Document ID: FDA-2009-N-0592-0005
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-30T05:00Z

<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<META name="generator" content="/humansubjects/guidance/ documents">
<META name="creation-date" content="29/12/2009 10:33:48 ">
<TITLE>/humansubjects/guidance/ documents</TITLE>
<SCRIPT LANGUAGE="JavaScript1.2"> var agt=navigator.userAgent.toLowerCase();if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('mozilla')!=-1) && (agt.indexOf('spoofer')==-1)&& (agt.indexOf('compatible') == -1) ){msie = false;} else if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('msie') != -1) ) {msie = true;	} page=0;</SCRIPT>
</HEAD>
<BODY bgcolor="#ffffff" text="#000000" topmargin=0 leftmargin=0 marginheight=0 marginwidth=0 >
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:3.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:224.75pt;top:42.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">The Belmont Report</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:214.80pt;top:78.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Office of the Secretary</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:58.20pt;top:114.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Ethical Principles and Guidelines for the Protection of Human</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:220.90pt;top:133.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Subjects of Research</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:49.65pt;top:168.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">The National Commission for the Protection of Human Subjects</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:148.25pt;top:188.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">of Biomedical and Behavioral Research</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.85pt;top:223.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">April 18, 1979</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:297.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">AGENCY: </FONT></b><FONT STYLE="font-size: 14.00pt">Department of Health, Education, and Welfare.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:333.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">ACTION: </FONT></b><FONT STYLE="font-size: 14.00pt">Notice of Report for Public Comment.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:369.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">SUMMARY: </FONT></b><FONT STYLE="font-size: 14.00pt">On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:386.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">law, there-by creating the National Commission for the Protection of Human Subjects of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:403.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Biomedical and Behavioral Research. One of the charges to the Commission was to identify</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:420.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the basic ethical principles that should underlie the conduct of biomedical and behavioral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:436.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research involving human subjects and to develop guidelines which should be followed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:453.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">assure that such research is conducted in accordance with those principles. In carrying out the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:470.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">above, the Commission was directed to consider: </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(i) </FONT></b><FONT STYLE="font-size: 14.00pt">the boundaries between biomedical and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:486.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">behavioral research and the accepted and routine practice of medicine, </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(ii) </FONT></b><FONT STYLE="font-size: 14.00pt">the role of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:504.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">assessment of risk-benefit criteria in the determination of the appropriateness of research</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:520.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">involving human subjects, </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(iii) </FONT></b><FONT STYLE="font-size: 14.00pt">appropriate guidelines for the selection of human subjects for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:537.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">participation in such research and </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(iv) </FONT></b><FONT STYLE="font-size: 14.00pt">the nature and definition of informed consent in various</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:554.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research settings.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:590.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The Belmont Report attempts to summarize the basic ethical principles identified by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:607.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Commission in the course of its deliberations. It is the outgrowth of an intensive four-day</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:624.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:640.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Conference Center supplemented by the monthly deliberations of the Commission that were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:657.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">held over a period of nearly four years. It is a statement of basic ethical principles and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:674.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">guidelines that should assist in resolving the ethical problems that surround the conduct of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:691.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research with human subjects. By publishing the Report in the Federal Register, and providing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:708.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">reprints upon request, the Secretary intends that it may be made readily available to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:724.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">scientists, members of Institutional Review Boards, and Federal employees. The two-volume</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:776.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (1 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:0.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:795.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:816.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Appendix, containing the lengthy reports of experts and specialists who assisted the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:833.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:850.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:866.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Printing Office, Washington, D.C. 20402.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:902.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Unlike most other reports of the Commission, the Belmont Report does not make specific</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:919.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">recommendations for administrative action by the Secretary of Health, Education, and Welfare.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:936.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:953.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">statement of the Department's policy. The Department requests public comment on this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:969.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">recommendation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:66.95pt;top:1040.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">National Commission for the Protection of Human Subjects</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:148.25pt;top:1059.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">of Biomedical and Behavioral Research</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:191.10pt;top:1097.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Members of the Commission</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1136.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Kenneth John Ryan, M.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1153.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., Chairman, Chief of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1170.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Staff, Boston</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1187.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Hospital for Women.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1203.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Joseph V. Brady, Ph.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1220.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., Professor of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1237.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Behavioral Biology,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1254.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Johns Hopkins</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1271.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">University.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1287.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Robert E. Cooke, M.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1304.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., President, Medical</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1321.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">College of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1338.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Pennsylvania.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1355.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Dorothy I. Height,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1371.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">President, National</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1388.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Council of Negro</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1405.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Women, Inc.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1422.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Albert R. Jonsen, Ph.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1439.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., Associate</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1455.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Professor of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1472.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Bioethics, University</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1489.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">of California at San</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1506.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Francisco.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1523.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Patricia King, J.D.,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:1568.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (2 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:792.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background1.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:1584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:1587.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1608.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Associate Professor of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1625.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Law, Georgetown</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1641.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">University Law Center.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1658.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Karen Lebacqz, Ph.D.,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1675.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Associate Professor of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1692.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Christian Ethics,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1709.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Pacific School of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1725.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Religion.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1742.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">*** </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">David W. Louisell, J.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1759.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., Professor of Law,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1776.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">University of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1793.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">California at Berkeley.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1809.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Donald W. Seldin, M.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1826.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., Professor and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1843.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Chairman, Department</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1860.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">of Internal Medicine,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1877.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">University of Texas at</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1893.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Dallas.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1910.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">***</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Eliot Stellar, Ph.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1927.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">D., Provost of the</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1944.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">University and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1961.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Professor of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1977.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Physiological</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:1994.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Psychology, University</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2011.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">of Pennsylvania.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2028.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">*** </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Robert H. Turtle, LL.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2045.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">B., Attorney,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2061.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">VomBaur, Coburn,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2078.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Simmons & Turtle,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2095.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Washington, D.C.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2126.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">*** </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 14.31pt">Deceased.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:234.70pt;top:2196.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Table of Contents</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2251.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">Ethical Principles and Guidelines for Research Involving Human Subjects</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2289.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">A. Boundaries Between Practice and Research</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:2360.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (3 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:1584.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background2.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:2376.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:2379.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2400.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">B. Basic Ethical Principles</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2438.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">1. Respect for Persons</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2457.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">2. Beneficence</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2475.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">3. Justice</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2513.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">C. Applications</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2551.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">1. Informed Consent</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2570.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">2. Assessment of Risk and Benefits</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:50.00pt;top:2589.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">3. Selection of Subjects</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:19.75pt;top:2661.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Ethical Principles & Guidelines for Research Involving Human Subjects</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2700.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Scientific research has produced substantial social benefits. It has also posed some troubling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2717.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">ethical questions. Public attention was drawn to these questions by reported abuses of human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2733.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects in biomedical experiments, especially during the Second World War. During the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2750.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2767.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">judging physicians and scientists who had conducted biomedical experiments on concentration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2784.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">camp prisoners. This code became the prototype of many later codes</FONT></FONT><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">(1) </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">intended to assure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2803.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">that research involving human subjects would be carried out in an ethical manner.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2838.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The codes consist of rules, some general, others specific, that guide the investigators or the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2855.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">reviewers of research in their work. Such rules often are inadequate to cover complex</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2872.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">situations; at times they come into conflict, and they are frequently difficult to interpret or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2889.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">apply. Broader ethical principles will provide a basis on which specific rules may be formulated,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2906.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">criticized and interpreted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2941.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Three principles, or general prescriptive judgments, that are relevant to research involving</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2958.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">human subjects are identified in this statement. Other principles may also be relevant. These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2975.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">three are comprehensive, however, and are stated at a level of generalization that should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:2992.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">assist scientists, subjects, reviewers and interested citizens to understand the ethical issues</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3009.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">inherent in research involving human subjects. These principles cannot always be applied so</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3025.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">as to resolve beyond dispute particular ethical problems. The objective is to provide an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3042.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">analytical framework that will guide the resolution of ethical problems arising from research</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3059.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">involving human subjects.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3095.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">This statement consists of a distinction between research and practice, a discussion of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3112.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">three basic ethical principles, and remarks about the application of these principles.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:3152.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (4 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:2376.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background3.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3168.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:3171.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3206.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">[RETURN TO TABLE OF CONTENTS]</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.55pt;top:3278.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Part A: Boundaries Between Practice & Research</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3317.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">A. Boundaries Between Practice and Research</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3353.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">It is important to distinguish between biomedical and behavioral research, on the one hand,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3370.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and the practice of accepted therapy on the other, in order to know what activities ought to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3387.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">undergo review for the protection of human subjects of research. The distinction between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3404.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research and practice is blurred partly because both often occur together (as in research</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3420.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">designed to evaluate a therapy) and partly because notable departures from standard practice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3437.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">are often called "experimental" when the terms "experimental" and "research" are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3454.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">carefully defined.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3490.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">For the most part, the term "practice" refers to interventions that are designed solely to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3507.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">enhance the well-being of an individual patient or client and that have a reasonable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3523.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">expectation of success. The purpose of medical or behavioral practice is to provide diagnosis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3540.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">preventive treatment or therapy to particular individuals.</FONT></FONT><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">(2) </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">By contrast, the term "research'</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3559.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">designates an activity designed to test an hypothesis, permit conclusions to be drawn, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3576.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">thereby to develop or contribute to generalizable knowledge (expressed, for example, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3593.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">theories, principles, and statements of relationships). Research is usually described in a formal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3609.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">protocol that sets forth an objective and a set of procedures designed to reach that objective.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3645.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">When a clinician departs in a significant way from standard or accepted practice, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3662.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">innovation does not, in and of itself, constitute research. The fact that a procedure is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3679.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">"experimental," in the sense of new, untested or different, does not automatically place it in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3696.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the category of research. Radically new procedures of this description should, however, be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3712.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">made the object of formal research at an early stage in order to determine whether they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3729.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">safe and effective. Thus, it is the responsibility of medical practice committees, for example, to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3746.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">insist that a major innovation be incorporated into a formal research project.</FONT></FONT><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">(3)</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3784.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Research and practice may be carried on together when research is designed to evaluate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3801.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">safety and efficacy of a therapy. This need not cause any confusion regarding whether or not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3817.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the activity requires review; the general rule is that if there is any element of research in an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:3834.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">activity, that activity should undergo review for the protection of human subjects.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:182.75pt;top:3904.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Part B: Basic Ethical Principles</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:3944.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (5 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:3168.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background4.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3960.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:3963.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4005.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">B. Basic Ethical Principles</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4041.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The expression "basic ethical principles" refers to those general judgments that serve as a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4058.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">basic justification for the many particular ethical prescriptions and evaluations of human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4075.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">actions. Three basic principles, among those generally accepted in our cultural tradition, are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4092.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">particularly relevant to the ethics of research involving human subjects: the principles of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4108.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">respect of persons, beneficence and justice.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4144.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">1. Respect for Persons. </FONT></b><FONT STYLE="font-size: 14.00pt">-- Respect for persons incorporates at least two ethical convictions:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4161.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">first, that individuals should be treated as autonomous agents, and second, that persons with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4178.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">diminished autonomy are entitled to protection. The principle of respect for persons thus</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4195.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">divides into two separate moral requirements: the requirement to acknowledge autonomy and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4211.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the requirement to protect those with diminished autonomy.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4247.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">An autonomous person is an individual capable of deliberation about personal goals and of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4264.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">acting under the direction of such deliberation. To respect autonomy is to give weight to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4281.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">autonomous persons' considered opinions and choices while refraining from obstructing their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4298.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">actions unless they are clearly detrimental to others. To show lack of respect for an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4314.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">autonomous agent is to repudiate that person's considered judgments, to deny an individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4331.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the freedom to act on those considered judgments, or to withhold information necessary to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4348.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">make a considered judgment, when there are no compelling reasons to do so.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4384.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">However, not every human being is capable of self-determination. The capacity for self-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4401.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">determination matures during an individual's life, and some individuals lose this capacity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4417.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">wholly or in part because of illness, mental disability, or circumstances that severely restrict</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4434.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">liberty. Respect for the immature and the incapacitated may require protecting them as they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4451.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">mature or while they are incapacitated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4487.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Some persons are in need of extensive protection, even to the point of excluding them from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4504.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">activities which may harm them; other persons require little protection beyond making sure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4520.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">they undertake activities freely and with awareness of possible adverse consequence. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4537.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">extent of protection afforded should depend upon the risk of harm and the likelihood of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4554.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">benefit. The judgment that any individual lacks autonomy should be periodically reevaluated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4571.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and will vary in different situations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4607.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">In most cases of research involving human subjects, respect for persons demands that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4623.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects enter into the research voluntarily and with adequate information. In some situations,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4640.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">however, application of the principle is not obvious. The involvement of prisoners as subjects</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4657.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of research provides an instructive example. On the one hand, it would seem that the principle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4674.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of respect for persons requires that prisoners not be deprived of the opportunity to volunteer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4691.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">for research. On the other hand, under prison conditions they may be subtly coerced or unduly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:4736.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (6 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4752.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:4755.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4776.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">influenced to engage in research activities for which they would not otherwise volunteer.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4793.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Respect for persons would then dictate that prisoners be protected. Whether to allow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4810.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4826.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">hard cases, is often a matter of balancing competing claims urged by the principle of respect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4843.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">itself.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4879.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">2. Beneficence. </FONT></b><FONT STYLE="font-size: 14.00pt">-- Persons are treated in an ethical manner not only by respecting their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4896.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">decisions and protecting them from harm, but also by making efforts to secure their well-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4913.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">being. Such treatment falls under the principle of beneficence. The term "beneficence" is often</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4930.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">understood to cover acts of kindness or charity that go beyond strict obligation. In this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4946.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">document, beneficence is understood in a stronger sense, as an obligation. Two general rules</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4963.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">have been formulated as complementary expressions of beneficent actions in this sense: </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">(1)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:4980.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">do not harm and </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(2) </FONT></b><FONT STYLE="font-size: 14.00pt">maximize possible benefits and minimize possible harms.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5016.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5033.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Claude Bernard extended it to the realm of research, saying that one should not injure one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5049.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">person regardless of the benefits that might come to others. However, even avoiding harm</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5066.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">requires learning what is harmful; and, in the process of obtaining this information, persons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5083.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5100.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">their patients "according to their best judgment." Learning what will in fact benefit may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5117.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">require exposing persons to risk. The problem posed by these imperatives is to decide when it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5133.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">is justifiable to seek certain benefits despite the risks involved, and when the benefits should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5150.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">be foregone because of the risks.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5186.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The obligations of beneficence affect both individual investigators and society at large,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5203.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">because they extend both to particular research projects and to the entire enterprise of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5220.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research. In the case of particular projects, investigators and members of their institutions are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5236.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">obliged to give forethought to the maximization of benefits and the reduction of risk that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5253.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">might occur from the research investigation. In the case of scientific research in general,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5270.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">members of the larger society are obliged to recognize the longer term benefits and risks that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5287.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">may result from the improvement of knowledge and from the development of novel medical,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5304.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">psychotherapeutic, and social procedures.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5339.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The principle of beneficence often occupies a well-defined justifying role in many areas of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5356.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research involving human subjects. An example is found in research involving children.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5373.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Effective ways of treating childhood diseases and fostering healthy development are benefits</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5390.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">that serve to justify research involving children -- even when individual research subjects are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5407.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">not direct beneficiaries. Research also makes it possible to avoid the harm that may result</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5423.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">from the application of previously accepted routine practices that on closer investigation turn</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5440.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">out to be dangerous. But the role of the principle of beneficence is not always so</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5457.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">unambiguous. A difficult ethical problem remains, for example, about research that presents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5474.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">more than minimal risk without immediate prospect of direct benefit to the children involved.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5491.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Some have argued that such research is inadmissible, while others have pointed out that this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:5528.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (7 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:5544.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:5547.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5569.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">limit would rule out much research promising great benefit to children in the future. Here</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5586.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">again, as with all hard cases, the different claims covered by the principle of beneficence may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5603.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">come into conflict and force difficult choices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5639.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">3. Justice. </FONT></b><FONT STYLE="font-size: 14.00pt">-- Who ought to receive the benefits of research and bear its burdens? This is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5656.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5673.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">occurs when some benefit to which a person is entitled is denied without good reason or when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5689.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">some burden is imposed unduly. Another way of conceiving the principle of justice is that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5706.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">equals ought to be treated equally. However, this statement requires explication. Who is equal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5723.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and who is unequal? What considerations justify departure from equal distribution? Almost all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5740.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">commentators allow that distinctions based on experience, age, deprivation, competence,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5757.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">merit and position do sometimes constitute criteria justifying differential treatment for certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5773.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">purposes. It is necessary, then, to explain in what respects people should be treated equally.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5790.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">There are several widely accepted formulations of just ways to distribute burdens and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5807.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">benefits. Each formulation mentions some relevant property on the basis of which burdens</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5823.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and benefits should be distributed. These formulations are </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(1) </FONT></b><FONT STYLE="font-size: 14.00pt">to each person an equal share,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5840.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(2) </FONT></b><FONT STYLE="font-size: 14.00pt">to each person according to individual need, </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(3) </FONT></b><FONT STYLE="font-size: 14.00pt">to each person according to individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5857.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">effort, </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(4) </FONT></b><FONT STYLE="font-size: 14.00pt">to each person according to societal contribution, and </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(5) </FONT></b><FONT STYLE="font-size: 14.00pt">to each person according</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5874.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">to merit.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5910.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Questions of justice have long been associated with social practices such as punishment,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5927.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">taxation and political representation. Until recently these questions have not generally been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5944.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">associated with scientific research. However, they are foreshadowed even in the earliest</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5960.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">reflections on the ethics of research involving human subjects. For example, during the 19th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5977.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and early 20th centuries the burdens of serving as research subjects fell largely upon poor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:5994.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">ward patients, while the benefits of improved medical care flowed primarily to private patients.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6011.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6028.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6044.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6061.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">a disease that is by no means confined to that population. These subjects were deprived of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6078.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">demonstrably effective treatment in order not to interrupt the project, long after such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6095.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">treatment became generally available.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6131.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Against this historical background, it can be seen how conceptions of justice are relevant to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6147.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research involving human subjects. For example, the selection of research subjects needs to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6164.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">be scrutinized in order to determine whether some classes (e.g., welfare patients, particular</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6181.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">racial and ethnic minorities, or persons confined to institutions) are being systematically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6198.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">selected simply because of their easy availability, their compromised position, or their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6215.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">manipulability, rather than for reasons directly related to the problem being studied. Finally,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6231.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">whenever research supported by public funds leads to the development of therapeutic devices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6248.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and procedures, justice demands both that these not provide advantages only to those who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6265.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">can afford them and that such research should not unduly involve persons from groups</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6282.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">unlikely to be among the beneficiaries of subsequent applications of the research.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:6320.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (8 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:6336.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:6339.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:226.15pt;top:6414.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.15pt">Part C: Applications</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6453.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">C. Applications</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6489.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Applications of the general principles to the conduct of research leads to consideration of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6506.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">following requirements: informed consent, risk/benefit assessment, and the selection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6523.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects of research.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6558.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">1. Informed Consent. </FONT></b><FONT STYLE="font-size: 14.00pt">-- Respect for persons requires that subjects, to the degree that they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6575.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">are capable, be given the opportunity to choose what shall or shall not happen to them. This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6592.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">opportunity is provided when adequate standards for informed consent are satisfied.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6628.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">While the importance of informed consent is unquestioned, controversy prevails over the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6645.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">nature and possibility of an informed consent. Nonetheless, there is widespread agreement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6661.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">that the consent process can be analyzed as containing three elements: information,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6678.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">comprehension and voluntariness.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6714.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">Information. </FONT></b><FONT STYLE="font-size: 14.00pt">Most codes of research establish specific items for disclosure intended to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6731.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">assure that subjects are given sufficient information. These items generally include: the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6748.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research procedure, their purposes, risks and anticipated benefits, alternative procedures</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6764.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">(where therapy is involved), and a statement offering the subject the opportunity to ask</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6781.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">questions and to withdraw at any time from the research. Additional items have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6798.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">proposed, including how subjects are selected, the person responsible for the research, etc.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6834.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">However, a simple listing of items does not answer the question of what the standard should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6851.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">be for judging how much and what sort of information should be provided. One standard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6867.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">frequently invoked in medical practice, namely the information commonly provided by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6884.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">practitioners in the field or in the locale, is inadequate since research takes place precisely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6901.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">when a common understanding does not exist. Another standard, currently popular in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6918.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">malpractice law, requires the practitioner to reveal the information that reasonable persons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6935.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">would wish to know in order to make a decision regarding their care. This, too, seems</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6951.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">insufficient since the research subject, being in essence a volunteer, may wish to know</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6968.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">considerably more about risks gratuitously undertaken than do patients who deliver</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:6985.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">themselves into the hand of a clinician for needed care. It may be that a standard of "the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7002.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">reasonable volunteer" should be proposed: the extent and nature of information should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7019.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">such that persons, knowing that the procedure is neither necessary for their care nor perhaps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7035.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">fully understood, can decide whether they wish to participate in the furthering of knowledge.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7052.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Even when some direct benefit to them is anticipated, the subjects should understand clearly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7069.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the range of risk and the voluntary nature of participation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:7112.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (9 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:6336.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background8.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:7128.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:7131.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7167.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">A special problem of consent arises where informing subjects of some pertinent aspect of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7184.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research is likely to impair the validity of the research. In many cases, it is sufficient to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7200.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">indicate to subjects that they are being invited to participate in research of which some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7217.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">features will not be revealed until the research is concluded. In all cases of research involving</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7234.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">incomplete disclosure, such research is justified only if it is clear that </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(1) </FONT></b><FONT STYLE="font-size: 14.00pt">incomplete disclosure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7251.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">is truly necessary to accomplish the goals of the research, </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(2) </FONT></b><FONT STYLE="font-size: 14.00pt">there are no undisclosed risks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7267.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">to subjects that are more than minimal, and </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(3) </FONT></b><FONT STYLE="font-size: 14.00pt">there is an adequate plan for debriefing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7285.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects, when appropriate, and for dissemination of research results to them. Information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7301.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">about risks should never be withheld for the purpose of eliciting the cooperation of subjects,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7318.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and truthful answers should always be given to direct questions about the research. Care</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7335.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">should be taken to distinguish cases in which disclosure would destroy or invalidate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7352.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research from cases in which disclosure would simply inconvenience the investigator.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7387.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">Comprehension. </FONT></b><FONT STYLE="font-size: 14.00pt">The manner and context in which information is conveyed is as important</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7404.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">as the information itself. For example, presenting information in a disorganized and rapid</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7421.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">fashion, allowing too little time for consideration or curtailing opportunities for questioning, all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7438.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">may adversely affect a subject's ability to make an informed choice.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7474.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Because the subject's ability to understand is a function of intelligence, rationality, maturity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7491.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and language, it is necessary to adapt the presentation of the information to the subject's</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7507.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">capacities. Investigators are responsible for ascertaining that the subject has comprehended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7524.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the information. While there is always an obligation to ascertain that the information about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7541.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">risk to subjects is complete and adequately comprehended, when the risks are more serious,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7558.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">that obligation increases. On occasion, it may be suitable to give some oral or written tests of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7575.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">comprehension.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7610.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Special provision may need to be made when comprehension is severely limited -- for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7627.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">example, by conditions of immaturity or mental disability. Each class of subjects that one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7644.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">might consider as incompetent (e.g., infants and young children, mentally disable patients, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7661.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">terminally ill and the comatose) should be considered on its own terms. Even for these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7678.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">persons, however, respect requires giving them the opportunity to choose to the extent they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7694.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">are able, whether or not to participate in research. The objections of these subjects to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7711.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">involvement should be honored, unless the research entails providing them a therapy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7728.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">unavailable elsewhere. Respect for persons also requires seeking the permission of other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7745.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">parties in order to protect the subjects from harm. Such persons are thus respected both by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7762.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">acknowledging their own wishes and by the use of third parties to protect them from harm.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7797.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The third parties chosen should be those who are most likely to understand the incompetent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7814.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subject's situation and to act in that person's best interest. The person authorized to act on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7831.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">behalf of the subject should be given an opportunity to observe the research as it proceeds in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7848.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">order to be able to withdraw the subject from the research, if such action appears in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7865.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subject's best interest.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:7904.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (10 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:7920.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:7923.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7962.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">Voluntariness. </FONT></b><FONT STYLE="font-size: 14.00pt">An agreement to participate in research constitutes a valid consent only if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7979.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">voluntarily given. This element of informed consent requires conditions free of coercion and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:7996.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">undue influence. Coercion occurs when an overt threat of harm is intentionally presented by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8013.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">one person to another in order to obtain compliance. Undue influence, by contrast, occurs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8030.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">through an offer of an excessive, unwarranted, inappropriate or improper reward or other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8047.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8063.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">may become undue influences if the subject is especially vulnerable.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8099.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Unjustifiable pressures usually occur when persons in positions of authority or commanding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8116.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">influence -- especially where possible sanctions are involved -- urge a course of action for a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8133.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subject. A continuum of such influencing factors exists, however, and it is impossible to state</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8150.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">precisely where justifiable persuasion ends and undue influence begins. But undue influence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8166.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">would include actions such as manipulating a person's choice through the controlling influence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8183.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of a close relative and threatening to withdraw health services to which an individual would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8200.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">otherwise be entitle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8235.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">2. Assessment of Risks and Benefits. </FONT></b><FONT STYLE="font-size: 14.00pt">-- The assessment of risks and benefits requires a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8253.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8269.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">benefits sought in the research. Thus, the assessment presents both an opportunity and a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8286.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">responsibility to gather systematic and comprehensive information about proposed research.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8303.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">For the investigator, it is a means to examine whether the proposed research is properly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8320.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">designed. For a review committee, it is a method for determining whether the risks that will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8337.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">presented to subjects are justified. For prospective subjects, the assessment will assist the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8353.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">determination whether or not to participate.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8389.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">The Nature and Scope of Risks and Benefits. </FONT></b><FONT STYLE="font-size: 14.00pt">The requirement that research be justified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8406.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">on the basis of a favorable risk/benefit assessment bears a close relation to the principle of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8423.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">beneficence, just as the moral requirement that informed consent be obtained is derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8440.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">primarily from the principle of respect for persons. The term "risk" refers to a possibility that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8456.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">harm may occur. However, when expressions such as "small risk" or "high risk" are used, they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8473.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8490.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the severity (magnitude) of the envisioned harm.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8526.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">The term "benefit" is used in the research context to refer to something of positive value</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8543.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">related to health or welfare. Unlike, "risk," "benefit" is not a term that expresses probabilities.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8559.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8576.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">harms rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8593.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">with the probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8610.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">possible harms and benefits need to be taken into account. There are, for example, risks of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8627.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">psychological harm, physical harm, legal harm, social harm and economic harm and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8643.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">corresponding benefits. While the most likely types of harms to research subjects are those of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:8696.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (11 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:8712.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:8715.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8736.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">psychological or physical pain or injury, other possible kinds should not be overlooked.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8772.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Risks and benefits of research may affect the individual subjects, the families of the individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8789.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects, and society at large (or special groups of subjects in society). Previous codes and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8805.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Federal regulations have required that risks to subjects be outweighed by the sum of both the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8822.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8839.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">knowledge to be gained from the research. In balancing these different elements, the risks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8856.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and benefits affecting the immediate research subject will normally carry special weight. On</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8873.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the other hand, interests other than those of the subject may on some occasions be sufficient</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8889.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">by themselves to justify the risks involved in the research, so long as the subjects' rights have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8906.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">been protected. Beneficence thus requires that we protect against risk of harm to subjects and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8923.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">also that we be concerned about the loss of the substantial benefits that might be gained from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8940.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8975.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">The Systematic Assessment of Risks and Benefits. </FONT></b><FONT STYLE="font-size: 14.00pt">It is commonly said that benefits and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:8993.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">risks must be "balanced" and shown to be "in a favorable ratio." The metaphorical character of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9009.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">these terms draws attention to the difficulty of making precise judgments. Only on rare</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9026.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">occasions will quantitative techniques be available for the scrutiny of research protocols.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9043.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">However, the idea of systematic, nonarbitrary analysis of risks and benefits should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9060.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">emulated insofar as possible. This ideal requires those making decisions about the justifiability</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9077.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of research to be thorough in the accumulation and assessment of information about all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9093.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">aspects of the research, and to consider alternatives systematically. This procedure renders</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9110.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the assessment of research more rigorous and precise, while making communication between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9127.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">review board members and investigators less subject to misinterpretation, misinformation and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9144.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">conflicting judgments. Thus, there should first be a determination of the validity of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9161.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">presuppositions of the research; then the nature, probability and magnitude of risk should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9177.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">distinguished with as much clarity as possible. The method of ascertaining risks should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9194.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">explicit, especially where there is no alternative to the use of such vague categories as small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9211.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">or slight risk. It should also be determined whether an investigator's estimates of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9228.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">probability of harm or benefits are reasonable, as judged by known facts or other available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9245.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">studies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9280.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Finally, assessment of the justifiability of research should reflect at least the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9297.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">considerations: </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(i) </FONT></b><FONT STYLE="font-size: 14.00pt">Brutal or inhumane treatment of human subjects is never morally justified.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9314.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(ii) </FONT></b><FONT STYLE="font-size: 14.00pt">Risks should be reduced to those necessary to achieve the research objective. It should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9331.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">determined whether it is in fact necessary to use human subjects at all. Risk can perhaps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9348.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">never be entirely eliminated, but it can often be reduced by careful attention to alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9364.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">procedures. </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(iii) </FONT></b><FONT STYLE="font-size: 14.00pt">When research involves significant risk of serious impairment, review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9381.80pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">committees should be extraordinarily insistent on the justification of the risk (looking usually to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9398.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9415.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of the participation). </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(iv) </FONT></b><FONT STYLE="font-size: 14.00pt">When vulnerable populations are involved in research, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9432.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">appropriateness of involving them should itself be demonstrated. A number of variables go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9449.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">into such judgments, including the nature and degree of risk, the condition of the particular</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:9488.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (12 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:9504.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:9507.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9528.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">population involved, and the nature and level of the anticipated benefits. </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">(v) </FONT></b><FONT STYLE="font-size: 14.00pt">Relevant risks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9545.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">and benefits must be thoroughly arrayed in documents and procedures used in the informed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9562.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">consent process.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9597.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 14.00pt">3. Selection of Subjects. </FONT></b><FONT STYLE="font-size: 14.00pt">-- Just as the principle of respect for persons finds expression in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9614.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">the requirements for consent, and the principle of beneficence in risk/benefit assessment, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9631.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">principle of justice gives rise to moral requirements that there be fair procedures and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9648.50pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">outcomes in the selection of research subjects.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9684.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Justice is relevant to the selection of subjects of research at two levels: the social and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9701.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">individual. Individual justice in the selection of subjects would require that researchers exhibit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9717.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">fairness: thus, they should not offer potentially beneficial research only to some patients who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9734.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">are in their favor or select only "undesirable" persons for risky research. Social justice requires</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9751.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">that distinction be drawn between classes of subjects that ought, and ought not, to participate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9768.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">in any particular kind of research, based on the ability of members of that class to bear</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9785.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">burdens and on the appropriateness of placing further burdens on already burdened persons.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9801.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Thus, it can be considered a matter of social justice that there is an order of preference in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9818.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">selection of classes of subjects (e.g., adults before children) and that some classes of potential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9835.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9852.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects, if at all, only on certain conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9888.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Injustice may appear in the selection of subjects, even if individual subjects are selected fairly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9904.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">by investigators and treated fairly in the course of research. Thus injustice arises from social,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9921.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">racial, sexual and cultural biases institutionalized in society. Thus, even if individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9938.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">researchers are treating their research subjects fairly, and even if IRBs are taking care to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9955.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">assure that subjects are selected fairly within a particular institution, unjust social patterns</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9972.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">may nevertheless appear in the overall distribution of the burdens and benefits of research.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:9988.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Although individual institutions or investigators may not be able to resolve a problem that is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10005.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">pervasive in their social setting, they can consider distributive justice in selecting research</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10022.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">subjects.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10058.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Some populations, especially institutionalized ones, are already burdened in many ways by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10075.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">their infirmities and environments. When research is proposed that involves risks and does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10091.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">include a therapeutic component, other less burdened classes of persons should be called</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10108.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">upon first to accept these risks of research, except where the research is directly related to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10125.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">specific conditions of the class involved. Also, even though public funds for research may often</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10142.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">flow in the same directions as public funds for health care, it seems unfair that populations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10159.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">dependent on public health care constitute a pool of preferred research subjects if more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10175.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">advantaged populations are likely to be the recipients of the benefits.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10211.65pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">One special instance of injustice results from the involvement of vulnerable subjects. Certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10228.45pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">groups, such as racial minorities, the economically disadvantaged, the very sick, and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:10280.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (13 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:10296.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:10299.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">/humansubjects/guidance/ documents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10320.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">institutionalized may continually be sought as research subjects, owing to their ready</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10337.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">availability in settings where research is conducted. Given their dependent status and their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10354.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">frequently compromised capacity for free consent, they should be protected against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10370.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">danger of being involved in research solely for administrative convenience, or because they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10387.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">are easy to manipulate as a result of their illness or socioeconomic condition.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10458.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">(1) </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Since 1945, various codes for the proper and responsible conduct of human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10477.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">experimentation in medical research have been adopted by different organizations. The best</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10494.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">known of these codes are the Nuremberg Code of 1947, the Helsinki Declaration of 1964</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10510.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">(revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10527.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">by the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10544.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">behavioral research have also been adopted, the best known being that of the American</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10561.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Psychological Association, published in 1973.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10597.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">(2) </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Although practice usually involves interventions designed solely to enhance the well-being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10615.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of a particular individual, interventions are sometimes applied to one individual for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10632.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">enhancement of the well-being of another (e.g., blood donation, skin grafts, organ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10649.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">transplants) or an intervention may have the dual purpose of enhancing the well-being of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10666.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">particular individual, and, at the same time, providing some benefit to others (e.g.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10683.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">vaccination, which protects both the person who is vaccinated and society generally). The fact</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10699.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">that some forms of practice have elements other than immediate benefit to the individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10716.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">receiving an intervention, however, should not confuse the general distinction between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10733.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">research and practice. Even when a procedure applied in practice may benefit some other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10750.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">person, it remains an intervention designed to enhance the well-being of a particular individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10767.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">or groups of individuals; thus, it is practice and need not be reviewed as research.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10802.95pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><u><FONT COLOR="660000"><FONT STYLE="font-size: 14.00pt">(3) </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">Because the problems related to social experimentation may differ substantially from those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10821.75pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">of biomedical and behavioral research, the Commission specifically declines to make any policy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10838.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">determination regarding such research at this time. Rather, the Commission believes that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:10.00pt;top:10855.35pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 14.00pt">problem ought to be addressed by one of its successor bodies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:18.00pt;top:11072.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">h</FONT><FONT STYLE="font-size: 9.00pt"><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm">ttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm</a></FONT><FONT STYLE="font-size: 9.00pt"> (14 of 14) [12/23/2009 4:27:45 PM]</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:10296.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile1379159723.htm_files\outputfile1379159723_background13.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:11088.00pt"> </SPAN>
</BODY>
</HTML>