Informed Consent Process. The Investigator, or his/her representative, will explain the nature of the study to the patient or his/her legally authorized representative, and will review the informed consent and answer any questions regarding the study. No study assessments or procedures will be performed until all the patient’s questions have been answered and the patient has signed the ICF. 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. If the ICF is revised, patients must be reconsented to the most current version of the ICF during their active participation in the study. A copy of the ICF must be provided to the patient or the patient’s legally authorized representative. A patient who is rescreened is required to sign another ICF.
Informed Consent Process. It is the responsibility of the Investigator to obtain signed (written or electronic signature) ICF from all study participants prior to any study-related procedures including screening assessments. • The Investigator or his/her representative will explain the nature of the study (including but not limited to the objectives, potential benefits and risks, inconveniences, and the participant’s rights and responsibilities) to the participant or his/her legally authorized representative, defined according to local and country regulations where the study is taking place, and answer all questions regarding the study. • Participants must be informed that their participation is voluntary. Participants or their legally authorized representative will be required to sign a statement of informed consent or a certified translation if applicable, that meets the requirements of 21 CFR 50, local regulations, EU General Data Protection Regulation (GDPR), 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 signed (written or electronic) informed consent was obtained before the participant was screened in the study and the date the written consent was obtained. The authorized person obtaining the informed consent must also sign the ICF(s). • Participants must be reconsented to the most current version of the ICF(s) during their participation in the study. • A copy of the signed (written or electronic) informed consent documentation (ie, a complete set of participant information sheets and fully executed signature pages) must be provided to the participant or the participant’s legally authorized representative, as applicable. This document may require translation into the local language. Signed (written or electronic) consent [or assent] forms must remain in each participant’s study file and must be available for verification at any time.
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.
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.
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.
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.
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.
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 ...
