Humans in Research
The Science and Ethics of Humans in Research
Why do scientists involve humans in biomedical research? Who participates in research and why? Furthermore, how does the complex--and sometimes difficult--history of research with humans influence current attitudes, policies and practices?
This curriculum introduces students to how research with humans is conducted, the rules and regulations involved, and the bioethical principles that guide scientists when involving humans in research. Lesson strategies and bioethical discussions engage students in science content, as well as promote an understanding of the role of science in society.
Individual lessons and support materials can be found on the Lessons page.
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Download The Science and Ethics of Humans in Research curriculum.
Complete Lesson Plans
RARE Film Guide Rare_Film_Guide_HinR.pdf
This activity is designed to be used with the film RARE, a documentary which explores the major issues affecting people living with a rare genetic disorder- Hermansky-Pudlak Syndrome (HPS). Before the film, students explore and share their ideas about general themes that will be eventually displayed in the film by responding to statements in a Silent Chalk Talk. Students are then asked to view the film from the perspective of a stakeholder in regard to clinical trial testing a new drug for HPS. Stakeholders include Donna Appell, a mother working to find a cure for her twenty-one year old daughter who has HPS; Heather Kirkwood, a woman with HPS who is involved in a clinical trial for a drug to treat people with HPS; and Dr. William Gahl, a researcher from the National Institutes of Health (NIH) who works with people with HPS and runs the clinical trial in which Heather is enrolled. After watching the film, students gather for another Silent Chalk Talk and meet in small groups to discuss the film's ethical issues from different perspectives.
Download the PowerPoint slide set that accompanies this lesson.
Overview, Credits and Standards 0Overview_Credits_Standards_HinR.pdf
This document provides an overview of the five lessons in the curriculum, the formative and summative assessments, and the master glossary in the appendix. It also gives credit to the authors and contributors, and maps the curriculum to the Framework for the Next Generation Science Standards, National Science Standards and Common Core State Standards.
Formative Assesment: Identifying Misconceptions 0Formative_Assessment_HinR.pdf
Students begin the unit with an activity in which students sort their prior knowledge and any misconceptions about research involving human participants. In the Human Research Background Sort, students decide whether research statements are accurate or not by sorting them into two categories and explaining their thinking. This helps teachers elicit student ideas about research involving human participants and take students’ prior knowledge into account for the remainder of the unit. Students will revisit the statements to confirm or refute their positions throughout the unit.
Lesson One: The Historical Context of Humans in Research 1Historical_Context_HinR.pdf
In this lesson, students gain insight into the historical context related to the involvement of human participants in research. Students participate in an activity in which they analyze four historically notable case studies where ethics remain unclear. Students develop their own list of ethical guidelines by creating a concept map and then compare their list to the principles put forth in the Belmont Report: Respect for Persons (including autonomy), Beneficence, and Justice. This lesson provides a preliminary understanding of the difficulties and considerations that need to be taken into account when involving humans in research.
Dowload the Historical Case Studies and Student Guiding Questions from this lesson.
Lesson Two: Applying the Belmont Principles 2Belmont_Principles_HinR.pdf
This lesson guides students in applying the specific principles of the Belmont Report to complex case studies involving human participants as research subjects. Students analyze a case using the concept map they produced in Lesson One. They then work together in mixed-case groups to present their findings and evaluate each other's work using a peer evaluation process.
Lesson Three: Institutional Review Boards -- The Nitty Gritty 3IRB_HinR.pdf
Students are introduced to the concept of an Institutional Review Board (IRB), also known as an Ethics Committee (EC), and perform a skit to learn about the regulations and membership requirements of an IRB. Students use information learned from the skit to further discuss the rationale for having IRBs review research studies involving humans. In small groups, students visit different stations to perform three activities typical of the work of IRBs. They work together to 1) simplify the language of a section of an informed consent document to be more easily understood, 2) analyze three advertisements made for fictional clinical trials to assess whether they are accurate and/or coercive, and 3) examine a segment of a research proposal written by an investigator describing the process for obtaining informed consent. Students report back to the class and discuss the benefits and limitations of the rigorous IRB process. Lastly, students read an article in which bioethicists encourage shorter, easier to understand consent forms.
Download a sample informed consent.
Download mock study advertisements from this lesson.
Lesson Four: Participating in Research 4Participating_in_Research_HinR.pdf
Students begin by gathering their own behavioral, medical, and genetic information, and prepare a mock cheek swab DNA sample. Next, students consider using their information to participate in a number of simulated research projects. This leads to a discussion about how the amount of time, degree of involvement, level of risk and reasons for participation can vary for different types of research studies. Finally, students think about the ramifications of the fast-growing technology of biobanking in the context of clinical research and discuss their personal views.
Lesson Five: Clinical Trials 5Clinical_Trials_Beads_HinR.pdf
In this lesson, students learn about the purpose and structure of clinical trials by simulating three phases of a trial using colored beads to represent a local population that could be involved in research. Using colored beads to represent a local population that could be involved in research, students recruit participants for a study researching the effects of a medication on high blood pressure, a fairly common condition. After students complete the three clinical trial phases for this drug, they consider the challenges of running a clinical trial testing medication for a rare disease. Students will also be introduced to elements of study design for clinical trials such as the use of placebos, randomization, and blinded studies.
Download the Drug Discovery and Development Overview PowerPoint Slide.
Summative Assessment: Position Paper 6Summative_Assessment_HinR.pdf
Students demonstrate what they have learned over the course of the unit by identifying and justifying their personal position regarding their own participation in a real clinical trial. Students evaluate a trial using a decision-making model to consider ethical protections, the scientific and social value of the trial, and the potential risks and benefits of their possible participation in the trial. Students then write a paper detailing how their actions reflect their position on research involving humans.
Appendix and Master Glossary 7Appendix_HinR.pdf
Lesson Three: A sample informed consent form can be found here.
Lesson Five: Click here for the Drug Discovery & Development Overview PowerPoint slide from Innovation.org.
Lesson Six: Interested in resources for the film Rare?
Click on the green text for the accompanying PowerPoint slide set.