Jeffrey A. Cooper, MD, MMM jcooper@huronconsultinggroup.com Huron Consulting Group Stuart Horowitz, PhD, MBA shorowitz@huronconsultinggroup.com Huron Consulting Group. 1 Huron Consulting Group Inc. All rights reserved. Neither Huron Consulting Group Inc. nor any of its affiliates is a CPA firm.
Course Objectives Understand the origin of the exemption categories Know how to use the exemption checklist
Exempt Research
DHHS Exemptions: Subpart A 46.101 To what does this policy apply? (b) Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
DHHS Exemptions: Subpart b 46.201 To what do these regulations apply? (b) The exemptions at 46.101(b)(1) through (6) are applicable to this subpart.
DHHS Exemptions: Subpart C 46.301 Applicability. (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or supported by the Department of Health and Human Services involving prisoners as subjects.
DHHS Exemptions: Subpart D 46.401 To what do these regulations apply? (b) Exemptions at 46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at 46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.
FDA Exemptions 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981. b) Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date. c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review. d) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
DHHS versus FDA Little overlap DHHS: Exempt from IRB review requirement Exempt from informed consent requirements FDA: Exempt from IRB review requirement NOT exempt from informed consent requirements
Consolidated Exempt Categories
CHECKLIST: Exemption Determination General Exclusions The research is USFDA-regulated Look for whether data from the research will be submitted to or held for inspection by USFDA. Beware of research that is commercially sponsored. The research involves prisoners and is funded by DHHS or United States Department of Defense (USDOD).
CHECKLIST: Exemption Determination Category #1 Research conducted in established or commonly accepted educational settings, involving normal educational practices. Both the procedures involve normal education practices and the objectives of the research involve normal educational practices.
CHECKLIST: Exemption Determination Category #2 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: Information obtained is recorded in such a manner that Human Subjects can be identified, directly or through identifiers linked to the subjects; AND Any disclosure of the Human Subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, or reputation. If the research involves children and is funded by DHHS, the United States Department of Defense (USDOD), the Department of Education (USED), or the United States Environmental Protection Agency (USEPA) the procedures are limited to (1) the observation of public behavior when the investigator(s) do not participate in the activities being observed and (2) the use of educational tests.
CHECKLIST: Exemption Determination Category #2 in such a manner that Human Subjects can be identified Identifiable: the identity of the subject is or may readily be ascertained by the investigator or associated with the information
CHECKLIST: Exemption Determination Category #3 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: The Human Subjects are elected or appointed public officials or candidates for public office; or Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
CHECKLIST: Exemption Determination Category #4 Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. For research funded by a federal agency existing means existing at the time the research is proposed. Otherwise, it means existing at the time the research is proposed or will exist in the future for non-research purposes.
How to have investigator record information in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects 1. Record a list of identifiers with no other information 2. Create data sheets of recorded information with no identifiers 3. Pick an identifier from the list, gather source documents, record information on data sheet, cross identifier off the list 4. Repeat step 3 until done 5. Analyze data
CHECKLIST: Exemption Determination Category #5 Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: Public benefit or service programs; Procedures for obtaining benefits or services under those programs; Possible changes in or alternatives to those programs or procedures; or Possible changes in methods or levels of payment for benefits or services under those programs. In addition: The program under study delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). The research or demonstration project is conducted pursuant to specific federal statutory authority. There is no statutory requirement that the project be reviewed by an IRB. The project does not involve significant physical invasions or intrusions upon the privacy of subjects. The funding agency concurs with the exemption.
CHECKLIST: Exemption Determination Category #6 Taste and food quality evaluation and consumer acceptance studies, If wholesome foods without additives are consumed or If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the United States Food and Drug Administration or approved by the United States Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Ethical review of exempt research
The AUB HRPP still mandates IRB review of all research Exempt = No regulations apply Exempt No IRB review and approval Exempt = AUB policies apply
AUB approval criteria for exemptions The research holds out no more than minimal risk to subjects Selection of subjects is equitable If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data If there are interactions with subjects: There will be a consent process The consent process will disclose that the activities involve research The consent process will disclose the procedures to be performed The consent process will disclose that participation is voluntary The consent process will disclose the name and contact information for the investigator There are adequate provisions to maintain the privacy interests of subjects
Jeffrey A. Cooper, MD, MMM jcooper@huronconsultinggroup.com Huron Consulting Group Stuart Horowitz, PhD, MBA shorowitz@huronconsultinggroup.com Huron Consulting Group. 23 Huron Consulting Group Inc. All rights reserved. Neither Huron Consulting Group Inc. nor any of its affiliates is a CPA firm.