Some human subjects research is exempt from the HHS regulations (45 CFR Part 46). OHRP guidance states that Exemptions should be independently determined (http://www.hhs.gov/ohrp/humansubjects/guidance/irb71102.pdf). Institutions often designate their IRB to make this determination. Because NIH does not require IRB approval at time of application, the exemptions designated in item 4a often represent the opinion of the PI, and the justification provided for the exemption by the PI is evaluated during peer review.
The research described in your application may include more than one research project; thus the application may include individual projects that meet the requirements for non-exempt or exempt human subjects research, or are not defined as human subjects research.
If research activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution, then your answer is “Yes” to Question 1 “Does your proposed research involve human subjects” even if the research is exempt from regulations for the protection of human subjects.
Research involving individuals who are or who become prisoners cannot be exempt under any exemption categories (see 45 CFR Part 46 Subpart C).
Your human subjects research is exempt if all of the proposed research meets the criteria for one or more of the following six exemptions.
Exemption 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.
Exemption 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.
Exemption 2 for research involving survey or interview procedures or observation of public behavior, does not apply to research with children (see 45 CFR Part 46, Subpart D), except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
Exemption 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.
Exemption 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.
The human subjects regulations decision charts (http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm) from the Office of Human Research Protection (OHRP) will help you to see whether your research falls under the human subjects regulations and if so, whether it meets the criteria for Exemption 4. See also the information contained at: Exemption 4 Guidance and Information.
The NIH Office of Extramural Research website also contains information that is helpful for determining whether your human subjects research meets the criteria for Exemption 4. See http://grants.nih.gov/grants/policy/hs/index.htm.
Research that meets the criteria for Exemption 4 is not considered “clinical research” as defined by NIH. Therefore the NIH policies for inclusion of women, minorities and children in clinical research do not apply to research projects covered by Exemption 4.
Exemption 5: Research and demonstration projects that are conducted by or subject to the approval of Department or Agency heads and that 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.
Exemption 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.
If you answered "Yes" to Question 2, then your research meets the criteria for an exemption.
Remember that you need to identify which exemption(s) you believe is applicable to your research, and provide a justification for the exemption(s) with sufficient information about the involvement of human subjects to allow a determination by peer reviewers and NIH staff that the claimed exemption(s) is appropriate.
If you answered "No" to Question 2, then your research does not qualify for one of the exemptions, and your research is not exempt from full IRB review. Proceed to Question 3.