The Common Rule allows exemption from the need for IRB review. Exemption from the IRB review requirement does not exempt anyone from the requirements for the responsible conduct of research, obligations to respect subjects, or the need to adhere to the ethical standards for research.
The Food and Drug Administration has only one exemption available to most investigators.
45 CFR §46.101 To what does this policy apply?
The exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization, subparts B and C.
(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.
(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.
(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.
The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
(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.
(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.
(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:
(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.
(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.
OPRR Guidance on 45 CFR 46.101(b)(5):
Exemption for Research and Demonstration Projects on
Public Benefit and Service Programs
The Office for Protection from Research Risks (OPRR) has determined that the following criteria (see 48 FR 9266-9270, March 4, 1983) must be satisfied to invoke the exemption for research and demonstration projects examining "public benefit or service programs" as specified under Department of Health and Human Services (HHS) regulations at 45 CFR 46.101(b)(5):
(1) The program under study must deliver 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).
(2) The research or demonstration project must be conducted pursuant to specific federal statutory authority.
(3) There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).
(4) The project must not involve significant physical invasions or intrusions upon the privacy of participants.
Institutions should consult with the HHS funding agency regarding the above conditions before invoking this exemption. In addition, it is extremely important that staff in all HHS agencies understand and respect the following principles, which are critical to the successful implementation of human subject protections under HHS regulations:
(1) Institutions conducting (nonexempt) HHS-supported human subjects research must provide OPRR with an acceptable Assurance of Compliance with the human subjects regulations [45 CFR 46.103(a)]. Under the terms of such Assurances, it is typically the responsibility of the Institutional Review Board (IRB) or other designated institutional official(s), not the investigator, to determine whether research activities qualify for exemption. Institutions holding OPRR-approved Assurances generally require that all research involving human intervention/interaction or identifiable private information [45 CFR 46.102(f)(2)] be subjected to independent verification of exempt status.
(2) Institutions may elect under their Assurance not to claim the exemptions provided in the regulations, choosing instead to require IRB review of all research involving human intervention/interaction or identifiable private information.
(3) While HHS requires neither an Assurance nor a Certification of IRB Review [45 CFR 46.103(f)] for exempt research, institutional requirements regarding review of such research are, nevertheless, binding on investigators. It would be inappropriate for staff of any HHS agency to discourage potential awardees from submitting their activities for institutionally required IRB review.
|Last Updated ( Wednesday, 16 September 2015 13:54 )|