Human Subject Protection. The research to be conducted under this CRADA involves Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all research to be performed under this CRADA will conform to applicable federal laws and regulations. Additional information is available from the HHS Office for Human Research Protections (xxxx://xxx.xxx.xxx/ohrp/).
Human Subject Protection. The research to be conducted under this CRADA involves Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all research to be performed under this CRADA will conform to applicable federal laws and regulations. Additional information is available from the HHS Office for Human Research Protections (xxxx://xxx.xxx.xxx/ohrp/). The confidentiality of IPI of subjects enrolled in studies at NIH facilities is protected pursuant to the Privacy Act (5 U.S.C. 552a, implementing regulations 45 CFR Part 5b). Any disclosure to Collaborator will be done in accordance with applicable law and regulations. ICD will provide a copy of the informed consent template to Collaborator for its records. All informed consent forms used in clinical studies conducted under this CRADA must identify the existence of Collaborator and Collaborator’s right to access and use IPI contained in the Raw Data as provided in Paragraph 3.10.2 above. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Human Subject Protection. The Facility will satisfy the provisions contained in 45 C.F.R. Part 46, existing for the protection of human subjects, (to the extent that such regulations are applicable) to the respective program involved.
Human Subject Protection. The research and development activities to be conducted under this CRADA involve Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46 and therefore shall conform to applicable federal laws and regulations. Additional information is available from the HHS Office for Human Research Protections (xxxx://xxx.xxx.xxx/ohrp/). Collaborator shall under no circumstances receive Identifiable Private Information. The Parties may exchange samples of human tissue, or data derived from Identifiable Private Information, but only if all of the samples or data have first been coded by the providing Party who will not provide the key to such codes to the receiving Party. The receiving Party will not contact or make any effort to identify individuals who are, or may be, the sources of human tissue or data derived from identifiable private information, without the specific written approval of the providing Party. PHS ICT-CRADA Page 14 of 32 Agreement Ref. No. 03039 Confidential MODEL ADOPTED June 18, 2009 Revised May 15, 2014
Human Subject Protection. Human subjects are defined as individuals who are participants in an experimental procedure or who are asked to provide information about themselves, their attitudes, feelings, opinions, and/or experiences through an interview, questionnaire, or other data collection technique. All research involving human subjects must be conducted with the informed consent of those subjects and in a manner that will ensure their privacy and freedom from risk or harm and the protection of persons who are not subjects of the research but would be affected by it—unless such procedures and safeguards would make the research impractical. In such instances, SJI must approve procedures designed by the grantee to provide human subjects with relevant information about the research after their involvement and minimize or eliminate risk or harm to those subjects due to their participation.
