title: Development of a Health Professions Education Research-Specific Institutional Review Board Template.
abstract: OBJECTIVE
  Health professions education (HPE) has become a core component of the mission of academic health centers (AHCs) nationwide. The volume of HPE research projects being reviewed has increased, presenting new challenges for institutional review boards (IRBs). As HPE research becomes increasingly sophisticated in its design and methods, IRBs and researchers alike have a duty to better understand its unique characteristics. Researchers must be better able to conceptualize and describe their research to IRBs, and IRBs should be able to provide timely review and assure protection of research subjects (or participants).
  
  
  METHODS
  The creation of HPE research-specific IRB templates may be one way to improve the interactions between education researchers and IRBs. This report describes the development and early implementation of an HPE research-specific IRB template at Duke University from 2013 to 2014.
  
  
  RESULTS
  Early adopters have noted increased ease of preparation and submission, while IRB staff have reported improved proposal clarity and more attention to protecting learners as research participants. Focus during educational or training sessions about the new template has shifted-from merely a description of the new submission process to a more comprehensive education series that includes discussion of regulatory definitions, examination of case studies, and opportunity for audience feedback.
  
  
  CONCLUSIONS
  Continued collection of quantitative and qualitative data regarding the implementation of this IRB template will help its developers more precisely describe its effects on HPE research projects. Formalizing and streamlining the interactions between HPE researchers and IRBs is an important goal for all AHCs.
authors.affiliation: S.D. DeMeo is attending neonatologist, WakeMed Health & Hospitals, Raleigh, North Carolina, and adjunct professor of pediatrics, Duke University Medical Center, Durham, North Carolina. A. Nagler is assistant director, Accreditation, Validation, and Credentialing, American College of Surgeons, Chicago, Illinois. M.T. Heflin is associate professor of medicine, Department of Medicine-Geriatrics, Duke University Medical Center, Durham, North Carolina.
authors.forename: Stephen D
authors.initials: SD
authors.lastname: DeMeo
authors.forename: Alisa
authors.initials: A
authors.lastname: Nagler
authors.forename: Mitchell T
authors.initials: MT
authors.lastname: Heflin
mesh_terms: D035843:Biomedical Research / Q000193:education*; D040381:Education, Public Health Professional / Q000639:trends*; D028744:Ethics Committees, Research / Q000458:organization & administration*; D006281:Health Occupations / Q000193:education*; D006801:Humans; D016730:Program Development; D012108:Research Personnel / Q000193:education*