What is the Iterative Case Study?
The Iterative Case Study is an innovative approach to using ethics case studies in the classroom environment, allowing students to experience how risks and benefits in research change under different conditions and talk through the ethics of human subjects research in a creative and conversational way. This series of Case Studies begins with a very simply example of a human subjects research protocol. In each step of the Iterative Case Study (ICS), one additional protocol element is changed or added, which changes the entire set of ethical questions posed by the study. Each step of the ICS includes a standardized set of questions prompting ethical reflection and discussion. These standardized questions are also designed to allow faculty to use the ICS as a pre-made assessment for courses interested in the ethics of social, behavioral, educational, and biomedical research.
How do I use the Iterative Case Study?
Below you will find the full outline of the Case Study series in an accordion format. This series is also available as a set of Canvas modules, which are packaged in three phases for:
- Social and Behavioral Research
- Behavioral and Basic Physiological Research
- Biomedical Research
Here are some helpful tips for using the Iterative Case Study:
- This page can be used in the classroom environment to prompt discussion.
- A Canvas version of the ICS is available as ready made quizzes.
- Each Case Study includes a standardized set of questions which can be used for assessment and student reflection.
The Iterative Case Study
This is an Iterative Case Study, where each step of the case series changes exactly one variable from the research design examined in the previous example. For each iteration, some aspects of the ethical considerations will change. Think about how the potential risks and benefits change with each iteration. You may be asked to consider how issues with informed consent might change from case to case. You will also be asked how the potential risks might be minimized in each new case. Answer the questions provided with each iteration.
Iteration 1
A researcher is interested in studying how listening to calming music for a short period every day may affect memory retention over one week. Participants 18 years or older will listen to calming music every day for 7 days for 30 minutes. The 30 minute period will begin at 9:30 a.m.. At 10 a.m., participants will complete a memory game.
Questions:
- What are the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 2
What has changed: Instead of listening to calming music for 30 minutes, participants will observe violent images for 30 minutes prior to completing memory tests.
New protocol: A researcher is interested in studying how being exposed to violent images for a short period every day may affect memory retention over one week. Participants 18 years or older will watch a prerecorded 30 minute set of violent images on YouTube every day for 7 days. The images are taken from current and historical war and crime photojournalism available online. The 30 minute period will begin at 9:30 a.m.. At 10 a.m., participants will complete a memory test.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 3
What has changed: The amount of time participants will watch violent images has been reduced to 5 minutes.
New protocol: A researcher is interested in studying how being exposed to violent images for a short period every day may affect memory retention over one week. Participants 18 years or older will watch a prerecorded 5 minute set of violent images on YouTube every day for 7 days. The images are taken from current and historical war and crime photojournalism available online. The 30 minute period will begin at 9:30 a.m.. At 10 a.m., participants will complete a memory test.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 4
What has changed: Instead of watching violent images, participants will drink two cups of coffee 5 minutes prior to completing memory tests.
New protocol: A researcher is interested in studying how drinking two cups of coffee at a specific time every day may affect memory retention over one week. Participants 18 years or older will drink two cups of coffee at 9:55 a.m. every day for 7 days. The researcher will make this coffee available to participants. Participants will begin drinking coffee at 9:55 a.m.. At 10 a.m., participants will complete a memory game.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 5
What has changed: Participants will drink coffee at regular intervals throughout a day, not just 5 minutes before the memory test, while completing memory tests.
New protocol: A researcher is interested in studying how drinking cups of coffee at regular times every day may affect memory retention over one week. Participants 18 years or older will drink two cups of coffee at 8 a.m., 11 a.m., 8 p.m., and 11 p.m. every day for 7 days. The researcher will make this coffee available to participants. At 10 a.m. every day, participants will complete a memory game.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 6
What has changed: Participants will drink coffee or placebo at regular intervals throughout the day and complete memory tests.
New protocol: A researcher is interested in studying how drinking cups of coffee at regular times every day may affect memory retention over one week. Participants 18 years or older will be randomized into two groups. Group A will drink two cups of coffee at 8 a.m., 11 a.m., 8 p.m., and 11 p.m. every day for 7 days. Group B will drink two cups of decaffeinated coffee at 8 a.m., 11 a.m., 8 p.m., and 11 p.m. every day for 7 days. The researcher will make this coffee available to participants. At 10 a.m. every day, participants will complete a memory game.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 7
What has changed: Participants will take a nutritional supplement or a placebo at regular intervals throughout the day and complete memory tests daily.
New protocol: A researcher is interested in studying how taking a nutritional supplement may affect memory retention over one week. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m., 11 a.m., 8 p.m., and 11 p.m. every day for 7 days. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8am, 11am, 8pm, and 11 p.m. every day. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will complete a memory game.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 8
What has changed: Participants will take a nutritional supplement or placebo once daily and complete memory tests daily.
New protocol: A researcher is interested in studying how taking a nutritional supplement once a day may affect memory retention over one week. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m. every morning. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8 a.m. every morning. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will complete a memory game.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 9
What has changed: Participants will take a nutritional supplement once daily followed by reflex testing.
New protocol: A researcher is interested in studying how taking a nutritional supplement once a day may affect reflexes over one week. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m. every morning. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8 a.m. every morning. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will complete two reflex tests. The first test is a reflex test available online in which participants click on objects with a mouse to gauge speed and accuracy of response. The second test consists of striking the patellar tendon (above the kneecap) of participants with a reflex hammer and recording results.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 10
What has changed: Participants will take a nutritional supplement once daily followed by running on a treadmill to exhaustion.
New protocol: A researcher is interested in studying how taking a nutritional supplement once a day may affect endurance in a running test. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m. every morning. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8 a.m. every morning. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will come to a laboratory and run on a treadmill until exhaustion, meaning that they are no longer able to run. Participants will wear a face mask to measure the oxygen concentrations of inspired and expired air.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
Iteration 11
What has changed: Participants will take a nutritional supplement once daily followed by running on a treadmill to exhaustion and a blood draw.
New protocol: A researcher is interested in studying how taking a nutritional supplement once a day may affect endurance in a running test. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m. every morning. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8 a.m. every morning. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will come to a laboratory and run on a treadmill until exhaustion, meaning that they are no longer able to run. Participants will wear a face mask to measure the oxygen concentrations of inspired and expired air. They will also have blood drawn after the treadmill test.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 12
What has changed: Participants will take a nutritional supplement once daily followed by performing maximum weight lifts.
New protocol: A researcher is interested in studying how taking a nutritional supplement once a day may affect endurance in a running test. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m. every morning. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8 a.m. every morning. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will come to a laboratory and perform a series of maximum weight lifts. They will perform a series of warm-up lifts followed by a maximum weight dead lift and bench press. Participants will have blood drawn after the weightlifting session.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
Iteration 13
What has changed: Participants will have blood drawn before and after weightlifting.
New protocol: A researcher is interested in studying how taking a nutritional supplement once a day may affect endurance in a running test. Participants 18 years or older will be randomized into two groups. Group A will take a nutritional supplement at 8 a.m. every morning. Group B will take a placebo capsule with harmless cellulose which looks exactly like the nutritional supplement at 8 a.m. every morning. The researcher will provide this supplement to participants. At 10 a.m. every day, participants will come to a laboratory and perform a series of maximum weight lifts. They will perform a series of warm-up lifts followed by a maximum weight dead lift and bench press. Participants will have blood drawn before and after the weightlifting session.
Questions:
- What has changed about the research population?
- What are the most significant research design changes?
- What has changed in regard to the risks and benefits of the research?
- How would you address the ethical issues posed by this iteration of the study?
- How would you minimize the risks in this iteration?
