Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.
J Empir Res Hum Res Ethics
; 12(1): 14-25, 2017 02.
Article
en En
| MEDLINE
| ID: mdl-28078953
ABSTRACT
Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Comunicación
/
Comprensión
/
Investigación Biomédica
/
Formularios de Consentimiento
/
Consentimiento Informado
Tipo de estudio:
Qualitative_research
Límite:
Humans
Idioma:
En
Revista:
J Empir Res Hum Res Ethics
Asunto de la revista:
ETICA
Año:
2017
Tipo del documento:
Article
País de afiliación:
Estados Unidos