Abstract
Background: Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. Purpose and methods: We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results: IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. Limitations: The generalizabilty of results is limited by the inclusion/ exclusion criteria of the trial. Conclusions: Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 443-456 |
| Number of pages | 14 |
| Journal | Clinical Trials |
| Volume | 3 |
| Issue number | 5 |
| DOIs | |
| State | Published - 2006 |
ASJC Scopus subject areas
- Pharmacology
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Consent for genetics studies among clinical trial participants : Findings from action for health in diabetes (Look AHEAD). / Espeland, Mark A.; Dotson, K.; Jaramillo, A. S.; Kahn, E. S.; Harrison, B.; Montez, M.; Foreyt, P. J.; Montgomery, B.; Knowler, C. W.; Brancati, Frederick; Celnik, Debi; Clark, Jeanne; Charleston, Jeanne; Cheskin, Lawrence; Stewart, Kerry; Rubin, Richard; Horak, Kathy; Bray, George A.; Rau, Kristi; Strate, Allison; Greenway, Frank L.; Ryan, Donna H.; Williamson, Donald; Tucker, Elizabeth; Armand, Brandi; Shipp, Mandy; Landry, Kim; Perault, Jennifer; Lewis, Cora; Thomas, Sheikilya; DiLillo, Vicki; Safford, Monika; Glasser, Stephen; Smith, Clara; Roche, Cathy; Bragg, Charlotte; Webb, Nita; Gilbert, Staci; Dobelstein, Amy; Oden, L. Christie; Johnsey, Trena; Nathan, David M.; Turgeon, Heather; Schumann, Kristina P.; Cagliero, Enrico; Hayward, Kathryn; Delahanty, Linda; Steiner, Barbara; Goldman, Valerie; Anderson, Ellen; Bissett, Laurie; McNamara, Alan; Ginsburg, Richard; Harlan, Virginia; Michel, Theresa; Horton, Edward S.; Jackson, Sharon D.; Hamdy, Osama; Caballero, A. Enrique; Ledbury, Sarah; Malloy, Maureen; Goebel-Fabbri, Ann; Ovalle, Kerry; Bain, Sarah; Bovaird, Elizabeth; Lambert, Lori; Blackburn, George; Mantzoros, Christos; McNamara, Ann; McCormick, Heather; Hill, James O.; Miller, Marsha; VanDorsten, Brent; Regensteiner, Judith; Schwartz, Robert; Hamman, Richard; McDermott, Michael; Phillipp, JoAnn A.; Reddin, Patrick; Wallace, Kristin; Cohrs, Paulette; Hamilton, April; Benchekroun, Salma; Green, Susan; Rome, Loretta; Munkwitz, Lindsey; Wallace, Kristin; Cohrs, Paulette; Hamilton, April; Benchekroun, Salma; Green, Susan; Rome, Loretta; Munkwitz, Lindsey; Foreyt, John P.; Reeves, Rebecca S.; Pownall, Henry; Jones, Peter; Balasubramanyam, Ashok; Gee, Molly; Saad, Mohammed F.; Chiu, Ken C.; Ghazarian, Siran; Szamos, Kati; Perpetua, Magpuri; Chan, Michelle; Botrous, Medhat; Johnson, Karen C.; Kitabchi, Abbas E.; Lambeth, Helen; Carmichael, Leeann; Lichtermann, Lynne; Jeffery, Robert W.; Thorson, Carolyn; Bantle, John P.; Redmon, J. Bruce; Crow, Richard S.; Carls, Jeanne; Campbell, Carolyne; James, La Donna; Ockenden, T.; Brelje, Kerrin; Snyder, M. Patricia; Keranen, Amy; Walcheck, Cara; Finch, Emily; Rice, Birgitta I.; Maddy, Vicki A.; Skarphol, Tricia; Pi-Sunyer, Xavier; Patricio, Jennifer; Mayer, Jennifer; Heshka, Stanley; Pal, Carmen; Holowaty, Mary Anne; Hirsch, Diane; Wadden, Thomas A.; Maschak-Carey, Barbara J.; Foster, Gary D.; Berkowitz, Robert I.; Schwartz, Stanley; Kumanyika, Shiriki K.; Mullen, Monica; Hesson, Louise; Lipschutz, Patricia; Fabricatore, Anthony; Crerand, Canice; Kuehnel, Robert; Carvajal, Ray; Davenport, Renee; Chomentowski, Helen; Kelley, David E.; Wesche-Thobaben, Jacqueline; Kuller, Lewis; Kriska, Andrea; Edmundowicz, Daniel; Klem, Mary L.; Bonk, Janet; Rush, Jennifer; Danchenko, Rebecca; Elnyczky, Barb; Vujevich, Karen; Krulia, Janet; Wolf, Donna; Mancino, Juliet; Harper, Pat; Mathews, Anne; Wing, Rena R.; Pera, Vincent; Jakicic, John; Tate, Deborah; Gorin, Amy; Bright, Renee; Coward, Pamela; Robinson, Natalie; Monk, Tammy; Gallagher, Kara; Bertorelli, Anna; Daly, Maureen; Charron, Tatum; Nicholson, Rob; Patterson, Erin; Currin, Julie; Foss, Linda; Robles, Deborah; Bancroft, Barbara; Gauvin, Jennifer; Maier, Deborah; Egan, Caitlin; Phelan, Suzanne; Raynor, Hollie; Kieffer, Don; Raynor, Douglas; Lessard, Lauren; Chula-Maguire, Kimberley; Ferguson, Erica; Carey, Richard; Tavares, Jane; Chenot, Heather; Massaro, J. P.; Haffner, Steve; Montez, Maria; Mobley, Connie; Lorenzo, Carlos; Kahn, Steven E.; Montgomery, Brenda; Knopp, Robert H.; Lipkin, Edward W.; Maciejewski, Matthew L.; Trence, Dace L.; Murillo, Roque M.; Terry Barrett, S.; Knowler, William C.; Bolin, Paula; Killean, Tina; Percy, Carol; Donaldson, Rita; Todacheenie, Bernadette; Glass, Justin; Michaels, Sarah; Krakoff, Jonathan; Curtis, Jeffrey; Bennett, Peter H.; Morgan, Tina; Johnson, Ruby; Manus, Cathy; Smiley, Janelia; Sangster, Sandra; Begay, Shandiin; Roanhorse, Minnie; Fallis, Didas; Scurlock, Nancy; Shovestull, Leigh; Espeland, Mark A.; Bahnson, Judy; Wagenknecht, Lynne; Reboussin, David; Rejeski, W. Jack; Lang, Wei; Bertoni, Alain; Vitolins, Mara; Miller, Gary; Ribisl, Paul; Dotson, Kathy; Hodges, Amelia; Hogan, Patricia; Lane, Kathy; Combs, Carrie; Speas, Christian; West, Delia S.; Herman, William; Nevitt, Michael; Schwartz, Ann; Shepherd, John; Maeda, Jason; Hayashi, Cynthia; Rahorst, Michaela; Palermo, Lisa; Marcovina, Santica M.; Strylewicz, Greg; Prineas, Ronald J.; Zhang, Zhu Ming; Campbell, Charles; Hall, Sharon; Mayer-Davis, Elizabeth J.; Farach, Cecilia; Harrison, Barbara; Yanovski, Susan Z.; Hubbard, Van S.; Cooper, Lawton S.; Obarzanek, Eva; Simons-Morton, Denise; Williamson, David F.; Gregg, Edward W.
In: Clinical Trials, Vol. 3, No. 5, 2006, p. 443-456.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Consent for genetics studies among clinical trial participants
T2 - Findings from action for health in diabetes (Look AHEAD)
AU - Espeland, Mark A.
AU - Dotson, K.
AU - Jaramillo, A. S.
AU - Kahn, E. S.
AU - Harrison, B.
AU - Montez, M.
AU - Foreyt, P. J.
AU - Montgomery, B.
AU - Knowler, C. W.
AU - Brancati, Frederick
AU - Celnik, Debi
AU - Clark, Jeanne
AU - Charleston, Jeanne
AU - Cheskin, Lawrence
AU - Stewart, Kerry
AU - Rubin, Richard
AU - Horak, Kathy
AU - Bray, George A.
AU - Rau, Kristi
AU - Strate, Allison
AU - Greenway, Frank L.
AU - Ryan, Donna H.
AU - Williamson, Donald
AU - Tucker, Elizabeth
AU - Armand, Brandi
AU - Shipp, Mandy
AU - Landry, Kim
AU - Perault, Jennifer
AU - Lewis, Cora
AU - Thomas, Sheikilya
AU - DiLillo, Vicki
AU - Safford, Monika
AU - Glasser, Stephen
AU - Smith, Clara
AU - Roche, Cathy
AU - Bragg, Charlotte
AU - Webb, Nita
AU - Gilbert, Staci
AU - Dobelstein, Amy
AU - Oden, L. Christie
AU - Johnsey, Trena
AU - Nathan, David M.
AU - Turgeon, Heather
AU - Schumann, Kristina P.
AU - Cagliero, Enrico
AU - Hayward, Kathryn
AU - Delahanty, Linda
AU - Steiner, Barbara
AU - Goldman, Valerie
AU - Anderson, Ellen
AU - Bissett, Laurie
AU - McNamara, Alan
AU - Ginsburg, Richard
AU - Harlan, Virginia
AU - Michel, Theresa
AU - Horton, Edward S.
AU - Jackson, Sharon D.
AU - Hamdy, Osama
AU - Caballero, A. Enrique
AU - Ledbury, Sarah
AU - Malloy, Maureen
AU - Goebel-Fabbri, Ann
AU - Ovalle, Kerry
AU - Bain, Sarah
AU - Bovaird, Elizabeth
AU - Lambert, Lori
AU - Blackburn, George
AU - Mantzoros, Christos
AU - McNamara, Ann
AU - McCormick, Heather
AU - Hill, James O.
AU - Miller, Marsha
AU - VanDorsten, Brent
AU - Regensteiner, Judith
AU - Schwartz, Robert
AU - Hamman, Richard
AU - McDermott, Michael
AU - Phillipp, JoAnn A.
AU - Reddin, Patrick
AU - Wallace, Kristin
AU - Cohrs, Paulette
AU - Hamilton, April
AU - Benchekroun, Salma
AU - Green, Susan
AU - Rome, Loretta
AU - Munkwitz, Lindsey
AU - Wallace, Kristin
AU - Cohrs, Paulette
AU - Hamilton, April
AU - Benchekroun, Salma
AU - Green, Susan
AU - Rome, Loretta
AU - Munkwitz, Lindsey
AU - Foreyt, John P.
AU - Reeves, Rebecca S.
AU - Pownall, Henry
AU - Jones, Peter
AU - Balasubramanyam, Ashok
AU - Gee, Molly
AU - Saad, Mohammed F.
AU - Chiu, Ken C.
AU - Ghazarian, Siran
AU - Szamos, Kati
AU - Perpetua, Magpuri
AU - Chan, Michelle
AU - Botrous, Medhat
AU - Johnson, Karen C.
AU - Kitabchi, Abbas E.
AU - Lambeth, Helen
AU - Carmichael, Leeann
AU - Lichtermann, Lynne
AU - Jeffery, Robert W.
AU - Thorson, Carolyn
AU - Bantle, John P.
AU - Redmon, J. Bruce
AU - Crow, Richard S.
AU - Carls, Jeanne
AU - Campbell, Carolyne
AU - James, La Donna
AU - Ockenden, T.
AU - Brelje, Kerrin
AU - Snyder, M. Patricia
AU - Keranen, Amy
AU - Walcheck, Cara
AU - Finch, Emily
AU - Rice, Birgitta I.
AU - Maddy, Vicki A.
AU - Skarphol, Tricia
AU - Pi-Sunyer, Xavier
AU - Patricio, Jennifer
AU - Mayer, Jennifer
AU - Heshka, Stanley
AU - Pal, Carmen
AU - Holowaty, Mary Anne
AU - Hirsch, Diane
AU - Wadden, Thomas A.
AU - Maschak-Carey, Barbara J.
AU - Foster, Gary D.
AU - Berkowitz, Robert I.
AU - Schwartz, Stanley
AU - Kumanyika, Shiriki K.
AU - Mullen, Monica
AU - Hesson, Louise
AU - Lipschutz, Patricia
AU - Fabricatore, Anthony
AU - Crerand, Canice
AU - Kuehnel, Robert
AU - Carvajal, Ray
AU - Davenport, Renee
AU - Chomentowski, Helen
AU - Kelley, David E.
AU - Wesche-Thobaben, Jacqueline
AU - Kuller, Lewis
AU - Kriska, Andrea
AU - Edmundowicz, Daniel
AU - Klem, Mary L.
AU - Bonk, Janet
AU - Rush, Jennifer
AU - Danchenko, Rebecca
AU - Elnyczky, Barb
AU - Vujevich, Karen
AU - Krulia, Janet
AU - Wolf, Donna
AU - Mancino, Juliet
AU - Harper, Pat
AU - Mathews, Anne
AU - Wing, Rena R.
AU - Pera, Vincent
AU - Jakicic, John
AU - Tate, Deborah
AU - Gorin, Amy
AU - Bright, Renee
AU - Coward, Pamela
AU - Robinson, Natalie
AU - Monk, Tammy
AU - Gallagher, Kara
AU - Bertorelli, Anna
AU - Daly, Maureen
AU - Charron, Tatum
AU - Nicholson, Rob
AU - Patterson, Erin
AU - Currin, Julie
AU - Foss, Linda
AU - Robles, Deborah
AU - Bancroft, Barbara
AU - Gauvin, Jennifer
AU - Maier, Deborah
AU - Egan, Caitlin
AU - Phelan, Suzanne
AU - Raynor, Hollie
AU - Kieffer, Don
AU - Raynor, Douglas
AU - Lessard, Lauren
AU - Chula-Maguire, Kimberley
AU - Ferguson, Erica
AU - Carey, Richard
AU - Tavares, Jane
AU - Chenot, Heather
AU - Massaro, J. P.
AU - Haffner, Steve
AU - Montez, Maria
AU - Mobley, Connie
AU - Lorenzo, Carlos
AU - Kahn, Steven E.
AU - Montgomery, Brenda
AU - Knopp, Robert H.
AU - Lipkin, Edward W.
AU - Maciejewski, Matthew L.
AU - Trence, Dace L.
AU - Murillo, Roque M.
AU - Terry Barrett, S.
AU - Knowler, William C.
AU - Bolin, Paula
AU - Killean, Tina
AU - Percy, Carol
AU - Donaldson, Rita
AU - Todacheenie, Bernadette
AU - Glass, Justin
AU - Michaels, Sarah
AU - Krakoff, Jonathan
AU - Curtis, Jeffrey
AU - Bennett, Peter H.
AU - Morgan, Tina
AU - Johnson, Ruby
AU - Manus, Cathy
AU - Smiley, Janelia
AU - Sangster, Sandra
AU - Begay, Shandiin
AU - Roanhorse, Minnie
AU - Fallis, Didas
AU - Scurlock, Nancy
AU - Shovestull, Leigh
AU - Espeland, Mark A.
AU - Bahnson, Judy
AU - Wagenknecht, Lynne
AU - Reboussin, David
AU - Rejeski, W. Jack
AU - Lang, Wei
AU - Bertoni, Alain
AU - Vitolins, Mara
AU - Miller, Gary
AU - Ribisl, Paul
AU - Dotson, Kathy
AU - Hodges, Amelia
AU - Hogan, Patricia
AU - Lane, Kathy
AU - Combs, Carrie
AU - Speas, Christian
AU - West, Delia S.
AU - Herman, William
AU - Nevitt, Michael
AU - Schwartz, Ann
AU - Shepherd, John
AU - Maeda, Jason
AU - Hayashi, Cynthia
AU - Rahorst, Michaela
AU - Palermo, Lisa
AU - Marcovina, Santica M.
AU - Strylewicz, Greg
AU - Prineas, Ronald J.
AU - Zhang, Zhu Ming
AU - Campbell, Charles
AU - Hall, Sharon
AU - Mayer-Davis, Elizabeth J.
AU - Farach, Cecilia
AU - Harrison, Barbara
AU - Yanovski, Susan Z.
AU - Hubbard, Van S.
AU - Cooper, Lawton S.
AU - Obarzanek, Eva
AU - Simons-Morton, Denise
AU - Williamson, David F.
AU - Gregg, Edward W.
PY - 2006
Y1 - 2006
N2 - Background: Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. Purpose and methods: We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results: IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. Limitations: The generalizabilty of results is limited by the inclusion/ exclusion criteria of the trial. Conclusions: Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.
AB - Background: Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. Purpose and methods: We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results: IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. Limitations: The generalizabilty of results is limited by the inclusion/ exclusion criteria of the trial. Conclusions: Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.
UR - http://www.scopus.com/inward/record.url?scp=41249098723&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=41249098723&partnerID=8YFLogxK
U2 - 10.1177/1740774506070727
DO - 10.1177/1740774506070727
M3 - Article
C2 - 17060218
AN - SCOPUS:41249098723
VL - 3
SP - 443
EP - 456
JO - Clinical Trials
JF - Clinical Trials
SN - 1740-7745
IS - 5
ER -