Page 1 of 6 Document Number: IRB-P106 Version Number: 1.3 Institutional Official: David Carlisle, MD, PhD Title: Institutional Review Board Standard Operating Procedures Education and Training on Human Subject Research Date Last Revised: Date Policy Approved by IRB: Effective Date: April 15, 2009 November 5, 2014 February 12, 2015 Policy Owner: Department: Junko Nishitani, PhD Office of Research Integrity and Compliance Signature of Institutional Official: Date: Signature of Policy Owner: Date: OVERVIEW Charles R. Drew University of Medicine and Science (CDU) provides education and training for individuals who protect the rights and welfare of human participants in research. These individuals include investigators and research staff, students and their faculty sponsors, Institutional Review Board (IRB) members, Office for the Protection of Human Subjects (OPHS) staff, monitors, institutional official(s) and community. The type of research project and/or the role of the individual dictate the education and training requirements. The mode of education and training includes online courses, webinars, lectures, workshops, attending conferences and others. Education is comprehensive in terms of knowing the current federal regulations, state and local law, institutional policies and procedures, and understanding the current ethical challenges in the face of new research fields and advancing technologies. Training concentrates on the application of the regulations and policies, operationalizing best practices, and developing skills for respectful and ethical conduct of human subject research. OBJECTIVE To describe education and training requirements for (1) investigators and research staff (whether professional or student), (2) faculty sponsors or mentors, (3) IRB members, and (4) IRB staff. POLICIES 1. All researchers, whether faculty, staff, or students, who obtain data through intervention or interaction with participants and/or collect or analyze participant s identifiable private information, must complete initial and continuing education and training to conduct human subject research. 2. Faculty sponsors must complete the same training as investigators conducting human subject research. Faculty sponsors are responsible for the conduct of the students, as
Page 2 of 6 well as taking full responsibility of the human subject research if the student is unable to continue with the study or when there is noncompliance. 3. CDU IRB members must satisfy initial and continuous education and training to maintain membership on the board. 4. OPHS staff must be knowledgeable and understand the applicable regulations, institutional policies and procedures, appropriate to their job description. 5. OPHS staff must maintain a training record of individuals involved in human subject research, faculty sponsors, IRB members, and themselves. 6. OPHS staff must evaluate the education and training effectiveness and make any changes as part of the quality improvement program. PROCEDURES Required Training for Investigators and Research Staff Conducting Human Subject Research, Faculty Sponsors, IRB Members, and OPHS Staff 1. Collaborative Institutional Training Initiative (CITI) online course. All investigators, research staff, and student researchers planning to conduct human subject research, faculty sponsors, IRB members, and OPHS staff must initially complete Collaborative Institutional Training Initiative (CITI) online course for both Human Subject Research and Health Information Privacy and Security (HIPS). a. Human Subject Research (HSR) Basic Course. The completion certificate for basic course is valid for 3 years. Before the certificate expires, the learner must take a refresher course. Refresher courses also have a three-year expiration date. b. Health Information Privacy and Security (HIPS) Course. The completion certificate is valid for 3 years. The learner should take the same course again after 3 years. There are no separate refresher courses for HIPS. 2. CITI Good Clinical Practice Course. Investigators and research staff who plan to conduct clinical research or clinical trials involving FDA-regulated products must complete Good Clinical Practice (GCP) Course through CITI. This Course is also required for IRB Members and OPHS Staff. GCP is renewable every 3 years. 3. To take CITI online course, individuals must register under Charles R. Drew University of Medicine and Science. For detailed instruction on how to register, choose courses, and select a learner group, please review Guidance on taking CITI online course.
Page 3 of 6 Additional Education and Training for Investigators and Research Staff, Students, Faculty Sponsors, Monitors, Community Members, Institutional Official(s) OPHS offers several education and training opportunities other than CITI training to reinforce knowledge gained from CITI to actual application. 1. Lectures and workshops (quarterly). Participants will obtain certificates of attendance from OPHS upon full participation. Some of the topics, but not limited to, include the following, a. What activities are considered human subject research b. Investigator responsibilities c. Informed consent process and documentation d. Recruitment e. Data security f. Risks and benefits g. Unanticipated problems and post-approval reporting requirements h. FDA requirements and Good Clinical Practice i. Additional protections for vulnerable populations j. Biospecimens in research k. Conflict of interest l. How to fill out an IRB application m. IRB submission process for exempt and non-exempt studies n. How to organize IRB files o. Monitoring your study 2. IRB or ethics consultation on specific research area or protocol involving human participants (by request). 3. Group training based on research role. 4. Webinars from Public Responsibilities in Medicine and Research (PRIM&R), Association for the Accreditation of Human Research Protection Program (AAHRPP) and others. 5. Education and training for corrective and preventive action plan. 6. E-mail correspondences with information on issues related to human subject research, upcoming education or training opportunities, OPHS announcements AXIS Quality Assurance (QA) Monitor provides additional education and training as part of the on-site QA review on specific protocols. Additional Training for IRB Members
Page 4 of 6 Initial Education and Training 1. New IRB members receive the following as part of their orientation session. a. Introductory Packet Letter discusses the review process b. General Responsibilities of IRB Reviewers c. How to Lead a Discussion during an IRB Meeting instruction for primary reviewers d. IRB Member Reviewer Sheet e. List of motions f. Criteria for waiver or alteration of informed consent and documentation g. Checklist for Studies Involving Prisoners h. Criteria for IRB Approval of Research and Elements of Informed Consent 2. New IRB members complete an one to two hour orientation session with the OPHS staff, which includes overview of the U.S. Department of Health and Human Services (DHHS) and U.S. Food and Drug Administration (FDA) regulations, state laws, the three Belmont Principles, general responsibilities as a reviewer, how to conduct a review, primary reviewer presentation at the meeting, conflict of interest, criteria for IRB approval and elements of informed consent. 3. Each new IRB member receives a book entitled, Institutional Review Board, Member Handbook, Robert J. Amdur and Elizabeth A. Bankert, Jones and Bartlett Publishers, Inc., Sudbury, MA 2007. Continuing Education and Training 1. Participate in any workshops or lectures presented by OPHS. 2. Attend webinars by Public Responsibilities in Medicine and Research (PRIM&R), Association for the Accreditation of Human Research Protection Program (AAHRPP) and others. 3. Attend Advancing Ethical Research (AER) annual conference and pre-conference workshop as available. Members must present what they learned from the conference during the convened IRB meeting. 4. OPHS presentation during the IRB meetings on selected articles on ethics and human research protection, updates on Federal regulations, state laws and CDU policies, case studies on noncompliance, and current hot topics.
Page 5 of 6 5. Request individual training at any time during the year or as recommended by OPHS staff. 6. Opportunity for IRB members to present current or assigned topics relevant to human participant research. 7. Opportunity for IRB members to participate in subcommittees lead by IRB Director to update and revise current IRB policies and procedures, IRB forms, and guidance. Additional Training for OPHS Staff Initial Education and Training 1. New staff receives intense training from an experienced OPHS staff on CDU IRB policies and procedures, university policies and procedures, applicable federal regulations, state and local laws, and ethical principles of conducting human subject research. a. The Nuremberg Code b. World Medical Association Declaration of Helsinki c. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects d. CDU IRB Standard Operating Procedures e. ICH-GCP (Guidelines for Good Clinical Practice E6) f. 45CFR46 g. 21CFR50 and 21CFR56 h. 21CFR312 and 21CFR812 i. Others Continuing Education and Training 1. OPHS staff receives educational materials from the Director by e-mail. 2. Discuss current issues during IRB staff meeting. 3. Discuss interesting or new ideas from IRB Forum on a routine basis. 4. Read IRB periodicals subscribed by OPHS. 5. Read the Institutional Review Board: Management and Function and other resources as appropriate.
Page 6 of 6 6. Attend national or regional conference on the protection of human research participants. Conference attendees must present conference materials to other OPHS staff and to the IRB. OPHS Responsibilities 1. OPHS will conduct educational courses throughout the year for all CDU faculty, staff, and others. 2. OPHS will monitor education and training requirements. 3. OPHS will maintain an IRB training database for research investigators and staff, IRB members, and OPHS staff.