Human Subjects Protection. If applicable to Recipient’s program, the Recipient bears ultimate responsibility for protecting human subjects under the award, including human subjects at all sites, and for ensuring that a Federal-wide Assurance (FWA) approved by the Office for Human Research Protections (OHRP) and certification of Institutional Review Board (IRB) review and approval have been obtained before human subjects research can be conducted at each collaborating site. For more information about OHRP, FWA, and IRBs, please see the following link: xxxx://xxx.xxx.xxx/ohrp/index.html. Recipients may not draw funds from the payment system, request funds from the paying office, or make obligations against Federal funds for research involving human subjects at any site engaged in nonexempt research for any period not covered by both an OHRP-approved assurance and IRB approval consistent with 45 CFR Part 46. Costs associated with IRB review of human research protocols are not allowable as direct charges under grants and cooperative agreements unless such costs are not covered by the organization’s indirect cost rate. HHS requires Recipients and others involved in grant/cooperative agreement-supported research to take appropriate actions to protect the confidentiality of information about and the privacy of individuals participating in the research. Investigators, IRBs, and other appropriate entities must ensure that policies and procedures are in place to protect identifying information and must oversee compliance with those policies and procedures.
Human Subjects Protection. The Parties shall promptly notify each other upon identifying a serious unanticipated problem involving risks to subjects or others and/or an unanticipated serious adverse event which may be related to the Protocol. VA shall promptly notify the Collaborator of any Protocol deviations using the notification method and time frame described in the IRB-approved Protocol. Collaborator shall promptly notify VA in writing upon identifying an interim data-analysis result, or study-result finding that may adversely affect the safety or well-being of subjects. If study result findings are provided to VA for conveyance to subjects, such communication to subjects shall be subject to Federal law and regulations and VA policy. VA always reserves the right to communicate and notify any safety concerns to the subjects.
Human Subjects Protection. The research to be conducted under this CRADA involves human subjects or human tissues as described in 38 C.F.R. Part 16. All research to be performed under this CRADA shall conform to laws, regulations and VA policies and procedures pertaining to protections for human subjects. VA shall promptly notify Collaborator and the IRB upon identifying any aspect of the Protocol or study results that may adversely affect the safety, well-being, or medical care of subjects, or that may affect the willingness of subjects to continue participation in the research, may influence the conduct of the study, or may alter the IRB’s approval to continue the study. When subject safety or medical care could be directly affected by study results, VA shall send study subjects a written communication the content of which is subject to IRB approval.
Human Subjects Protection. The CONTRACTOR agrees to comply with the requirements of 28 C.F.R. Part 46 and all Office of Justice Programs policies and procedures regarding the protection of human research subjects, including obtainment of Institutional Review Board approval, and subject informed consent.
Human Subjects Protection. If applicable to Recipient’s program, the Recipient bears ultimate responsibility for protecting human subjects under the award, including human subjects at all sites, and for ensuring that an assurance approved by OHRP and certification of IRB review and approval have been obtained before human subjects research can be conducted at each collaborating site. Recipients may not draw funds from the payment system, request funds from the paying office, or make obligations against Federal funds for research involving human subjects at any site engaged in nonexempt research for any period not covered by both an OHRP-approved assurance and IRB approval consistent with 45 CFR Part 46. Costs associated with IRB review of human research protocols are not allowable as direct charges under grants and cooperative agreements unless such costs are not covered by the organization’s indirect cost rate. HHS requires Recipients and others involved in grant/cooperative agreement-supported research to take appropriate actions to protect the confidentiality of information about and the privacy of individuals participating in the research. Investigators, IRBs, and other appropriate entities must ensure that policies and procedures are in place to protect identifying information and must oversee compliance with those policies and procedures.
Human Subjects Protection. If applicable to Recipient’s program, the Recipient bears ultimate responsibility for protecting human subjects under the award, including human subjects at all sites, and for ensuring that an assurance approved by OHRP and certification of IRB review and approval have been obtained before human subjects research can be conducted at each collaborating site. Recipients may not draw funds from the payment system, request funds from the paying office, or make obligations against Federal funds for research involving human subjects at any site engaged in nonexempt research for any period not covered by both an OHRP-approved assurance and IRB approval consistent with 45 CFR Part
Human Subjects Protection. 8.1 The NHLBI and the Company recognize the principles of respect for persons, beneficence (including minimization of xxxxx and maximization of benefits), and justice as stated in the Belmont Report and will apply these principles in all research covered under this Agreement. The informed consent of each Human Subject participating in the Clinical Trial at a Clinical Research Site will be obtained prospectively using an IRB approved informed consent process, provided that the informed consent form will enable the Parties disclosure of the data generated under this Clinical Trial, subject to the applicable Privacy Laws. The informed consent document will be reviewed in advance by the Company, accepted by the study team (which will consider in good faith the comments provided by Company), and will be approved by the NHLBI, the FDA, and all appropriate IRBs.
8.2 The NHLBI or its designee and the Company acknowledge and accept their responsibilities for protecting the rights and welfare of Human Subjects set forth in 45 C.F.R. Part 46, Protection of Human Subjects (Revised November 13, 2001).
Human Subjects Protection. 8.1 The NIAID and the Company recognize the principles of respect for persons, beneficence (including minimization of xxxxx and maximization of benefits), and justice as stated in the Belmont Report and will apply these principles in all research covered under this Agreement. The informed consent of each Human Subject participating in the Clinical Trial at the Clinical Research Site will be obtained prospectively using an IRB approved informed consent process. The informed consent document may be reviewed in advance by the Company and approved by the NIAID (which will consider in good faith any comments provided by the Company) and all appropriate Institutional Review Board (IRB). NIAID Intramural Clinical Trial Agreement (Clinical Center) NIAID Xxxxxxxx # 00-X-0000
8.2 The NIAID and the Company acknowledge and accept their responsibilities for protecting the rights and welfare of human research subjects set forth in 45 C.F.R. Part 46, Protection of Human Subjects (Revised November 13, 2001) and in a Certificate of Confidentiality issued by NIH in accordance with 42 U.S.C 241(d) of the Public Health Service Act. Therefore:
8.2.1 Any ISI that Company receives from NIH is covered by a CoC and therefore all copies of ISI are immune from the legal process, and will not, without the consent of the Human Subject, be admissible as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceeding.
8.2.2 The NIAID and the Company will maintain the confidentiality of ISI of Human Subjects collected under the Clinical Trial and protect the privacy of each of the individual Human Subjects in the Clinical Trial unless disclosure is required by law (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding. Prior to making any permitted disclosures, Company will ensure that any recipient of ISI protected by a CoC is aware of its confidential nature and the requirement to comply with the CoC.
8.2.3 The NIAID and the Company may inspect, but not copy, Human Subjects’ medical records that might also include information not directly connected to this Clinical Trial. However, the NIAID and the Company agree that this information will remain confidential and will not be used for any purpose o...
Human Subjects Protection. Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. If research involving human subjects is anticipated, grantees must meet the requirements of the HHS regulations to protect human subjects from research risks as specified in the Code of Federal Regulations, Title 45 – Public Welfare, Part 46 – Protection of Human Subjects (45 CFR 46), available online at xxxx://xxx.xxx.xxx/ohrp/humansubjects/guidance/45cfr46.html. Studies may be submitted to journals for publication adhering to the following criteria:
Human Subjects Protection. 8.1 The NIAID and the Company recognize the principles of respect for persons, beneficence (including minimization of xxxxx and maximization of benefits), and justice as stated in the Belmont Report and will apply these principles in all research covered under this Agreement. The informed consent of each Human Subject participating in the Clinical Trial at a Clinical Research Site will be obtained prospectively using an IRB approved informed consent process. The informed consent document may be reviewed in advance by the Company and approved by the NIAID and all appropriate Institutional Review Board (IRB).
8.2 The NIAID and the Company acknowledge and accept their responsibilities for protecting the rights and welfare of human research subjects set forth in 45 C.F.R. Part 46, Protection of Human Subjects (Revised November 13, 2001).
