PUBH 6035 Module 4 Discussion 2; Ethics in Epidemiological Research

AnExperimentalStudyinthePrimaryPreventionofType2DiabetesImaginethatresearchersareconductingarandomizedcontrolledtrialofahigh-fibersupplementasapreventivemeasureinpersonsatincreasedriskoftype2diabetes. Peopleenrolledin thestudyaredisease-freeatthetime theyagreetoparticipateinthetrial,buttheyallhaveafamilyhistoryoftype2diabetesandareconsideredathigh-risk(80%)todevelopthediseaseduring their lifetime. The 10,000 participants who start the trial are healthyindividuals who are randomly allocated to receive either high-fibersupplementsorplaceboforseveralyears.Asyoucanimagine,thisstudywillbequiteexpensiveandwill require alargeinfrastructure ofpersonnelandmaterialstocarryitoutsuccessfully. Becausetype2diabeteshasreachedepidemicproportionsintheUnitedStates, the potential benefits of this research are important at a populationlevel.Unfortunately,high-fibersupplementshavealsobeenshowninafewstudiestobeassociatedwithgastrointestinalblockage(whichcanbelife-threatening)andreducednutrientabsorption,whichmayleadtoanemia,osteoporosis,andotherdebilitatingchronicdiseases.Thesupplementsmayalsoreduceabsorptionofcertainmedicationsandcausegastrointestinaldistress.Thepotentialsideeffectsofcontinuoushigh-fibersupplementationareonlypartiallyunderstood,and long-termeffectsareunknown. 1. Whatarethepotentialrisksandbenefitstobeconsideredwhendesigningthisstudy? 2. When the side effects and long-term effects of a potential preventivemeasurearelargelyunknown,isitethicaltoexposeparticipantstotheserisks?Whyorwhy not? 3. Is it ethical to deny the possible prevention benefits of high-fibersupplementstopersonsintheplacebogroup?Whyorwhynot? 4. Dothepotential benefits outweighthepotential riskstotheparticipantsandto society?Whyor whynot?