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EXEMPTION FROM REVIEW
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In some limited cases, research may be exempted from Scientific Committee review. Examples include research which involves observation of adults in public places; record reviews and historical surveys using preexisting data; and surveys, questionnaires and structured interviews involving adults in which respondents' personal identifiers are not linked to their responses.
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Note that an investigator may not make the final decision that his/her research is exempt without confirmation of this status from the appropriate Scientific Committee. Use Form D-III.d for this purpose.
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The following excerpt from federal regulations (45 CFR PART 46) details the criteria by which a project may qualify for exemption from review:
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CRITERIA FOR EXEMPTION FROM REVIEW
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1. Research conducted in established or commonly accepted educational setting, 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.
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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.
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3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation 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.
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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.
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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.
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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 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.
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Most research conducted at Bureau affiliates that is eligible for exemption falls in Category 2 (interviews, surveys, educational testing) or Category 4 (for retrospective compilation of existing data -- note that "Retrospective" means that the data already exist at the inception of the study.). Under Category 4, information may not be linked directly or indirectly to personal identifiers such as subjects' names or medical record numbers.
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| Under Category 2, such linkage is not allowed in cases where such linkage could pose some risk to the subjects.
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| Under Category 4, such identifiers must be removed at the time the data is compiled. Category 4 also includes data prepared for publication from individual cases or small case series and reports of quality assurance activities which after completion seem to merit general dissemination outside the institution.
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| If a research project seems to fall into one of the exempt categories, the research investigator must receive confirmation of the project's exempt status from the Chair of the Scientific Committee. A short form for this purpose is included is found in Section D-III.f.
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