IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
IRB approval means that the IRB has reviewed the research and that the research may be conducted at an institution within the policies and procedures outlined in this booklet and within the constraints of other institutional and federal requirements. IRB approval must be granted prior to starting any research. GENERAL PROCEDURES FOR SUBMITTING AN APPLICATION There are specific guidelines for completing the research proposal for each of the three types of IRB protocol review.These types are:Exempt Review: No risk to the subject (requires an application).Expedited Review: Minimal risk to the subject.Full Review: Research for which there is a risk to the subject and the research does not fall into the Expedited Review category. The basic premise of the human subjects review process is that all studies are subject to continuous review. However, some studies may require only an initial review and are EXEMPT from ongoing review. No study is totally exempt from review. The University has adopted eight categories of research as exempt from the continuing Institutional Review Board for the Protection of Human Subjects (IRB) review based upon the Department of Health and Human Services (DHHS) regulations published in the Code of Federal Regulations, 45 CFR 46, amended in 2018. In order to establish anindividual research project as exempt, an investigator must complete an IRB application. Final determination as to whether a project is exempt rests with the IRB.If a research project is certified as exempt by the IRB, the investigator need not resubmit the project for continuing IRB review as long as there are no modificationsin the exempted procedures. In other words, the use of the term "exempt" refers to the requirement for continuing IRB review but not to the general requirements for informed consent and protection of subjects. Thus, even if a project is determined to be exempt, the investigator still must inform potential subjects of the proposed procedures and their rights as subjects.In accordance with DHHS regulations for the Protection of Human Subjects (45 CFR 46, as amended), the following categories of exemption have been adopted by East Stroudsburg University of Pennsylvania. The exempt categories do not, however, apply to research involving deception of subjects (i.e., where the researcher deceives the subject with regard to the purpose of the research and/or the results of the subject's actions in the study), sensitive behavioral research, or to research involving pr...
IRB approval means approval from an institutional review board (“IRB”) of a Project.
Examples of IRB approval in a sentence
For sites using the CIRB, IRB approval information is received from the CIRB and applied to the RSS in an automated process.
The system triggers a program to verify that all regulatory requirements (OHRP assurance, IRB approval) have been met by the institution.
Although IRB approval is not required at the time of award, you are required to provide the documentation below prior to enrolling participants into your project.
Seek IRB approval before any changes are made in the research study, except when necessary to eliminate hazards to the patients/subjects.
Agents may be ordered by a participating site only after the initial IRB approval for the site has been forwarded by the Coordinating Center to the CTEP PIO (PIO@ctep.nci.nih.gov) except for Group studies.
More Definitions of IRB approval
IRB approval. (will the requested data be used in research that requires Institutional Review Board approval? If yes, then please also complete the ICC Research Request Form) Yes No Comments PHI: (Does the data requested include Protected Health Information?) Yes No
IRB approval means the deter- mination of the IRB that the research has been reviewed and may be con- ducted at an institution within the Department of Veterans Affairs § 16.103 constraints set forth by the IRB and by other institutional and federal require- ments.
IRB approval has the meaning set forth in Section 2.26(a).
IRB approval means the deter- mination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.[46 FR 8975, Jan. 27, 1981, as amended at 54FR 9038, Mar. 3, 1989; 56 FR 28028, June 18,1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct.20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599,Apr. 24, 2001; 74 FR 2368, Jan. 15, 2009]
IRB approval means the receipt of approval by an IRB for a research proposal involving human subjects.
IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. [46 FR 8975, Jan. 27, 1981, as amended at 54 FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599, Apr. 24, 2001] § 56.103 Circumstances in which IRB review is required.(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.(b) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
IRB approval means the written approval by the IRB of the Protocol and the EAP in the corresponding Site.