Informed Consent Process Sample Clauses

Informed Consent Process. The informed consent process was managed by the interviewers. Before starting the interviews, a summary of the study and the role of the participant was read out by the interviewer. The objectives and nature of the study, as well as potential risks and benefits, were clearly explained to the participant. Each participant was assured of confidentiality; names were not to be recorded on the questionnaire, only phone numbers. It was also emphasized that participation in the study was completely voluntary, and that there was no penalty for refusing to participate. It was also explained to participants that they could still participate in the program intervention even when they decided to not participate in the study. The participants were given opportunities to ask questions before they appended their signatures on the informed consent. The consent forms were separated from the actual questionnaires and stored in a locked drawer. The information from the informed consent forms were not recorded anywhere, or entered into the study database.
Sample 1
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Informed Consent Process. ‌ The Informed Consent Form (ICF) and the process to obtain the informed consent will comply with all local laws, regulations, and guidance. Karyopharm will provide to Investigators, in a separate document, proposed ICFs that are considered appropriate for this study and comply with the ICH GCP guidelines and regulatory requirements. Any changes to the ICFs suggested by the Investigator must be agreed to by Xxxxxxxxxx before submission to the IRB/IEC, and a copy of the approved version(s) must be provided to the Karyopharm after IRB/IEC approval. All patients, proxies or legal guardians must provide signed written or verbal informed consent as follows: • In a COVID-19 clinical trial, informed consent may be verbal in the presence of another hospital employee and/or a patient representative. In this case informed consent will be documented in the patient’s chart and informed consent will be obtained per usual practice when the patient or patient’s representative is able to provide after contamination concerns are no longer an issue. • In a COVID-19 clinical trial, if a patient is in an emergency situation informed consent will be obtained consistent with 21 CFR 50.24. Females of childbearing potential should be informed that taking the study drug may involve unknown risks to the fetus if pregnancy were to occur during the study and agree that in order to participate in the study they must adhere to the contraception requirement for the duration of the study and for 3 months after the last dose. If there is any question that the patient will not reliably comply, they should not be entered in the study. • The investigator or his/her representative will explain the nature of the study to the patient or his/her legally authorized representative or proxy and answer all questions regarding the study. • Patients must be informed that their participation is voluntary. Patients or their legally authorized representative will be required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study center. • The medical record must include a statement that written informed consent was obtained before the patient was enrolled in the study and the date the written consent was obtained. The authorized person obtaining the informed consent must also sign the ICF. • Patients must be re-consented to the ...
Sample 1
Informed Consent Process. Potential participants will be presented with the Baseline Sleep Apnea Study #2 eICF on the Baseline Sleep Apnea Study #2 Web Portal.. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local Document Number regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB. If the potential participant agrees to the terms described in the Baseline Sleep Apnea Study #2 eICF and provides consent, study eligibility will be further assessed.
Sample 1
Informed Consent Process. Obtaining informed consent is a process rather than an event and discussions to ensure participant understanding and continued willingness to participate should take place at every study visit. No trial activities will take place before the informed consent form has been signed by a participant or before the respective ethical review boards have given permission for the study. A research nurse will discuss the purpose, duration, procedures, alternatives, risks and benefits of the study with potentially eligible participants. The potential participant will be given the opportunity to ask questions or discuss the study with family members before signing the consent form. The nurse conducting the discussion will also ask the participant questions to assess the participant’s understanding. People who are not able to give informed consent for themselves, will not be included in this study. At Stellenbosch University the informed consent discussion will be conducted in English or Afrikaans, according to the preference of the participant. In the case of Xhosa speaking participants, an interpreter could be used to translate English or Afrikaans to Xhosa. Informed consent forms will be available in English, Afrikaans and Xhosa. The language used will be documented in the participant file. In the case of a participant who cannot read and write, an independent witness will be present during the discussion and will sign in addition to the participant’s thumbprint. This will also be documented in the participant file. The participant may withdraw consent at any stage and will be informed that withdrawal will not influence their routine clinical care. A participant may also be withdrawn from the study at the discretion of the study investigators if their further participation is somehow deemed to be a risk to their safety or if lack of the participant’s cooperation compromises the quality of the study.
Sample 1
Informed Consent Process. Prior to enrolling in the study, and before performance of any procedures, potential subjects will attend a screening session at which time they will be provided with full information concerning details of the study assessments and procedures. The investigator or his/her representative will explain the nature of the study to the subject or his/her legally authorized representative and answer all questions regarding the study. Subjects must be informed that their participation is voluntary. Subjects or their legally authorized representative will be required to sign a statement of informed consent that meets the requirements of 21 CFR 50, ICH guidelines, local regulations, and data privacy laws (eg, The General Data Protection Regulation (EU) 2016/679 [GDPR] and Health Insurance Portability and Accountability Act [HIPAA]) requirements, where applicable, and the IRB/IEC or study center. The medical record must include a statement that written informed consent was obtained before the subject entered the study and the date the written consent was obtained. The authorized person obtaining the informed consent must also sign the ICF. Subjects must be re-consented to the most current version of the ICF(s) during their participation in the study. A copy of the ICF(s) must be provided to the subject or the subject’s legally authorized representative.
Sample 1
Informed Consent Process. Study participation is voluntary. Potential subjects, and/or their legal representatives, are given the most current IRB-approved consent form) to read. They will be provided ample time for review and an opportunity to ask questions about the study. If they agree to participate, they will sign the consent form and be given a copy of the signed document for their records. The original signed copy of the consent form will be retained by the Principal Investigator. Each of these actions/steps will be documented. Only after Informed Consent has been obtained, may the study procedures begin.
Sample 1

Related to Informed Consent Process

  • Informed Consent Both of us have reviewed this Agreement with independent legal counsel. We understand the content, legal effect, and consequences of this Agreement, and we are entering into this Agreement voluntarily, free from duress, fraud, undue influence, or coercion of any kind.

  • Deemed Consent The Series 2012-1 Noteholders will be deemed to have consented to any amendment to any Related Document that changes the definition of “Rating Agency Condition” in such Related Document to match the definition of “Rating Agency Condition” in this Indenture Supplement.

  • Required Consent In addition, without limiting the generality of Section 4.1(a), except as permitted by the terms of this Agreement, and except as provided in Article IV of the Company Disclosure Letter or as required by applicable Legal Requirements or the regulations or requirements of Nasdaq, during the period from the date hereof and continuing until the earlier of the termination of this Agreement pursuant to its terms or the Effective Time, the Company shall not do any of the following, and shall not permit any of its Subsidiaries to do any of the following, without the prior written consent of Parent:

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information. If the Interconnection Customer's data is materially different from what was originally provided to the Participating TO and the CAISO for the Interconnection Studies, then the Participating TO and the CAISO will conduct appropriate studies pursuant to the LGIP to determine the impact on the Participating TO’s Transmission System and affected portions of the CAISO Controlled Grid based on the actual data submitted pursuant to this Article 24.3. The Interconnection Customer shall not begin Trial Operation until such studies are completed and all other requirements of this LGIA are satisfied.

  • Authority; No Conflict; Required Filings and Consents (a) iPrint and Sub have all requisite corporate power and authority to execute and deliver this Agreement and all other documents to which they are or will be parties (the "iPrint Transaction Documents") and to consummate the ---------------------------- transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the other iPrint Transaction Documents to which iPrint or Sub is or will be a party and the consummation of the transactions contemplated hereby and thereby have been duly and validly approved and authorized by the board of directors of iPrint and Sub and, subject to obtaining the iPrint Stockholder Approval, as defined in Section 6.16, no other actions or proceedings on the part of the iPrint or Sub are necessary to authorize this Agreement and the other iPrint Transaction Documents and the transactions contemplated hereby and thereby. This Agreement has been, and the other iPrint Transaction Documents to which iPrint and/or Sub are parties have been or will be when they are executed by iPrint and/or Sub, as applicable, duly executed and delivered by iPrint and/or Sub and constitute, or will constitute when they are executed by iPrint and/or Sub, as applicable, the valid and binding obligations of iPrint and/or Sub, enforceable against iPrint and/or Sub, as the case may be, in accordance with their respective terms, except as such enforceability may be limited by (i) bankruptcy, insolvency, moratorium or other similar laws affecting creditors' rights generally and (ii) general principles of equity.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Governmental and Third-Party Notices and Consents (a) Each Party shall use its Reasonable Best Efforts to obtain, at its expense, all waivers, permits, consents, approvals or other authorizations from Governmental Entities, and to effect all registrations, filings and notices with or to Governmental Entities, as may be required for such Party to consummate the transactions contemplated by this Agreement and to otherwise comply with all applicable laws and regulations in connection with the consummation of the transactions contemplated by this Agreement.

  • Authorization to Release and Transfer Necessary Personal Information The Grantee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of the Grantee’s personal data by and among, as applicable, the Company and its Subsidiaries for the exclusive purpose of implementing, administering and managing the Grantee’s participation in the Plan. The Grantee understands that the Company may hold certain personal information about the Grantee, including, but not limited to, the Grantee’s name, home address and telephone number, date of birth, social security number (or any other social or national identification number), salary, nationality, job title, number of Award Units and/or shares of Common Stock held and the details of all Award Units or any other entitlement to shares of Common Stock awarded, cancelled, vested, unvested or outstanding for the purpose of implementing, administering and managing the Grantee’s participation in the Plan (the “Data”). The Grantee understands that the Data may be transferred to the Company or to any third parties assisting in the implementation, administration and management of the Plan, that these recipients may be located in the Grantee’s country or elsewhere, and that any recipient’s country (e.g., the United States) may have different data privacy laws and protections than the Grantee’s country. The Grantee understands that he or she may request a list with the names and addresses of any potential recipients of the Data by contacting his or her local human resources representative or the Company’s stock plan administrator. The Grantee authorizes the recipients to receive, possess, use, retain and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing the Grantee’s participation in the Plan, including any requisite transfer of such Data to a broker or other third party assisting with the administration of Award Units under the Plan or with whom shares of Common Stock acquired pursuant to the vesting of the Award Units or cash from the sale of such shares may be deposited. Furthermore, the Grantee acknowledges and understands that the transfer of the Data to the Company or to any third parties is necessary for the Grantee’s participation in the Plan. The Grantee understands that the Grantee may, at any time, view the Data, request additional information about the storage and processing of the Data, require any necessary amendments to the Data or refuse or withdraw the consents herein by contacting the Grantee’s local human resources representative or the Company’s stock plan administrator in writing. The Grantee further acknowledges that withdrawal of consent may affect his or her ability to vest in or realize benefits from the Award Units, and the Grantee’s ability to participate in the Plan. For more information on the consequences of refusal to consent or withdrawal of consent, the Grantee understands that he or she may contact his or her local human resources representative or the Company’s stock plan administrator.

  • Transmission Delivery Service Implications Network Resource Interconnection Service allows Interconnection Customer's Large Generating Facility to be designated by any Network Customer under the Tariff on Transmission Provider's Transmission System as a Network Resource, up to the Large Generating Facility's full output, on the same basis as existing Network Resources interconnected to Transmission Provider's Transmission System, and to be studied as a Network Resource on the assumption that such a designation will occur. Although Network Resource Interconnection Service does not convey a reservation of transmission service, any Network Customer under the Tariff can utilize its network service under the Tariff to obtain delivery of energy from the interconnected Interconnection Customer's Large Generating Facility in the same manner as it accesses Network Resources. A Large Generating Facility receiving Network Resource Interconnection Service may also be used to provide Ancillary Services after technical studies and/or periodic analyses are performed with respect to the Large Generating Facility's ability to provide any applicable Ancillary Services, provided that such studies and analyses have been or would be required in connection with the provision of such Ancillary Services by any existing Network Resource. However, if an Interconnection Customer's Large Generating Facility has not been designated as a Network Resource by any load, it cannot be required to provide Ancillary Services except to the extent such requirements extend to all generating facilities that are similarly situated. The provision of Network Integration Transmission Service or firm Point-to-Point Transmission Service may require additional studies and the construction of additional upgrades. Because such studies and upgrades would be associated with a request for delivery service under the Tariff, cost responsibility for the studies and upgrades would be in accordance with FERC's policy for pricing transmission delivery services. Network Resource Interconnection Service does not necessarily provide Interconnection Customer with the capability to physically deliver the output of its Large Generating Facility to any particular load on Transmission Provider's Transmission System without incurring congestion costs. In the event of transmission constraints on Transmission Provider's Transmission System, Interconnection Customer's Large Generating Facility shall be subject to the applicable congestion management procedures in Transmission Provider's Transmission System in the same manner as Network Resources. There is no requirement either at the time of study or interconnection, or at any point in the future, that Interconnection Customer's Large Generating Facility be designated as a Network Resource by a Network Service Customer under the Tariff or that Interconnection Customer identify a specific buyer (or sink). To the extent a Network Customer does designate the Large Generating Facility as a Network Resource, it must do so pursuant to Transmission Provider's Tariff. Once an Interconnection Customer satisfies the requirements for obtaining Network Resource Interconnection Service, any future transmission service request for delivery from the Large Generating Facility within Transmission Provider's Transmission System of any amount of capacity and/or energy, up to the amount initially studied, will not require that any additional studies be performed or that any further upgrades associated with such Large Generating Facility be undertaken, regardless of whether or not such Large Generating Facility is ever designated by a Network Customer as a Network Resource and regardless of changes in ownership of the Large Generating Facility. However, the reduction or elimination of congestion or redispatch costs may require additional studies and the construction of additional upgrades. To the extent Interconnection Customer enters into an arrangement for long term transmission service for deliveries from the Large Generating Facility outside Transmission Provider's Transmission System, such request may require additional studies and upgrades in order for Transmission Provider to grant such request.

  • Voluntariness and Consequences of Consent Denial or Withdrawal The Participant’s participation in the Plan and the Participant’s grant of consent is purely voluntary. The Participant may deny or withdraw his or her consent at any time. If the Participant does not consent, or if the Participant withdraws his or her consent, the Participant cannot participate in the Plan. This would not affect the Participant’s salary as an employee or his or her career; the Participant would merely forfeit the opportunities associated with the Plan.

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