Short Description of CITI Modules.
Biomedical Human Research Modules |
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Students in Research |
This module is designed as a "one-stop shop" for students who may be involved in a human subjects research study as an investigator and/or a subject. An institution may choose to use this module in lieu of an extended course for student research that qualifies as no greater than "minimal risk." Degree requirements in undergraduate, masters, or doctoral degree programs often require students to conduct or assist in research projects that include human subjects. In addition, students may be asked or "required" to participate as subjects in research projects. Main topic sections include a review of the history and principles of ethics for research involving human subjects, including a definition of research and categories of review; students as researchers; and students as subjects. A resource section is included. |
History and Ethical Principles |
This module discusses why ethics are necessary when conducting research involving human subjects including the major historical events that have influenced how research involving human subjects is conducted. It describes problems with past studies that have violated ethical standards. The Belmont Principles are discussed as the basis for the ethical standards for research that guide us today. |
Basic Institutional Review Board (IRB) |
This module provides basic information about the human subject protection regulations that govern the participation of human volunteers in research in the United States. It describes the role, authority, and composition of the IRB, the requirements for conducting research involving human subjects, and the types of IRB review. The module includes a description of the process of working with the IRB and includes information on other regulations and regulatory groups that require compliance based on the type of research being conducted. |
Informed Consent |
This module discusses the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. There is also a discussion of the circumstances under which an IRB may waive any of the requirements for informed consent as well as differences between FDA and DHHS regulations. |
Social and Behavioral Research |
This module describes social and behavioral research and the most likely risks associated with this type of research. The discussion extends the basic concepts of protection for human subjects to these situations for biomedical researchers. |
Records Based Research |
The modules describe special considerations for the conduct of research involving collection of information from various kinds of records such as medical records, motor vehicle records, criminal justice records, and school records. The module discusses concerns about inappropriate access and unauthorized disclosure as well as ways to protect the confidentiality of the information. The module includes a description of how an IRB determines the type of review required for studies using information from records and requirements for informed consent. |
Genetics Research in Human Populations |
This module describes ethical issues in genetics research. The issues differ in terms of type and magnitude from those that arise in other kinds of human subjects research. The major topics discussed are privacy and confidentiality, informed consent, and risks of harm specific to genetics research. |
Research with Protected Populations – Vulnerable Subjects: A Definition |
This module describes the partial lists of subjects who should be considered vulnerable that are contained in DHHS and FDA regulations, and International Conference of Harmonization (ICH) guidelines. The module discusses the lack of a specific definition in the regulations or guidelines and aims to provide an understanding of the concept of vulnerability and to discuss some of the characteristics of vulnerability. |
Vulnerable Subjects – Research with Prisoners |
This module describes the special requirements for conducting research involving prisoners. It includes a discussion of each of the permitted categories for research involving prisoners and IRB considerations in reviewing proposed research with prisoners. |
Vulnerable Subjects – Research Involving Minors |
This module describes the major historical events that influenced how research with children as subjects is currently conducted. It describes problems with research involving children that may violate ethical standards, the assent and informed consent requirements on different types of studies involving children, and the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs. |
Vulnerable Subjects-Research Involving Women of Child Bearing Potential, Pregnant Women, and Fetuses |
This module describes the historical exclusion of women of child bearing potential and the special requirements for conducting research involving pregnant women and fetuses. It includes a discussion of each of the permitted categories for research involving the latter populations and IRB considerations in reviewing proposed research with these populations. |
Avoiding Group Harms -International Research Perspectives -U.S. Research Perspectives |
These modules describe some distinct groups or communities of people who are vulnerable; provide examples of research that has harmed groups; and, discuss strategies that researchers can take to reduce the risk of group harms. The material is customized for either International Research Perspectives or U.S. Research Perspectives. Institutions can choose to assign either of the versions depending upon the learner’s research activities. |
FDA-Regulated Research |
This module addresses FDA-regulated clinical research and the responsibilities of investigators, IRBs, and sponsors when they participate in a study of an FDA-regulated product. A sub-module is provided that discusses the International Conference on Harmonization (ICH) guidelines. |
Research Protections in the Department of Veterans Affairs |
This module describes special requirements for protection of research participants at VA facilities. Many academic medical centers are affiliated with a VA clinic or hospital. Researchers proposing to recruit research participants from VA facilities must follow the VA requirements in addition to the requirements of their home institution if it is not the VA. |
HIPAA and Human Subjects Research |
This module discusses the special requirements of the Health Insurance Portability and Accountability Act (HIPAA) and how they supplement the DHHS and FDA requirements. |
Workers as Research Subjects: A Vulnerable Population |
This module describes why workers may be a vulnerable population when they participate in research and discusses the special protections that need to be afforded them. It proposes that while workers may be study subjects for political as well as scientific reasons, adequacy of the science and adherence to the Common Rule still must be the expectation. |
Hot Topics |
This optional module is designed to provide learners with on-going timely information on recent developments in the IRB Universe. It is designed to be updated regularly with previous content archived and accessible to learners. |
Conflicts of Interest in Research Involving Human Subjects |
This module describes conflict of interest, an issue that is under debate and in transition. It includes a general discussion of conflicts of interest and the related ethical concerns that arise in the context of research involving human subjects. The module also summarizes current reporting and disclosure requirements for investigators, and discusses the May 2004 Federal guidance on the management of conflicts of interest. |
The IRB Member Module |
This module is designed to answer questions for individuals considering becoming an IRB member. It includes discussions of frequently asked questions and provides an overview of IRB tools such as the Human Studies Application and the processes involved in an IRB meeting. It is designed for new scientific and non-scientific members, but may also be useful for all members of the IRB.
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Social and Behavioral Sciences Basic Course |
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Students in Research |
This module is designed as a "one-stop shop" for students who may be involved in a human subjects research study as an investigator and/or a subject. An institution may choose to use this module in lieu of an extended course for student research that qualifies as no greater than "minimal risk." Degree requirements in undergraduate, masters, or doctoral degree programs often require students to conduct or assist in research projects that include human subjects. In addition, students may be asked or "required" to participate as subjects in research projects. Main topic sections include a review of the history and principles of ethics for research involving human subjects, including a definition of research and categories of review; students as researchers; and students as subjects. A resource section is included |
History and Ethical Principles - SBR |
This module discusses the evolution of the ethical principles that guide research design and the development of the federal regulations that govern the conduct of research in the United States from a perspective relevant to researchers in the social and behavioral sciences. It reviews why ethics are necessary when conducting research involving human subjects including some major historical events that have influenced how research involving human subjects is conducted. It describes problems with past studies that have violated ethical standards. The Belmont Principles are discussed as the basis for the ethical standards for research that guide us today. |
Defining Research with Human Subjects - SBR |
This module discusses an interpretation of definitions of the terms “human subject” and “research” with an emphasis on the interpretation for the social and behavioral sciences. |
Regulatory Overview: The Regulations Applied to Social and Behavioral Sciences |
This module provides an overview of the federal regulations so that researchers can become conversant with their basic provisions. Researchers in the social and behavioral sciences and the humanities often assert that the regulations for the protection of human research subjects don't really apply to the kind of research that they do, believing that the rules were written exclusively for biomedical research. This module provides specific examples of the ways in which the federal regulations are particularly pertinent to social and behavioral science researchers. This module provides basic information about the human subject protection regulations that govern the participation of human volunteers in research in the United States. It describes the requirements for and the types of review that may be necessaryfor social and behavioral science research projects. The composition and functions of the IRB and the review processes are also discussed. |
Assessing Risk in Social and Behavioral Sciences |
This module discusses the challenges in identifying and evaluating risks associated with participation in social and behavioral sciences research. Unlike biomedical research studies or clinical trials, risks associated with participation in social and behavioral science research are often more elusive and less predictable. Topics include assessing risks, balancing risks and potential benefits, minimizing and managing risks, and ways to address risks in the informed consent. |
Informed Consent |
This module discusses the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. There is also a discussion of the circumstances under which an IRB may waive any of the requirements for informed consent with examples of how this commonly is applied in social and behavioral sciences research. |
Privacy and Confidentiality |
This module defines privacy and confidentiality. It will discuss protecting privacy in the research context and will provide some guidelines for designing confidentiality procedures. Topics include discussions of private versus public behavior, controlling access to private information, privacy and exempt research, privacy and research methods, confidentiality, privacy and reporting laws and certificates of confidentiality. The discussions focus on how these concepts apply to social and behavioral science research. |
Research with Prisoners as Subjects |
This module describes the special requirements for conducting research involving prisoners. It includes a discussion of each of the permitted categories for research involving prisoners and IRB considerations in reviewing proposed research with prisoners. |
Research with Children |
This module describes regulations that define “children” and apply to research with children. It discusses examples of exempt and expedited research with children as subjects. Issues involved in obtaining and documenting parental permission and child assent also are discussed. |
Research in Public Elementary and Secondary Schools |
This module provides an overview of the types of public school research and regulations that apply to research in the public schools. Individual sections discuss the Family Education Rights and Privacy Act (FERPA), the Protection of Pupil Rights Amendment (PPRA) and Subpart D of 45 CFR 46: Additional Safeguards for Children. Examples are provided of activities that may qualify for exemption. Other discussions focus on parental permission and child assent, research-related harms to children and requirements for reporting observed child abuse and neglect. |
International Research |
Social and behavioral scientists conduct research around the globe. The module includes a discussion of applicable regulations and guidelines and the importance of the local research context. Additional topics include determining where research should be reviewed, exempt research, and informed consent considerations. |
Research Protections in the Department of Veterans Affairs |
This module describes special requirements for protection of research participants at VA facilities. Many academic centers are affiliated with a VA clinic or hospital. Researchers proposing to recruit research participants from VA facilities must follow the VA requirements in addition to the requirements of their home institution if it is not the VA. |
HIPAA and Human Subjects Research |
This module discusses the special requirements of the Health Insurance Portability and Accountability Act (HIPAA) and how they supplement the DHHS requirements |
Workers as Research Subjects: A Vulnerable Population |
This module describes why workers may be a vulnerable population when they participate in research and discusses the special protections that need to be afforded them. It proposes that while workers may be study subjects for political as well as scientific reasons, adequacy of the science and adherence to the Common Rule still must be the expectation. |
Hot Topics |
This optional module is designed to provide learners with on-going timely information on recent developments in the IRB Universe. It is designed to be updated regularly with previous content archived and accessible to learners. |
Financial Conflicts of Interest in Research Involving Human Subjects |
This module describes conflict of interest, an issue that is under debate and in transition. It includes a general discussion of conflicts of interest and the related ethical concerns that arise in the context of research involving human subjects. The module also summarizes current reporting and disclosure requirements for investigators, and discusses the May 2004 Federal guidance on the management of conflicts of interest. |
The IRB Member Module |
This module is designed to answer questions for individuals considering becoming an IRB member. It includes discussions of frequently asked questions and provides an overview of IRB tools such as the Human Studies Application and the processes involved in an IRB meeting. It is designed for new scientific and non-scientific members, but may also be useful for all members of the IRB. |
Good Clinical Practice Modules |
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| Good Clinical Practice (GCP): This course is intended for use by research personnel involved in conducting drug, device, or biologic studies. For the GCP Course, it is strongly recommended that all modules be included and that they be completed in the order listed in the GCP Introduction. | |
GCP Introduction |
This module provides a listing of all modules in the course, required computer system parameters, and mechanisms for obtaining CE credits. |
Overview of New Drug Development |
This module describes the role of industry sponsors in the conduct of clinical trials under an Investigational New Drug (IND) application in the U.S. according to FDA regulations. It provides an overview of important definitions, procedures and timelines involved in the development of a new drug. |
International Conference on Harmonisation (ICH): GCP Requirements |
The purpose of this module is to provide a basic understanding of the role of the International Conference on Harmonisation (ICH) Guidelines and the impact on conducting human clinical research according to Good Clinical Practice (GCP). The purpose of ICH and the basic requirements for compliance with ICH are described. How ICH fits with U.S. federal regulations regarding clinical research is discussed. |
Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices |
This module discusses topics important to researchers who are also the sponsor of a study. These individuals are conducting investigator-initiated studies. Topics discussed include how to determine whether an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) is required, the role of the sponsor-investigator, documentation required for INDs and IDEs, and reports that must be submitted to the FDA for active INDs/IDEs. |
Investigator Obligations in FDA-Regulated Clinical Research |
Investigators assume responsibilities when participating in clinical investigations sponsored by pharmaceutical companies under IND requirements. This module describes the commitments and obligations assumed by investigators, including those contained in Form FDA 1572, Statement of Investigator. A discussion of the investigator's relationship with the sponsor organization as well as the investigator's commitments to the subjects, the Institutional Review Board/Ethics Committee (IRB/IEC), and the U.S. Food and Drug Administration (FDA) is included. |
Managing Investigational Agents According to GCP Requirements |
This module focuses on specific requirements for the management of investigational products by principal investigators. This includes requirements for storage of investigational agents as well as recording the receipt, use, and final disposition of investigational agents. The module also reviews the management requirements for the use of investigational agents by study subjects. |
Conducting Clinical Trials of Medical Devices |
This module reviews the responsibilities of investigators conducting clinical research involving medical devices. It includes a discussion of the difference between devices involving significant risk versus nonsignificant risk. The characteristics and marketing requirements for Class I, II, and III devices are reviewed. |
Informed Consent |
This module discusses the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. There is also a discussion of the differences between FDA and DHHS regulations. |
Detection and Evaluation of Adverse Events |
This module reviews the definition of adverse events (AEs) and related terminology for clinical trials. It describes the process for identifying AEs in clinical research, and identifies the factors to consider in assessing the severity and causality of AEs. Examples are provided to illustrate the evaluation process. |
Reporting Serious Adverse Events |
This module discusses the criteria for reporting SAEs to regulatory agencies, sponsors, etc. The discussion includes definitions for "serious" and "unexpected" adverse events and reviews the requirements for reporting of SAEs within time frames required by FDA and ICH. The module provides categories of relatedness to the investigational agent for SAEs and how they affect reporting. |
Monitoring of Clinical Trials by Industry Sponsors |
This module describes the obligation of industry research sponsors to monitor the progress of clinical trials under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application in the U.S. The types of site visits conducted by industry sponsors are described along with the basic requirements for each type of site visit. The module describes the role of the investigative site during interactions with industry sponsors as well as the requirements for site record-keeping in studies regulated by the U.S. Food and Drug Administration (FDA). |
Audits and Inspections in Clinical Trials |
This module provides a basic understanding of monitoring, audits, and inspections of clinical trials conducted according to standards for good clinical practice (GCP). It describes the different entities that can inspect or audit a clinical trial and investigator and the factors that can determine whether an investigator will be audited. The purpose of the FDA Bioresearch Monitoring Program is discussed. |
Non-U.S. Centric Modules for Use by the International Research Community |
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History, Principles of Research Ethics, and Application of Research Ethics Principles to Human Subject Research |
This module describes how the principles of research ethics evolved as well as how these principles have influenced the conduct of research by providing a framework to achieve a balance between the goal of advancing science and the goal of protecting the rights and welfare of research subjects. |
Research Ethics Committees: Their Authority and Role in the Ethical Review of Research |
This module builds on the tenets of the Belmont Report in discussing Research Ethics Committees (REC), their authority, role, and functions in the international research setting. The REC requirements for approval of human subject research and the different types of REC review are discussed, including the obligations of investigators when working with RECs. |
Informed Consent in International Research |
This module discusses the informed consent guidelines as well as the process for obtaining informed consent in an international setting. The text acknowledges special challenges in obtaining informed consent in the international setting as well as the conditions under which informed consent can be waived. |
International Studies |
This module discusses research ethics in an international setting including a table providing comparisons of U.S. and international guidelines for research involving humans. This module is designed to be a prelude to the review of country-specific materials. It is designed to enable students to describe ethical issues that may affect planning research outside the U.S. borders. Discussions are presented of specific ethical issues that have been raised in international research and the responsibilities of researchers seeking ethical review in host countries. |
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