Review ArticleREVIEWS AND CONTEMPORARY UPDATES
Open Access
Understanding Broad Consent
John W. Maloy and Pat F. Bass
Ochsner Journal March 2020, 20 (1) 81-86; DOI: https://doi.org/10.31486/toj.19.0088
John W. Maloy
1Assistant Vice Chancellor for Research Management, Louisiana State University Health Sciences Center Shreveport, Shreveport, LA
JDPat F. Bass III
2Office of Research, Louisiana State University Health Sciences Center Shreveport, Shreveport, LA
MD, MS, MPHREFERENCES
- 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.↵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.↵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.↵
- Swerdlow PS,
- Macrina FL.
- 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.↵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.↵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.↵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.↵
- 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.↵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.↵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.
In this issue
Understanding Broad Consent
John W. Maloy, Pat F. Bass
Ochsner Journal Mar 2020, 20 (1) 81-86; DOI: 10.31486/toj.19.0088