Understanding Broad Consent

REFERENCES

1. 1.↵
   Federal policy for the protection of human subjects (‘common rule’). Office for Human Research Protection. Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html. Accessed November 12, 2019.
2. 2.↵
   Federal policy for the protection of human subjects. Federal Regist. 2017 Jan 19;82(12). www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf. Accessed November 11, 2019.
3. 3.↵
   Revised common rule. Office for Human Research Protections. Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html. Accessed November 12, 2019.
4. 4.↵
   1. Swerdlow PS,
   2. Macrina FL.

   Use of humans in biomedical experimentation. In: Macrina FL, ed. Scientific Integrity. Washington, DC: ASM Press; 2003:137.
5. 5.↵
   Companion Q&As about the revised common rule. Office for Human Research Protections. Department of Health and Human Services. www.hhs.gov/ohrp/sites/default/files/Revised-Common-Rule-Q-and-As-march2019.pdf#page7. Updated February 25, 2019. Accessed November 12, 2019.
6. 6.↵
   General requirements for informed consent. 45 CFR §46.116. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1116. Accessed November 12, 2019.
7. 7.↵
   Definitions for purposes of this policy. 45 CFR §46.102(e)(5). US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1102. Accessed November 12, 2019.
8. 8.↵
   Bureau of justice statistics. 34 USC §10132. Office of the Law Revision Counsel. United States Code. uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title34-section10132&num=0&edition=prelim. Accessed November 11, 2019.
9. 9.↵
   1. Lynch HF,
   2. Wolf LE,
   3. Barnes M

   . Implementing regulatory broad consent under the revised common rule: clarifying key points and the need for evidence. J Law Med Ethics. 2019 Jun;47(2):213-231. doi: 10.1177/1073110519857277.

   OpenUrlCrossRef
10. 10.↵
    IRB review of research. 45 CFR §46.109. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1109. Accessed November 12, 2019.
11. 11.↵
    Exempt research. 45 CFR §46.104. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1104. Accessed November 12, 2019.
12. 12.↵
    Criteria for IRB approval of research. 45 CFR §46.111. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1111. Accessed November 12, 2019.