@article {631,
	title = {Enrolling Genomics Research Participants through a Clinical Setting: the Impact of Existing Clinical Relationships on Informed Consent and Expectations for Return of Research Results.},
	journal = {J Genet Couns},
	volume = {27},
	year = {2018},
	month = {2018 02},
	pages = {263-273},
	abstract = {<p>Genetic counselors working in a clinical setting may find themselves recruiting, enrolling, and returning results for genomic research, and existing clinical relationships with study participants may impact these research interactions. We present a qualitative study using semi-structured interviews of participants enrolled in a genome sequencing/exome sequencing (GS/ES) study at the same institution where they receive clinical care. Interviews were coded for motivations to participate and expectations of this research. The interviews revealed common motivations for participation, including altruism and hope for benefit for themselves, family members, and/or others with their condition. Additionally, themes emerged related to unintentional influence based on trust of the clinical provider that recruited them to the study. Participant trust in the enrolling provider at times appeared to extend to the study team to decide which research results to return and to do so in an appropriate format. Participants also based expectations for research results return on previous clinical genetic testing experiences, which may or may not be realistic depending on study design. It is imperative that genetic counselors enrolling patients into research studies be aware of the potential influence of their clinical relationship on potential subjects, be transparent about their role on the study team, and help set expectations about the study process, including results return.</p>},
	keywords = {Base Sequence, Decision Making, Family, Female, Genetic Testing, Humans, Informed Consent, Male, Motivation, Qualitative Research, Research Design, Trust},
	issn = {1573-3599},
	doi = {10.1007/s10897-017-0143-2},
	author = {Berrios, Courtney and James, Cynthia A and Raraigh, Karen and Bollinger, Juli and Murray, Brittney and Tichnell, Crystal and Applegate, Carolyn D and Bergner, Amanda L}
}
@article {221,
	title = {Informed consent for exome sequencing research in families with genetic disease: the emerging issue of incidental findings.},
	journal = {Am J Med Genet A},
	volume = {164A},
	year = {2014},
	month = {2014 Nov},
	pages = {2745-52},
	abstract = {<p>Genomic sequencing technology is increasingly used in genetic research. Studies of informed consent for exome and genome sequencing (ES/GS) research have largely involved hypothetical scenarios or healthy individuals enrolling in population-based studies. Studies have yet to explore the consent experiences of adults with inherited disease. We conducted a qualitative interview study of 15 adults recently enrolled in a large-scale ES/GS study (11 affected adults, four parents of affected children). Our study had two goals: (1) to explore three theoretical barriers to consent for ES/GS research (interpretive/technical complexity, possibility of incidental findings, and risks of loss of privacy); and (2) to explore how interviewees experienced the consent process. Interviewees could articulate study goals and processes, describe incidental findings, discuss risks of privacy loss, and reflect on their consent experience. Few expected the study would identify the genetic cause of their condition. All elected to receive incidental findings. Interviewees acknowledged paying little attention to potential implications of incidental findings in light of more pressing goals of supporting research regarding their own medical conditions. Interviewees suggested that experience living with a genetic condition prepared them to adjust to incidental findings. Interviewees also expressed little concern about loss of confidentiality of study data. Some experienced the consent process as very long. None desired reconsent prior to return of study results. Families with inherited disease likely would benefit from a consent process in which study risks and benefits were discussed in the context of prior experiences with genetic research and genetic disease.</p>},
	keywords = {Adolescent, Adult, Aged, Confidentiality, Ethics, Medical, Exome, Family, Female, Genetic Diseases, Inborn, Genetic Research, High-Throughput Nucleotide Sequencing, Humans, Incidental Findings, Informed Consent, Male, Middle Aged, Young Adult},
	issn = {1552-4833},
	doi = {10.1002/ajmg.a.36706},
	author = {Bergner, Amanda L and Bollinger, Juli and Raraigh, Karen S and Tichnell, Crystal and Murray, Brittney and Blout, Carrie Lynn and Telegrafi, Aida Bytyci and James, Cynthia A}
}
