title: Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.
abstract: Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials.
authors.affiliation: FHI 360, Durham, NC, USA kmacqueen@fhi360.org.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: MacQueen
authors.affiliation: FHI 360, Durham, NC, USA.
authors.forename: Natalie T
authors.initials: NT
authors.lastname: Eley
authors.affiliation: Treatment Action Group, New York, NY, USA.
authors.forename: Mike
authors.initials: M
authors.lastname: Frick
authors.affiliation: Community Research Advisors Group of the Tuberculosis Trials Consortium, Barcelona, Spain.
authors.forename: Laia Ruiz
authors.initials: LR
authors.lastname: Mingote
authors.affiliation: Reagan-Udall Foundation for the Food and Drug Administration, Washington, DC, USA.
authors.forename: Alicia
authors.initials: A
authors.lastname: Chou
authors.affiliation: TB Alliance, New York, NY, USA.
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: Seidel
authors.affiliation: AVAC, New York, NY, USA.
authors.forename: Stacey
authors.initials: S
authors.lastname: Hannah
authors.affiliation: FHI 360, Durham, NC, USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Hamilton
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D055812:Community-Based Participatory Research / Q000941:ethics*; D006801:Humans; D017063:Outcome Assessment, Health Care; D012111:Residence Characteristics; D014376:Tuberculosis / Q000188:drug therapy*
keywords: clinical trials; community engagement; evaluation; global research; good participatory practices; research networks; stakeholder engagement; theory of change; tuberculosis