Research Involving Human Subjects. If the Services involve research with human subjects, or if otherwise applicable to the Services to be performed, Vendor shall obtain approval or exemption by an Institutional Review Board or Ethics Committee prior to Vendor engaging with human subjects, unless RTI notifies Vendor that it will obtain such approval or exemption.
Research Involving Human Subjects. 1. All proposed research involving human subjects must be conducted in accordance with 15 C.F.R. Part 27 (Protection of Human Subjects). No research involving human subjects is permitted under this award unless expressly authorized by specific award condition, or otherwise in writing by the Grants Officer.
2. Federal policy defines a human subject as a living individual about whom an investigator (whether professional or student) conducting research (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
3. DOC regulations at 15 C.F.R. Part 27 require that non-Federal entities maintain appropriate policies and procedures for the protection of human subjects. In the event it becomes evident that human subjects may be involved in this project, the non-Federal entity (generally through the recipient) must submit appropriate documentation to the Federal Program Officer for approval by the appropriate DOC officials. As applicable, this documentation must include:
i. Documentation establishing approval of an activity in the project by an Institutional Review Board (IRB) under a Federal wide Assurance issued by Department of Health and Human Services or other Federal agency guidelines (see also 15 C.F.R. § 27.103);
ii. Documentation to support an exemption for an activity in the project under 15 C.F.R. § 27.104(d);
iii. Documentation of IRB approval of any modification to a prior approved protocol or to an informed consent form;
iv. Documentation of an IRB approval of continuing review approved prior to the expiration date of the previous IRB determination; and
v. Documentation of any reportable events, such as serious adverse events, unanticipated problems resulting in risk to subjects or others, and instances of noncompliance.
4. No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged for human subjects research, until the appropriate documentation is approved in writing by the Grants Officer. In accordance with 15 C.F.R. § 27.118, if research involving human subjects is proposed after an award is made, the non-Federal entity must contact the Fed...
Research Involving Human Subjects. If the Grant is to be used in whole or in part for research involving human subjects, Grantee hereby certifies that Grantee, applying the ethical standards and the criteria for approval of grants set forth in its Internal Review Boards and professional oaths, has determined that the human subjects involved in this Grant will not experience risk over and above that involved in the normal process of care and are likely to benefit from the proposed research program.
Research Involving Human Subjects. No research involving human subjects, as defined in 45 CFR Part 46, may be performed by Seller on this purchase order without prior written approval of Buyer's Human Research Protection Administrator (HRPA). Any Buyer approved research involving human subjects must, at all times, (a) conform to any conditions or restrictions provided in the HRPA's written approval, (b) be guided by "Ethical Principals and Guidelines for the Protection of Human Subjects," The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979 ("The Belmont Report"), and (c) remain in full compliance with the applicable regulations of the Government agency or instrumentality funding the research (e.g., 32 CFR Part 219 for the Department of Defense).
Research Involving Human Subjects.
1. All proposed research involving human subjects must be conducted in accordance with 15 C.F.R. Part 27, “Protection of Human Subjects.” No research involving human subjects is permitted under this award unless expressly authorized by special award condition, or otherwise in writing by the Grants Officer.
2. Federal policy defines a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
3. DOC regulations at 15 C.F.R. Part 27 require that non-Federal entities maintain appropriate policies and procedures for the protection of human subjects. In the event it becomes evident that human subjects may be involved in this project, the non-Federal entity shall submit appropriate documentation to the Federal Program Officer for approval by the appropriate DOC officials. This documentation may include:
i. Documentation establishing approval of the project by an Institutional Review Board (IRB) approved for Federal-wide use under Department of Health and Human Services guidelines (see also 15 C.F.R. § 27.103);
ii. Documentation to support an exemption for the project under 15 C.F.R. § 27.101(b); or
iii. Documentation of IRB approval of any modification to a prior approved protocol or to an informed consent form.
4. No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged for human subjects research, until the appropriate documentation is approved in writing by the Grants Officer. In accordance with 15 C.F.R. § 27.118, if research involving human subjects is proposed after an award is made, the non-Federal entity must contact the Federal Program Officer and provide required documentation. Notwithstanding this prohibition, work may be initiated or costs incurred and/or charged to the project for protocol or instrument development related to human subjects research.
Research Involving Human Subjects. 7.1 Ethical Aspects It is the responsibility of the Institution and the Principal Investigator to safeguard the rights and welfare of human subjects involved in research supported in whole or in part by funds from WHO, in accordance with the appropriate national code of ethics or legislation, if any, and in the absence thereof, the Helsinki Declaration and any subsequent amendments. Such funds may be used only to support investigations where (a) the rights and welfare of the subjects involved in the research are adequately protected, (b) freely given informed consent has been obtained, (c) the balance between risk and potential benefits involved has been assessed and deemed acceptable by a panel of independent experts appointed by the Institution and (d) any special national requirements have been met.
Research Involving Human Subjects. All proposed research involving human subjects must be conducted in accordance with 15 C.F.R. Part 27 (Protection of Human Subjects). No research involving human subjects is permitted under this award unless expressly authorized by specific award condition, or otherwise in writing by the Grants Officer.
Research Involving Human Subjects. If Program Funds are to be used in whole or in part for research involving human subjects, Grantee hereby certifies that it will conduct the research in compliance with the ethical standards and the criteria for approval and conduct of research set forth in United States Department of Health and Human Services policy for the protection of human research subjects (45 C.F.R. Part 46 and related guidance, as amended from time to time) and all other federal and state laws applicable to the research project. Such requirements may include, but are not limited to, obtaining and maintaining institutional review board (“IRB”) approval and obtaining informed consent of participating research subjects.
Research Involving Human Subjects a. All proposed research involving human subjects must be conducted in accordance with 15 C.F.R. Part 27, “Protection of Human Subjects.” No research involving human subjects is permitted under this award unless expressly authorized by special award condition, or otherwise in writing by the Grants Officer.
b. Federal policy defines a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
c. DOC regulations at 15 C.F.R. Part 27 require that recipients maintain appropriate policies and procedures for the protection of human subjects. In the event it becomes evident that human subjects may be involved in this project, the recipient shall submit appropriate documentation to the Federal Program Officer for approval by the appropriate DOC officials. This documentation may include:
1. Documentation establishing approval of the project by an institutional review board (IRB) approved for Federal-wide use under Department of Health and Human Services guidelines (see also 15 C.F.R. § 27.103);
2. Documentation to support an exemption for the project under 15 C.F.R. § 27.101(b);
3. Documentation to support deferral for an exemption or IRB review under 15 C.F.R.
Research Involving Human Subjects. The Recipient and any Recipient institutions shall conduct all Research Involving Human Subjects in compliance with the requirements set forth in 45 C.F.R. § 46, Subparts A-D, DHS Directive 026-04, Protection of Human Subjects , and any related DHS policies and instructions prior to initiating any work with human subjects under this Award. Each Recipient and any Recipient institutions planning to perform research involving human subjects under this Award must submit the documentation outlined in this section for RCO review.
