{"id":39,"date":"2021-01-26T19:49:33","date_gmt":"2021-01-26T19:49:33","guid":{"rendered":"https:\/\/pressbooks.usnh.edu\/hrt1\/chapter\/the-institutional-review-board-at-granite-state-college\/"},"modified":"2023-03-24T15:06:50","modified_gmt":"2023-03-24T15:06:50","slug":"the-institutional-review-board-at-granite-state-college","status":"publish","type":"chapter","link":"https:\/\/pressbooks.usnh.edu\/hrt1\/chapter\/the-institutional-review-board-at-granite-state-college\/","title":{"raw":"The Institutional Review Board at Granite State College","rendered":"The Institutional Review Board at Granite State College"},"content":{"raw":"At Granite State College, research involving human subjects requires prior review by the IRB and receipt of written, unconditional approval from the IRB, regardless of discipline.\n\nFederal regulations define <em>research<\/em> as:\n<p style=\"padding-left: 40px;\"><strong><em>Research:<\/em><\/strong> \"A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.\" The regulations state that following activities are <em>not<\/em> deemed research: (1) Scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected; (2) Public health surveillance activities conducted, supported, requested, ordered, required, or authorized by a public health authority; (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes; or (4) Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.\u201d [<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1102\" target=\"_blank\" rel=\"noopener noreferrer\">45 CFR 46.102(l)<\/a>].<\/p>\nFederal regulations define <em>human subject<\/em> as:\n<p style=\"padding-left: 40px;\"><strong><em>Human Subject<\/em><\/strong>: \u201cHuman subject means a living individual about whom an investigator(whether professional or student) conducting research: (i) Obtains information or biospecimens through\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">intervention<\/a>\u00a0or\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">interaction<\/a>\u00a0with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">identifiable private information<\/a>\u00a0or identifiable biospecimens.\u201d [<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1102\" target=\"_blank\" rel=\"noopener noreferrer\">45 CFR 46.102(e)(1)<\/a>].<\/p>\nUsing this definition of human subjects, all research activities involving the prospective collection of information about individuals via intervention\/interaction are considered using human subjects and thus require Granite State College IRB approval before commencing.\n\nWhen studies involve the use of secondary\/existing data (data\/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]) and if the secondary\/existing data do not contain private information,\u00a0GSC IRB approval is NOT needed to use such data for research purposes.\n\nSome common examples of secondary\/existing data that are not considered private information include, but are not limited to:\n<ul>\n \t<li>Some information on the internet - comments on TripAdvisor; content of public tweets and blogs; information on public Facebook pages; census information; freely-available datasets (whether or not anonymous)<\/li>\n \t<li>Archives - identifiable information about individuals in a public archive<\/li>\n \t<li>Datasets - anonymous datasets, whether privately held or publicly available<\/li>\n<\/ul>\nResearchers should be aware that not all information on the internet is considered publicly available and not all datasets that are characterized as anonymous actually are. Examples include, but are not limited to:\n<ul>\n \t<li>Comments on a non-public chatroom or listserv<\/li>\n \t<li>Restricted-access datasets<\/li>\n \t<li>Privately held datasets where individuals may be identified, either directly through a code associated with a name or through a combination of variables<\/li>\n<\/ul>\n\n<hr>\n\n<h3><strong>Does Your Project Need an IRB Review?<\/strong><\/h3>\n<table class=\"grid\" style=\"height: 287px; width: 100%;\">\n<tbody>\n<tr style=\"height: 183px;\">\n<td class=\"shaded\" style=\"width: 37.0625px; height: 62px; text-align: center;\"><strong>No<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 109.062px; height: 62px;\">Not \u201cResearch\u201d<\/td>\n<td class=\"shaded\" style=\"width: 572.062px; height: 62px;\">\n<ul>\n \t<li>Literature reviews or meta-analysis<\/li>\n \t<li>Archival studies of records available to the general public<\/li>\n \t<li>Anonymous surveys conducted for internal quality improvement<\/li>\n \t<li>Educational settings involving accepted educational testing<\/li>\n \t<li>Class projects in the \u2018benign\u2019 research category<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 30px;\">\n<td style=\"width: 746.062px; height: 30px;\" colspan=\"3\">\n<p style=\"text-align: center;\"><strong>The following categories MUST be reviewed by the GSC IRB!<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 357px;\">\n<td style=\"width: 37.0625px; height: 94px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td style=\"width: 109.062px; height: 94px;\"><strong><em>Exempt from Further Review<\/em><\/strong>\n\nA designee of the IRB will make this determination\n\n&nbsp;\n\n1-2 weeks<\/td>\n<td style=\"width: 572.062px; height: 94px;\">\n<ul>\n \t<li>Capstone projects involving information from\/about individuals<\/li>\n \t<li>Observational studies where the identity of participants remains anonymous<\/li>\n \t<li>Archival studies, with permission of agency holding the records, and results remain confidential<\/li>\n \t<li>Surveys or interviews with the following:\n<ul>\n \t<li>Non-vulnerable adult population <strong>AND<\/strong><\/li>\n \t<li>Informed consent of participants obtained <strong>AND<\/strong><\/li>\n \t<li>Minimal risk: no physical, emotional, social, legal or economic risk to participants <strong>AND<\/strong><\/li>\n \t<li>Confidentiality\/data protection procedures<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 215px;\">\n<td class=\"shaded\" style=\"width: 37.0625px; height: 79px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 109.062px; height: 79px;\"><strong>Expedited Review<\/strong>\n\n<strong>\u00a0<\/strong>\n\nConducted by the IRB designee or chair and another IRB member\n\n&nbsp;\n\n2-3 weeks<\/td>\n<td class=\"shaded\" style=\"width: 572.062px; height: 79px;\">\n<ul>\n \t<li>Anonymous interviews\/surveys\/observations that involve:\n<ul>\n \t<li>Vulnerable population (children, prisoners, health care patients, impaired decision-making capacity) <strong>OR<\/strong><\/li>\n \t<li>Sensitive content or content with physical, emotional, social, legal, economic risk <strong>OR<\/strong><\/li>\n \t<li>Intervention, treatment, or deception<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 72px;\">\n<td style=\"width: 37.0625px; height: 12px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td style=\"width: 109.062px; height: 12px;\"><strong>Full Board Review<\/strong><\/td>\n<td style=\"width: 572.062px; height: 12px;\">\n<ul>\n \t<li>More than minimal risk that may require mitigation<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 88px;\">\n<td class=\"shaded\" style=\"width: 37.0625px; height: 10px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 109.062px; height: 10px;\"><strong>Level TBD<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 572.062px; height: 10px;\">\n<ul>\n \t<li>Publication or presentation of human participant research (includes dissertation research)<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>","rendered":"<p>At Granite State College, research involving human subjects requires prior review by the IRB and receipt of written, unconditional approval from the IRB, regardless of discipline.<\/p>\n<p>Federal regulations define <em>research<\/em> as:<\/p>\n<p style=\"padding-left: 40px;\"><strong><em>Research:<\/em><\/strong> &#8220;A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.&#8221; The regulations state that following activities are <em>not<\/em> deemed research: (1) Scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected; (2) Public health surveillance activities conducted, supported, requested, ordered, required, or authorized by a public health authority; (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes; or (4) Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.\u201d [<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1102\" target=\"_blank\" rel=\"noopener noreferrer\">45 CFR 46.102(l)<\/a>].<\/p>\n<p>Federal regulations define <em>human subject<\/em> as:<\/p>\n<p style=\"padding-left: 40px;\"><strong><em>Human Subject<\/em><\/strong>: \u201cHuman subject means a living individual about whom an investigator(whether professional or student) conducting research: (i) Obtains information or biospecimens through\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">intervention<\/a>\u00a0or\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">interaction<\/a>\u00a0with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates\u00a0<a href=\"https:\/\/rit.sr.unh.edu\/training\/rcr-training\/human-subjects.html\" target=\"_blank\" rel=\"noopener noreferrer\">identifiable private information<\/a>\u00a0or identifiable biospecimens.\u201d [<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1102\" target=\"_blank\" rel=\"noopener noreferrer\">45 CFR 46.102(e)(1)<\/a>].<\/p>\n<p>Using this definition of human subjects, all research activities involving the prospective collection of information about individuals via intervention\/interaction are considered using human subjects and thus require Granite State College IRB approval before commencing.<\/p>\n<p>When studies involve the use of secondary\/existing data (data\/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]) and if the secondary\/existing data do not contain private information,\u00a0GSC IRB approval is NOT needed to use such data for research purposes.<\/p>\n<p>Some common examples of secondary\/existing data that are not considered private information include, but are not limited to:<\/p>\n<ul>\n<li>Some information on the internet &#8211; comments on TripAdvisor; content of public tweets and blogs; information on public Facebook pages; census information; freely-available datasets (whether or not anonymous)<\/li>\n<li>Archives &#8211; identifiable information about individuals in a public archive<\/li>\n<li>Datasets &#8211; anonymous datasets, whether privately held or publicly available<\/li>\n<\/ul>\n<p>Researchers should be aware that not all information on the internet is considered publicly available and not all datasets that are characterized as anonymous actually are. Examples include, but are not limited to:<\/p>\n<ul>\n<li>Comments on a non-public chatroom or listserv<\/li>\n<li>Restricted-access datasets<\/li>\n<li>Privately held datasets where individuals may be identified, either directly through a code associated with a name or through a combination of variables<\/li>\n<\/ul>\n<hr \/>\n<h3><strong>Does Your Project Need an IRB Review?<\/strong><\/h3>\n<table class=\"grid\" style=\"height: 287px; width: 100%;\">\n<tbody>\n<tr style=\"height: 183px;\">\n<td class=\"shaded\" style=\"width: 37.0625px; height: 62px; text-align: center;\"><strong>No<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 109.062px; height: 62px;\">Not \u201cResearch\u201d<\/td>\n<td class=\"shaded\" style=\"width: 572.062px; height: 62px;\">\n<ul>\n<li>Literature reviews or meta-analysis<\/li>\n<li>Archival studies of records available to the general public<\/li>\n<li>Anonymous surveys conducted for internal quality improvement<\/li>\n<li>Educational settings involving accepted educational testing<\/li>\n<li>Class projects in the \u2018benign\u2019 research category<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 30px;\">\n<td style=\"width: 746.062px; height: 30px;\" colspan=\"3\">\n<p style=\"text-align: center;\"><strong>The following categories MUST be reviewed by the GSC IRB!<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 357px;\">\n<td style=\"width: 37.0625px; height: 94px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td style=\"width: 109.062px; height: 94px;\"><strong><em>Exempt from Further Review<\/em><\/strong><\/p>\n<p>A designee of the IRB will make this determination<\/p>\n<p>&nbsp;<\/p>\n<p>1-2 weeks<\/td>\n<td style=\"width: 572.062px; height: 94px;\">\n<ul>\n<li>Capstone projects involving information from\/about individuals<\/li>\n<li>Observational studies where the identity of participants remains anonymous<\/li>\n<li>Archival studies, with permission of agency holding the records, and results remain confidential<\/li>\n<li>Surveys or interviews with the following:\n<ul>\n<li>Non-vulnerable adult population <strong>AND<\/strong><\/li>\n<li>Informed consent of participants obtained <strong>AND<\/strong><\/li>\n<li>Minimal risk: no physical, emotional, social, legal or economic risk to participants <strong>AND<\/strong><\/li>\n<li>Confidentiality\/data protection procedures<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 215px;\">\n<td class=\"shaded\" style=\"width: 37.0625px; height: 79px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 109.062px; height: 79px;\"><strong>Expedited Review<\/strong><\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p>Conducted by the IRB designee or chair and another IRB member<\/p>\n<p>&nbsp;<\/p>\n<p>2-3 weeks<\/td>\n<td class=\"shaded\" style=\"width: 572.062px; height: 79px;\">\n<ul>\n<li>Anonymous interviews\/surveys\/observations that involve:\n<ul>\n<li>Vulnerable population (children, prisoners, health care patients, impaired decision-making capacity) <strong>OR<\/strong><\/li>\n<li>Sensitive content or content with physical, emotional, social, legal, economic risk <strong>OR<\/strong><\/li>\n<li>Intervention, treatment, or deception<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 72px;\">\n<td style=\"width: 37.0625px; height: 12px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td style=\"width: 109.062px; height: 12px;\"><strong>Full Board Review<\/strong><\/td>\n<td style=\"width: 572.062px; height: 12px;\">\n<ul>\n<li>More than minimal risk that may require mitigation<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 88px;\">\n<td class=\"shaded\" style=\"width: 37.0625px; height: 10px; text-align: center;\"><strong>Yes!<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 109.062px; height: 10px;\"><strong>Level TBD<\/strong><\/td>\n<td class=\"shaded\" style=\"width: 572.062px; height: 10px;\">\n<ul>\n<li>Publication or presentation of human participant research (includes dissertation research)<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"author":11,"menu_order":7,"template":"","meta":{"pb_show_title":"","pb_short_title":"","pb_subtitle":"","pb_authors":[],"pb_section_license":""},"chapter-type":[49],"contributor":[],"license":[],"class_list":["post-39","chapter","type-chapter","status-publish","hentry","chapter-type-numberless"],"part":23,"_links":{"self":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters\/39","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\/39\/revisions"}],"predecessor-version":[{"id":40,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapters\/39\/revisions\/40"}],"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\/39\/metadata\/"}],"wp:attachment":[{"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/media?parent=39"}],"wp:term":[{"taxonomy":"chapter-type","embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/pressbooks\/v2\/chapter-type?post=39"},{"taxonomy":"contributor","embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/contributor?post=39"},{"taxonomy":"license","embeddable":true,"href":"https:\/\/pressbooks.usnh.edu\/hrt1\/wp-json\/wp\/v2\/license?post=39"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}