Institutional Review Board (IRB. A specifically constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical or behavioral/social science research.
Institutional Review Board (IRB. The Resident acknowledges that RUHS-MC has an IRB and agrees that no research activities will be conducted by Resident without prior approval of the IRB. Research is defined to include:
Institutional Review Board (IRB. This trial requires IRB approval prior to initiation. This protocol, subject informed consent, and subsequent amendments will be reviewed and approved by an IRB. Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any other written information given to subjects, and any advertisements planned for subject recruitment must be approved by an IRB. The Investigator must provide documentation of the IRB approval to the Study Sponsor. The approval must be dated and must identify the applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting materials, written information for subject, and subject compensation programs. The IRB must be provided with a copy of the Investigator’s Brochure, any periodic safety updates, and all other information as required by local regulation and/or the IRB. At the end of the study, the Investigator must notify the IRB about the study’s completion. The IRB also must be notified if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the progress of the study at intervals stipulated by the IRB. Voluntary informed consent must be obtained from every subject (and/or legal representative, as applicable) prior to the initiation of any screening or other study-related procedures. The Investigator must have a defined process for obtaining consent. Specifically, the Investigator, or delegate, must explain the clinical study to each potential subject and the subject must indicate voluntary consent by signing and dating the approved informed consent form. The subject must be provided an opportunity to ask questions of the Investigator, and if required by local regulation, other qualified personnel. The Investigator must provide the subject with a copy of the consent form written in a language the subject understands. The consent document must meet all applicable local laws and provide subjects with information regarding the purpose, procedures, requirements, and restrictions of the study, along with any known risks and potential benefits associated with the IP, the available compensation, and the established provisions for maintaining confidentiality of personal, protected health information. Subjects will be told about the voluntary nature of participation in the study and must be provided with contact information for the appropriate individuals should questions or concerns arise during the study. The subject also must be told that...
Institutional Review Board (IRB. The independent ethics committee (IEC), ethical review board (XXX), or research ethics board (REB), which is/are committee(s) designated to safeguard ethical conduct of studies using human subjects by monitoring and reviewing biomedical and behavioral research under certain national and international laws, regulations, codes and/or norms.
Institutional Review Board (IRB. The Resident acknowledges that RCRMC has an IRB and agrees that no research activities will be conducted by Resident without prior approval of the IRB. Research is defined to include:
Institutional Review Board (IRB a. Amend IRB approval to include instrument development.
Institutional Review Board (IRB. This trial requires IRB approval prior to initiation. This protocol, subject informed consent, and subsequent amendments will be reviewed and approved by an IRB. Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any other written information given to subjects, and any advertisements planned for subject recruitment must be approved by an IRB. The Investigator must provide documentation of the IRB approval to the Study Sponsor. The approval must be dated and must identify the applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting materials, written information for subject, and subject compensation programs. The IRB must be provided with a copy of the Investigator’s Brochure and Package Insert, any periodic safety updates, and all other information as required by local regulation and/or the IRB. At the end of the study, the Investigator must notify the IRB about the study’s completion. The IRB also must be notified if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the progress of the study at intervals stipulated by the IRB. Voluntary informed consent must be obtained from every subject (and/or legal representative, as applicable) prior to the initiation of any screening or other study-related procedures.
Institutional Review Board (IRB. The independent ethics committee (IEC), ethical review board (XXX), or research ethics board (REB), which is/are committee(s) designated to safeguard ethical conduct of studies using human subjects by monitoring and reviewing biomedical and behavioral research under certain national and international laws, regulations, codes and/or norms. Protected Health Information (PHI): Individually Identifiable Health Information that is transmitted by electronic media; maintained in any medium described in the definition of the term electronic media in the HIPAA regulations; or transmitted or maintained in any other form or medium as defined in 45 C.F.R. § 164.501. Protected Health Information excludes Individually Identifiable Health Information in education records covered by the Family Educational Right and Privacy Act, as amended, 20 U.S.C. § 1232g, and records described at 20 U.S.C. § 1232g(a)(4)(B)(iv). Personally Identifiable Information (PII): Information or data that (i) identifies an individual, including by name, signature, address, telephone number or other unique identifier, (ii) can be used to identify or authenticate an individual, including passwords, PINs, biometric data, unique identification numbers (e.g., social security numbers), answers to security questions or other personal identifiers, (iii) PHI under HIPAA and the HITECH Act and/or (iv) can be used in combination with other information or data to identify an individual, including but not limited to the individual's gender, race, income, date of birth, geographic location, school or workplace name, group affiliations, mental, emotional or physical characteristics, or other indirect identifiers.
Institutional Review Board (IRB. The Investigator must obtain IRB/IEC approval for the investigation. Initial IRB approval, and all materials approved by the IRB for this study including the patient consent form and recruitment materials must be maintained by the Investigator and made available for inspection.
Institutional Review Board (IRB. All relevant documents for this study will be submitted to an appropriate Institutional Review Board (IRB) for review. A signed and dated letter documenting IRB approval must be obtained prior to entering participants at the site. IRBs must be constituted and their authority delegated through the institution's normal process of governance according to applicable regulatory requirements for each participating site. Each participating institution must provide for the review and approval of this protocol and the associated informed consent documents and relevant participant materials by an appropriate IRB. For each participating site, the protocol and associated informed consent and relevant participant materials will be submitted for approval to the local IRB, as per site local regulatory policies and procedures. The study will not commence at any site until initial approval is obtained from the designated IRB and an approval to enroll notification is released to the site.
