Common use of Investigator Meetings Clause in Contracts

Investigator Meetings. Where the Agreement between the Institution and Sponsor recommend or obligate the Principal Investigator, Study Nurse, or other representative to attend an Investigators’ Meeting, it is understood and agreed that Sponsor will provide and pay all reasonable and appropriate expenses, including transportation, room and board, and incidental expenses. It is the understanding of the parties that attending of the Investigators’ Meetings is reasonable and necessary to ensure all parties engaged in the study have a clear understanding of the protocol. It is the understanding of the parties that the compensation for attending the Investigators’ meeting is fair and reasonable, and that said payments represent fair market value and are not merely a token arrangement. It is the understanding of the parties that attending of the Investigators’ Meetings does not constitute any form of payment for referral and that neither the person attending the Investigators’ Meeting nor the Institution is obligated to Sponsor in any way. It is the understanding of the parties that attending the Investigators’ Meeting does not obligate either party to ensure a certain number of patients will be enrolled in a study and does not constitute a promise of payment in the future. Both parties agree that if any physicians, healthcare professionals, study nurses, or other personnel connected with the Institution are engaged by Sponsor to act as consultants, advisors, or researchers in connection with various types of marketing and research activities, these arrangements will only be for a legitimate purpose and all payments for said activities shall be fair and reasonable. These activities may include, but are not limited to: performing research, data collection, consulting services, serving on advisory boards, and taking part in focus groups. Human Subjects Protection and HIPAA Human Subjects Protection: The parties agree that research investigators are entrusted with an essential role in assuring the adequate protection of human subjects. In activities they conduct or which are conducted under their direction, they have a direct and continuing responsibility to safeguard the rights and the welfare of the individuals who are or may become subjects of the research. Investigators must comply with the DHHS regulations, with the applicant organization's Assurance of Compliance, and with the requirements and determinations of the IRB concerning the conduct of the research. Investigators must ensure the minimum of unnecessary risks to subjects by using procedures which are consistent with sound research design. Whenever appropriate, investigators should use procedures already being performed on the subjects for diagnostic or treatment purposes. Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. Investigators must obtain the legally effective informed consent of each subject or of the subject's legally authorized representative before involving the subject in the research, to the extent required by and in accordance with 45 CFR 46, or as required by applicable Federal, State, or local law. The consent form must be approved by the IRB. HIPAA: Sponsor agrees to be bound by the requirements contained in the HIPAA Privacy Rule 42 C.F.R. 164.501 et seq. Sponsor acknowledges that disclosure of Protected Health Information in violation of the patient authorization or in breach of this Agreement will cause irreparable damage to Institution. Both parties hereto therefore agree that all Protected Health Information will be kept confidential and will not be released for any purpose other than authorized by the patient, enumerated in this Agreement or as provided by law. The Sponsor agrees that Sponsor, and any of its agents, will disclose Protected Health Information only to those individuals who agree to be bound by the terms of this Section and who reasonably require such information for the performance of this Agreement. Sponsor further agrees to indemnify and hold harmless Institution for any and all damages arising out of Sponsor’s unauthorized release/re-disclosure of Protected Health Information, including, but not limited to damages, fines, penalties, attorney fees, and interest.

Investigator Meetings. Where the Agreement between the Institution and the Sponsor recommend recommends or obligate obligates the Principal Investigator, Study Nurse, or other representative to attend an Investigators’ Meeting, it is understood and agreed that the Sponsor will provide and pay all reasonable and appropriate expenses, including transportation, room and board, and incidental expenses. It is the understanding of the parties that attending attendance of the Investigators’ Meetings is reasonable and necessary to ensure all parties engaged in the study Study have a clear understanding of the protocolProtocol. It is the understanding of the parties that the compensation for attending the Investigators’ meeting is fair and reasonable, and that said payments represent fair market value and are not merely a token arrangement. It is the understanding of the parties that attending attendance of the Investigators’ Meetings does not constitute any form of payment for referral and that neither the person attending the Investigators’ Meeting nor the Institution is obligated to the Sponsor in any way. It is the understanding of the parties that attending attendance of the Investigators’ Meeting does not obligate either party to ensure a certain number of patients will be enrolled in a study Study and does not constitute a promise of payment in the future. Both parties agree that if any physiciansphysician, healthcare professionalsprofessional, study nursesStudy nurse, or other personnel connected with the Institution are engaged by the Sponsor to act as consultants, advisors, or researchers in connection with various types of marketing and research activities, these arrangements will only be for a legitimate purpose and all payments for said activities shall be fair and reasonable. These activities may include, but are not limited to: performing research, data collection, consulting services, serving on advisory boards, and taking part in focus groups. Human SUBJECT INJURY REIMBURSEMENT For purposes of this section, “Injury” shall mean bodily injury, sickness or disease, including mental injury or mental anguish, sustained by a person, including death, resulting from any of these at any time. In the event of a Subject Injury, the Sponsor agrees to reimburse the Institution, other accredited medical care providers, or Subjects Protection (as appropriate) for any medical care required by the Subjects that occur as a direct result of participation in the Study and HIPAA Human Subjects Protectionthat is not covered by the Subject’s medical insurance. The Institution will xxxx the patient’s insurance for the items or services needed for the reasonable and necessary care arising from the provision of an investigational item or service, in particular, for the diagnosis or treatment of complications per CMS Rule 310.1 (commonly referred to as the Final National Coverage Decision). If, after billing the patient’s insurance and exhausting any appropriate appeals process, unpaid expenses remain, the Sponsor shall be responsible for all costs, including: All reasonable and associated costs incurred and associated with the diagnosis of an adverse event involving the Study Drug(s)/Device(s) or a Protocol Procedure; and All reasonable and associated costs incurred for treatment of an injury to the Subject if the Sponsor and the Institution together determine that the adverse event was reasonably related to the administration of the Study Drug(s)/Devices(s) or a Protocol procedure; provided however that: The parties agree that research investigators are entrusted with an essential role in assuring adverse event is not attributable to the adequate protection of human subjects. In activities they conduct negligence or which are conducted under their directionmisconduct by the Institution, they have a direct and continuing responsibility to safeguard the rights and the welfare Investigator, or any sub-investigator/agent of the individuals who are Institution; The adverse event is not attributable to any underlying illness, whether previously diagnosed or may become subjects of the research. Investigators must comply with the DHHS regulationsnot, with the applicant organization's Assurance of Compliance, and with the requirements and determinations of the IRB concerning the conduct of the research. Investigators must ensure the minimum of unnecessary risks to subjects by using procedures which are consistent with sound research design. Whenever appropriate, investigators should use procedures already being performed on the subjects for diagnostic and; The Study Drug(s)/Devices(s) or treatment purposes. Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. Investigators must obtain the legally effective informed consent of each subject or of the subject's legally authorized representative before involving the subject in the research, to the extent required by and Protocol procedure was administered in accordance with 45 CFR 46, or as required by applicable Federal, State, or local law. The consent form must be approved by the IRB. HIPAA: Sponsor agrees to be bound by the requirements contained in the HIPAA Privacy Rule 42 C.F.R. 164.501 et seq. Sponsor acknowledges that disclosure of Protected Health Information in violation of the patient authorization or in breach of this Agreement will cause irreparable damage to Institution. Both parties hereto therefore agree that all Protected Health Information will be kept confidential and will not be released for any purpose other than authorized by the patient, enumerated in this Agreement or as provided by law. The Sponsor agrees that Sponsor, and any of its agents, will disclose Protected Health Information only to those individuals who agree to be bound by the terms of this Section and who reasonably require such information for the performance of this Agreement. Sponsor further agrees to indemnify and hold harmless Institution for any and all damages arising out of Sponsor’s unauthorized release/re-disclosure of Protected Health Information, including, but not limited to damages, fines, penalties, attorney fees, and interestProtocol.