title: Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings.
abstract: BACKGROUND
  To improve equity in access to medical research, successful strategies are needed to recruit diverse populations. Here, we examine experiences of community health center (CHC) staff who guided an informed consent process to overcome recruitment barriers in a medical record review study.
  
  
  METHODS
  We conducted ten semi-structured interviews with CHC staff members. Interviews were audiotaped, transcribed, and structurally and thematically coded. We used NVivo, an ethnographic data management software program, to analyze themes related to recruitment challenges.
  
  
  RESULTS
  CHC interviewees reported that a key challenge to recruitment included the difficult balance between institutional review board (IRB) requirements for informed consent, and conveying an appropriate level of risk to patients. CHC staff perceived that the requirements of IRB certification itself posed a barrier to allowing diverse staff to participate in recruitment efforts. A key barrier to recruitment also included the lack of updated contact information on CHC patients. CHC interviewees reported that the successes they experienced reflected an alignment between study aims and CHC goals, and trusted relationships between CHCs and staff and the patients they recruited.
  
  
  CONCLUSIONS
  Making IRB training more accessible to CHC-based staff, improving consent form clarity for participants, and developing processes for routinely updating patient information would greatly lower recruitment barriers for diverse populations in health services research.
authors.affiliation: Division of Women’s Health, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, USA.
authors.forename: Heather E
authors.initials: HE
authors.lastname: Riden
authors.forename: Kya N
authors.initials: KN
authors.lastname: Grooms
authors.forename: Cheryl R
authors.initials: CR
authors.lastname: Clark
authors.forename: Laura R
authors.initials: LR
authors.lastname: Cohen
authors.forename: Josh
authors.initials: J
authors.lastname: Gagne
authors.forename: Dora A
authors.initials: DA
authors.lastname: Tovar
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Ommerborn
authors.forename: Piper S
authors.initials: PS
authors.lastname: Orton
authors.forename: Paula A
authors.initials: PA
authors.lastname: Johnson
mesh_terms: D003151:Community Health Centers / Q000458:organization & administration*; D006302:Health Services Research; D006801:Humans; D007258:Informed Consent; D035862:Vulnerable Populations