{"id":33,"date":"2021-01-26T19:42:01","date_gmt":"2021-01-26T19:42:01","guid":{"rendered":"https:\/\/pressbooks.usnh.edu\/hrt1\/chapter\/belmont-report-beneficence\/"},"modified":"2023-03-24T15:06:50","modified_gmt":"2023-03-24T15:06:50","slug":"belmont-report-beneficence","status":"publish","type":"chapter","link":"https:\/\/pressbooks.usnh.edu\/hrt1\/chapter\/belmont-report-beneficence\/","title":{"raw":"Belmont Report: Beneficence","rendered":"Belmont Report: Beneficence"},"content":{"raw":"<em><strong>Beneficence obliges researchers to protect persons from harm by maximizing the research\u2019s anticipated benefits and minimizing its possible risks<\/strong><\/em>. Beneficence requires:\n<h3>5.1 Minimizing risks<\/h3>\nResearch procedures must result in\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">minimal risk<\/a>\u00a0to subjects consistent with justifiable scientific necessity. All risks must be fully and disclosed to subjects prior to participation, using language that the subjects will understand.\n\nIn this context, risk is the probability of harm occurring as a result of participation in study. Risks may be:\n<ul>\n \t<li><strong>Psychologica<\/strong>l: does the study involve sensitive issues (e.g. sexuality, victimization, alcohol or drug use) that may create emotional upset, anxiety, distress, or that could trigger a behavioral disorder?<\/li>\n \t<li><strong>Social<\/strong>: if confidentiality were breached, could a participant\u2019s answers create embarrassment, ostracism, loss of status, or personal conflict?<\/li>\n \t<li><strong>Economic<\/strong>: could the subject lose their job, be passed over for advancement, lose income, resources, or benefits? Could a breach of confidentiality hurt a business?<\/li>\n \t<li><strong>Physical<\/strong>: does the study involve blood draws, use of medical equipment, or strenuous exercise? Is there any risk that participation could cause discomfort, illness, injury or death?<\/li>\n \t<li><strong>Legal<\/strong>: are subjects asked to report illegal behaviors? Could a breach of confidentiality put subjects at risk of arrest, prosecution, civil or criminal liability, or punishment? Could subjects be identified by demographics or their answers?<\/li>\n<\/ul>\nThe IRB reviews risks that are reasonably foreseeable, even if unlikely, and determines if there are adequate safeguards in place against them.\n\n<hr>\n\n<h3>5.2 Privacy and confidentiality<\/h3>\n<h6><strong>Definitions:<\/strong><\/h6>\n<p style=\"padding-left: 40px;\"><em><strong>Privacy<\/strong><\/em>\u00a0is an individual\u2019s control over the extent, timing, and circumstances of sharing him\/herself (physically, behaviorally, or intellectually) with others (Amdur &amp; Bankert, 2001). Privacy pertains to individuals and is a right that must be protected in research.<\/p>\n<p style=\"padding-left: 40px;\"><em><strong>Confidentiality <\/strong><\/em>is the treatment of information disclosed in a trust relationship and with the expectation that it will not be divulged to others in ways inconsistent with the understanding of the original disclosure without permission (Amdur &amp; Bankert, 2001). Confidentiality pertains to data and refers to an agreement about how it will be used. Researchers cannot guarantee absolute or complete confidentiality and must inform subjects of this. Confidentiality also cannot \u00a0be guaranteed if conducting a focus group or transmitting information via the internet (except when transmission is encrypted).<\/p>\n<p style=\"padding-left: 40px;\"><em><strong>Anonymous<\/strong><\/em>\u00a0 refers to data that contains no information that identifies or can be linked with the individual providing it. The presence of a list of codes and associated identifiers such as names or IP addresses means that data are NOT anonymous. When reporting data from a small population, demographic information may lead to the identity of unique individuals. This risk can be minimized by not reporting demographics or specific locations on samples of less than ten (e.g. \u2018book club in western NH\u2019 rather than \u2018book club in Claremont\u2019)..<\/p>\n<p style=\"padding-left: 40px;\"><em><strong>Identifiable<\/strong>\u00a0<strong> private information or identifiable biospecimens<\/strong><\/em> are those for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information.<\/p>\n&nbsp;\n<h6><strong>Exceptions to confidentiality:<\/strong><\/h6>\nResearchers have \u00a0to comply with applicable mandatory reporting laws, court orders, or other legal actions. For example, in the case of a complaint, the IRB may have to review data. Individuals in New Hampshire are legally required to report suspected child abuse or the abuse, neglect or exploitation of an incapacitated adult. If research may result in a duty to report, this must be disclosed in the informed consent.\n\n&nbsp;\n<h6><strong>Data handling and storage:<\/strong><\/h6>\nData should be stored securely\u00a0and accessed only by those individuals identified in the IRB application. Researchers should not store data on portable memory devices (e.g., thumb drives\/memory sticks) as such media are not secure and are easily lost. Researchers should store data on password-protected computers that are regularly backed-up, and when necessary, transported via portable memory devices from which they should be erased. De-identify data at the end of a study if it is to be stored.\n\n<hr>\n\n<h3>5.3 Competent research personnel<\/h3>\nIf a researcher involves another researcher, faculty member, or assistant in the <em>conduct<\/em> of the research, that person must also have completed Human Research Protection training and their certification must also be included in the IRB proposal.\n\nAny additional members of the research team must be familiar with the purposes and protocol of the research and must follow that protocol exactly.","rendered":"<p><em><strong>Beneficence obliges researchers to protect persons from harm by maximizing the research\u2019s anticipated benefits and minimizing its possible risks<\/strong><\/em>. Beneficence requires:<\/p>\n<h3>5.1 Minimizing risks<\/h3>\n<p>Research procedures must result in\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">minimal risk<\/a>\u00a0to subjects consistent with justifiable scientific necessity. All risks must be fully and disclosed to subjects prior to participation, using language that the subjects will understand.<\/p>\n<p>In this context, risk is the probability of harm occurring as a result of participation in study. Risks may be:<\/p>\n<ul>\n<li><strong>Psychologica<\/strong>l: does the study involve sensitive issues (e.g. sexuality, victimization, alcohol or drug use) that may create emotional upset, anxiety, distress, or that could trigger a behavioral disorder?<\/li>\n<li><strong>Social<\/strong>: if confidentiality were breached, could a participant\u2019s answers create embarrassment, ostracism, loss of status, or personal conflict?<\/li>\n<li><strong>Economic<\/strong>: could the subject lose their job, be passed over for advancement, lose income, resources, or benefits? Could a breach of confidentiality hurt a business?<\/li>\n<li><strong>Physical<\/strong>: does the study involve blood draws, use of medical equipment, or strenuous exercise? Is there any risk that participation could cause discomfort, illness, injury or death?<\/li>\n<li><strong>Legal<\/strong>: are subjects asked to report illegal behaviors? Could a breach of confidentiality put subjects at risk of arrest, prosecution, civil or criminal liability, or punishment? Could subjects be identified by demographics or their answers?<\/li>\n<\/ul>\n<p>The IRB reviews risks that are reasonably foreseeable, even if unlikely, and determines if there are adequate safeguards in place against them.<\/p>\n<hr \/>\n<h3>5.2 Privacy and confidentiality<\/h3>\n<h6><strong>Definitions:<\/strong><\/h6>\n<p style=\"padding-left: 40px;\"><em><strong>Privacy<\/strong><\/em>\u00a0is an individual\u2019s control over the extent, timing, and circumstances of sharing him\/herself (physically, behaviorally, or intellectually) with others (Amdur &amp; Bankert, 2001). Privacy pertains to individuals and is a right that must be protected in research.<\/p>\n<p style=\"padding-left: 40px;\"><em><strong>Confidentiality <\/strong><\/em>is the treatment of information disclosed in a trust relationship and with the expectation that it will not be divulged to others in ways inconsistent with the understanding of the original disclosure without permission (Amdur &amp; Bankert, 2001). Confidentiality pertains to data and refers to an agreement about how it will be used. Researchers cannot guarantee absolute or complete confidentiality and must inform subjects of this. Confidentiality also cannot \u00a0be guaranteed if conducting a focus group or transmitting information via the internet (except when transmission is encrypted).<\/p>\n<p style=\"padding-left: 40px;\"><em><strong>Anonymous<\/strong><\/em>\u00a0 refers to data that contains no information that identifies or can be linked with the individual providing it. The presence of a list of codes and associated identifiers such as names or IP addresses means that data are NOT anonymous. When reporting data from a small population, demographic information may lead to the identity of unique individuals. This risk can be minimized by not reporting demographics or specific locations on samples of less than ten (e.g. \u2018book club in western NH\u2019 rather than \u2018book club in Claremont\u2019)..<\/p>\n<p style=\"padding-left: 40px;\"><em><strong>Identifiable<\/strong>\u00a0<strong> private information or identifiable biospecimens<\/strong><\/em> are those for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information.<\/p>\n<p>&nbsp;<\/p>\n<h6><strong>Exceptions to confidentiality:<\/strong><\/h6>\n<p>Researchers have \u00a0to comply with applicable mandatory reporting laws, court orders, or other legal actions. For example, in the case of a complaint, the IRB may have to review data. Individuals in New Hampshire are legally required to report suspected child abuse or the abuse, neglect or exploitation of an incapacitated adult. If research may result in a duty to report, this must be disclosed in the informed consent.<\/p>\n<p>&nbsp;<\/p>\n<h6><strong>Data handling and storage:<\/strong><\/h6>\n<p>Data should be stored securely\u00a0and accessed only by those individuals identified in the IRB application. Researchers should not store data on portable memory devices (e.g., thumb drives\/memory sticks) as such media are not secure and are easily lost. Researchers should store data on password-protected computers that are regularly backed-up, and when necessary, transported via portable memory devices from which they should be erased. De-identify data at the end of a study if it is to be stored.<\/p>\n<hr \/>\n<h3>5.3 Competent research personnel<\/h3>\n<p>If a researcher involves another researcher, faculty member, or assistant in the <em>conduct<\/em> of the research, that person must also have completed Human Research Protection training and their certification must also be included in the IRB proposal.<\/p>\n<p>Any additional members of the research team must be familiar with the purposes and protocol of the research and must follow that protocol exactly.<\/p>\n","protected":false},"author":11,"menu_order":4,"template":"","meta":{"pb_show_title":"","pb_short_title":"","pb_subtitle":"","pb_authors":[],"pb_section_license":""},"chapter-type":[49],"contributor":[],"license":[],"class_list":["post-33","chapter","type-chapter","status-publish","hentry","chapter-type-numberless"],"part":23,"_links":{"self":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters\/33","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters"}],"about":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/types\/chapter"}],"author":[{"embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/users\/11"}],"version-history":[{"count":1,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters\/33\/revisions"}],"predecessor-version":[{"id":34,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters\/33\/revisions\/34"}],"part":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/parts\/23"}],"metadata":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters\/33\/metadata\/"}],"wp:attachment":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/media?parent=33"}],"wp:term":[{"taxonomy":"chapter-type","embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapter-type?post=33"},{"taxonomy":"contributor","embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/contributor?post=33"},{"taxonomy":"license","embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/license?post=33"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}