IRB approval definition

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 the deter- mination of the IRB that the research has been reviewed and may be con- ducted at an institution within the constraints set forth by the IRB and by other institutional and federal require- ments.

IRB approval means the determination of the IRB that the research has been re- viewed and may be conducted at an institu- tion within the constraints set forth by the IRB and by other institutional and Federal requirements (32 CFR 219.102(h)).

Examples of IRB approval in a sentence

• By approving and submitting the attached DAR, the Institutional Signing Official provides assurance that relevant institutional policies and applicable local, state, tribal, and federal laws and regulations, as applicable, have been followed, including IRB approval, if required.

• Approved Users may be required to have IRB approval if they have access to personal identifying information for research participants in the original study at their institution, or through their collaborators.

• Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

• These provisions do not apply to research investigators operating with specific IRB approval, pursuant to 45 CFR 46, to contact individuals within datasets or to obtain and use identifying information under an 2 The project anniversary date can be found in “My Projects” after logging in to the dbGaP authorized-access portal.

• 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.

More Definitions of IRB approval

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 an individual 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 notresubmit 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 involvi...

IRB approval means the determination of the Grantee’s IRB that the Project has been reviewed and may be conducted within the constraints set forth by the IRB and any other institutional or federal requirements.

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 Yes No

IRB approval means approval from an institutional review board (“IRB”) of a Project.

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 determination of the IRB that the