Aim: To develop a process for returning medically actionable genomic variants to Latino patients receiving care in a Federally Qualified Health Center. Methods: Prior to recruitment, researchers met with primary care providers to (1) orient clinicians to the project, (2) establish a process for returning actionable and nonactionable results to participants and providers through the electronic health record, and (3) develop a process for offering clinical decision support for follow-up education and care. A Community Advisory Board was engaged to provide input on recruitment strategies and materials for conveying results to participants. Participants in the Sangre Por Salud (Blood for Health) Biobank with hyperlipidemia or colon polyps represented the pool of potentially eligible participants. Results: A total of 1,621 individuals were invited to participate and 710 agreed to an in- person consenting visit (194 no-showed and 16 declined). Over 12-months, 500 participants were enrolled. Participants were primarily Spanish-speaking (81.6%), female (74.2%), and enrolled because of hyperlipidemia (95.4%). All but 2 participants opted to receive primary (i.e., related to enrollment phenotypes) as well as secondary actionable results. Conclusion: Efforts to bring precision medicine to community-based health centers serving minority patients may require multilevel engagement activities to include individuals, providers, health systems, and the community.

1.
Weitzel
KW
,
Alexander
M
,
Bernhardt
BA
,
Calman
N
,
Carey
DJ
,
Cavallari
LH
, et al.;
IGNITE Network
.
The IGNITE network: a model for genomic medicine implementation and research
.
BMC Med Genomics
.
2016
Jan
;
9
(
1
):
1
.
[PubMed]
1755-8794
2.
Popejoy
AB
,
Fullerton
SM
.
Genomics is failing on diversity
.
Nature
.
2016
Oct
;
538
(
7624
):
161
4
.
[PubMed]
0028-0836
3.
Oh
SS
,
Galanter
J
,
Thakur
N
,
Pino-Yanes
M
,
Barcelo
NE
,
White
MJ
, et al.
Diversity in clinical and biomedical research: a promise yet to be fulfilled
.
PLoS Med
.
2015
Dec
;
12
(
12
):
e1001918
.
[PubMed]
1549-1277
4.
Collins
FS
,
Varmus
H
.
A new initiative on precision medicine
.
N Engl J Med
.
2015
Feb
;
372
(
9
):
793
5
.
[PubMed]
0028-4793
5.
Gottesman
O
,
Kuivaniemi
H
,
Tromp
G
,
Faucett
WA
,
Li
R
,
Manolio
TA
, et al.;
eMERGE Network
.
The Electronic Medical Records and Genomics (eMERGE) Network: past, present, and future
.
Genet Med
.
2013
Oct
;
15
(
10
):
761
71
.
[PubMed]
1098-3600
6.
Fossey
R
,
Kochan
D
,
Winkler
E
,
Pacyna
JE
,
Olson
J
,
Thibodeau
S
, et al.
Ethical considerations related to return of results from Genomic Medicine Projects: the eMERGE Network (Phase III) Experience
.
J Pers Med
.
2018
Jan
;
8
(
1
):
8
.
[PubMed]
2075-4426
7.
Grimaldi
P
.
Latest Medicare benefit: FQHC (Federally Qualified Health Center) services
.
Healthc Financ Manage
.
1993
Jan
;
47
(
1
):
34
.
[PubMed]
0735-0732
8.
Shaibi
G
,
Singh
D
,
De Filippis
E
,
Hernandez
V
,
Rosenfeld
B
,
Otu
E
, et al.
The Sangre Por Salud Biobank: facilitating genetic research in an underrepresented Latino community
.
Public Health Genomics
.
2016
;
19
(
4
):
229
38
.
[PubMed]
1662-4246
9.
Kullo
IJ
,
Fan
X
,
Olson
J
,
Jose
M
,
Safarova
M
,
Radecki Breitkopf
C
, et al.
The Return of Actionable Variants Empiric (RAVE) Study, a Mayo Clinic genomic medicine implementation study: design and initial results
.
Mayo Clin Proc
. Forthcoming.0025-6196
10.
Spatz
ES
,
Krumholz
HM
,
Moulton
BW
.
The new rra of informed consent: getting to a reasonable-patient standard through shared decision making
.
JAMA
.
2016
May
;
315
(
19
):
2063
4
.
[PubMed]
0098-7484
11.
Green
RC
,
Berg
JS
,
Grody
WW
,
Kalia
SS
,
Korf
BR
,
Martin
CL
, et al.;
American College of Medical Genetics and Genomics
.
ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing
.
Genet Med
.
2013
Jul
;
15
(
7
):
565
74
.
[PubMed]
1098-3600
12.
McGill
N.
As Hispanics lag in clinical trials, health researchers take action: Outreach expands. The Nation's Health.
2013
;43:1,16.
13.
Haga
SB
.
Impact of limited population diversity of genome-wide association studies
.
Genet Med
.
2010
Feb
;
12
(
2
):
81
4
.
[PubMed]
1098-3600
14.
Avilés-Santa
ML
,
Heintzman
J
,
Lindberg
NM
,
Guerrero-Preston
R
,
Ramos
K
,
Abraído-Lanza
AL
, et al.
Personalized medicine and Hispanic health: improving health outcomes and reducing health disparities - a National Heart, Lung, and Blood Institute workshop report
.
BMC Proc
.
2017
Oct
;
11
(
S11
Suppl 11
):
11
.
[PubMed]
1753-6561
15.
Lavery
JV
.
Building an evidence base for stakeholder engagement
.
Science
.
2018
Aug
;
361
(
6402
):
554
6
.
[PubMed]
0036-8075
16.
Jarvik
GP
,
Amendola
LM
,
Berg
JS
,
Brothers
K
,
Clayton
EW
,
Chung
W
, et al.;
eMERGE Act-ROR Committee and CERC Committee
;
CSER Act-ROR Working Group
.
Return of genomic results to research participants: the floor, the ceiling, and the choices in between
.
Am J Hum Genet
.
2014
Jun
;
94
(
6
):
818
26
.
[PubMed]
0002-9297
17.
Burke
W
,
Antommaria
AH
,
Bennett
R
,
Botkin
J
,
Clayton
EW
,
Henderson
GE
, et al.
Recommendations for returning genomic incidental findings? We need to talk!
Genet Med
.
2013
Nov
;
15
(
11
):
854
9
.
[PubMed]
1098-3600
18.
Stoll
K
,
Kubendran
S
,
Cohen
SA
.
The past, present and future of service delivery in genetic counseling: keeping up in the era of precision medicine
.
Am J Med Genet C Semin Med Genet
.
2018
Mar
;
178
(
1
):
24
37
.
[PubMed]
1552-4868
19.
Hilgart
JS
,
Hayward
JA
,
Coles
B
,
Iredale
R
.
Telegenetics: a systematic review of telemedicine in genetics services
.
Genet Med
.
2012
;
14
(
9
):
765
76
. 1098-3600
20.
Hoskovec
JM
,
Bennett
RL
,
Carey
ME
,
DaVanzo
JE
,
Dougherty
M
,
Hahn
SE
, et al.
Projecting the supply and demand for certified genetic counselors: a workforce study
.
J Genet Couns
.
2018
Feb
;
27
(
1
):
16
20
.
[PubMed]
1059-7700
21.
Rubanovich
CK
,
Cheung
C
,
Mandel
J
,
Bloss
CS
.
Physician preparedness for big genomic data: a review of genomic medicine education initiatives in the United States
.
Hum Mol Genet
.
2018
Aug
;
27
R2
:
R250
8
.
[PubMed]
0964-6906
22.
Williams
JR
,
Yeh
VM
,
Bruce
MA
,
Szetela
C
,
Ukoli
F
,
Wilkins
CH
, et al.
Precision medicine: familiarity, perceived health drivers, and genetic testing considerations across health literacy levels in a diverse sample
.
J Genet Couns
.
2018
Aug
.
[PubMed]
1059-7700
23.
Halverson
CM
,
Ross
LF
.
Incidental findings of therapeutic misconception in biobank-based research
.
Genet Med
.
2012
Jun
;
14
(
6
):
611
5
.
[PubMed]
1098-3600
24.
Lakes
KD
,
Vaughan
E
,
Jones
M
,
Burke
W
,
Baker
D
,
Swanson
JM
.
Diverse perceptions of the informed consent process: implications for the recruitment and participation of diverse communities in the National Children’s Study
.
Am J Community Psychol
.
2012
Mar
;
49
(
1-2
):
215
32
.
[PubMed]
0091-0562
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.