Dr. Wilfond conducts research on ethical issues related to genetics research and the integration of genetic testing into clinical practice. To reach a balanced, constructive understanding and use of genetic technology, scholars, policy makers, and the public need to examine the benefits and risks of genetic testing and weigh them carefully before drawing conclusions. Dr. Wilfond’s research follows two broad approaches to address these issues: (1) conceptual projects that clarify distinctions and develop theoretical frameworks for evaluating genetic testing issues; and (2) empirical projects that involve collecting and analyzing data for addressing these issues. The two approaches are complementary, and many of his projects utilize components of both approaches.

In one project, Dr. Wilfond’s group is examining the clinical integration of genetic screening tests for newborns. For many years in the United States, state health departments have screened all newborns for 10 or fewer disorders. However, in recent years, some states have expanded these programs to test for disorders such as cystic fibrosis and for an even wider array of metabolic conditions. Before health policy makers widely adopt these new genetic tests, Dr. Wilfond’s group seeks to evaluate the criteria used to make ethical judgments about the health benefits versus the risks and costs of these tests. Decisions about how to design a screening program must take into account such trade-offs.

In another project, Dr. Wilfond is examining issues surrounding direct-to consumer advertisements for genetic tests on the Internet. As more and more disease-associated genes are identified, it is likely that such direct marketing to consumers will expand. In addition, he is investigating issues surrounding genetic research that involves collecting blood and/or tissue samples from people. One issue is whether to disclose preliminary research findings directly to research subjects or to wait until tests are ready for routine use in a clinical setting.

genetic testing

bioethics

Public policy

gene transfer

informed consent

genetic research

genetic counseling

Wilfond BS and Gollust SE. Policy issues for expanding newborn screening programs: The cystic fibrosis newborn screening experience in the United States. J Peds 2005 46:668-74

Leib JR, Gollust SE, Hull SC, and Wilfond BS. Carrier Screening Panels for Ashkenazi Jews: Is More Better? Genetics in Medicine 2005 7:185-190

King NMP, Henderson GE, Churchill LR, Davis AM, Hull SC, Nelson DK,Parham-Vetter PC, Rothschild BR, Easter MM, and Wilfond BS. Consent forms and the therapeutic misconception: The example of gene transfer research. IRB:Ethics & Human Research 2005 27:1-9

Hull SC, Glanz K, Steffan A, and Wilfond BS. Recruitment approaches for family studies. IRB:Ethics & Human Research 2004 26:12-18

Henderson GE, Davis AM, King NM, Easter MM, Zimmer CR, Rothschild BB, Wilfond BS, Nelson DK, Churchill LR. Uncertain benefit: investigators' views and communications in early phase gene transfer trials. Mol Ther 2004 10: 225-31.

Taylor H and Wilfond B. Ethical Issues in Newborn Screening Research: Lessons from the Wisconsin Cystic Fibrosis Trial. J Peds 2004 145:292-6.

Hull SC, Gooding H, Klein AP, Washauer-Baker E, Metosky S, and Wilfond BS. Genetics research involving human biological materials: A need to tailor consent forms IRB:Ethics & Human Research 2004 26(3):1-7

Whittle A, Shah S, Wilfond B, Gensler G, Wendler D. Institutional review practices regarding assent in pediatric research. Pediatrics 2004 113:1747-1752

Freund CL, Clayton EW, and Wilfond BS. Natural Settings Trials: Improving the introduction of new clinical genetic tests. Journal of Law Medicine and Ethics 2004 32:106-110

Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research. JAMA 2004 291:476-482

Coffey MJ, Wilfond B and Ross LF. Ethical assessment of clinical asthma trials including children subjects. Pediatrics 2004 113:87-94

Churchill LR, Nelson DK, Henderson GE, King NMP, Davis AM, Leahey E, Wilfond BS. Assessing benefits in clinical research: Why diversity in benefit assessment can be risky IRB:Ethics & Human Research 2003 25 (3):1-3

Wendler D, Shah S, Whittle A, and Wilfond B. Non-beneficial research in individuals who cannot consent: Is it ethically better to enroll healthy or affected individuals? IRB:Ethics & Human Research 2003 24 (4):1-4

Gollust S, Wilfond BS, and Hull SC. Direct to consumer sales of genetic services over the Internet. Genetics in Medicine 2003 5:332-337

Koogler T, Wilfond B and Ross LF. Lethal language, lethal decisions. Hastings Center Report 2003 33:37-41

Miler F, Wendler D, and Wilfond B. When do the federal regulations allow placebo controlled trials in children. J Peds 2003 142:102-7

Wilfond BS, Geller G, Lerman C, Audrain-McGovern J, and Shields AE. Ethical issues in conducting behavioral genetics research: the case of smoking prevention trials among adolescents. Journal of Health Care Law & Policy 2002 6:73-88

Horng S, Emanuel EJ, Wilfond B, Rackoff J, Martz K, Grady G. Do Consent Forms for Phase I Oncology Trials Over Promise Benefits and Downplay Risks? N Engl J Med 2002 347:2134-40.

Davis AM, Hull SC, Grady G, Wilfond BS and Henderson GE. The Invisible Hand in Clinical Research: The Study Coordinator’s Critical Role in Human Subjects Protection. Journal of Law Medicine and Ethics 2002 30:411-9

Gollust SE, Hull SC, Wilfond BS. Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing. JAMA. 2002 288:1762-7