• Students will be able to provide an explanation for their perspective.
• Students will be able to explain how a case study violates the Belmont Report.
• Students will be able to discuss perspectives with their classmates in a respectful manner.

The history of research has not always been ethical. This lesson will allow students to explore their own ethical code as well as learn about mistakes from the past to understand the need for ethics panels in research. Students will learn about the Belmont Report and how it attempts to provide a future for research that is based in ethical debates.

Teacher Preparation

Before class, label the 4 corners of the room with the following words: strongly agree; agree; disagree; strongly disagree. Print out the Medical Ethics Case Study Report and the Case Study Summary printable.

Lesson

Start with the Medical Ethics Slide Show. Begin with a discussion on what ethics are. Point out how each person has their own community that helps them to develop their ethics. This means there are different perspectives of what is “right.”

Four Corners Activity | What Do You Think?
It is a good idea to preface this activity with behavior expectations. Students should be quiet during the movement piece of this activity. Using the Medical Ethics Slide Show, provide students with each scenario, beginning with animal research (slide 7). Ask students to move to the corner that best aligns with their opinion: strongly agree, agree, disagree, or strongly disagree.

Once students have moved to their corner, choose one student per corner to explain their rationale. It is also beneficial to point out that those who moved with their friends should think about their own rationale for their choice. Allow students to move if their opinions change throughout the discussion.

Below are questions to consider for each scenario. Feel free to use questions that will help students think deeper on the topic.

Slide 7: Animal Research

• Does it matter which animals are used? Examples of animals that have been used in research are: mice, rabbits, guinea pigs, cows, pigs, dogs, monkeys and chimpanzees.
• How can you determine which animals are acceptable to use?
• In some cases, treatments will work in animals but when it gets to humans, it doesn’t work. Does that change your views?

 Slide 8: Gene Editing

• There are over 3,000 species of mosquitoes. Only a few of these species feed off humans. By adding this gene to the population, there would only be one species of mosquitoes affected. Does this change your views?
• There have been no long-term studies to determine the consequences to ecosystems across the world. Can you think of any long-term consequences?

Slide 9: Gene Therapy

• If gene therapy existed for a genetic condition you had, would you want to get it?
• If a child has a genetic condition that can be treated by gene therapy and a parent refused to get it, would that be ethical?
• It is likely that gene therapy will be expensive. Could you see any issues with people’s ability to access the treatment? Based on cost or other variables?

Slide 10: Gene Modification

• Do you see any harm in producing cattle with human immune systems? Keep in mind these animals are considered research animals and would never be used for meat.
• Is there any animal that you would think is not acceptable to do this to?
• What regulations do you think should be in place to protect animals?

Slide 11: Organ Transplant

• The shortage of organs has created a black market for organs where people are paid to give up their organs. Does this change your mind about using pig organs?
• The pigs that are used for organs cannot be used for meat. Does that change the way you view this?
• There are many people who need just a part of an organ, like a heart valve. In this way, a healthy human organ can be saved for someone who needs a whole organ. Many people are walking around right now with a porcine (pig) valve in their heart. Does it change your mind if you consider just a part of an organ over the whole organ?

When finished with the Four Corners Activity, have a discussion with students about the experience. Ideas for discussion include a personal written reflection:

• Think-pair-share: Students individually reflect, then share with a partner, then share with the class.
• Roundtable discussion: Place students into small groups. Give each person in a group 2 minutes to talk about their experience. Set a timer!

The next portion of the lesson includes a discussion on how research is done and what rules scientists need to follow. To understand the current state of research, we can refer to times in history where science has violated ethical principles. Using the Medical Ethics Slide Show, discuss the need for animal models in order to develop treatments for humans (slides 13 and 14). Treatment in humans goes through three phases, called clinical trials. The need for these phases and the need for animal models have arisen from the improper use of humans in research in the past.

Discuss the experiments by Nazis during World War II and the subsequent Nuremberg Code (slide 15), which attempted to guide science principles after the war was over. Read the Nuremberg Code with students (slide 16). Have them identify which one they believe to be the most important. (Note: This is a simplification of the Nuremberg Code.)

Next, discuss the Belmont Report (slide 17), which arose after many unethical experiments came to light. The main idea of the Belmont Report is that there are three main points to guide ethical research involving human subjects. Discuss the main points of the Belmont Report with students. Ask students to fill out the information about the Belmont Report on their Medical Ethics Case Study Report. This will provide them with information for the jigsaw activity. This video offers an explanation of the Belmont Report in more detail.

Case Study Jigsaw
Break students up into groups of four. Discuss the group work norms. All members are responsible for reporting on their case study to the best of their ability. Give students 8 minutes to read their case study from the Case Study Summary and write about it.

Next, ask students to meet with the other students that have the same case study as them. Students should discuss what they learned and ask each other questions about what part of the Belmont Report was violated. This should take about 8 minutes.

At the end of the 8 minutes, have students return to their original group. Give students 2 minutes to report on their case study. Set a timer to make sure all students have uninterrupted time to talk.

Tip: Use a talking stick to indicate who is speaking. The person who has the stick has two full minutes to speak before passing it on.

Assessment: Ask students to fill out the Medical Ethics Case Study Report.

Suggestion for extension: Allow students to reflect on what they learned about medical ethics. This could be a free-write activity, a Flipgrid or group discussion activity.

Here are a few questions for students to consider:

• What guides your ability to decide whether something is right or wrong?
• Were you surprised at the opinions held by your classmates?
• What do you want to learn more about?
• What surprised you about the case studies you read?
• What did you learn about how research is conducted?

The Sanford Connection
Sanford Research oversees several research studies as well as their own institutional review board (IRB). Under FDA regulations, the IRB is a group that has been formally designated to review and monitor biomedical research involving human subjects. The IRB has the authority to approve, require modifications, or disapprove research projects. The IRB serves a paramount role in the protection of the human research subjects. To learn more about responsible research and clinical trials, click here.