Adventist HealthCare, Inc.

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1 IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human Protection (HRP) Training Since 2000, accreditation agencies and funding agencies have adopted policies which mandate institutions to require human research protection education for research personnel on all research projects regardless of funding source. As part of our institutional goal of maintaining training within the research community, Adventist has adopted the web-based training provided through the Collaborative Institutional Training Initiative (CITI) for human research protection training certification for: a) all research personnel; and b) those with research review, approval, and oversight responsibilities affiliated with Adventist Healthcare, Inc. The IRB Administrative staff is responsible for tracking training module completion according to the requirements outlined below. Those with responsibilities in the review, approval and oversight of aspects of the research program at Adventist and all research personnel who participate in the conduct of research with human subjects (i.e. are responsible for the study design, data or specimen collection, or who contribute to the scientific development or execution of the study in a substantive and measurable way) are required to meet this training requirement. This includes studies exempt from IRB review, but does not include projects that are deemed to be not human subjects research or if the investigators are found to be not engaged in human subjects personnel and other individuals meeting the above criteria shall initially complete modules based on their designated learner group (see Appendix I through Appendix VII for required modules and approximate completion time based on learner group). The learner groups are as follows: a) Biomedical investigators/research personnel b) Social and Behavioral investigators/research personnel c) Data or Specimen Investigators/ Personnel d) IRB members/staff e) Human Protection Quality Committee (HRPQC) members f) Institutional Officials g) Operations Evaluation (ROE) members Satisfactory completion of the assigned modules requires a composite passing score of 85% or higher. This policy establishes minimum institutional requirements. It does not limit the ability of departments or committees to require additional training requirements. Individuals must meet any funding agency or sponsor requirements, and any terms, conditions or regulatory requirements related to awards, contracts or specific projects. In addition to the listed required modules in the Appendices, those with responsibilities in the review, approval, oversight and conduct of research involving: a) Prisoners, will be required to complete the CITI module entitled Vulnerable Subjects with Prisoners ; and IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page of

2 b) Children, will be required to complete the CITI module entitled Vulnerable Subjects - Involving Minors. a. Timeframe for of Training FOR INITIAL LAUNCH IN 20 only (in BOLD): If you are current and up-to-date with your human research protection (HRP) training status, then you are still required to complete a CITI assignment. AHC requires the completion of assigned modules by September 2, 20 by all research personnel involved with studies that are currently open, as of March, 20. Adventist is providing 6 months to these applicable individuals to complete their assignment. Consideration was given to individuals other commitments along with the need to provide adequate protection to human research subjects. The Principal Investigator, co- and sub- investigator, and other research personnel listed on IRB submissions and the study Delegation of Authority form must satisfactorily complete or be current with all required modules before receiving IRB approval on initial or continuing review of a submission, or prior to a submission being declared exempt. Satisfactory completion of all required modules is also required as part of the just-in-time (JIT) information required for federal grants. b. Noncompliance with Required Training personnel and IRB members who have not completed their assigned required training by the designated completion date will be removed from their role by the Adventist IRB (through notification by the IRB Chairperson) or the Adventist Chief Quality and Integrity Officer (or designee), and not be permitted to continue in their respective role. Reinstatement will occur only once the required training is complete, and will be documented by the Adventist IRB or the Adventist Chief Quality and Integrity Officer (or designee). All other learner groups must complete the required education to continue in their oversight roles. c. Acceptable Alternatives The only acceptable initial training from another institution is documentation of completion of the Adventist required modules within the past years. personnel not affiliated with Adventist, who have completed human research protection training elsewhere may contact the IRB Administrative Office to determine if their training is acceptable to meet the Adventist requirement. d. Renewal of Training Renewal of CITI training is required every three years in order to continue research activities that involve human subjects. There are two options for renewing human research protection training:. CITI: Refresher modules for recertification will be available for renewal every three years on the anniversary date of the most recent CITI module completed. Thus, recertification is IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 2 of

3 based on a rolling date determined by when the individual last completed human research protocol education. The CITI system will send a reminder notice 90 days prior to expiration. 2. If you have attended a human research protection program (i.e. Public Responsibility in Medicine and (PRIM&R)) within the last six months, and have an attendance certificate from that training, it will satisfy the renewal requirement. Please note that attending an isolated session on human research protection as part of a conference on another subject matter will not satisfy the renewal requirement. II. Recommended Good Clinical Practice (GCP) Training Adventist recommends that investigators on both FDA-regulated and non-regulated clinical studies complete the GCP online training program on the CITI training site. The average learner spends approximately 4.5 hours and uses approximately 5 logins to complete the entire group of modules that comprise the GCP course. Each GCP module has text to read and a quiz to complete. Please see Appendix VIII for available modules Good Clinical Practice (GCP) is the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides regulators assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of clinical trial subjects are protected. Additionally, Food and Drug Administration (FDA) regulations (effective October 27, 2008) require that non-ind foreign clinical studies, that support an IND or application for marketing approval for a drug or biological product, be conducted in accordance with ICH GCP. Previously these studies had to be conducted in accordance with ethical principles stated in the 989 version of the Declaration of Helsinki version issued by the World Medical Association (WMA). The International Conference on Harmonisation (ICH) / WHO Good Clinical Practice (GCP) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry to achieve greater harmonisation both in technical guidelines and in requirements for pharmaceutical data acquisition to reduce or obviate the need for duplicate testing. III. Policy Questions For questions on this policy, please contact the AHC IRB Administrative Office by phone (at ) or IV. Policy Revisions This policy will be reviewed at least every year. IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page of

4 Appendix I: CITI REQUIRED ASSIGNMENTS FOR - BIOMEDICAL INVESTIGATORS/RESEARCH PERSONNEL 2 History and Ethical Principles Basic Institutional Review Board (IRB) Regulations and Review Process 4 Informed Consent 5 Records-Based Genetic in Human Populations With Protected Populations - Vulnerable Subjects: An Overview FDA-Regulated and Conference on Harmonisation Conflicts of Interest in Involving Human Subjects ) Identify the three major principles of the Belmont Report ) Discuss why ethics are necessary when conducting research involving human subjects. 2) Describe the major historical events that have influenced how research involving human subjects is ) Identify problems with past studies that have violated ethical standards. 4) Describe the Belmont Principles. Discuss the ethical standards for research that guide us today. ) Describe the role, authority, and composition of the IRB. 2) List the IRB requirements for conducting research involving human subjects. ) Describe the types of IRB review. 5 minutes 4) Describe the process of working with the IRB. 5) Identify other regulations and regulatory groups that require compliance based on the type of research being ) Describe the requirements for complying with informed consent regulations. 2) Describe the process for obtaining informed consent. ) Describe the regulations for waiving informed consent. ) Understand concerns about inappropriate access and unauthorized disclosure. 2) Describe ways to minimize risks in records-based ) Understand the regulations that control records-based ) Understand the leading ethical issues regarding genetics research that relate to privacy and confidentiality, informed consent, and risks of harm. ) Understand the concept and characteristics of vulnerability. 2) Describe classes of vulnerable populations. ) Describe the role of the FDA in regulating drugs, biologics, and devices 2) Describe the role of ICH in clinical research (from the submodule) ) Describe the elements of informed consent in FDA regulations 4) Identify sponsor and investigator responsibilities outlined in FDA regulations ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial conflict of interest 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, hours and for initial completion. IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 4 of

5 Appendix II: CITI REQUIRED ASSIGNMENTS FOR SOCIAL AND BEHAVIORAL INVESTIGATORS/RESEARCH PERSONNEL 2 History and Ethical Principles Defining with Human Subjects Regulations and the Sociobehavioral Sciences Assessing Risk in Social and Behavioral Sciences Informed Consent-SB Privacy and Confidentiality- SB Genetic in Human Populations Conflicts of Interest in Involving Human Subjects ) Identify the three major principles of the Belmont Report ) Discuss why ethics are necessary when conducting research involving human subjects. 2) Describe the major historical events that have influenced how research involving human subjects is ) Identify problems with past studies that have violated ethical standards. 4) Describe the Belmont Principles. Discuss the ethical standards for research that guide us today. ) Explain the definition of 2) Explain the definition of human subject. ) Describe the differences between private and public information and behavior. ) Determine whether research is exempt from the regulations. 2) Describe the criteria for expedited and full board review. ) Summarize the authority of an IRB. 4) Describe the kinds of review that approved research may need. ) Identify risks associated with participation in social and behavioral sciences research 2) Distinguish between probability and magnitude of harm when assessing risk ) Apply the concepts of minimizing and managing risk ) Distinguish between consent as a process and the documentation of consent. 2) Recognize the elements of consent. 25 minutes ) Understand when waivers are appropriate. 4) Identify methods for ensuring comprehension of consent. ) Distinguish between privacy and confidentiality 2) Identify privacy risks associated with study designs ) Identify a range of procedures for ensuring confidentiality 4) Identify relevant laws regarding collection of private information 5) Identify laws that limit the ability to ensure confidentiality ) Understand the leading ethical issues regarding genetics research that relate to privacy and confidentiality, informed consent, and risks of harm. ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial COI 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, hours and 0 minutes for initial completion IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 5 of

6 Appendix III: CITI REQUIRED ASSIGNMENTS FOR DATA OR SPECIMEN RESEARCH INVESTIGATORS/RESEARCH PERSONNEL 2 History and Ethical Principles Basic Institutional Review Board (IRB) Regulations and Review Process 5 minutes 4 Records-Based Genetic in Human Populations With Protected Populations - Vulnerable Subjects: An Overview Conflicts of Interest in Involving Human Subjects ) Identify the three major principles of the Belmont Report ) Discuss why ethics are necessary when conducting research involving human subjects. 2) Describe the major historical events that have influenced how research involving human subjects is ) Identify problems with past studies that have violated ethical standards. 4) Describe the Belmont Principles. Discuss the ethical standards for research that guide us today. ) Describe the role, authority, and composition of the IRB. 2) List the IRB requirements for conducting research involving human subjects. ) Describe the types of IRB review. 4) Describe the process of working with the IRB. 5) Identify other regulations and regulatory groups that require compliance based on the type of research being ) Understand concerns about inappropriate access and unauthorized disclosure. 2) Describe ways to minimize risks in records-based ) Understand the regulations that control records-based ) Understand the leading ethical issues regarding genetics research that relate to privacy and confidentiality, iinformed consent, and risks of harm. ) Understand the concept and characteristics of vulnerability. 2) Describe classes of vulnerable populations. ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial conflict of interest 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, 2 hours and for initial completion IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 6 of

7 Appendix IV: CITI REQUIRED ASSIGNMENTS FOR - IRB MEMBERS/STAFF 2 History and Ethical Principles Basic Institutional Review Board (IRB) Regulations and Review Process 5 minutes 4 Informed Consent 5 Records-Based Genetic in Human Populations With Protected Populations - Vulnerable Subjects: An Overview FDA-Regulated and Conference on Harmonisation Avoiding Group Harms: US Perspectives Vulnerable Subjects- Involving Minors ) Identify the three major principles of the Belmont Report ) Discuss why ethics are necessary when conducting research involving human subjects. 2) Describe the major historical events that have influenced how research involving human subjects is ) Identify problems with past studies that have violated ethical standards. 4) Describe the Belmont Principles. Discuss the ethical standards for research that guide us today. ) Describe the role, authority, and composition of the IRB. 2) List the IRB requirements for conducting research involving human subjects. ) Describe the types of IRB review. 4) Describe the process of working with the IRB. 5) Identify other regulations and regulatory groups that require compliance based on the type of research being ) Describe the requirements for complying with informed consent regulations. 2) Describe the process for obtaining informed consent. ) Describe the regulations for waiving informed consent. ) Understand concerns about inappropriate access and unauthorized disclosure. 2) Describe ways to minimize risks in records-based ) Understand the regulations that control records-based ) Understand the leading ethical issues regarding genetics research that relate to privacy and confidentiality, informed consent, and risks of harm. ) Understand the concept and characteristics of vulnerability. 2) Describe classes of vulnerable populations. ) Describe the role of the FDA in regulating drugs, biologics, and devices 2) Describe the role of ICH in clinical research (from the submodule) ) Describe the elements of informed consent in FDA regulations 4) Identify sponsor and investigator responsibilities outlined in FDA regulations ) Describe some distinct groups or communities of people who are vulnerable. 2) Identify examples of research that has harmed groups. ) Identify strategies that researchers can take to reduce the risk of group harms. ) Describe the major historical events that influenced how research with children as subjects is currently 2) Identify problems with research involving children that may violate ethical standards. IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 7 of

8 Conflicts of Interest in Involving Human Subjects IRB Member : What every IRB member need to know Regulations and the Sociobehavioral Sciences Assessing Risk in Social and Behavioral Sciences Informed Consent-SB Privacy and Confidentiality- SB Appendix IV: CITI REQUIRED ASSIGNMENTS FOR - IRB MEMBERS/STAFF ) Understand the assent and informed consent requirements on different types of studies involving children. 4) Understand the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs. ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial conflict of interest 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, ) Describe what to know before you join the IRB 2) Describe components of the initial and continuing review IRB application ) Understand how IRB members review protocols and procedures of the IRB meeting ) Determine whether research is exempt from the regulations or not 2) Describe the criteria for expedited and full board review ) Summarize the authority of an IRB 4) Describe the kinds of review that approved research may need ) Identify risks associated with participation in social and behavioral sciences research 2) Distinguish between probability and magnitude of harm when assessing risk ) Apply the concepts of minimizing and managing risk ) Distinguish between consent as a process and the documentation of consent. 2) Recognize the elements of consent. 25 minutes ) Understand when waivers are appropriate. 4) Identify methods for ensuring comprehension of consent. ) Distinguish between privacy and confidentiality 2) Identify privacy risks associated with study designs ) Identify a range of procedures for ensuring confidentiality 4) Identify relevant laws regarding collection of private information 5) Identify laws that limit the ability to ensure confidentiality 5 hours 40 minutes for initial completion IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 8 of

9 Appendix V: CITI REQUIRED ASSIGNMENTS FOR - HUMAN RESEARCH PROTECTION QUALITY COMMITTEE MEMBERS 2 History and Ethical Principles Basic Institutional Review Board (IRB) Regulations and Review Process 5 minutes 4 Informed Consent 5 Social and Behavioral for Biomedical ers 6 Records-Based Genetic in Human Populations With Protected Populations - Vulnerable Subjects: An Overview FDA-Regulated and Conference on Harmonisation Avoiding Group Harms: US Perspectives ) Identify the three major principles of the Belmont Report ) Discuss why ethics are necessary when conducting research involving human subjects. 2) Describe the major historical events that have influenced how research involving human subjects is ) Identify problems with past studies that have violated ethical standards. 4) Describe the Belmont Principles. Discuss the ethical standards for research that guide us today. ) Describe the role, authority, and composition of the IRB. 2) List the IRB requirements for conducting research involving human subjects. ) Describe the types of IRB review. 4) Describe the process of working with the IRB. 5) Identify other regulations and regulatory groups that require compliance based on the type of research being ) Describe the requirements for complying with informed consent regulations. 2) Describe the process for obtaining informed consent. ) Describe the regulations for waiving informed consent. ) Characterize social and behavioral research, presenting the most likely and typical risks. 2) Extend the basic concepts of human subjects protection to these situations for biomedical researchers. ) Understand concerns about inappropriate access and unauthorized disclosure. 2) Describe ways to minimize risks in records-based ) Understand the regulations that control records-based ) Understand the leading ethical issues regarding genetics research that relate to privacy and confidentiality, informed consent, and risks of harm. ) Understand the concept and characteristics of vulnerability. 2) Describe classes of vulnerable populations. ) Describe the role of the FDA in regulating drugs, biologics, and devices 2) Describe the role of ICH in clinical research (from the submodule) ) Describe the elements of informed consent in FDA regulations 4) Identify sponsor and investigator responsibilities outlined in FDA regulations ) Describe some distinct groups or communities of people who are vulnerable. 2) Identify examples of research that has harmed groups. ) Identify strategies that researchers can take to reduce the risk of group harms. IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 9 of

10 2 4 5 Appendix V: CITI REQUIRED ASSIGNMENTS FOR - HUMAN RESEARCH PROTECTION QUALITY COMMITTEE MEMBERS Vulnerable Subjects- Involving Minors Conflicts of Interest in Involving Human Subjects IRB Member : What every IRB member need to know Defining with Human Subjects ) Describe the major historical events that influenced how research with children as subjects is currently 2) Identify problems with research involving children that may violate ethical standards. ) Understand the assent and informed consent requirements on different types of studies involving children. 4) Understand the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs. ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial conflict of interest 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, ) Describe what to know before you join the IRB 2) Describe components of the initial and continuing review IRB application ) Understand how IRB members review protocols and procedures of the IRB meeting ) Explain the definition of research 2) Explain the definition of human subject ) Describe the differences between private and public information and behavior Regulations and the Sociobehavioral Sciences Assessing Risk in Social and Behavioral Sciences Informed Consent-SB Privacy and Confidentiality- SB ) Determine whether research is exempt from the regulations or not 2) Describe the criteria for expedited and full board review ) Summarize the authority of an IRB 4) Describe the kinds of review that approved research may need ) Identify risks associated with participation in social and behavioral sciences research 2) Distinguish between probability and magnitude of harm when assessing risk ) Apply the concepts of minimizing and managing risk ) Distinguish between consent as a process and the documentation of consent. 2) Recognize the elements of consent. 25 minutes ) Understand when waivers are appropriate. 4) Identify methods for ensuring comprehension of consent. ) Distinguish between privacy and confidentiality 2) Identify privacy risks associated with study designs ) Identify a range of procedures for ensuring confidentiality 4) Identify relevant laws regarding collection of private information 5) Identify laws that limit the ability to ensure confidentiality ~ 4 hours and for initial completion IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 0 of

11 Appendix VI: CITI REQUIRED ASSIGNMENTS FOR - INSTITUTIONAL OFFICIALS Max Time for Basic Institutional Review Board (IRB) Regulations and Review Process FDA-Regulated and Conference on Harmonisation Conflicts of Interest in Involving Human Subjects Regulations and the Sociobehavioral Sciences ) Identify the three major principles of the Belmont Report ) Describe the role, authority, and composition of the IRB. 2) List the IRB requirements for conducting research involving human subjects. ) Describe the types of IRB review. 5 minutes 4) Describe the process of working with the IRB. 5) Identify other regulations and regulatory groups that require compliance based on the type of research being ) Describe the role of the FDA in regulating drugs, biologics, and devices 2) Describe the role of ICH in clinical research (from the submodule) ) Describe the elements of informed consent in FDA regulations 4) Identify sponsor and investigator responsibilities outlined in FDA regulations ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial conflict of interest 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, ) Determine whether research is exempt from the regulations or not 2) Describe the criteria for expedited and full board review ) Summarize the authority of an IRB 4) Describe the kinds of review that approved research may need 2 hours and 0 min for initial completion. IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page of

12 Appendix VII: CITI REQUIRED ASSIGNMENTS FOR - RESEARCH OPERATIONS EVALUATION (ROE) MEMBERS Max Time for Basic Institutional Review Board (IRB) Regulations and Review Process FDA-Regulated and Conference on Harmonisation Conflicts of Interest in Involving Human Subjects Regulations and the Sociobehavioral Sciences ) Identify the three major principles of the Belmont Report ) Describe the role, authority, and composition of the IRB. 2) List the IRB requirements for conducting research involving human subjects. ) Describe the types of IRB review. 5 minutes 4) Describe the process of working with the IRB. 5) Identify other regulations and regulatory groups that require compliance based on the type of research being ) Describe the role of the FDA in regulating drugs, biologics, and devices 2) Describe the role of ICH in clinical research (from the submodule) ) Describe the elements of informed consent in FDA regulations 4) Identify sponsor and investigator responsibilities outlined in FDA regulations ) Describe data protection requirements for human subjects research, principally those that derive from ) Define a conflict of interest (COI), and specifically, a financial conflict of interest 2) Describe the ethical concerns related to research COI ) Understand the primary strategies for eliminating, ) Determine whether research is exempt from the regulations or not 2) Describe the criteria for expedited and full board review ) Summarize the authority of an IRB 4) Describe the kinds of review that approved research may need 2 hours and 0 min for initial completion. IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page 2 of

13 Appendix VIII: RECOMMENDED CITI COURSE OFFERINGS IN GOOD CLINICAL PRACTICE (GCP) FOR CLINICAL INVESTIGATORS GCP Introduction (ID: 50) Overview of New Drug Development (ID: 5) International Conference on Harmonization (ID: 52) FDA Regulated and ICH (ID: 5) International Conference on Harmonization - Part 2 (ID: 54) Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices (ID: 55) Investigator Obligations in FDA-Regulated Clinical (ID: 56) Managing Investigational Agents According to GCP Requirements (ID: 57) Conducting Clinical Trials of Medical Devices (ID: 58) Informed Consent : An Ongoing Process (ID: 59) Detection and Evaluation of Adverse Events (ID: 60) Reporting Serious Adverse Events (ID: 6) Monitoring of Clinical Trials by Industry Sponsors (ID: 62) Audits and Inspections in Clinical Trial (ID: 6) Completing the CITI GCP Course (ID: 64) IRB POLICY ON HUMAN RESEARCH PROTECTION AND GOOD CLINICAL PRACTICE TRAINING Page of

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