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• Phase III: Researchers give the experimental study drug ortreatment to even larger groups of people (1,000 to 3,000) toconfirm its effectiveness, monitor side effects, compare it withcommonly used treatments, and collect information that will allowpeople to use the experimental drug or treatment safely. Controlgroups are used, and the studies are blind or double-blind.• Phase IV: Researchers conduct post-marketing studies to furtherassess the risks, benefits, and optimal use of the drug or treatment.Source: Modified from U.S. National Institutes of Health. 2007. Understandingclinical trials. Retrieved September 16, 2008, from http://clinicaltrials.gov/ct2/info/understand.12345Module 5 5-176
Organizer for Day 1: Research with Humans—Why Does It Matter? What Should the Guidelines Be?Activity 1: Recruiting ParticipantsEstimated Time: 10 minutesDisplay the transparency of Master 5.1.Page 5-6, Step 1Show students the bottle of “pills” and ask them to imagine that they all haveasthma and that researchers believe that the medicine will help with asthma.Give students five minutes to write down their initial answers to these questions:• Do you want to participate? Why or why not?• What are the pros and cons of being involved in this research study?Ask students who chose to participate to raise their hands and share their reasons.Then ask those who chose not to participate to do the same. Record students’ proand con ideas on the board or a transparency.Ask, “What would you want to know before participating?” Display the responses.Tell students a little more background information, and then ask the ones who choseto participate to raise their hands again. Ask, “Should I just give the medicine toeveryone raising their hand and see what happens? If I do that, how will I be able totell that taking the medication is more effective than not taking it?”Activity 2: Scientific Research DesignEstimated Time: 15 minutes (Less if students are very familiar with study design.)Ask students, “What are some of the elements of a good experiment?” Shareinformation about experimental research design with students.Ask students, “How would you design a randomized controlled trial to test theasthma medication?” Give them one to two minutes to discuss this in pairs, andthen have them share their responses with the class.Ask students, “What counts as ‘randomly splitting the class’?” Divide the studentswho chose to participate in half, and assign half to the treatment group and half tothe control group.Ask students,• “How do you feel about being in your assigned group?”• “Would your prior feelings and knowledge about being in a particular groupinfluence the outcome of the experiment? Why or why not?”Page 5-6, Steps 2–3Page 5-6, Steps 4–5Page 5-6, Steps 6–8Page 5-7, Steps 9–10Page 5-7,Steps 11–13Page 5-8, Steps 1–2Page 5-9, Steps 3–4Page 5-9, Steps 5–6Page 5-9, Step 75-18 Exploring Bioethics
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NIH CurriculumSupplement SeriesGrad
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Education Development Center, Inc.D
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This material is based on work supp
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About the National Institutes of He
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Introduction
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activity of assessing different rea
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teaching strategies that will help
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2. The ability to distinguish an et
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quence of choosing one path over an
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Table 1. Assessing Student Justific
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Challenges in TeachingBioethics and
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How Exploring Bioethics Can HelpFor
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Prompts to encourage students to re
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Table 2d. Students say they already
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Resources forTeaching BioethicsBeau
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Table 3. Ethical Issues and Curricu
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Each module is divided into three d
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Table 4. Alignment with NSES Life S
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About the Web SiteThe Web site for
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1Module 1Bioethics Concepts and Ski
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• apply important ethical conside
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In Advance1Copies, Equipment, and M
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Teaching Sequence1Day 1: What’s i
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new medication, she is able to stay
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6. Read the list of Round 1 questio
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• With respect to performance enh
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LE/LE/LLE/LPoint out that some of t
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Organizer for Day 1: What’s in a
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Day 2: Four Key Questions1PurposeDa
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4. Emphasize that when bioethicists
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15. Ask students to list as many et
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Organizer for Day 2: Four Key Quest
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Encourage students to share example
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Activity 7:Using Ethical Considerat
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4. Ask a representative from each g
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Organizer for Day 3: Core Ethical C
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References and Resources1Informatio
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What Type of Question? ROUND 1—Et
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What Type of Question? ROUND 3: Eth
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Round 4Q9Should embryonic stem cell
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Oscar Pistorius—The Fastest Man w
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Four Key Questions and Statementof
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Carl’s CaseCarl listened to his t
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1Module 2Balancing Individual and C
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adopting vaccination policies that
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In Advance1Copies, Equipment, and M
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Teaching Sequence1Day 1: Exploring
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the key stakeholders, and taken int
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You may wish to highlight the dange
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ClosureAsk students to reflect on t
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Day 2: Community Immunity1PurposeOn
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10. Ask all students in the class t
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• While an unvaccinated person’
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ClosureRecap for students that the
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Tell only the students who were tag
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5. Divide students into pairs, and
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17. Share with students that becaus
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13. Note that the Boston and Dublin
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Teaching StrategiesYou may want to
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Ask each member of the pair to read
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1Centers for Disease Control and Pr
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Get Kids Vaccinated or ElseGet Kids
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Name(s)Station 2—Vaccine RisksDir
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Station 1: Vaccine-Preventable Dise
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MumpsBefore the mumps vaccine was i
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Station 2—Vaccine RisksNote: Like
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Smallpox VaccineThe smallpox vaccin
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Station 4—ExemptionsExemptions vs
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State Exemptions Allowed as of Fall
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Name(s)What are the ethical conside
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Vaccination Status CardsVaccinated
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Opting Out of a Vaccine—Variables
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Measles in DublinIn 2000, an outbre
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What are some of the different pers
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Issues Explored• What is the fair
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Day 3—What Is Your Recommendation
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Teaching SequenceNoteAssign this ho
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Teaching Strategies: Jigsaw Techniq
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Some students might think that the
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11. Explain to students that they w
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Inform students that they will now
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2. Tell them that one liver has bec
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6. If it does not naturally arise,
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Criteria relevant to allocating liv
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Organizer for Day 2: Identifying St
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Day 3: What Is Your Recommendation?
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Activity 9:Understanding Past and C
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ClosureReinforce to students that t
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Ask students whether they think the
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Liver Function and FailureHepatitis
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Name(s)Banting decided that he woul
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Name(s)The COC distributed the peni
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Name(s)The Admissions and Policy Co
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Liver and Liver-Transplant Fact She
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The Liver and Liver Transplants—C
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Patient ProfilesAnitaAnita is a 19-
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Additional Patient InformationAnita
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The United Network for Organ Sharin
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Comparing the Past and Current UNOS
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1Module 4Weighing Benefits and Harm
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An optional extension activity incl
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In Advance1Preparing the Envelopes
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Teaching Sequence1Day 1: Deciding t
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6. Explain that each student should
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Activity 2:Introducing Max’s Thyr
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See Teacher Support MaterialsSupple
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ClosureTo close the class, remind s
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Page 232 and 233: ReflectionDisplay the posters from
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Page 249 and 250: Your Tentative ThoughtsName(s)1. Do
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Page 253 and 254: Extension (Optional)About Retinitis
Page 255 and 256: Issues Explored• Why is it import
Page 257 and 258: Key Science Knowledge*• Nature of
Page 259 and 260: Teaching SequenceDay 1: Research wi
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Page 281 and 282: Organizer for Day 2:Harms and Benef
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Page 295 and 296: Letter to ParentsThis is the letter
Page 297 and 298: What Are the Relevant Ethical Consi
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Page 301 and 302: Name(s)(Fill out individually.)Your
Page 303 and 304: Issues Explored• Should there be
Page 305 and 306: Key Science Knowledge*• DNA, RNA,
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Organizer for Day 2: Deepening Your
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Day 3: Making a Recommendation—Se
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Those cases where students do not t
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3. Ask a representative from each g
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Activity 9: Returning to Alba’s C
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1Ear MiceBBC News. 2002. Artificial
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Alba’s CaseSince the early 1990s,
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Dyed FeathersPeople dye bird feathe
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Giant Panda BreedingThe giant panda
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Mad-Cow-Disease CowsMad cow disease
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Purebred DogsHumans have geneticall
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Spider-Silk GoatsSpider silk is str
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VealVeal is meat from calves that i
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Assessing Harms, Benefits, and Pote
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Final Assessment of Alba’s CaseRe
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This curriculum supplementwas devel
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