Frequently asked questions for the Requirement for Education on the Protection of Human Subjects

What are the education requirements for International Institutions under the Federalwide Assurance (FWA)?

Online Training/Courses in Human Subjects Protections and Research Ethics

Online General human subjects protections training - "This tutorial is intended for use by those involved in the design and conduct of research involving human participants, including: biomedical and behavioral researchers, nurses and data managers who are part of the research team. This tutorial presents common concepts, principles, and issues related to protection of human participants." (certificate available upon completion)

Online Computer-based training module: Protection of Human Research Subjects "The Johns Hopkins Bloomberg School of Public Health, Committee on Human Research computer-based training module was developed in response to the National Institutes of Health (NIH) directive requiring education and training on the protection of human research subjects for all investigators. The Public Health Service (PHS) later extended the requirement to all persons supported by PHS funds. The successful completion of this module is designed to fulfill the PHS requirement.

Online Assurance training - "These modules were not designed or intended to serve as general training on human subject protections. The purpose of the modules is to ensure that the three key individuals (The Institutional Signatory Official, the IRB Chair, and the Human Protections Administrator) are aware of the responsibilities that must be fulfilled under an FWA. As such, the modules focus on these responsibilities; general topics such as ethics and the regulations are only given a cursory review." [5 March 2001 Newsflash regarding OHRP Assurance Training Modules] (certificate available upon completion)

Collaborative IRB Training Initiative (CITI) - Human subjects research educational program. "The CITI human subjects research educational program consists of 13 Parts each focused on a different aspect of bio-ethics and human subjects research. Each Part, developed by experts in the "IRB community" has an associated quiz. The software maintained at the University of Miami, U.S., compiles the quiz scores. The institution specific training data is forwarded to the respective training coordinators at the participating institutions on a regular basis. Your institution can decide what score is sufficient to pass the course. The individual institution also distributes certificates or letters of completion based on the predetermined level of achievement. The CITI office at the University of Miami retains all records in strict confidence. Importantly, there is the opportunity for each participating institution to post specific material on an "Institutional Page" that their own IRB's believe their faculty and staff should be familiar with… CITI charges a user fee of $1000 per year to offset the administrative costs of running the site. This also includes the set up fee for your institutional page. There are no limits on how many of your people go through the course. The use fee also includes institutional access to the new CITI Continuing Education Course site."

Family Health International (FHI) Interactive Research Ethics Training Curriculum, web version - [The following is from the July-September 2002 issue of in Research into Action, The Newsletter of the Council on Health Research for Development] "FHI has developed a "Research Ethics Training Curriculum" (RETC) based on 30 years experience of conducting research in collaboration with developing countries from all regions of the world. This is available, currently in English only, as a 3-ring binder, or on CD-ROM, and can be downloaded from FHI's website...

...Translation into other languages is anticipated. The curriculum was developed with support from United States Agency for International Development (USAID), The National Institutes of Health (NIH) and the Andrew W. Mellon Foundation for an international audience of both biomedical and social science researchers. It has been reviewed by experts in research ethics and field-tested in India, Kenya, the Philippines and Zimbabwe. The curriculum may be used as an interactive self-study program or as a tool for participatory, group training. It addresses internationally recommended basic elements of research ethics, including the principles of human research ethics, informed consent, ethical review committees, and international guidelines. It uses case studies developed by FHI researchers to provide a focus for the discussion of these issues. WHO and CIOMS documents were used as key sources, and complete copies of these documents are included in the curriculum. The RETC is a practical tool to provide updated and standardized basic training on human research ethics. It is intended for an international and multidisciplinary audience of individuals involved at different levels of the research process." "This curriculum is made up of 5 chapters, each focusing on a core content area related to research ethics. The core content areas are: (i) Principles of Research Ethics, (ii) Foundations of Research Ethics, (iii) Responsible Conduct of Research, (iv) Supervision of Research, (v) Special issues in Research."

Computer-Based Training
Any FWA-holding institution may obtain a free copy of the OHRP/PRIM&R "Investigator 101" CD-ROM and a Site License allowing the institution to make additional copies for investigators. The program is based on PRIM&R's "IRB 101- On the Road" training program and includes presentations on the "history and ethics of human subject research," and "the top10 responsibilities of investigators," slide presentations, hyper-linked references and reading materials-including regulatory and compliance documents.

Institutions/Organizations Offering Human Subjects Protections or IRB Training Courses in the U.S.

Ethical Issues in International Health Research Workshop, June 14-18, 2004, Harvard School of Public Health, Boston, Massachusetts, U.S.A. (applications due April 16, 2004) "Who should attend. Ethical issues in International Research is intended for individuals involved in all areas of international health research, including medicine, anthropology, epidemiology, education, journalism, political science and law; government, foundations, and industry officials with funding responsibilities; and members of institutional and governmental review boards… Why you should attend. To address current issues, anticipate potential future problems, and facilitate productive communication, this interactive program draws on the combined talents of leaders in the filed. Participants from both developing and industrialized countries have an opportunity to compare experiences, receive expert advice, and voice their concerns in five days of lectures, case studies, and panel discussions. Recognizing that current guidelines are both subject to interpretation and likely to create conflict, the program encourages candid comments, questions, and open critique of available materials…. Key topics (include but are not limited to) Ethical guidelines for research involving human subjects, proposed changes to international guidelines, cultural absolutism vs. cultural relativism, individual and group rights, ethical review boards/institutional review boards, informed consent, standards of care, responsibility of researchers to the community…"

Short Courses in International Research Ethics, (dates to be announced), the Johns Hopkins School of Public Health in conjunction with the Johns Hopkins University Bioethics Institute, Baltimore, Maryland, U.S.A. offers a one week course in international research ethics. Course topics include: introduction to ethical principles and analysis, cultural relativism, pluralism and moral disagreement, informed consent, justice and exploitation, authority, oversight, and responsibility for the ethics of research, ethics issues in the choice of research design.

Intensive Bioethics Course, June 8-13, 2004, Kennedy Institute of Ethics, Georgetown University, Washington, D.C., U.S.A. "The target audience for the program includes physicians, nurses, and other relevant healthcare professionals from medical schools, universities, or healthcare facilities. Past participants have had backgrounds in health care, philosophy, religion, law, and public policy, but enrollment is not limited to these fields…Specific aims for the course are to introduce participants to the philosophical underpinnings of bioethics and current major topics in the field, and to provide them with the skills to define and describe various principles and approaches to bioethics. These principles can then e applied to an enhanced understanding of medical practice, law and public policy. Participants will understand and be able to demonstrate bioethical principles within a solid framework of decision making in clinical, research and policy settings…These courses provide the opportunity for participants form different fields and disciplines to come together for a few days to explore the theoretical framework and practical issues of bioethics with a distinguished faculty."

Public Responsibility in Medicine and Research (PRIM&R) "PRIM&R's primary activity is the sponsorship of conferences that provide an educational forum for the analysis of various biomedical and bioethical issues."

"Since its founding in 1974, Public Responsibility in Medicine and Research (PRIM&R) has been committed to the advancement of strong research programs and to the consistent application of ethical precepts in both medicine and research. Through national conferences and published reports thereon, it has addressed a broad range of issues in biomedical and behavioral research, clinical practice, ethics, and the law… Topics addressed by PRIM&R include: The ethical and procedural issues surrounding the operation of Institutional Review Boards (IRBs),… educating for the responsible conduct of research; the range of problems affecting AIDS research and treatment; …healthcare ethics committees; scientific integrity and conflicts of interest; … By providing a multidisciplinary forum for addressing such issues, PRIM&R hopes to help educate the medial and legal professions, the pharmaceutical and biotechnology industries, and the public about the ethical, legal and policy dimensions of appropriate and ethical biomedical research and clinical practice."

The Ethics of International AIDS Research: Contemporary Practices & Controversies, June 13-18, 2004, Second Annual Yale International AIDS Summer Institute, New Haven Connecticut, USA. "The theme of the second annual Yale International AIDS Summer Institute, "The Ethics of International AIDS Research: Contemporary Practices and Controversies," responds to the increasing interest of researchers to explore and address the ethical questions emerging in the field of international AIDS research… The objects … will be: to provide participants a thorough understanding of the complex ethical considerations in conducting international AIDS research; to advance participants' ability to plan and conduct ethically sound research projects or plan research specifically designed to examine ethical issues in international AIDS research; to allow participants to interact with experts in the field of international research ethics; to train participants in the steps required to obtain research ethics committee approval for a research project funded by a Unites States government agency." Additional information and an application form are available at the website.

Grants to Fund the Development of Research Ethics Education - Capacity Building

The Wellcome Trust, U.K. - "is launching a new research funding initiative as part of its Biomedical Ethics Programme. The Ethics of Biomedical Research in Developing Countries grant schemes aim: (i) to build the knowledge base by supporting research into the social, ethical, legal, and public policy aspects of biomedical research in developing countries; (ii) to build research capacity within developing countries by increasing the number of experts with the experience and training to address ethical questions raised by such research; and (iii) to encourage application of that research by developing strategies for making research useful to researchers, funders, policy makers and others, including those involved in developing national and international guidelines for the ethical conduct of research…. Type of support: project grants, research studentships, seminars and other capacity building initiatives."

The National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Agency for Health and Research Quality (AHRQ), U.S.A., "invite applications for grants to develop, conduct, evaluate, and disseminate short-term courses on ethical issues in research, particularly those involving human participants. Course should improve the skills of biomedical, behavioral, nursing, social science, and public health researchers in identifying and addressing the ethical, legal, and social implications of their research, especially when human participants are involved."