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 StrateFrank 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, JoAnn A. 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 C. 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 journalArticlepeer-review

26 Scopus citations

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 - 2006

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