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Lesson 1

We will explore the options for further research and the related issues, questions, and controversies from the realm of public health. We will build background knowledge for Subtopic 2, concerning the research and testing behind vaccine development, by examining a seminal US document, the Belmont Report, which sets ethical and practical standards for human subject testing.

Lesson Goals

  • Can I unpack and understand the expectations and options for the Culminating Task?

  • Can I express an accurate understanding of the central ideas of the Belmont Report?

  • Can I work in an expert team to closely analyze sections of the Belmont Report and present our analysis?

  • Can I make connections and comparisons among ethical perspectives, approaches, and issues related to research involving human subjects?

Texts

Core

  • Digital Access
    • “Part 3 — The Belmont Report: Basic Ethical Principles and Their Application,” US Department of Health and Human Services, Public Domain, 1979
  • Unit Reader
    • “The Belmont Report,” US Department of Health and Human Services, Public Domain, 1979

Materials

Tools

Reference Guides

Question Sets

Editable Google Docs

Activity 1: Read – Discuss – Write

We will review the section 3 diagnostic checklist and discuss the options for further research in the areas of public health, ethics, and issues related to vaccinations. We will then begin to focus on subtopic 2: research and testing.

Step 1

Access the Section 3 Diagnostic Checklist, and as a class, read through the task questions again. Focus on the four options listed for subtopic research and writing:

  • Subtopic 1: Vaccines - Mandates and Objections: In light of personal beliefs, individual rights, and social justice, how should we address the common good as it relates to mandatory vaccination?

  • Subtopic 2: Vaccines - Research and Testing: How should we address ethical issues and questions involving the development, testing, approval, and dispersal of vaccines in light of immediate public need for protection from infectious diseases?

  • Subtopic 3: Access to Public Health Resources: How should we address issues of unequal access to public health resources, healthcare, and preventative measures such as vaccines?

  • Subtopic 4: Other Ethical Issues: Based on the current state of public health in the US and the world, what is a pressing ethical issue and a defensible response?

Begin by discussing the first option, which is what you studied in Section 2. Talk about what it would mean to continue to research an issue in the area of mandates and objections, and review the various issues and perspectives.

Step 2

Move to Subtopic 2: Research and Testing. Based on what you have learned so far and current healthcare issues, brainstorm a list of possible issues and topics that might be pursued through further research.

Note that the development and testing of any new vaccine or treatment must involve, at some point in the process, the use of human test subjects. Discuss some of the potential ethical issues and problems with using humans and, in some cases, animals as test subjects.

Activity 2: View – Write – Discuss

We will watch the opening segment of an informational video about the belmont report, a US Document developed to provide ethical standards for research on humans.

Follow along as your teacher provides brief background information on the Belmont Report, a landmark document developed in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Watch to 5:30, and use a copy of the Video Note-Taking Tool to note details connected to the following questions:

  1. What about the institution of research made it seem necessary to develop a set of core ethical principles?

  2. What ethical questions and concerns led Congress to convene a national commission and to the development of the Belmont Report?

  3. What are the three basic ethical principles underlying all research involving human subjects? How do these principles relate to other philosophical and ethical perspectives we have studied previously?

As a class, discuss what you have noted on your Video Note-Taking Tools, focusing on the third question and how the Belmont Report’s principles are related to what you have learned about ethics and guiding ethical principles.

Activity 3: Discuss – Read

We will discuss what we have initially learned about the belmont report by reading the report’s summary and first section: “Ethical Principles & Guidelines for Research Involving Human Subjects.”

Access the Belmont Report in the Unit Reader. Individually, read and annotate the report’s summary and first section: "Ethical Principles & Guidelines for Research Involving Human Subjects." Write down new or interesting words in your Vocabulary Journal.

Identify one idea or piece of information that adds something new to what you have learned from watching the video. Discuss as a class the new ideas and information you have gained from the first two sections of the report.

Activity 4: Discuss – Read

We will join groups to learn more about the Belmont Report.

Join with two other students in a group to set up an activity in which you will examine the three sections of the report that address its three broad ethical principles: respect for persons, beneficence, and justice. Briefly discuss what you think these three principles might mean and entail, and how they might be connected to other ethical approaches you have studied.

Assign one principle to each member of the group.

Activity 5: Discuss – Read – Write

We will continue to work in groups to analyze a section of the Belmont Report dealing with one of its three basic ethical principles: respect for persons, beneficence, and justice.

Step 1

Based on the principle that you were assigned in your last group, join a new group with members having the same principle as you. Briefly discuss what you think that principle might mean and entail before you read about it in the Belmont Report. Generate questions about something your team hopes to learn through close reading of your section.

Use the following question set to guide your reading and annotation of your section of the report:

  1. How does the report initially define and break down the principle into its component parts?

  2. How is the principle applied in research involving human subjects? What are its implications for research practice?

  3. How is the principle related to other ethical principles and approaches, particularly the common good and individual rights? How do you know? Cite evidence from the text to demonstrate the connection.

As a team, form an evidence-based claim in response to Question 3.

Step 2

Individually read the first two paragraphs of a section from Part C: Applications, based on your expert team’s principle, as follows:

  • Respect for Persons: Informed Consent

  • Beneficence: Assessment of Risks and Benefits

  • Justice: Selection of Subjects

Read the first two paragraphs of your section closely, considering the following question:

  1. What are the relationships between the guiding principle we studied and the corresponding application requirement?

Form a second evidence-based claim that expresses the relationship between your principle and its corresponding application requirement.

Review your annotations. Write down at least two keywords from the except in your Vocabulary Journal.

Activity 6: Discuss

We will rejoin our original group and present what we have learned about the three basic ethical principles of the belmont report. We will then examine the application of those principles in the related realms of informed consent, assessment of risks and benefits, and selection of subjects.

Step 1

Rejoin your original group and report what your team has learned in response to the three guiding questions:

  1. How does the report initially define and break down the principle into its component parts?

  2. How is the principle applied in research involving human subjects? What are its implications for research practice?

  3. How is the principle related to other ethical principles and approaches, particularly the common good and individual rights? How do you know? Cite evidence from the text to demonstrate the connection.

Share and discuss the claims your expert teams have developed. Identify connections among the three principles and the claims about their relationships to other ethical principles and approaches, particularly the common good and individual rights.

Step 2

Next, discuss what you have learned about the applications of the three principles in the areas of informed consent, assessment of risks and benefits, and selection of subjects. Share the claims you have developed in response to the following question:

  1. What are the relationships between the guiding principle we studied and the corresponding application requirement?

Activity 7: Discuss

As a class, we will discuss how the belmont report relates to other ethical approaches and seminal documents we have studied, and how its principles and applications are relevant to current public health and research controversies, particularly those involving vaccine development.

As a class, discuss what you have learned about the principles and applications presented in the Belmont Report, and their relationships to the following:

  • the concept and ethical approach of the common good

  • the concept and ethical approach of individual rights and personal liberty

  • the Hippocratic Oath

  • the Bill of Rights and other seminal US documents

  • other ethical frameworks and approaches we have studied

  • ethical problems in public health that we have identified

Return to Subtopic 2: Research and Testing

  • Vaccines - Research and Testing: How should we address ethical issues and questions involving the development, testing, approval, and dispersal of vaccines in light of immediate public need for protection from infectious diseases?

Discuss how the Belmont Report is a foundational document in this subtopic, and how it might relate to other texts in the research set for that subtopic.

Activity 8: Read – Write – Discuss

We will interact with the words we wrote down in our Vocabulary Journals to cement our understanding of their meaning.

Work with a partner or group to respond to the vocabulary exercises, as directed by your teacher.

Activity 9: Read – Write

For homework, explore one or more of the texts listed in the subtopic 2 supplemental text handout to determine if you are interested in further reading and research in this area.

For homework, access the Subtopic 2 Supplemental Text Handout. Skim the lists of texts, looking for one that might provide an interesting entry into further research. Use the information in the handout to access an online version of the text. As you read through it, identify one or more key takeaways that you can share with other students.

Write new or interesting words you encounter in your Vocabulary Journal.