Common use of Informed Consent Form Clause in Contracts

Informed Consent Form. ‌ Informed consent will be obtained for each study in accordance with the Declaration of Helsinki, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), HIPAA (if applicable), and local regulations. The Investigator will prepare the informed consent form and HIPAA authorization and provide the documents to the Sponsor or designee for approval prior to submission to the IRB. The consent form generated by the Investigator must be acceptable to the Sponsor and be approved by the IRB. The written consent document will embody the elements of informed consent as described in the ICH GCP and will also comply with local regulations. The Investigator will send an IRB-approved copy of the informed consent form to the Sponsor (or designee) for the study file. A properly executed, written, informed consent will be obtained from each subject prior to entering the subject into a study. Information should be given in both oral and written form and subjects (or their legal representatives) must be given ample opportunity to inquire about details of the study. If appropriate and required by the IRB, assent from the subject will also be obtained. If a subject is unable to sign the informed consent form and the HIPAA authorization, a legal representative may sign for the subject. A copy of the signed consent form (and assent) will be given to the subject or legal representative of the subject and the original will be maintained with the subject’s records. During the course of the study, if modifications are made to the consent form that impact the subject, the subject will be re-consented as described above.

Informed Consent Form. ‌ Informed consent will be obtained for each study in accordance with the Declaration of Helsinki, ICH GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), HIPAA the Health Insurance Portability and Accountability Act (HIPAA), if applicable), and local regulations. The Investigator will prepare the informed consent form form, assent and HIPAA authorization and provide the documents to the Sponsor or designee for approval prior to submission to the IRB/IEC. The consent form generated by the Investigator must be acceptable to the Sponsor and be approved by the IRB/IEC. The written consent document will embody the elements of informed consent as described in the ICH GCP International Conference on Harmonisation and will also comply with local regulations. The Investigator will send an IRB/IEC-approved copy of the informed consent form Informed Consent Form to the Sponsor (or designee) for the study file. A properly executed, written, informed consent will be obtained from each subject prior to entering the subject into a studythe trial. Information should be given in both oral and written form and subjects (or their legal representatives) must be given ample opportunity to inquire about details of the study. If appropriate and required by the local IRB/IEC, assent from the subject will also be obtained. If a subject is unable to sign the informed consent form (ICF) and the HIPAA authorization, a legal representative may sign for the subject. A copy of the signed consent form (and assent) will be given to the subject or legal representative of the subject and the original will be maintained with the subject’s records. During the course of the study, if modifications are made to the consent form that impact the subject, the subject will be re-consented as described above.

Informed Consent Form. ‌ Informed consent will be obtained for each study in accordance with the Declaration of Helsinki, ICH GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), HIPAA the Health Insurance Portability and Accountability Act (HIPAA, if applicable), and local regulations. The Investigator will prepare the informed consent form and HIPAA authorization and provide the documents to the Sponsor or designee for approval prior to submission to the IRB. The consent form generated by the Investigator must be acceptable to the Sponsor and be approved by the IRB. The written consent document will embody the elements of informed consent as described in the ICH GCP International Conference on Harmonisation and will also comply with local regulations. The Investigator will send an IRB-approved copy of the informed consent form Informed Consent Form to the Sponsor (or designee) for the study file. A properly executed, written, informed consent will be obtained from each subject (or legal representative) prior to entering the subject into a studythe trial. Information should be given in both oral and written form and subjects (or their legal representatives) must be given ample opportunity to inquire about details of the study. If appropriate and required by the IRB, assent from the subject will also be obtained. If a subject is unable to sign the informed consent form (ICF) and the HIPAA authorization, a legal representative may sign for the subject. A copy of the signed consent form (and assent) will be given to the subject or legal representative of the subject and the original will be maintained with the subject’s records. During the course of the study, if modifications are made to the consent form that impact the subject, the subject will be re-consented as described above.

Informed Consent Form. ‌ Informed consent will be obtained for each study in accordance with the Declaration of Helsinki, ICH GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), HIPAA the Health Insurance Portability and Accountability Act (HIPAA, if applicable), and local regulations. The Investigator will prepare the informed consent form form, assent and HIPAA authorization and provide the documents to the Sponsor or designee for approval prior to submission to the IRB/IEC. The consent form generated by the Investigator must be acceptable to the Sponsor and be approved by the IRB/IEC. The written consent document will embody the elements of informed consent as described in the ICH GCP and will also comply with local regulations. The Investigator will send an IRB/IEC-approved copy of the informed consent form Informed Consent Form to the Sponsor (or designee) for the study file. A properly executed, written, informed consent will be obtained from each subject prior to entering the subject into a studythe trial. Information should be given in both oral and written form and subjects (or their legal representatives) must be given ample opportunity to inquire about details of the study. If appropriate and required by the local IRB/IEC, assent from the subject will also be obtained. If a subject is unable to sign the informed consent form ICF and the HIPAA authorization, a legal representative may sign for the subject. A copy of the signed consent form (and assent) will be given to the subject or legal representative of the subject and the original will be maintained with the subject’s records. During the course of the study, if modifications are made to the consent form that impact the subject, the subject will be re-consented as described above.