Policy on Human Subject Protection Training, Certification and Recertification at AUB

Transcription

1 Policy on Human Subject Protection Training, Certification and Recertification at AUB Policy Number: 005 Draft Version Number: 1 Dated: Prepared and Edited by: Mona Nabulsi and Mary Ellen Sheridan (Consultant) Reviewed by: IRB Chair, Vice Chairs, and Members of Social and Behavioral and Biomedical IRBs, IRB administrator, and Policies and Procedures Ad hoc HRPP committee on Risk Reduction and Management Finalized and Approved by: Ghada El Hajj Fuleihan Pending Final Institutional Approval Accessibility Level Choose One: 1. Full access to all browsers 2. Access limited to persons with AUB IDs 3. Access restricted to users designated by the champion American University of Beirut Policy on human subject protection training, certification, and recertification at AUB Issuing Officer: Director Office for the Human Research Protection Program Responsible Dept: Office for the Human Research Protection Program (HRPP) Initial version/date: 1.1/ Revised versions: Approved by: Provost I. Background II. Policy III. Initial Training and Certification IV. Recertification V. Continuing Education VI. Training Requirements for Off-site Collaborators VII. Training Requirements for Non English speaking Investigators/ Study Personnel VIII. Requirements from Companies Subcontracting with AUB to conduct Field Research IX. Frequently Asked Questions: Human Subjects Protection (HSP) Certification Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 1 of 14

2 I. BACKGROUND Education is key to the ethical and responsible conduct of research involving human subjects. Most accreditation agencies, funding agencies and academic institutions in America and Europe have adopted policies that mandate human research protection education for investigators and study personnel for ALL research projects regardless of funding source (Table). The Research Education Unit at the American University of Beirut (AUB) provides training opportunities on the protection of human subjects in research and ensures that the requirements for human subjects certification for both the National Institutes of Health (NIH) and the Institutional Review Board (IRB) at AUB are met. Collaborative Institutional Training Initiative (CITI) is a web-based educational program that provides research ethics education to the research community, and may be used for both core initial certification as well as continuing education requirements. The program became available to AUB faculty, staff, and students as of Fall 2009, and may be accessed at ( II. POLICY The Human Research Protection Program (HRPP) at AUB requires certification of the Principal Investigator (PI) and all research team members (co-investigators, coordinators, nurses, research fellows, students, etc.) involved in the conduct of research with human subjects. This requirement applies to any research activity that involves obtaining consent, collection of data or biological specimens on any research protocol regardless of funding, and including research determined by the IRB to be exempt from IRB oversight. Protocols can be submitted to the IRB pending certifications of PI and other research team members; however, protocol approvals will not be issued until certification of all research team members is complete. If certification lapses, recertification must be complete before approval for the continuing review is issued. III. INITIAL TRAINING AND CERTIFICATION All investigators and study personnel are required to successfully complete the CITI web-based human subjects protection training program prior to initiating any research-related activity. This applies to ALL research projects regardless of funding source or IRB review status (full review, expedited or exempt review). The PI is responsible for submitting to the IRB CITI certificates of all study personnel at initial project review. AUB policy requires the following CITI training modules: Biomedical Researchers: CITI Biomedical Research Basic Course (Appendix I): 17 modules. Social-behavioral Researchers: CITI Social Behavioral Research Basic Course (Appendix 1): 16 modules. Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 2 of 14

3 Students: Student CITI Course for students partaking in research projects exempt from IRB oversight (Two modules: Belmont Report & CITI Course Introduction module and Students in Research-SBR module). Students involved in non-exempt proposals are required to complete the modules requested from all members of a research team, depending on the type of investigation, biomedical or social and behavioral as detailed above. Students are strongly encouraged to take the 11 modules of Responsible Conduct of Research (Appendix II). IRB Course: Course for IRB chairs, vice-chairs, members, and administrator officers. It is composed of 34 modules from both Biomedical and Social Behavioral Basic Courses, in addition to other modules of interest (Appendix I). Optional Course for Research Teams: AUB recommends the Responsible Conduct of Research Course (11 modules) for Biomedical or Social Behavioral Research as optional for investigators/study personnel or students involved in human subjects research (Appendix II). CITI Good Clinical Practice Course (GCP): This course is required for all investigators that hold Investigational New Drug (IND) or Investigational Device Exemption (IDE). GCP is optional for investigators/study personnel conducting clinical trials, but is strongly recommended for investigators and research staff participating in FDA-regulated research involving a drug, device or biologic that may undergo an FDA audit (Appendix III). IV. RECERTIFICATION The AUB policy requires all investigators/study personnel to successfully complete CITI refresher training every three years. Refresher courses (Appendix IV) will be available for any trainee when recertification is due. Failure to complete refresher training when due, or to provide recertification evidence to the IRB may result in delaying continuing review of an on-going research project, or delay initial review of a new research study from a previously certified investigator. V. CONTINUING EDUCATION AUB holds an Office of Human Research Protection (OHRP) approved Federalwide Assurance (FWA). As such, AUB is responsible for establishing training and oversight mechanisms to ensure that investigators/study personnel maintain continuing knowledge of, and comply with, the following principles and regulations for the protection of human subjects: - Relevant ethical principles - Relevant federal regulations - Written IRB procedures - OHRP guidance - Other applicable guidance - National and local laws - Institutional policies Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 3 of 14

4 To ensure that investigators/study personnel understand and act in accordance with the above principles and regulations, the AUB Human Research Protection Program (HRPP) offers regular educational seminars in topics relating to the responsible conduct of human research. Each seminar is awarded certain HRPP credits. AUB recommends that all personnel involved in human subject research attend HRPP seminars equivalent to at least 6 CE credits each year. VI. TRAINING REQUIREMENT FOR OFF-SITE COLLABORATORS Off-site investigators, co-investigators or study personnel, whether national or international are required to have training in human subjects protection, and ensure that the principles of the Belmont Report are respected, prior to initiating any research-related activity. AUB will accept the training and certification requirements stipulated by the collaborating institution, if available. Certificates can be provided to the IRB office where they will be reviewed to determine whether the minimal requirements for human subjects training are met, or whether additional training is required. In the absence of certification requirements in the collaborating institution, the type of training required from collaborators will depend on the nature of the research activity the collaborator is partaking in. Direct contact with human subjects, identifiable human samples, or records requires evidence and a plan for formal training as detailed above. If human subject training is unavailable at the collaborating institution, then the PI is required to provide a plan to assure that collaborating personnel know and understand the principles of the Belmont Report, the Declaration of Helsinki, or other national or international standards or ethical principles that guide research involving human subjects. In particular, the principles of Beneficence, Respect for Persons, and Justice need to be understood and adhered to. Training should include how to obtain oral or written consent from study participants, ensuring that participants are fully informed of the nature and purpose of the research project, and that they agree to participate willingly, and are entitled to withdraw from study at any time. The IRB may in addition request that the off-site collaborators take the CITI course on line and provide a certificate, when applicable. VII. TRAINING REQUIREMENTS FOR NON-ENGLISH SPEAKING INVESTIGATORS/STUDY PERSONNEL CITI Program is currently available in English, French, Spanish, Portuguese, Japanese, Thai, Korean, Chinese, and Russian. Investigators/study personnel fluent in French but not English can complete the French CITI training version by clicking on the Language option and choosing French. At present, no Arabic CITI version is available. Principal Investigators should provide a plan for training their study personnel whose only language is Arabic in human subject protection and the ethical conduct of research. This involves ensuring that personnel understand and apply the principles of the Belmont Report: Respect for Persons, Beneficence, and Justice. Training should include how to obtain oral or written voluntary consent from study participants, ensuring that participants are fully informed of the nature and purpose of the research project, and agree to participate willingly, and that participants may discontinue study participation at Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 4 of 14

5 any time, with no penalty or change in their relationship with AUB/AUBMC (for example, no change in continuing medical treatment from AUBMC). VIII. REQUIREMENTS FROM COMPANIES SUBCONTRACTING WITH AUB TO CONDUCT FIELD RESEARCH Any company contracted with to conduct field work and surveys on the behalf of an AUB investigator shall conduct its activities in compliance with the Belmont Report, and shall agree that its employees/contract staff obtain consent and conduct interviews in accordance with an AUB IRB-approved study, and use IRB-approved consent forms/procedures. It is the responsibility of the AUB PI to ensure that the company s staff/employees adhere to the above-stated requirements. It is also the responsibility of the PI to submit to the IRB a document outlining the training plan for field workers implementing the study for IRB approval, prior to the initiation of training. In addition, AUB IRB may request that persons conducting interviews or obtaining consent complete certain CITI modules pertinent to the type of study or its participants (e.g., person conducting study involving prisoners may need to complete the CITI module on prisoners). Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 5 of 14

6 IX. FREQUENTLY ASKED QUESTIONS: HUMAN SUBJECTS PROTECTION (HSP) CERTIFICATION 1. How do I access the Collaborative Institutional Training Initiative (CITI) website? The CITI program is accessible through the AUB IRB website at ( - Login as a New User and select American University of Beirut as your institution affiliation. Create your username and password, complete registration stating your member information specifying your role in research and highest degree. - Read the View American University of Beirut Instructions Page at the right upper corner of the Main Menu page. Choose your courses according to the type of your investigation/discipline. - Complete the Integrity Assurance module so that you can begin taking the course. - Under My Courses on the left side of the Main Menu Page, you will have to choose your courses (Biomedical Human Research Basic Course, Social and Behavioral Sciences Basic course, Good Clinical Practice Course, IRB Member Basic Course). - To begin each course click on Enter, you will be directed to the modules of the course. Click on the course to start reading and taking quizzes. 2. When am I required to complete my CITI training? You are required to complete CITI training prior to starting any research-related activity. You should submit your CITI certificate to the IRB prior to approval of new, renewal, and continuation applications, or for amendment applications. The PI is responsible for assuring that all personnel listed on the protocol have completed the CITI Training requirements. New or additional research staff proposed to be added to an already approved protocol must complete the appropriate CITI training before the IRB will approve the modification/amendment of the protocol to add new investigators or research staff, including students. 3. Who is required to complete CITI training and certification? - Any investigator or research personnel who participate in the conduct of research with human subjects (i.e. responsible for study design, data or specimen collection) - Staff, including IRB members, involved in the review, approval, or oversight of research. 4. When is CITI certification not required? CITI certification is not required from investigators or research personnel not involved in human subject research, identifiable human samples, or records. You can contact the IRB Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 6 of 14

7 office for any inquiries on whether your study requires CITI certification or not at 5. Which CITI courses should I complete? For biomedical research, you are required to complete the Biomedical Research Basic Course, and for social behavioral research, you should complete the Social Behavioral Research Basic Course. It is recommended that you complete the Biomedical Responsible Conduct of Research Basic Course or the Social Behavioral Responsible Conduct of Research Basic Course as optional courses. 6. How many CITI modules do I have to complete to get my certification? AUB requires 17 modules for biomedical investigations and 16 modules for social behavioral investigations. AUB recommends 11 modules of the Responsible Conduct of Research Basic course for both biomedical and social behavioral research as elective course. The estimated time for completion of the basic modules is 4-6 hours. IRB members, including chairs, vice chairs, and administrators, are required to take 34 modules, and students partaking in IRB-exempt research have to complete the CITI student Course (2 modules). 7. Do I have to complete CITI training all at once? You can stop and start any time using your user name and password. 8. Who should complete Good Clinical Practice Course (GCP)? GCP is required for all investigators that hold Investigational New Drug (IND) or Investigational Device Exemption (IDE). GCP is optional for investigators/study personnel conducting clinical trials, but is strongly recommended for investigators and research staff participating in FDA-regulated research involving a drug, device or biologic that may undergo an FDA audit. 9. When will I have to renew my CITI training? The CITI modules need to be renewed every three years. Refresher courses will be available for you at that time. The estimated time for completion of refresher modules is 1-2 hours. 10. Does AUB accept any other exams for AUB investigators or collaborators? Training in Human Subjects Protection received at other institutions or meetings will be accepted on a case-by-case basis when the request for approval is received from the investigator in writing, along with a course outline and letter or certificate of course completion from the referenced program. Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 7 of 14

8 11. What is the passing score? A passing score of at least 75% is required for the Biomedical or Social Behavioral Basic Courses. The IRB Course requires a passing score of at least 80%. 12. Does CITI offer CME/CEU credits? The University of Miami will provide a Continuing Medical Education credits for Physicians, Physician's Assistants, Nurse Practitioners, Psychologists and other health care providers. See the CITI web-site for more information < If I have more questions, who can I contact? You can contact the IRB administrators at extensions 5442 or 5443, or send an to irb@aub.edu.lb. Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 8 of 14

9 Table: Human Subject Training requirements in selected US academic centers. Program Initial Requirement Recertification Frequency Boston Face to Face seminars or Read and answer questions Q 2 yrs University NIH Course min online research newsletter; Score Harvard Web-based Harvard Ethics Training in Human Research (HETHR): 10 modules good for 3 Y; required prior to protocol approval > 75 % Refresher Training: 8 modules. Additional modules may be required by Committee Q 2 yrs * Stanford CITI Basic course + 2 elective CITI refresher course Q 2 yrs modules *Duke 6 CITI Biomedical modules At least 2 elective CITI modules Q 2 yrs Medicine *Michigan Ann Arbor Institutional web-based training modules (PEERRS) composed of CITI & other PEERRS Q 3 yrs YALE *Case Western Reserve University Kentucky Weill Cornell Medical College *Johns modules - Yale web-based training program OR - CITI Basic OR - NIH protecting human research participant training program OR - Other University program ± HIPPA CITI Basic course - CITI OR - Online book + web-based material on HSP - One CITI subject OR - 1 HRPP large group session - OR 2 small group administrative sessions - CITI Basic - CITI Refresher - Good clinical practice - CITI refresher course OR - NIH refresher course OR - Institutional HSP conferences/modules training Q 3 yrs Q 3 yrs Q 3 yrs CITI Basic course CITI refresher Q 4 yrs Institutional Compliance N/A N/A Hopkins training courses - CITI Basic courses for biomedical or social behavioral research are 13 modules each, unless specified otherwise by the institution. - CITI Refresher Courses vary by institution. - All institutions offer HSP training courses, workshops, seminars and conferences as recommended continuing education activities. Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 9 of 14

10 *Links to Human Subject Protection training policies in selected American universities: Stanford University Johns Hopkins University of Michigan Duke University Medical System Case Western Reserve University Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 10 of 14

11 APPENDIX I CITI Basic Courses required for initial certification Social & Behavioral Modules Belmont Report & CITI Course Introduction Students in Research-SBR History & Ethical Principles- SBR Defining Research with Human Subjects-SBR The Regulations & the Social Behavioral Sciences- SBR Assessing Risk in Social & Behavioral Sciences-SBR Informed Consent-SBR Privacy & Confidentiality- SBR Research with Prisoners- SBR Research with Children-SBR Research in Public Elementary & Secondary Schools-SBR International Research-SBR Internet Research-SBR Biomedical Modules Belmont Report & CITI Course Introduction History & Ethical Principles Basic Institutional Review Board (IRB) Regulations & Review Process Informed Consent Social & Behavioral Research for Biomedical Researchers Records-Based Research Genetic Research in Human Populations Research with Protected Populations-Vulnerable Subjects: An Overview Vulnerable Subjects- Research with Prisoners Vulnerable Subjects- Research involving Minors Vulnerable Subjects- Research Involving Pregnant Women and Fetuses in Utero Group Harms: Research with Culturally or Medically Vulnerable Groups FDA-Regulated Research Other Modules Of Interest International Research (Required for Biomedical Research) Human Subjects Research at the VA HIPAA and Human Subjects Research (Optional for Biomedical, SB, and student Research) Workers as Research Subjects-A Vulnerable Population (Required for Biomedical & SB Research) Hot Topics Conflicts of Interest in Research Involving Human Subjects (Required for Biomedical & SB Research) You Want to be an IRB Community Member, Now What? The IRB Member Module- What Every New IRB Member Needs to Know Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 11 of 14

12 APPENDIX II CITI Responsible Conduct of Research Courses Social and Behavioral Modules Introduction to the Responsible Conduct of Research Research Misconduct Data Acquisition, Management, Sharing and Ownership Publication Practices and Responsible Authorship Peer Review Mentor and Trainee Responsibilities Animal Welfare Conflicts of Interest and Commitment Collaborative Research Human Subjects The CITI RCR Course Completion Page Biomedical Modules Introduction to the Responsible Conduct of Research Research Misconduct Data Acquisition, Management, Sharing and Ownership Publication Practices and Responsible Authorship Peer Review Responsible Mentoring Animal Welfare Conflicts of Interest and Commitment Collaborative Research Human Subjects The CITI RCR Course Completion Page Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 12 of 14

13 CITI Good Clinical Practice Course APPENDIX III Good Clinical Practice Modules GCP Introduction Overview of New Drug Development International Conference on Harmonization FDA Regulated Research and ICH International Conference on Harmonization-Part 2 Conducting Investigator-Initiated Studies According to FDA Regulations & Good Clinical Practices Investigator Obligations in FDA-Regulated Clinical Research Managing Investigational Agents According to GCP Requirements Conducting Clinical Trials of Medical Devices Informed Consent: An Ongoing Process Detection & Evaluation of Adverse Events Reporting Serious Adverse Events Monitoring of Clinical Trials by Industry Sponsors Audits & Inspections in Clinical Trial Completing the CITI GCP Course Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 13 of 14

14 APPENDIX IV CITI Refresher Courses required for recertification Biomedical Research 101 Refresher Modules Social Behavioral Research 101 Refresher Modules Refresher Course 101 Introduction SBR Refresher Module 1: History & Ethics 101 Refresher Course-History and Ethics SBR Refresher Module2: Regulatory Overview 101 Refresher Course- Regulations and Process SBR Refresher Module 3: Fundamental Issues 101 Refresher Course-Informed Consent SBR Refresher Module 4: Vulnerable Subjects 101 Refresher Course-Social and Behavioral Research SBR Refresher Module 5: Additional Subjects 101 Refresher Course-Records Based Research How to Complete the CITI Refresher Course & Receive the Completion Report 101 Refresher Course-Genetics Research SBR Refresher Module 1: History & Ethics 101 Refresher Course-An Overview of Research with Vulnerable Subjects 101 Refresher Course-Research with Vulnerable Populations-Prisoners 101 Refresher Course-Research with Vulnerable Populations-Minors 101 Refresher Course-Pregnant Women and Fetuses 101 Refresher Course-FDA regulated Research and Conference on Harmonization 101 Refresher Course-Conducting Human Subjects Research at the VA 101 Refresher Course-Complete the Course SBR Refresher Module2: Regulatory Overview Policy on Human Subject Protection Training, Certification, and Recertification at AUB Page 14 of 14