Informed Consent Clause Samples

Informed Consent. Principal Investigator shall ensure that the ICF approved by Sponsor, IEC and/or RA is signed on behalf of each Trial Subject before the first Trial related procedure starts for the Trial Subject. 8. Informovaný souhlas. Hlavní zkoušející je povinen zajistit, že před zahájením prvních postupů klinického hodnocení u subjektu klinického hodnocení bude jménem každého subjektu klinického hodnocení podepsán formulář informovaného souhlasu schválený zadavatelem, NEK a/nebo RÚ.

Informed Consent. Informed Consent requires that: the Provider has obtained informed consent from the Donor(s) to provide Materials to the Recipient to undertake the Project as contemplated. In the event of Secondary Use of the Materials, the Donor(s) have consented thereto insofar as the Secondary Uses have been approved by the HREC. the Donor(s) have been informed that, where reasonably possible, the Provider will inform them of developments or progress made by the Recipient in the Project and which is relevant to the Donor(s)’ Informed Consent. the Donor(s) have been informed and have accepted that on termination of this agreement, the Material will be returned to the Provider or destroyed, or any other arrangements made, as determined by the Provider under clause 8. the Donor(s) are aware that all Materials and associated data are de-identified. Disclosure to Donor(s) has been made in the event that Materials will be released into the public domain. should the Recipient wish to conduct studies or use the Material for any other purpose than that approved by the HREC, the Provider must be notified in writing and HREC approval must first be obtained.

Informed Consent. 1.6.1 Institution/Principal Investigator undertakes to use the patient information sheet as approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.

Informed Consent. Collaborator shall prepare the patient informed-consent form for the MSD Compound Study (which shall include provisions regarding MSD Compound safety, data sharing and the use of Samples in Sample Testing) in consultation and with approval of MSD (it being understood and agreed that the portions of the informed-consent form relating to the MSD Compound will be provided to Collaborator by MSD and adopted without modification by Collaborator).

Informed Consent i. CDO and CAC must obtain informed consent from Consumers for any creation, collection, use or disclosure of information that is not authorized under the CMS-CDO Agreement and the agreement between CDO and CAC. Such informed consent must be in writing, signed by the consenting party, and subject to a right of revocation. ii. CDO and CAC are prohibited from denying information or assistance to persons or entities that do not wish to grant consent for any creation, collection, use or disclosure of Consumer information that is not authorized under the CMS-CDO Agreement and the agreement between CDO and CAC. iii. Informed consent must: 1. Be provided in specific terms and in plain language; 2. Identify who will obtain access to the Consumer’s information under the terms of the informed consent; 3. Describe the purpose for which the informed consent is being obtained; 4. Explain what information the CDO and/or CAC will use or disclose to a specific recipient(s); 5. Provide notice of a Consumer’s ability to revoke the consent at any time; and 6. Include an expiration date or event, unless effectively revoked in writing by the Consumer before that date or event. iv. Informed consent documents must be appropriately secured and retained for no less than six (6) years, unless a different and longer retention period has already been provided under other applicable Federal law.

Informed Consent. 5 Pharmacy must obtain written informed consent from the individual prior to administering the vaccine. Consent to the immunization of a child must be in writing and signed by an authorized person. The written consent must include: the name of the child, the name of one or both parents, if known, the name of any managing conservator or guardian of the child, the name of the person giving consent and the person’s relationship to the child, a statement of the nature of the medical treatment to be given, and the date the treatment is to begin.

Informed Consent. Pharmacy must obtain written informed consent from each individual (or if the individual is incapable of consenting, the person legally responsible for the individual) prior to administering a vaccine.8 Pharmacy must ensure that each individual is informed of potential side effects and adverse reactions orally and in writing prior to administering a vaccine.9 Each individual must be provided with information on the importance of having a primary care provider, in a form or format developed by the Commissioner of Health.10

Informed Consent. Investigator shall have each Study subject sign a written informed consent form in the form approved by the EC, which is provided Institution and Investigator by Sponsor/CRO (“ICF”) before the individual participates in the Study. . Investigator is obliged to use the most recent version of ICF approved by EC. Further, Sponsor/CRO shall ensure that the ICF complies with all Applicable Laws and shall further ensure that all Study subjects understand the contents of the ICF. Sponsor and its designees will have the right to use, in compliance with the Applicable Law, Study subjects’ protected personal health information (“PHI”) as permitted in a Study subject’s signed ICF. Institution and Investigator each agree that the Sponsor and its designees, including CRO, as well as the FDA, EMA, and regulatory authorities in other countries, will be named in the ICF as parties to whom PHI may be disclosed in connection with the Study and that such ICF will permit the FDA, EMA, regulatory authorities in other countries, Sponsor and its designees, including CRO, access to PHI as may be necessary to audit or monitor the Study 1.6 Informovaný souhlas. Zkoušející získá od každého subjektu ve Studii ještě před jeho účastí ve Studii písemný informovaný souhlas ve formě schválené EK, který Zdravotnickému zařízení a Zkoušejícímu poskytne Zadavatel/CRO (dále „Formulář informovaného souhlasu“). Zkoušející je povinnen použít nejaktuálnějsí verzi informovaného souhlasu schválenou EK. Zadavatel/CRO také zajistí, aby byl ▇▇▇▇▇▇▇▇ informovaného souhlasu v souladu se všemi Příslušnými právními předpisy, a dále zajistí, aby všechny subjekty ve Studii porozuměly obsahu Formuláře informovaného souhlasu. Zadavatel a jeho pověření zástupci budou oprávněni používat v souladu s Příslušnými právními předpisy chráněné osobní zdravotní údaje subjektů ve Studii (dále „Osobní zdravotní údaje“) tak, jak to dovoluje Formulář informovaného souhlasu podepsaný subjektem ve Studii. Jak Zdravotnické zařízení, tak Zkoušející souhlasí s tím, že Zadavatel a jeho pověření zástupci, včetně CRO, jakož i úřad FDA, EMA a kontrolní úřady v dalších zemích, budou uvedeni ve Formuláři informovaného souhlasu jako strany, kterým mohou být předávány Osobní zdravotní údaje v souvislosti se Studií, a že Formulář informovaného souhlasu bude umožňovat úřadu FDA, EMA, kontrolním úřadům v dalších zemích, Zadavateli a a jeho pověřeným zástupcům, včetně CRO, přístup k Osobním zdravotním údajům tak, jak to může být zapotřebí pr...

Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to any screening or participation in the Study using the Informed Consent Materials (as defined in Section 11.3) and in accordance with Applicable Laws. Institution shall cause each Subject to complete an informed consent form that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.