title: The ethics of withdrawal from study participation.
abstract: We investigated whether consent forms adhere to Federal Common Rule regulations pertaining to withdrawal from research, described the language of withdrawal provisions, and assessed differences in studies by withdrawal provisions. A random sample of 114 consent forms from a midwestern, academic medical center were examined for descriptive content of withdrawal parameters stated within consent forms. All consent forms included the required statement about withdrawal pursuant to the Code of Federal Regulations (CFR) 45 CFR (46.116(a)(8)), and all adhered to regulation 45 CFR (46.116(b)(4)) by including a statement that withdrawal will have no affect on care provided. Of 114 studies, thirty (26%) studies explicitly requested subjects/participants to engage in a further behavior before withdrawing from the study. Safety was mentioned in only 4 (13%) instances as the reason for an additional visit or test. None of the consent forms provided information about the consequences to the subject's health or well being by withdrawing from study participation. Consent forms generally conform to current regulations. Future research should examine subjects' experiences of withdrawing from research in order to help clinical investigators and Institutional Review Boards (IRBs) assess the extent to which consent forms indicate barriers to withdrawal and for compliance with Federal Common Rule regulations.
authors.affiliation: Alden March Bioethics Institute, Albany Medical Center, 47 New Scodand Avenue, MC 153, Albany, New York 12208-3478, USA. gordone1@mail.amc.edu
authors.forename: Elisa J
authors.initials: EJ
authors.lastname: Gordon
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Prohaska
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D032962:Consent Forms / Q000941:ethics / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence* / Q000639:trends; D006801:Humans; D010352:Patient Dropouts / Q000331:legislation & jurisprudence* / Q000523:psychology; D014481:United States