Is Your Research Involving Human Subjects Eligible for Exemption? John M. Falletta, M.D. Professor of Pediatrics Senior Chairman, DUHS IRB

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1 Is Your Research Involving Human Subjects Eligible for Exemption? John M. Falletta, M.D. Professor of Pediatrics Senior Chairman, DUHS IRB

2 Exemption From What??and/or By Whom? Scrutiny by anyone? SBR review? CRSO review? CTQA audit? IRB review?

3 Considerations To Be Made Does your project involve: Research? Human Subjects? If so, is it eligible for exemption from further IRB review? If not, is DUHS, its employees or agents to be engaged in research with humans? If so, is it eligible for expedited review?

4 Definition of Research Common Rule: 45 CFR (d) HIPAA: 45 CFR A systematic investigation designed to develop or contribute to generalizable knowledge.

5 Definition of a Human Subject Common Rule: 45 CFR (f) A living individual about whom an investigator...conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

6 Considerations To Be Made Does your project involve: Research? Human Subjects? If so, is it eligible for exemption from further IRB review? If not, is DUHS, its employees or agents to be engaged in research with humans? If so, is it eligible for expedited review?

7 Who Decides? DUHS HRPP Policy: When an activity is determined to be Research Involving Human Subjects, the investigator must submit the research for initial review by the DUHS IRB. Your Option: If you think your protocol meets one or more exemption criteria, please do request exemption.

8 When Requesting Exemption, You and the IRB must determine: Whether your research is subject to the Common Rule (45 CFR 46 Subpart A) Whether your research is subject to FDA regulations (21 CFR 50, 56, 312, 812) Does it involve the use of a non-fda-approved drug, device or biologic? Does it involve the use of an FDA-approved drug, device or biologic for which an IND or IDE is required? Is it otherwise regulated by FDA?

9 Is it otherwise regulated by FDA? Does your device research assess the safety or effectiveness of an FDA-approved device? If Yes, the research is subject to FDA research regulations. If No, the research possibly may not be subject to these regulations. Does your research involve the use of an FDA approved and marketed drug/biologic in the course of medical practice? If Yes, then the use of the drug/biologic is not subject to FDA research regulations.

10 Why Must You and the IRB Determine This? Because the Common Rule offers many more options for exemption than FDA regulations do.

11 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b)(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

12 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; *AND* (ii) 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, or reputation. *My emphasis*

13 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b)(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: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

14 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b) (4) Research involving the collection or study of *existing* data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or *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*. *Emphasis added*

15 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b)(5) Research and demonstration projects which are conducted by or subject to the approval of *FEDERAL* department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. *My addition*

16 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b) (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.

17 Which of the 6 exemption criteria under the Common Rule also apply to FDA-regulated research? Please don t all speak at once!

18 Exemption Criteria in Common Rule (45 CFR (b)(1-6)).101(b) (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.

19 Please Note None of the above exemption criteria apply to research involving prisoners. Exemption criteria 1-5 do not apply to FDA regulated research. The exemption 45 CFR (b)(2) does not apply to research involving children except for research involving observations of public behavior when the investigator does not participate in the activities being observed.

20 Exemption Criteria in Common Rule (45 CFR (b)(1-6)) re. Children.101(b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), *[survey procedures, interview procedures]* or observation of public behavior *and the investigator only observes*, unless: (i) and information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (ii) 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, or reputation. *My addition*

21 Exemption Criteria for FDA Regulated Research 21 CFR (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, (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.

22 Exemption Criteria for FDA Regulated Research 21 CFR (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. This must not meet the DHHS definition of research and involve human subjects.

23 Exemption Criteria for FDA Regulated Research 21 CFR (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.

24 Please Note Activities involving use of a drug, biologic or medical device will not be eligible for exemption from IRB review unless: the activity falls within 21 CFR , or the activity involves the use of an FDA approved drug, biologic or medical device in the course of medical practice (no safety or effectiveness assessment)

25 Also Please Note Activities involving the use of a drug, biologic or medical device for which the data will be submitted to or held for inspection by the FDA for regulatory purposes are not eligible for exemption from IRB review.

26 Exemption From What??and/or By Whom? Scrutiny by anyone? SBR review? CRSO review? CTQA audit? IRB review?

27 John M. Falletta, MD Senior Chairman, Institutional Review Board Duke University Health System Box 2712 Durham, NC