Patients' views on identifiability of samples and informed consent for genetic research

Sara Chandros Hull, Richard R Sharp, Jeffrey R. Botkin, Mark Brown, Mark Hughes, Jeremy Sugarman, Debra Schwinn, Pamela Sankar, Dragana Bolcic-Jankovic, Brian R. Clarridge, Benjamin S. Wilfond, Treuman Katz

Research output: Contribution to journalArticle

79 Citations (Scopus)

Abstract

It is unclear whether the regulatory distinction between non-identifiable and identifiable information - information used to determine informed consent practices for the use of clinically derived samples for genetic research - is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37%) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.

Original languageEnglish (US)
Pages (from-to)62-70
Number of pages9
JournalAmerican Journal of Bioethics
Volume8
Issue number10
DOIs
StatePublished - Oct 2008
Externally publishedYes

Fingerprint

Genetic Research
Informed Consent
Patient Preference
Medicine Chests
Research Personnel
Exploratory Behavior
Medical Oncology
Administrative Personnel
Research
Thoracic Surgery
Interviews
Education
Health

Keywords

  • Genetic research
  • Identifiable information
  • Informed consent
  • Non-identifiable information
  • Stored samples

ASJC Scopus subject areas

  • Health Policy
  • Issues, ethics and legal aspects

Cite this

Patients' views on identifiability of samples and informed consent for genetic research. / Hull, Sara Chandros; Sharp, Richard R; Botkin, Jeffrey R.; Brown, Mark; Hughes, Mark; Sugarman, Jeremy; Schwinn, Debra; Sankar, Pamela; Bolcic-Jankovic, Dragana; Clarridge, Brian R.; Wilfond, Benjamin S.; Katz, Treuman.

In: American Journal of Bioethics, Vol. 8, No. 10, 10.2008, p. 62-70.

Research output: Contribution to journalArticle

Hull, SC, Sharp, RR, Botkin, JR, Brown, M, Hughes, M, Sugarman, J, Schwinn, D, Sankar, P, Bolcic-Jankovic, D, Clarridge, BR, Wilfond, BS & Katz, T 2008, 'Patients' views on identifiability of samples and informed consent for genetic research', American Journal of Bioethics, vol. 8, no. 10, pp. 62-70. https://doi.org/10.1080/15265160802478404
Hull, Sara Chandros ; Sharp, Richard R ; Botkin, Jeffrey R. ; Brown, Mark ; Hughes, Mark ; Sugarman, Jeremy ; Schwinn, Debra ; Sankar, Pamela ; Bolcic-Jankovic, Dragana ; Clarridge, Brian R. ; Wilfond, Benjamin S. ; Katz, Treuman. / Patients' views on identifiability of samples and informed consent for genetic research. In: American Journal of Bioethics. 2008 ; Vol. 8, No. 10. pp. 62-70.
@article{0c6e847288ad4e1eb3020c6c0619b0be,
title = "Patients' views on identifiability of samples and informed consent for genetic research",
abstract = "It is unclear whether the regulatory distinction between non-identifiable and identifiable information - information used to determine informed consent practices for the use of clinically derived samples for genetic research - is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know about research being done was important to 72{\%} of patients when samples would be anonymous and to 81{\%} of patients when samples would be identifiable. Only 17{\%} wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37{\%}) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57{\%} would require researchers to seek permission, whereas 43{\%} would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.",
keywords = "Genetic research, Identifiable information, Informed consent, Non-identifiable information, Stored samples",
author = "Hull, {Sara Chandros} and Sharp, {Richard R} and Botkin, {Jeffrey R.} and Mark Brown and Mark Hughes and Jeremy Sugarman and Debra Schwinn and Pamela Sankar and Dragana Bolcic-Jankovic and Clarridge, {Brian R.} and Wilfond, {Benjamin S.} and Treuman Katz",
year = "2008",
month = "10",
doi = "10.1080/15265160802478404",
language = "English (US)",
volume = "8",
pages = "62--70",
journal = "American Journal of Bioethics",
issn = "1526-5161",
publisher = "Routledge",
number = "10",

}

TY - JOUR

T1 - Patients' views on identifiability of samples and informed consent for genetic research

AU - Hull, Sara Chandros

AU - Sharp, Richard R

AU - Botkin, Jeffrey R.

AU - Brown, Mark

AU - Hughes, Mark

AU - Sugarman, Jeremy

AU - Schwinn, Debra

AU - Sankar, Pamela

AU - Bolcic-Jankovic, Dragana

AU - Clarridge, Brian R.

AU - Wilfond, Benjamin S.

AU - Katz, Treuman

PY - 2008/10

Y1 - 2008/10

N2 - It is unclear whether the regulatory distinction between non-identifiable and identifiable information - information used to determine informed consent practices for the use of clinically derived samples for genetic research - is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37%) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.

AB - It is unclear whether the regulatory distinction between non-identifiable and identifiable information - information used to determine informed consent practices for the use of clinically derived samples for genetic research - is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37%) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.

KW - Genetic research

KW - Identifiable information

KW - Informed consent

KW - Non-identifiable information

KW - Stored samples

UR - http://www.scopus.com/inward/record.url?scp=56049124576&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=56049124576&partnerID=8YFLogxK

U2 - 10.1080/15265160802478404

DO - 10.1080/15265160802478404

M3 - Article

C2 - 19003716

AN - SCOPUS:56049124576

VL - 8

SP - 62

EP - 70

JO - American Journal of Bioethics

JF - American Journal of Bioethics

SN - 1526-5161

IS - 10

ER -