Research Project – Essay Example
Section III If you are choosing one of the six federal categories of exemption, which one are you choosing? **If your project falls under more than one exemption, choose the one that is most applicable. You may cite the others in #3 below.
Please note for questions 2, 3, and 4 : The text areas are limited to 2000 characters/approximately 300 words. Even though you are allowed to type more than the specified limit, those additional words/characters will be cropped/cut off when you move to the next question.
2. What is the purpose of the project? (300 words or less)
3. Explain how this exemption category pertains to your project: (300 words or less)
4. If you believe your project poses no risk to human participants or should be exempt from IRB review for other reasons, please explain: (300 words or less)
Bottom of Form
Categories of Exemption: (Return to Section III, Question 2)
Exempt Categories of Research listed at 45 CFR, Part 46, Sec. 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.
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.
(Please note: Surveys on sensitive or personal topics which may cause stress to study participants may not be exempt from IRB review.)
(Note: The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does NOT participate in that behavior or activity. However this section is NOT applicable to survey or interview research involving children.)
(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 (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.
(Example: existing data, records review, pathological specimens)
(Note: This data must be in existence before the project begins)
(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.
(Note: Exemption category refers to federal government research)
(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.