276 lines
25 KiB
HTML
276 lines
25 KiB
HTML
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<meta name="title" property="og:title" content="Human Subjects Research"><meta name="type" property="og:type" content="website"><meta name="image" property="og:image" content="https://www.nlm.nih.gov/images/NLMgeneric.jpg"><meta name="image:alt" property="og:image:alt" content="National Library of Medicine (NLM)"><meta name="twitter:card" content="summary_large_image"><meta name="twitter:site" content="@NLM_NIH"><meta name="twitter:title" content="Human Subjects Research"><meta name="twitter:image" content="https://www.nlm.nih.gov/images/NLMgeneric.jpg"><meta name="twitter:image:alt" content ="National Library of Medicine (NLM)">
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<title>Human Subjects Research</title>
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<link rel="schema.DC" href="http://purl.org/dc/elements/1.1/" title="The Dublin Core metadata Element Set" />
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<meta name="DC.Title" content="Human Subjects Research" />
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<meta name="DC.Date.Issued" content="2023-09-06" />
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<table class="table table-bordered border-dark w-auto" style="box-sizing: border-box; caption-side: bottom; border-collapse: collapse; border-width: initial; border-style: none; border-color: #212529 !important; border-image: initial; --bs-table-bg: transparent; --bs-table-accent-bg: transparent; --bs-table-striped-color: #212529; --bs-table-striped-bg: rgba(0, 0, 0, 0.05); --bs-table-active-color: #212529; --bs-table-active-bg: rgba(0, 0, 0, 0.1); --bs-table-hover-color: #212529; --bs-table-hover-bg: rgba(0, 0, 0, 0.075); width: auto !important; margin-bottom: 1rem; color: #212529; vertical-align: top; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" border="0" summary="contains body content tables" width="100%" cellspacing="0" cellpadding="0">
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<tr style="box-sizing: border-box; border-color: initial; border-style: none; border-width: 1px 0px; border-image: initial;">
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<td class="title" style="box-sizing: border-box; border-color: initial; border-style: none; border-width: 0px 1px; border-image: initial; padding: 0.5rem; background-color: var(--bs-table-bg); box-shadow: inset 0 0 0 9999px var(--bs-table-accent-bg); font-family: Arial, Helvetica, sans-serif; font-size: 16px; color: #000000; font-weight: bold;" align="center">Human Subjects Research<br style="box-sizing: border-box;" /><br style="box-sizing: border-box;" /></td>
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</tr>
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<tr style="box-sizing: border-box; border-color: initial; border-style: none; border-width: 1px 0px; border-image: initial;">
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<td class="bodytext" style="box-sizing: border-box; border-color: initial; border-style: none; border-width: 0px 1px; border-image: initial; padding: 0.5rem; background-color: var(--bs-table-bg); box-shadow: inset 0 0 0 9999px var(--bs-table-accent-bg);">
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<p style="box-sizing: border-box; margin-top: 0px; margin-bottom: 1rem;">Federal regulations (<a style="box-sizing: border-box; color: #326295; text-decoration: none;" href="https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html">45 CFR 46</a>) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.</p>
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<ul style="box-sizing: border-box; padding-left: 2rem; margin-top: 0px; margin-bottom: 1rem;">
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<li style="box-sizing: border-box; padding-top: 0.3rem;"><a style="box-sizing: border-box; color: #326295; text-decoration: none;" href="https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html">Human Subjects Regulations - Decision Charts</a></li>
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<li style="box-sizing: border-box; padding-top: 0.3rem;"><a style="box-sizing: border-box; color: #326295; text-decoration: none;" href="https://crpac.od.nih.gov/Annotated%20Compendium%20of%20NIH%20Resources%20on%20Informed%20Consent%20-%2028%20Nov%202007.pdf">Annotated Compendium of NIH Resources on Informed Consent</a></li>
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<li style="box-sizing: border-box; padding-top: 0.3rem;"><a style="box-sizing: border-box; color: #326295; text-decoration: none;" href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html">Guidance on NIH Office of Extramural Research (OER) on-line tutorial Protecting Human Research Participants (PHRP)</a></li>
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<li style="box-sizing: border-box; padding-top: 0.3rem;"><a style="box-sizing: border-box; color: #326295; text-decoration: none;" href="https://www.hhs.gov/ohrp/">Office for Human Research Protections (OHRP)</a></li>
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</ul>
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</td>
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</tr>
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</tbody>
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</table></div>
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<div class="tablet:grid-col-3"><h4 style="box-sizing: border-box; margin-top: 0px; margin-bottom: 0.5rem; font-weight: 500; line-height: 1.2; font-size: calc(1.275rem + 0.3vw); color: #212529; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Help Topics</h4>
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<a style="box-sizing: border-box; color: #326295; text-decoration: none; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff;" href="/ep/faq.html">Frequently Asked Questions</a><br style="box-sizing: border-box; color: #212529; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" /><a style="box-sizing: border-box; color: #326295; text-decoration: none; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff;" href="/ep/Acronyms.html">Acronyms</a><br style="box-sizing: border-box; color: #212529; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" /><a style="box-sizing: border-box; color: #326295; text-decoration: none; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff;" href="/ep/Lifecycle.html">Grant Application Lifecycle</a><br style="box-sizing: border-box; color: #212529; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" /><a style="box-sizing: border-box; color: #326295; text-decoration: none; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff;" href="/ep/Tutorial.html">NIH Grant Tutorials</a><br style="box-sizing: border-box; color: #212529; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" /><a style="box-sizing: border-box; color: #326295; text-decoration: none; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff;" href="/ep/Payplan.html">NLM Award Decisions and Budget Adjustments</a><br style="box-sizing: border-box; color: #212529; font-family: Roboto, 'Helvetica Neue', Arial, Tacoma; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: #ffffff; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" /><a style="box-sizing: border-box; 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