{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T20:14:42Z","timestamp":1777493682199,"version":"3.51.4"},"reference-count":57,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2014,9,1]],"date-time":"2014-09-01T00:00:00Z","timestamp":1409529600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed \u201crisks of daily life\u201d standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This study employed conceptual and normative analysis, as well as use of an illustrative example.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method,\n                      <jats:italic toggle=\"yes\">direct comparative analysis<\/jats:italic>\n                      , for implementing the \u201crisks of daily life\u201d standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how\n                      <jats:italic toggle=\"yes\">direct comparative analysis<\/jats:italic>\n                      can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO\n                      <jats:sub>2<\/jats:sub>\n                      challenge poses minimal or greater than minimal risks in children and adolescents.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      <jats:italic toggle=\"yes\">Direct comparative analysis<\/jats:italic>\n                      is a systematic method for applying the \u201crisks of daily life\u201d standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2014.0039","type":"journal-article","created":{"date-parts":[[2014,9,17]],"date-time":"2014-09-17T15:24:56Z","timestamp":1410967496000},"page":"390-398","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Evaluating the Risks of Clinical Research: Direct Comparative Analysis"],"prefix":"10.1177","volume":"24","author":[{"given":"Annette","family":"Rid","sequence":"first","affiliation":[{"name":"King's College London","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Abdoler","sequence":"additional","affiliation":[{"name":"University of California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roxann","family":"Roberson-Nay","sequence":"additional","affiliation":[{"name":"Virginia Commonwealth University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel S.","family":"Pine","sequence":"additional","affiliation":[{"name":"National Institute of Mental Health"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Wendler","sequence":"additional","affiliation":[{"name":"The Clinical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2014,9,1]]},"reference":[{"key":"e_1_3_3_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-263X.1993.tb00083.x"},{"key":"e_1_3_3_3_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.163.2.201"},{"key":"e_1_3_3_4_1","unstructured":"Canadian Institutes of Health Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research Council of Canada: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 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