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What are the categories of research that qualify as exempt?
What are the categories of research that qualify for expedited review?
What does "contingent approval" mean?
What does "tabled" mean?
What does "expedited approval" mean?
What does "acknowledged" mean?
What are the categories of research that qualify as exempt?
Although the IRB currently reviews all research involving human subjects, the regulations provide that certain human research activities, detailed below, may be eligible for a determination of "exempt" status by the IRB.
Although the IRB currently reviews all research involving human subjects, the regulations provide that certain human research activities, detailed below, may be eligible for a determination of "exempt" status by the IRB.
A Principal Investigator may request exemption from review by submitting an Application for Exemption from Review. A Principal Investigator must obtain such a determination from the IRB prior to initiating the study.
Research may be exempt from review when the only involvement of human subjects in the research falls into one of the following categories:
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 amonginstructional techniques, curricula, or classroom management methods.
. 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 amonginstructional 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. However, when a study involves children being interviewed, questioned or surveyed, that study must be reviewed by the IRB and may not be exempt. Similarly, studies involving children and observation of public behavior in which the Principal Investigator (or other investigator) participates in the activities being observed must be reviewed by the IRB.
. 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. However, when a study involves children being interviewed, questioned or surveyed, that study must be reviewed by the IRB and may not be exempt. Similarly, studies involving children and observation of public behavior in which the Principal Investigator (or other investigator) participates in the activities being observed must be reviewed by the IRB.
3). Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures (e.g. anonymous questionnaire), interview procedures, or observation of public behavior that is not otherwise exempt 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.
. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures (e.g. anonymous questionnaire), interview procedures, or observation of public behavior that is not otherwise exempt 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.
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.
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.
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.
Research that could qualify as exempt includes the following:
- Test, surveys, interviews or public observation
- Research on existing public or anonymous data or specimens
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Note: Only the IRB has the authority to determine if a protocol fits the exempt categories.
Only the IRB has the authority to determine if a protocol fits the exempt categories. |
What are the categories of research that qualify for expedited review?
Research that could qualify for expedited review includes:
- Research that presents no more than minimal risk to human subjects, and
- Involves only procedures listed in one or more of the categories listed by OHRP as eligible for expedited review.
What does "contingent approval" mean?
"Contingent approval" means minor revisions are needed that do not affect the safety of the research subject. The IRB Chair/designee may approve the study upon receipt of the satisfactory revisions without further review by the convened IRB.It is important to know that the study is not approved and cannot be initiated until the response is reviewed and the approval letter is issued. If revisions are not received by the IRB within 120 days, the protocol will be withdrawn from consideration.
What does "tabled" mean?
"Tabled" means substantive issues regarding the protocol and/or consent form must be addressed. The investigator's response to the issues raised must be reviewed by the IRB at a convened meeting. If the PI does not respond within 120 days, the protocol will be withdrawn from consideration.
What does "expedited approval" mean?
"Expedited approval" is approval given to issues/items that meet the criteria in the Federal regulations for review outside of a fully convened meeting(i.e., minor modifications, change of personnel, etc.).
What does "acknowledged" mean?
"Acknowledged" means the IRB has noted receipt of the item(s) (i.e., investigator's brochure, protocol violation, SAEs, etc.) which do not require approval.
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