title: Burdensome Research Procedures in Trials: Why Less Is More.
abstract: A large volume of trials involve invasive, nontherapeutic research procedures, like organ biopsy or sham surgeries, that can pose risks comparable with the experimental treatment itself but that have no direct benefit for volunteers. Though such procedures can enhance the value of clinical investigations, recent studies suggest that many studies involving invasive, nontherapeutic research procedures are not well planned and reported; some studies suggest that their results are often not utilized in the planning of new investigations. This commentary offers recommendations for how investigators, sponsors, and ethics committees might improve evaluation and implementation of studies involving invasive nontherapeutic procedures. We conclude by urging more demanding scientific standards for the rationale, design, and reporting of burdensome, nontherapeutic research procedures-particularly where they involve risk of serious complications.
authors.affiliation: Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Social Studies of Medicine, McGill University, Montréal, Canada.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kimmelman
authors.affiliation: National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Resnik
authors.affiliation: MGH Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Peppercorn
authors.affiliation: Department of Medicine, Comprehensive Cancer Center, and Center for Personalized Therapeutics, The University of Chicago, Chicago, IL, USA.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Ratain
mesh_terms: D001706:Biopsy / Q000009:adverse effects; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods* / Q000592:standards*; D064368:Healthy Volunteers; D006801:Humans; D033281:Nontherapeutic Human Experimentation / Q000941:ethics / Q000592:standards*; D010919:Placebos / Q000009:adverse effects
chemical_list: D010919:Placebos