{"id":947,"date":"2021-08-06T14:52:00","date_gmt":"2021-08-06T18:52:00","guid":{"rendered":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/?page_id=947"},"modified":"2021-08-06T14:52:00","modified_gmt":"2021-08-06T18:52:00","slug":"regulations","status":"publish","type":"page","link":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/topics\/regulations\/","title":{"rendered":"Regulations"},"content":{"rendered":"

[vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1647631759197{padding-right: 10px !important;padding-left: 10px !important;background-color: #f7f7f7 !important;border-radius: 20px !important;}”][vc_column][vc_column_text]Laws, regulations, and both regulatory and ethics committee guidance vary considerably across countries on the issue of return of individual research results (IRR) to study participants.<\/p>\n

In general, three major topics need to be considered:<\/strong><\/p>\n

    \n
  1. Laws and regulations on permissible test results that may e returned by researchers<\/li>\n
  2. Laws and regulations governing the individual\u2019s right of access to personal information<\/li>\n
  3. Privacy laws and regulations<\/li>\n<\/ol>\n

    In addition, issued guidance is often relevant and should be consulted.<\/p>\n

    In some countries, laws grant study participants broad access to their individual research results upon request; in other countries, laws may place restrictions on access. Further, the trustworthiness of the result itself (e.g., whether conducted in a research laboratory versus a clinical laboratory) is important.<\/p>\n

    If you are pursuing the return of IRR, make sure to identify individuals who know and can interpret the relevant laws, regulations, and guidance. Remember, these directives are constantly evolving.<\/p>\n

    Sections included on this page:<\/strong>[\/vc_column_text][vc_row_inner][vc_column_inner width=”1\/4″][vc_cta h2=”” txt_align=”center” style=”outline” color=”peacoc” add_icon=”top” i_icon_fontawesome=”fas fa-globe-americas” i_color=”black” i_background_style=”rounded” i_size=”sm” i_on_border=”true” el_class=”regs-cta”]<\/p>\n

    Selected US Regulations<\/strong><\/a><\/span><\/p>\n

    [\/vc_cta][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_cta h2=”” txt_align=”center” style=”outline” color=”peacoc” add_icon=”top” i_icon_fontawesome=”fas fa-globe-africa” i_color=”black” i_background_style=”rounded” i_size=”sm” i_on_border=”true” el_class=”regs-cta”]<\/p>\n

    Selected International Regulations<\/strong><\/span><\/a><\/p>\n

    [\/vc_cta][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_cta h2=”” txt_align=”center” style=”outline” color=”peacoc” add_icon=”top” i_icon_fontawesome=”fas fa-toolbox” i_color=”black” i_background_style=”rounded” i_size=”sm” i_on_border=”true” el_class=”regs-cta”]<\/p>\n

    General Resources<\/strong><\/span><\/a><\/p>\n

    [\/vc_cta][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_cta h2=”” txt_align=”center” style=”outline” color=”peacoc” add_icon=”top” i_icon_fontawesome=”fas fa-random” i_color=”black” i_background_style=”rounded” i_size=”sm” i_on_border=”true” el_class=”regs-cta”]<\/p>\n

    HIPAA\/CLIA Conflict<\/strong><\/span><\/a><\/p>\n

    [\/vc_cta][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1647634365238{background-color: #003468 !important;}” el_id=”us-regs”][vc_column][vc_custom_heading text=”Selected US Regulations” font_container=”tag:h1|text_align:center|color:%23ffffff” use_theme_fonts=”yes” css=”.vc_custom_1647633130707{margin-top: -20px !important;}”][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner equal_height=”yes” content_placement=”middle” css=”.vc_custom_1643383431225{padding-top: -6px !important;padding-bottom: -6px !important;}”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    Health Insurance Portability and Accountability Act of 1996 (HIPAA)<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Requires covered entities to give individuals access to the patient information held in a designated record set[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:http%3A%2F%2Fwww.hhs.gov%2Fhipaa%2F|target:_blank”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator border_width=”3″ css=”.vc_custom_1643383633913{margin-top: -25px !important;margin-bottom: 10px !important;}”][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    Clinical Laboratory Improvement Amendments of 1988 (CLIA)<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Requires clinical laboratories to meet certain quality standards, to ensure reliability of the lab test results[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fwww.cms.gov%2Fregulations-and-guidance%2Flegislation%2Fclia%3Fredirect%3D%2Fclia%2F”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator border_width=”3″ css=”.vc_custom_1643383656874{margin-top: -25px !important;margin-bottom: 10px !important;}”][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    Revised Common Rule<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Requires that informed consent for research, as appropriate, include a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions (45 CFR 46.116(c)(8))[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregulations-and-policy%2Fregulations%2Ffinalized-revisions-common-rule%2Findex.html”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator border_width=”3″ css=”.vc_custom_1643383656874{margin-top: -25px !important;margin-bottom: 10px !important;}”][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    Genetic Information Nondiscrimination Act (GINA)<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Prohibits discrimination on the basis of genetic information, affecting health insurance and employment[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fwww.eeoc.gov%2Fstatutes%2Fgenetic-information-nondiscrimination-act-2008″][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator border_width=”3″ css=”.vc_custom_1643383656874{margin-top: -25px !important;margin-bottom: 10px !important;}”][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    California Consumer Privacy Act (CCPA)<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Requires business privacy policies to include information on consumers’ privacy rights and how to exercise them; amended to exempt any research as defined in HIPAA[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Foag.ca.gov%2Fprivacy%2Fccpa”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1647634379223{background-color: #003468 !important;}” el_id=”international-regs”][vc_column][vc_custom_heading text=”Selected International Regulations” font_container=”tag:h1|text_align:center|color:%23ffffff” use_theme_fonts=”yes” css=”.vc_custom_1647633169564{margin-top: -20px !important;}”][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    European Union\u2019s General Data Protection Regulation (GDPR)<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Requires the consent of subjects for data processing, data anonymization, data breach notifications, safe handling of the transfer of data across borders, etc; applies to \u201cany information relating to an identified or identifiable natural person (\u2018data subject\u2019)\u201d[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fgdpr.eu%2Fwhat-is-gdpr%2F”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    Personal Information Protection Law of the People\u2019s Republic of China<\/strong><\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Modeled on the GDPR, details privacy provisions for personal information focusing on the protection of Chinese citizens\u2019 personally identifying information to protect the rights and interests of individuals, regulate personal information processing activities, and facilitate reasonable use of personal information[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More (English Language)” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fdigichina.stanford.edu%2Fwork%2Ftranslation-personal-information-protection-law-of-the-peoples-republic-of-china-effective-nov-1-2021%2F”][vc_btn title=”Learn More (Chinese Language)” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fzh.wikisource.org%2Fwiki%2F%25E4%25B8%25AD%25E5%258D%258E%25E4%25BA%25BA%25E6%25B0%2591%25E5%2585%25B1%25E5%2592%258C%25E5%259B%25BD%25E4%25B8%25AA%25E4%25BA%25BA%25E4%25BF%25A1%25E6%2581%25AF%25E4%25BF%259D%25E6%258A%25A4%25E6%25B3%2595″][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1647634389443{background-color: #003468 !important;}” el_id=”resources”][vc_column][vc_custom_heading text=”General Resources” font_container=”tag:h1|text_align:center|color:%23ffffff” use_theme_fonts=”yes” css=”.vc_custom_1647633197402{margin-top: -20px !important;}”][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner equal_height=”yes” content_placement=”middle”][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    U.S. HHS \/ OHRP: International Compilation of Human Research Standards<\/h3>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text]Enumerates over 1,000 laws, regulations, and guidelines that govern human subjects research in 130 countries[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”Learn More” style=”outline-custom” outline_custom_color=”#040059″ outline_custom_hover_background=”#040059″ outline_custom_hover_text=”#ffffff” align=”center” link=”url:https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Finternational%2Fcompilation-human-research-standards%2Findex.html”][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_empty_space][vc_column_text]<\/p>\n

    Please contact us<\/a> if you would like to share additional resources to include on this page.<\/strong><\/p>\n

    [\/vc_column_text][vc_empty_space][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1647634400806{background-color: #003468 !important;}” el_id=”hipaa-clia”][vc_column][vc_custom_heading text=”Implications of HIPAA and CLIA on the Return of Results” font_container=”tag:h1|text_align:center|color:%23ffffff” use_theme_fonts=”yes” css=”.vc_custom_1647633459893{margin-top: -20px !important;}”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<\/p>\n

    A regulatory conflict exists between HIPAA and CLIA<\/strong><\/h3>\n

    CLIA permits returning results to individuals for the \u201cdiagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings\u201d only if results are generated in a CLIA-certified laboratory.<\/p>\n

    Centers for Medicare and Medicaid Services (CMS) representatives appear to interpret this provision as prohibiting the return of results from a research laboratory and recommend referring an individual for re-testing (even if a potentially actionable result is found) at a CLIA-certified laboratory.<\/p>\n

    In contrast, HIPAA requires providing access to information held in the Designated Record Set (DRS), which may include research test results, depending on whether the test results are included in the covered entity\u2019s medical record, billing record, or otherwise used to make decisions about the individual, such as determining whether to offer the individual enrollment in a research study.<\/p>\n

    These regulations conflict when research participants desire access to test results from a non-CLIA-certified research laboratory that exists within a HIPAA covered entity.[\/vc_column_text][vc_column_text el_id=”wide-line-bullets”]<\/p>\n

    Joint HIPAA\/CLIA Rule (2014):<\/strong><\/h3>\n

    With the intent of harmonizing CLIA and HIPAA on individuals\u2019 access rights, a joint CMS\/Office for Civil Rights (OCR) rule<\/a> was issued in 2014.<\/p>\n