title: Management of incidental findings during imaging research in "healthy" volunteers: current UK practice.
abstract: OBJECTIVE
  Incidental findings (IF) are becoming increasingly common due to the proliferation of imaging research. IFs can be life-changing for "healthy" volunteers. This study examined variation in IF management in UK research studies of healthy volunteers, including comparison with ethical and legal guidelines, thus providing baseline data and informing future practice.
  
  
  METHODS
  Questionnaire of participant background [medical/non-medical; radiologist/non-radiologist; years as principal investigator (PI)], type of research (involving children or not), institutional policy, volunteer information, radiologist involvement in reporting scans and IF disclosure mechanisms. Investigator's current and perceived "ideal" practice was examined. Participants were PIs performing imaging research of healthy volunteers approved by UK ethics committees (2006-2009).
  
  
  RESULTS
  63/146 (43%) surveys completed. 54/61 (88.5%) had site-specific guidelines. Information commonly provided to volunteers should IF be found: personal data (51/62; 82%), contingency plans (54/62; 87%) and disclosure to general practitioner (GP)/treating physician (47/62; 76%). PIs used different strategies for image review. Commonest: radiologist reports research scans only when researcher suspicious of IF [15/57 (26%) compared with 5/28 (16%) in ideal practice]. Commonest ideal reporting strategy: routine reporting by specialist radiologists [9/28 (29%) compared with 8/57 (14%) in current practice]. 49/56 (87.5%) have a standardised disclosure contingency plan, usually involving GP. PIs most commonly disclosed IFs to volunteers when judged relevant (27/58; 47%), most commonly face to face (22/54; 41%), by volunteer's GP (26/60; 43%). Background of PI influenced consent, reporting and disclosure practice.
  
  
  CONCLUSIONS
  There is wide variation in handling IFs in UK imaging research. Much of the current practice contravenes the vague existing legal and ethical guidelines, and is unlikely to be in the best interests of volunteers or researchers.
authors.affiliation: Department of Biochemistry, University of Cambridge, Cambridge, UK.
authors.forename: T C
authors.initials: TC
authors.lastname: Booth
authors.forename: A D
authors.initials: AD
authors.lastname: Waldman
authors.forename: J M
authors.initials: JM
authors.lastname: Wardlaw
authors.forename: S A
authors.initials: SA
authors.lastname: Taylor
authors.forename: A
authors.initials: A
authors.lastname: Jackson
mesh_terms: D064368:Healthy Volunteers; D006805:Human Experimentation; D006801:Humans; D033162:Incidental Findings; D010818:Practice Patterns, Physicians'; D011859:Radiography; D011795:Surveys and Questionnaires; D006113:United Kingdom