TY - JOUR
T1 - Biobanking, consent, and commercialization in international genetics research
T2 - the Type 1 Diabetes Genetics Consortium
AU - T1DGC
AU - Hall, Mark A
AU - King, Nancy M P
AU - Perdue, Letitia H
AU - Hilner, Joan E
AU - Akolkar, Beena
AU - Greenbaum, Carla J
AU - McKeon, Catherine
AU - Van Der Auwera, Bart
PY - 2010
Y1 - 2010
N2 - BACKGROUND: andPURPOSE: This article describes several ethical, legal, and social issues typical of international genetics biobanking, as encountered in the Type 1 Diabetes Genetics Consortium (T1DGC).METHODS: By studying the examples set and lessons learned from other international biobanking studies and by devoting considerable time and resources to identifying, addressing, and continually monitoring ethical and regulatory concerns, T1DGC was able to minimize the problems reported by some earlier studies.CONCLUSIONS: Several important conclusions can be drawn based on the experience in this study: (1) Basic international standards for research ethics review and informed consent are broadly consistent across developed countries. (2) When consent forms are adapted locally and translated into different languages, discrepancies are inevitable and therefore require prompt central review and resolution before research is initiated. (3) Providing separate 'check-box' consent for different elements of a study creates confusion and may not be essential. (4) Creating immortalized cell lines to aid future research is broadly acceptable, both in the US and internationally. (5) Imposing some limits on the use of stored samples aids in obtaining ethics approvals worldwide. (6) Allowing potential commercial uses of donated samples is controversial in some Asian countries. (7) Obtaining government approvals can be labor-intensive and time-consuming, and can require legal and diplomatic skills.
AB - BACKGROUND: andPURPOSE: This article describes several ethical, legal, and social issues typical of international genetics biobanking, as encountered in the Type 1 Diabetes Genetics Consortium (T1DGC).METHODS: By studying the examples set and lessons learned from other international biobanking studies and by devoting considerable time and resources to identifying, addressing, and continually monitoring ethical and regulatory concerns, T1DGC was able to minimize the problems reported by some earlier studies.CONCLUSIONS: Several important conclusions can be drawn based on the experience in this study: (1) Basic international standards for research ethics review and informed consent are broadly consistent across developed countries. (2) When consent forms are adapted locally and translated into different languages, discrepancies are inevitable and therefore require prompt central review and resolution before research is initiated. (3) Providing separate 'check-box' consent for different elements of a study creates confusion and may not be essential. (4) Creating immortalized cell lines to aid future research is broadly acceptable, both in the US and internationally. (5) Imposing some limits on the use of stored samples aids in obtaining ethics approvals worldwide. (6) Allowing potential commercial uses of donated samples is controversial in some Asian countries. (7) Obtaining government approvals can be labor-intensive and time-consuming, and can require legal and diplomatic skills.
KW - Biomedical Research/ethics
KW - Cell Line
KW - Data Collection/ethics
KW - Diabetes Mellitus, Type 1/genetics
KW - Ethics, Research
KW - Humans
KW - Informed Consent/ethics
KW - Internationality
KW - Tissue Banks/ethics
U2 - 10.1177/1740774510373492
DO - 10.1177/1740774510373492
M3 - Article
C2 - 20693188
SN - 1551-7144
VL - 7
SP - S33-S45
JO - Contemporary clinical trials
JF - Contemporary clinical trials
IS - 1 Suppl
ER -