Consent for genetics studies among clinical trial participants

Findings from action for health in diabetes (Look AHEAD)

Mark A. Espeland, K. Dotson, A. S. Jaramillo, E. S. Kahn, B. Harrison, M. Montez, P. J. Foreyt, B. Montgomery, C. W. Knowler, Frederick Brancati, Debi Celnik, Jeanne Clark, Jeanne Charleston, Lawrence Cheskin, Kerry Stewart, Richard Rubin, Kathy Horak, George A. Bray, Kristi Rau, Allison Strate & 253 others Frank L. Greenway, Donna H. Ryan, Donald Williamson, Elizabeth Tucker, Brandi Armand, Mandy Shipp, Kim Landry, Jennifer Perault, Cora Lewis, Sheikilya Thomas, Vicki DiLillo, Monika Safford, Stephen Glasser, Clara Smith, Cathy Roche, Charlotte Bragg, Nita Webb, Staci Gilbert, Amy Dobelstein, L. Christie Oden, Trena Johnsey, David M. Nathan, Heather Turgeon, Kristina P. Schumann, Enrico Cagliero, Kathryn Hayward, Linda Delahanty, Barbara Steiner, Valerie Goldman, Ellen Anderson, Laurie Bissett, Alan McNamara, Richard Ginsburg, Virginia Harlan, Theresa Michel, Edward S. Horton, Sharon D. Jackson, Osama Hamdy, A. Enrique Caballero, Sarah Ledbury, Maureen Malloy, Ann Goebel-Fabbri, Kerry Ovalle, Sarah Bain, Elizabeth Bovaird, Lori Lambert, George Blackburn, Christos Mantzoros, Ann McNamara, Heather McCormick, James O. Hill, Marsha Miller, Brent VanDorsten, Judith Regensteiner, Robert Schwartz, Richard Hamman, Michael McDermott, Jo Ann Phillipp, Patrick Reddin, Kristin Wallace, Paulette Cohrs, April Hamilton, Salma Benchekroun, Susan Green, Loretta Rome, Lindsey Munkwitz, Kristin Wallace, Paulette Cohrs, April Hamilton, Salma Benchekroun, Susan Green, Loretta Rome, Lindsey Munkwitz, John P. Foreyt, Rebecca S. Reeves, Henry Pownall, Peter Jones, Ashok Balasubramanyam, Molly Gee, Mohammed F. Saad, Ken C. Chiu, Siran Ghazarian, Kati Szamos, Magpuri Perpetua, Michelle Chan, Medhat Botrous, Karen Johnson, Abbas E. Kitabchi, Helen Lambeth, Leeann Carmichael, Lynne Lichtermann, Robert W. Jeffery, Carolyn Thorson, John P. Bantle, J. Bruce Redmon, Richard S. Crow, Jeanne Carls, Carolyne Campbell, La Donna James, T. Ockenden, Kerrin Brelje, M. Patricia Snyder, Amy Keranen, Cara Walcheck, Emily Finch, Birgitta I. Rice, Vicki A. Maddy, Tricia Skarphol, Xavier Pi-Sunyer, Jennifer Patricio, Jennifer Mayer, Stanley Heshka, Carmen Pal, Mary Anne Holowaty, Diane Hirsch, Thomas A. Wadden, Barbara J. Maschak-Carey, Gary D. Foster, Robert I. Berkowitz, Stanley Schwartz, Shiriki K. Kumanyika, Monica Mullen, Louise Hesson, Patricia Lipschutz, Anthony Fabricatore, Canice Crerand, Robert Kuehnel, Ray Carvajal, Renee Davenport, Helen Chomentowski, David E. Kelley, Jacqueline Wesche-Thobaben, Lewis Kuller, Andrea Kriska, Daniel Edmundowicz, Mary L. Klem, Janet Bonk, Jennifer Rush, Rebecca Danchenko, Barb Elnyczky, Karen Vujevich, Janet Krulia, Donna Wolf, Juliet Mancino, Pat Harper, Anne Mathews, Rena R. Wing, Vincent Pera, John Jakicic, Deborah Tate, Amy Gorin, Renee Bright, Pamela Coward, Natalie Robinson, Tammy Monk, Kara Gallagher, Anna Bertorelli, Maureen Daly, Tatum Charron, Rob Nicholson, Erin Patterson, Julie Currin, Linda Foss, Deborah Robles, Barbara Bancroft, Jennifer Gauvin, Deborah Maier, Caitlin Egan, Suzanne Phelan, Hollie Raynor, Don Kieffer, Douglas Raynor, Lauren Lessard, Kimberley Chula-Maguire, Erica Ferguson, Richard Carey, Jane Tavares, Heather Chenot, J. P. Massaro, Steve Haffner, Maria Montez, Connie Mobley, Carlos Lorenzo, Steven E. Kahn, Brenda Montgomery, Robert H. Knopp, Edward W. Lipkin, Matthew L. Maciejewski, Dace L. Trence, Roque M. Murillo, S. Terry Barrett, William C. Knowler, Paula Bolin, Tina Killean, Carol Percy, Rita Donaldson, Bernadette Todacheenie, Justin Glass, Sarah Michaels, Jonathan Krakoff, Jeffrey Curtis, Peter H. Bennett, Tina Morgan, Ruby Johnson, Cathy Manus, Janelia Smiley, Sandra Sangster, Shandiin Begay, Minnie Roanhorse, Didas Fallis, Nancy Scurlock, Leigh Shovestull, Mark A. Espeland, Judy Bahnson, Lynne Wagenknecht, David Reboussin, W. Jack Rejeski, Wei Lang, Alain Bertoni, Mara Vitolins, Gary Miller, Paul Ribisl, Kathy Dotson, Amelia Hodges, Patricia Hogan, Kathy Lane, Carrie Combs, Christian Speas, Delia S. West, William Herman, Michael Nevitt, Ann Schwartz, John Shepherd, Jason Maeda, Cynthia Hayashi, Michaela Rahorst, Lisa Palermo, Santica M. Marcovina, Greg Strylewicz, Ronald J. Prineas, Zhu Ming Zhang, Charles Campbell, Sharon Hall, Elizabeth J. Mayer-Davis, Cecilia Farach, Barbara Harrison, Susan Z. Yanovski, Van S. Hubbard, Lawton S. Cooper, Eva Obarzanek, Denise Simons-Morton, David F. Williamson, Edward W. Gregg

Research output: Contribution to journalArticle

26 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)443-456
Number of pages14
JournalClinical Trials
Volume3
Issue number5
DOIs
StatePublished - Dec 1 2006

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Research Ethics Committees
Weight Loss
Clinical Trials
Consent Forms
Genetic Research
DNA
Health
Hispanic Americans
African Americans
Type 2 Diabetes Mellitus
Genes
Disease Progression
Life Style
Cohort Studies
Cardiovascular Diseases
Incidence
Research
Genetic Background

All Science Journal Classification (ASJC) codes

  • Pharmacology

Cite this

Espeland, M. A., Dotson, K., Jaramillo, A. S., Kahn, E. S., Harrison, B., Montez, M., ... Gregg, E. W. (2006). Consent for genetics studies among clinical trial participants: Findings from action for health in diabetes (Look AHEAD). Clinical Trials, 3(5), 443-456. https://doi.org/10.1177/1740774506070727

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, Jo Ann; 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; 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, 01.12.2006, p. 443-456.

Research output: Contribution to journalArticle

Espeland, MA, Dotson, K, Jaramillo, AS, Kahn, ES, Harrison, B, Montez, M, Foreyt, PJ, Montgomery, B, Knowler, CW, Brancati, F, Celnik, D, Clark, J, Charleston, J, Cheskin, L, Stewart, K, Rubin, R, Horak, K, Bray, GA, Rau, K, Strate, A, Greenway, FL, Ryan, DH, Williamson, D, Tucker, E, Armand, B, Shipp, M, Landry, K, Perault, J, Lewis, C, Thomas, S, DiLillo, V, Safford, M, Glasser, S, Smith, C, Roche, C, Bragg, C, Webb, N, Gilbert, S, Dobelstein, A, Oden, LC, Johnsey, T, Nathan, DM, Turgeon, H, Schumann, KP, Cagliero, E, Hayward, K, Delahanty, L, Steiner, B, Goldman, V, Anderson, E, Bissett, L, McNamara, A, Ginsburg, R, Harlan, V, Michel, T, Horton, ES, Jackson, SD, Hamdy, O, Caballero, AE, Ledbury, S, Malloy, M, Goebel-Fabbri, A, Ovalle, K, Bain, S, Bovaird, E, Lambert, L, Blackburn, G, Mantzoros, C, McNamara, A, McCormick, H, Hill, JO, Miller, M, VanDorsten, B, Regensteiner, J, Schwartz, R, Hamman, R, McDermott, M, Phillipp, JA, Reddin, P, Wallace, K, Cohrs, P, Hamilton, A, Benchekroun, S, Green, S, Rome, L, Munkwitz, L, Wallace, K, Cohrs, P, Hamilton, A, Benchekroun, S, Green, S, Rome, L, Munkwitz, L, Foreyt, JP, Reeves, RS, Pownall, H, Jones, P, Balasubramanyam, A, Gee, M, Saad, MF, Chiu, KC, Ghazarian, S, Szamos, K, Perpetua, M, Chan, M, Botrous, M, Johnson, K, Kitabchi, AE, Lambeth, H, Carmichael, L, Lichtermann, L, Jeffery, RW, Thorson, C, Bantle, JP, Redmon, JB, Crow, RS, Carls, J, Campbell, C, James, LD, Ockenden, T, Brelje, K, Snyder, MP, Keranen, A, Walcheck, C, Finch, E, Rice, BI, Maddy, VA, Skarphol, T, Pi-Sunyer, X, Patricio, J, Mayer, J, Heshka, S, Pal, C, Holowaty, MA, Hirsch, D, Wadden, TA, Maschak-Carey, BJ, Foster, GD, Berkowitz, RI, Schwartz, S, Kumanyika, SK, Mullen, M, Hesson, L, Lipschutz, P, Fabricatore, A, Crerand, C, Kuehnel, R, Carvajal, R, Davenport, R, Chomentowski, H, Kelley, DE, Wesche-Thobaben, J, Kuller, L, Kriska, A, Edmundowicz, D, Klem, ML, Bonk, J, Rush, J, Danchenko, R, Elnyczky, B, Vujevich, K, Krulia, J, Wolf, D, Mancino, J, Harper, P, Mathews, A, Wing, RR, Pera, V, Jakicic, J, Tate, D, Gorin, A, Bright, R, Coward, P, Robinson, N, Monk, T, Gallagher, K, Bertorelli, A, Daly, M, Charron, T, Nicholson, R, Patterson, E, Currin, J, Foss, L, Robles, D, Bancroft, B, Gauvin, J, Maier, D, Egan, C, Phelan, S, Raynor, H, Kieffer, D, Raynor, D, Lessard, L, Chula-Maguire, K, Ferguson, E, Carey, R, Tavares, J, Chenot, H, Massaro, JP, Haffner, S, Montez, M, Mobley, C, Lorenzo, C, Kahn, SE, Montgomery, B, Knopp, RH, Lipkin, EW, Maciejewski, ML, Trence, DL, Murillo, RM, Terry Barrett, S, Knowler, WC, Bolin, P, Killean, T, Percy, C, Donaldson, R, Todacheenie, B, Glass, J, Michaels, S, Krakoff, J, Curtis, J, Bennett, PH, Morgan, T, Johnson, R, Manus, C, Smiley, J, Sangster, S, Begay, S, Roanhorse, M, Fallis, D, Scurlock, N, Shovestull, L, Espeland, MA, Bahnson, J, Wagenknecht, L, Reboussin, D, Rejeski, WJ, Lang, W, Bertoni, A, Vitolins, M, Miller, G, Ribisl, P, Dotson, K, Hodges, A, Hogan, P, Lane, K, Combs, C, Speas, C, West, DS, Herman, W, Nevitt, M, Schwartz, A, Shepherd, J, Maeda, J, Hayashi, C, Rahorst, M, Palermo, L, Marcovina, SM, Strylewicz, G, Prineas, RJ, Zhang, ZM, Campbell, C, Hall, S, Mayer-Davis, EJ, Farach, C, Harrison, B, Yanovski, SZ, Hubbard, VS, Cooper, LS, Obarzanek, E, Simons-Morton, D, Williamson, DF & Gregg, EW 2006, 'Consent for genetics studies among clinical trial participants: Findings from action for health in diabetes (Look AHEAD)', Clinical Trials, vol. 3, no. 5, pp. 443-456. https://doi.org/10.1177/1740774506070727
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, Jo Ann ; 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 ; 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. / Consent for genetics studies among clinical trial participants : Findings from action for health in diabetes (Look AHEAD). In: Clinical Trials. 2006 ; Vol. 3, No. 5. pp. 443-456.
@article{b179cca9003248b5a7a5206efe181fd0,
title = "Consent for genetics studies among clinical trial participants: Findings from action for health in diabetes (Look AHEAD)",
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.",
author = "Espeland, {Mark A.} and K. Dotson and Jaramillo, {A. S.} and Kahn, {E. S.} and B. Harrison and M. Montez and Foreyt, {P. J.} and B. Montgomery and Knowler, {C. W.} and Frederick Brancati and Debi Celnik and Jeanne Clark and Jeanne Charleston and Lawrence Cheskin and Kerry Stewart and Richard Rubin and Kathy Horak and Bray, {George A.} and Kristi Rau and Allison Strate and Greenway, {Frank L.} and Ryan, {Donna H.} and Donald Williamson and Elizabeth Tucker and Brandi Armand and Mandy Shipp and Kim Landry and Jennifer Perault and Cora Lewis and Sheikilya Thomas and Vicki DiLillo and Monika Safford and Stephen Glasser and Clara Smith and Cathy Roche and Charlotte Bragg and Nita Webb and Staci Gilbert and Amy Dobelstein and Oden, {L. Christie} and Trena Johnsey and Nathan, {David M.} and Heather Turgeon and Schumann, {Kristina P.} and Enrico Cagliero and Kathryn Hayward and Linda Delahanty and Barbara Steiner and Valerie Goldman and Ellen Anderson and Laurie Bissett and Alan McNamara and Richard Ginsburg and Virginia Harlan and Theresa Michel and Horton, {Edward S.} and Jackson, {Sharon D.} and Osama Hamdy and Caballero, {A. Enrique} and Sarah Ledbury and Maureen Malloy and Ann Goebel-Fabbri and Kerry Ovalle and Sarah Bain and Elizabeth Bovaird and Lori Lambert and George Blackburn and Christos Mantzoros and Ann McNamara and Heather McCormick and Hill, {James O.} and Marsha Miller and Brent VanDorsten and Judith Regensteiner and Robert Schwartz and Richard Hamman and Michael McDermott and Phillipp, {Jo Ann} and Patrick Reddin and Kristin Wallace and Paulette Cohrs and April Hamilton and Salma Benchekroun and Susan Green and Loretta Rome and Lindsey Munkwitz and Kristin Wallace and Paulette Cohrs and April Hamilton and Salma Benchekroun and Susan Green and Loretta Rome and Lindsey Munkwitz and Foreyt, {John P.} and Reeves, {Rebecca S.} and Henry Pownall and Peter Jones and Ashok Balasubramanyam and Molly Gee and Saad, {Mohammed F.} and Chiu, {Ken C.} and Siran Ghazarian and Kati Szamos and Magpuri Perpetua and Michelle Chan and Medhat Botrous and Karen Johnson and Kitabchi, {Abbas E.} and Helen Lambeth and Leeann Carmichael and Lynne Lichtermann and Jeffery, {Robert W.} and Carolyn Thorson and Bantle, {John P.} and Redmon, {J. Bruce} and Crow, {Richard S.} and Jeanne Carls and Carolyne Campbell and James, {La Donna} and T. Ockenden and Kerrin Brelje and Snyder, {M. Patricia} and Amy Keranen and Cara Walcheck and Emily Finch and Rice, {Birgitta I.} and Maddy, {Vicki A.} and Tricia Skarphol and Xavier Pi-Sunyer and Jennifer Patricio and Jennifer Mayer and Stanley Heshka and Carmen Pal and Holowaty, {Mary Anne} and Diane Hirsch and Wadden, {Thomas A.} and Maschak-Carey, {Barbara J.} and Foster, {Gary D.} and Berkowitz, {Robert I.} and Stanley Schwartz and Kumanyika, {Shiriki K.} and Monica Mullen and Louise Hesson and Patricia Lipschutz and Anthony Fabricatore and Canice Crerand and Robert Kuehnel and Ray Carvajal and Renee Davenport and Helen Chomentowski and Kelley, {David E.} and Jacqueline Wesche-Thobaben and Lewis Kuller and Andrea Kriska and Daniel Edmundowicz and Klem, {Mary L.} and Janet Bonk and Jennifer Rush and Rebecca Danchenko and Barb Elnyczky and Karen Vujevich and Janet Krulia and Donna Wolf and Juliet Mancino and Pat Harper and Anne Mathews and Wing, {Rena R.} and Vincent Pera and John Jakicic and Deborah Tate and Amy Gorin and Renee Bright and Pamela Coward and Natalie Robinson and Tammy Monk and Kara Gallagher and Anna Bertorelli and Maureen Daly and Tatum Charron and Rob Nicholson and Erin Patterson and Julie Currin and Linda Foss and Deborah Robles and Barbara Bancroft and Jennifer Gauvin and Deborah Maier and Caitlin Egan and Suzanne Phelan and Hollie Raynor and Don Kieffer and Douglas Raynor and Lauren Lessard and Kimberley Chula-Maguire and Erica Ferguson and Richard Carey and Jane Tavares and Heather Chenot and Massaro, {J. P.} and Steve Haffner and Maria Montez and Connie Mobley and Carlos Lorenzo and Kahn, {Steven E.} and Brenda Montgomery and Knopp, {Robert H.} and Lipkin, {Edward W.} and Maciejewski, {Matthew L.} and Trence, {Dace L.} and Murillo, {Roque M.} and {Terry Barrett}, S. and Knowler, {William C.} and Paula Bolin and Tina Killean and Carol Percy and Rita Donaldson and Bernadette Todacheenie and Justin Glass and Sarah Michaels and Jonathan Krakoff and Jeffrey Curtis and Bennett, {Peter H.} and Tina Morgan and Ruby Johnson and Cathy Manus and Janelia Smiley and Sandra Sangster and Shandiin Begay and Minnie Roanhorse and Didas Fallis and Nancy Scurlock and Leigh Shovestull and Espeland, {Mark A.} and Judy Bahnson and Lynne Wagenknecht and David Reboussin and Rejeski, {W. Jack} and Wei Lang and Alain Bertoni and Mara Vitolins and Gary Miller and Paul Ribisl and Kathy Dotson and Amelia Hodges and Patricia Hogan and Kathy Lane and Carrie Combs and Christian Speas and West, {Delia S.} and William Herman and Michael Nevitt and Ann Schwartz and John Shepherd and Jason Maeda and Cynthia Hayashi and Michaela Rahorst and Lisa Palermo and Marcovina, {Santica M.} and Greg Strylewicz and Prineas, {Ronald J.} and Zhang, {Zhu Ming} and Charles Campbell and Sharon Hall and Mayer-Davis, {Elizabeth J.} and Cecilia Farach and Barbara Harrison and Yanovski, {Susan Z.} and Hubbard, {Van S.} and Cooper, {Lawton S.} and Eva Obarzanek and Denise Simons-Morton and Williamson, {David F.} and Gregg, {Edward W.}",
year = "2006",
month = "12",
day = "1",
doi = "10.1177/1740774506070727",
language = "English (US)",
volume = "3",
pages = "443--456",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "5",

}

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, Jo Ann

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

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 - 2006/12/1

Y1 - 2006/12/1

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

VL - 3

SP - 443

EP - 456

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 5

ER -