other regulatory bodies. 8. The primary investigator (or his/her physician alternate) may be required to be present at the meeting to discuss the protocol and answer committee members’ questions. 9. Notice of Decision. The IRB may take any of the following actions: 8.1. Approve 8.2 Approve with Minor Modifications 8.3 Table 8.4 Disapprove 10. All IRB decisions will be documented in the meeting minutes in accordance with the IRB Recordkeeping policy. The AMITA Health IRB signatory official will be provided with minutes of all IRB meetings. 11. The IRB may not approve a research study for more than one year. However, at the time of initial review or during any continuing review period the IRB can set a more frequent review interval for any study that it determines warrants more frequent review. Such determinations may be based on the initial risk and benefit factors, the investigator’s experience, and new findings, knowledge or adverse effects that come to light during the course of the study. PROCEDURE A. Investigators must submit a completed “Application to Conduct Clinical Investigation at AMITA Health” form along with the protocol, the informed consent document and any other documents requested, to the IRB Coordinator for submission to the IRB. B. It is the IRB Coordinator’s responsibility to provide all applicable documentation to IRB members in accordance with section 5, above. The documentation must be forwarded significantly in advance of the meeting to allow for adequate review. C. The IRB Coordinator will document all IRB decisions and deliberations in the meeting minutes in accordance with the AMITA Health Recordkeeping policy and forward a copy to the IRB signatory official of AMITA Health. References: A. 45 CFR 46.111 B. 21 CFR 56.108, 56.111 203-6 IRB Initial Review #203 Documentation (Documents & Forms): A. Application to Conduct Clinical Investigation at AMITA Health Other Related Policy/Procedures: A. Expedited Review B. Exempt Review C. Informed Consent D. Assent 203-7