Research ethics recommendations for whole-genome research: consensus statement.

摘要: Advances in technology have made it possible to sequence a whole human genome [1,2]. National and international funding initiatives stimulated whole-genome research activities [3,4], media coverage of both the science [5,6] emerging commercial offerings [7,8] related has heightened public awareness interest personal genomics. As continues advance, seem likely intensify expand, necessitating carefully considered consensus guidelines for ethical practice. To date, there been only minimal consideration ethics issues associated with this work [9–12]. We therefore convened an interdisciplinary workshop develop ethically rigorous practical guidance investigators boards. What follows are recommendations on four topics that were focus workshop. These topics—consent, withdrawal from research, return results, data release—were selected because they viewed as being among most pressing representing areas where analysis creates unique challenges. They not, course, policy need be considered; commercialization, patenting, benefit sharing, possibility genetic discrimination other warrant reflection. Regardless, covered paper current worthy immediate attention. The starts initial considerations, including general about governance characterization genome. It is important note while was all recommendations, good deal debate degree which satisfy existing legal norms [13]. All participants believed we empirical continued conceptual (Box 1). early days field research. Research needed immediately, but should continue explore ethical, legal, social implications rapidly evolving 2). Indeed, door must remain open further reflection these concerns. Box 1. Ethical Questions Future The following list questions future investigation analysis. not exhaustive Duty Recontact: Given numerous disciplines health care providers potentially involved obligations each (particularly context results) seems warranted. Who what obligations? Who, if anyone, duty results? Is “chain obligation” runs through various members team? Right Withdraw: Because potential rapid dissemination right withdraw can quickly become impractical. This raises issue requirement structure results manner will allow endure long possible. such, investigated norms, information tools may facilitate withdrawal, structures implemented. Risk/Benefit Analysis: There comprehensive risk/benefit sharing. Studies impact restricted access versus would useful, include costs actual risk harm. Governance Structures: systematically evaluate structures. ways new technologies utilized facilitate, inter alia: communication participants; withdraw; and, when appropriate, community engagement. Box 2. Personal Genome Research: Are Possible Risks? By Timothy Caulfield, Mildred Cho, Amy McGuire The ability individual's entire production unprecedented amount detailed information, helping researchers relationship genes environment development wide variety diseases. But imagine participant exciting field. Researchers seeking produce record your information. result, known predispositions available depending sharing policy, accessible range possibly, at large—this, time still understand social, clinical, information. These uncertainties create do you tell during consent process risks don't clear sense their nature? Also, difficult know, recruitment, exactly how used, by whom. While speculative, much conducted highly respected leading academic centers, one number controversial scenarios. Some far-fetched, intend alarmist, recognize just breach similar those described below, or even threat such breach, could hurt trust significantly hamper conduct research. Imagine watching news learn study linking race IQ, find offensive. You later used DNA study. donated five years ago use association cancer heart disease. At time, told might want types consent, too late. Your analyzed many now integrated databanks throughout world. Imagine sitting home, minding own business, police show up search warrant. looking suspect crime scene 2,000 miles away Des Moines, Iowa. turns out some left matched sample publicly scientific database contained brothers. Imagine first explained part no genetics returned you. Years later, heritable form team genetically predisposed To complicate matters further, large siblings, none whom know predispositions. all. Imagine opened electronics recycling business trying private insurance. friend recommends contact specific company. enrollment process, company finds participated released into database. By accessing database, increased early-onset Alzheimer disease susceptible chemicals encountered process. also greatly colon cancer, alerts take screening preventive measures. This is, doubt, And cannot move forward without participants. kind limited events rare. But history us occur devastating environment. critical moves forward, place, outlined paper, promote help avoid, possible, scenarios like above.