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Protecting Human Subjects and Institutional Review Boards: An Overview. Year Developed: 2017. Source: Justice Research and Statistics Association. Presenter(s): Ross Hickey, JD, CIP, CIPA; George Shaler, MPH. Type: Webinar. Level: Introductory. Length: 61 minutes.

Annotation: This webinar introduces participants to the basics of institutional review board (IRBs), the need for them and when to submit research protocols for review to an IRB. The webinar, webinar slides, and participant biographies are available.

Learning Objectives: • How do I know if I am doing human subject research? • How does an IRB ensure the rights and welfare of human subjects involved in research are adequately protected? • Participants will learn to "issue spot" where the need for an IRB is likely to arise. • Participants will understand the background and purpose of the relevant human subject research regulations. • Participants will understand how to draft functional IRB protocols and procedures.

Mini-tutorials [on human subjects research]. Year Developed: 2017. Source: U.S. Department of Health and Human Services, Office of Human Research Protections. Presenter(s): n.a.. Type: Video. Level: Introductory. Length: Series, various lengths.

Annotation: This series of short tutorials (about 15 minutes each) focus on specific aspects of U. S. Department of Health and Human Services' Office for Human Research Protections (OHRP) human subjects regulations and policy. They include Institutional Review Board (IRB) review criteria, quorum and voting in IRB meetings; membership requirements for IRBs, prisoner research series, and OHRP reporting requirements.

Institutional Review Board (IRB) Challenges in QI & Research. Year Developed: 2015. Source: U.S. Agency for Healthcare Research and Quality, Pratice-Based Research Networks. Presenter(s): Holly A. Taylor, PhD, MPH; Mark S. Schreiner, MD; Alex Fiks, MD, MSCE, CHOP. Type: Webinar Archive. Level: Introductory Intermediate Advanced. Length: 87 minutes.

Annotation: This webinar discusses (1) how to distinguish between clinical research and quality improvement (QI), (2) how to identify the need for IRB approval in the grey zone between QI and clinical research, and (3) how bulleted fact sheets and Q&A sessions for patients enrolled in clinical trials can be applied to quality improvement efforts. It includes a video, presentation slides, and links to critical reference information.

Continuing Education: American Academy of Family Physicians, 1.25 credits

Public Health Ethics Training Series. Year Developed: 2014. Source: North Carolina Institute for Public Health. Presenter(s): n.a.. Type: Online Course. Level: Introductory Intermediate Advanced. Length: Self-paced.

Annotation: The "Public Health Ethics" training series is designed to promote the ethical practice of public health by teaching about the ethical principles of public health and by providing resources for creating an ethical climate in public health agencies and schools of public health. This 8 Module series includes the following topics: • 1-Distinguishing Public Health Ethics from Medical Ethics • 2-Values and Beliefs Inherent to a Public Health Perspective • 3-The Public Health Code of Ethics • 4-Law and Ethics in Public Health • 5-Pandemic Influenza: A Justice Case Study • 6-Decision-making in Public Health Ethics • 7-Barriers to the Ethical Practice of Public Health • 8-Responding to Unethical Events

Learning Objectives: Module 1--Distinguishing Public Health Ethics from Medical Ethics • Describe the common practice settings from which medical ethics and public health ethics emerge. • Explain “the tyranny of the majority”. • Explain why the medical ethics principle of autonomy does not work as well in public health. Module 2--Values and Beliefs Inherent to a Public Health Perspective • Explain how a given value or belief from the list is important to public health. Module 3--The Public Health Code of Ethics • Describe how an aspirational code can guide an ethical discussion. • Describe a situation where a given ethical principle applies in public health. • Identify means of creating an ethical environment within public health organizations. Module 4--Law and Ethics in Public Health • Describe three of the several legal powers given to public health. • Describe an ethical principle in public health that is not encoded in public health law. • Describe how the exercise of any power is an ethical issue. Module 5--Pandemic Influenza: A Justice Case Study • Provide examples of how concepts of justice are applied to anticipated responses in an influenza pandemic. Module 6--Decision-making in Public Health Ethics • Describe how to recognize an ethical issue. • Describe the elements of a fair process. • Describe the steps of ethical decision-making in a group. Module 7--Barriers to the Ethical Practice of Public Health • Identify the facets of human nature and our social environment that are particularly relevant in leading to unethical behaviors in public health. Module 8--Responding to Unethical Events • Describe the range of possible responses to an event that is clearly unethical.

Special Instructions: To access this course, you first need to create an account.

Continuing Education: 0.92 Certificate of Attendance

Protecting Human Research Participants. Year Developed: 2008. Source: National Institutes of Health. Presenter(s): n/a. Type: Online Course. Level: Intermediate Advanced. Length: 180 minutes.

Annotation: This course is intended for use by individuals pursuing human subject research. It includes 7 modules and 4 quizzes. Topics addressed include the history of human subject participation, including War Crimes, and the Tuskegee Syphilis Study, the three ethical principles made in the Belmont Report, and the informed consent process. Justice, equity and special group consent also are covered, as are risks and benefits of participatory research, the role of Institutional Review Boards (IRB), and clinical trial requirements . The course has been retired as of Sept. 28, 2018; archival materials are available as a reference.

Learning Objectives: • Describe the history and importance of human subjects protections. • Identify research activities that involve human subjects. • Discover the risks a research project might pose to participants. • Understand how to minimize the risks posed by a research project. • Describe additional protections needed for vulnerable populations. • Understand additional issues that should be considered for international research. • Describe appropriate procedures for recruiting research participants and obtaining informed consent. • Identify the different committees that monitor human subjects protections. • Understand the importance of study design in the protection of research participants.

Special Instructions: Registration is required then click on "Registration".

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This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number UE8MC25742; MCH Navigator for $180,000/year. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.