Recontacting participants for expanded uses of existing samples and data: a case study.
Genet Med
; 19(8): 883-889, 2017 08.
Article
em En
| MEDLINE
| ID: mdl-28125076
ABSTRACT
PURPOSE:
Facilitating genomic research may require the use of samples and data collected via consent processes that did not include specific descriptions of secondary uses. We explore whether a waiver of consent with notification and the option to withdraw (WNOW) is a viable alternative to written informed consent for secondary uses of samples and data.METHODS:
We developed a retrospective case study of a rare-disease protocol involving 1,978 participants that implemented WNOW for genomic data-sharing activities. We analyzed institutional review board and investigator records and conducted in-depth semistructured interviews with key staff members.RESULTS:
WNOW was largely successful at achieving its goals in this case, although the recontact effort, relative to proceeding with a waiver, decreased participation in genomic data sharing by 13.8% (n = 253), primarily because 224 letters were returned as undeliverable. A small number of participants responded (n = 89), and some of them expressed confusion and frustration. In the pediatric arm of the study, the research may have been practicable without a waiver, given the relationship between the pediatric clinicians and families.CONCLUSION:
The practicability of conducting research on existing specimens without a waiver of informed consent, and whether WNOW is a viable alternative, depend on contextual factors, including a reliable way to communicate with participants.Genet Med advance online publication 26 January 2017.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Participação do Paciente
/
Dever de Recontatar
/
Disseminação de Informação
/
Pesquisa em Genética
Tipo de estudo:
Guideline
/
Observational_studies
/
Qualitative_research
Limite:
Adult
/
Child
/
Humans
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article