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Open Access Research article

Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

Heather E Riden12, Kya N Grooms3, Cheryl R Clark345*, Laura R Cohen12, Josh Gagne6, Dora A Tovar12, Mark J Ommerborn3, Piper S Orton2 and Paula A Johnson125

Author Affiliations

1 Division of Women’s Health, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts, USA

2 Connors Center for Women’s Health and Gender Biology, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts, USA

3 Center for Community Health and Health Equity, Brigham and Women’s Hospital, 1620 Tremont Street, Boston, Massachusetts, USA

4 Division of General Medicine and Primary Care, Brigham and Women’s-Faulkner Hospitalist Program, 1620 Tremont Street, Boston, Massachusetts, USA

5 Harvard Medical School, 25 Shattuck Street, Boston, Massachusetts, USA

6 Survey & Data Management Core, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts, USA

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BMC Research Notes 2012, 5:624  doi:10.1186/1756-0500-5-624

Published: 7 November 2012



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.


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.


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.


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.

Community-based participatory research; Patient selection; Health status disparities; Informed consent; Poverty; Vulnerable populations