The IRB would like to emphasize that this is not a complete or even uncontroversial list of ethical issues involved in research on human subjects. Rather, it is intended as a starting point for discussion. The IRB would like to act, not as an ethical dictator, but as a facilitator of a campus-wide conversation about research ethics.
The Office of Human Subjects Research at the National Institutes for Health has an online program on the protection of human subjects of research (a valuable two-hour tutorial). Go to http://phrp.nihtraining.com/users/login.php
Fort Lewis College Institutional Review Board
Exemption Criteria
CFR 46.101
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.
(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.
Download and save a Blank Exemption Application. ONLY THE APPLICATION should be submitted as an attachment to IRB@fortlewis.edu by the PRIMARY INVESTIGATOR (faculty). A complete and thorough application expedites the process!
Fort Lewis College Institutional Review Board
Documentation of Human Subject Research that has Exempt Status
[Download and save a Blank Exemption Application]
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Research Project Title:
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Principal Investigator (must be a faculty member):
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Department:
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Telephone: |
Email: |
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Co-Principal Investigator (student researcher):
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Department:
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Telephone: |
E-mail: |
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Date project activity to begin:
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As the investigator submitting this proposed research and signing below, I agree to conduct the research involving human subjects as presented in the protocol or modifications to it and as approved by the Department and the Institutional Review Board.
PI Signature: _______________________________________________Date: ____________
Co-PI Signature: _____________________________________________Date: _____________
1. Succinctly (in approximately fifty words or less) describe the purpose and methods of the research. Include a brief description of all procedures to be conducted. Attach any instruments (surveys, etc) that will be used.
2. Cite which exempt category you believe this research falls under, and explain why you believe it falls under this category (see above).
