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(4) That the informed consent of all potential subjects or their legal representatives is obtained in accordance with § 46.116 and to the extent required by it. Except as otherwise provided in another section of this standard, no researcher may involve a human subject in a research project covered by this standard unless the legal consent of the individual or the individual`s legal representative has been obtained. Consent will only be obtained in circumstances that give the prospective subject or his/her representative ample opportunity to determine whether or not to participate and to minimize the possibility of undue pressure or influence. The information given to the participant or his/her representative must be understandable to him/her. No oral or written informed consent shall provide that the subject or his or her representative waives or appears to waive his or her rights, or that any of his or her reviewers, study sponsors, institutions or representatives are exempt from liability for negligence. (5) The legally valid consent of both parents of the newborn is obtained in accordance with paragraph A of this Part, except that the waiver and amendment provisions of paragraphs 46.116(c) and (d) do not apply. However, if one of the parents is unable to give consent due to unavailability, mental incapacity or temporary incapacity, the informed consent of one of the parents of the non-viable child is sufficient to satisfy the requirements of paragraph (c) (5), except that it is not necessary to obtain the father`s consent: if the pregnancy is the result of rape or incest. The consent of an authorised legal representative of one or both parents of a non-viable newborn is not sufficient to meet the requirements of point (c)(5). (d) The head of the Agency or Division shall evaluate any assurance provided under this Standard by senior management and employees of the Department or Agency and experts or advisers engaged for that purpose as the Head of the Agency or Division deems it appropriate. The assessment by the head of the agency or department shall consider the relevance of the proposed IRB to the anticipated level of research activities of the institution and the type of subjects likely to be involved, as well as the appropriateness of the proposed initial and ongoing review procedures in relation to the likely risks; and the size and complexity of the institution. (b) at least one member of the Committee shall be an inmate or a representative of inmates with the knowledge and experience required to perform that function, except in specific cases of investigations where the same project is reviewed by more than one Review Board; In this case, only one of these committees is required to comply with this requirement.

(a) Minors are persons who have not reached the legal age required to consent to the treatment or procedures necessary for the research in accordance with the relevant laws of the jurisdiction in which the study is conducted. (2) A brief written certificate of consent attesting that the elements of informed consent required by section 46.116 were presented orally to the subject or the subject`s legal representative. In these cases, the presence of a witness at the oral presentation is required. The IRB will also approve a written summary of what is being said to the subject or his or her representative. The subject or his/her representative should only sign the short form itself. Instead, the witness signs both the short form and a copy of the summary, and the person receiving consent signs a copy of the summary. The subject or his representative receives copies of the abstract and the abbreviated form. (2) legally valid informed consent is obtained from one of the parents of the newborn or, if neither parent is able to give consent because he or she is unavailable, mentally competent or temporarily disabled, valid informed consent is obtained from the authorized legal representative of one of the parents in accordance with Subdivision A of this Part; Except that parental consent does not need to be obtained if the pregnancy is the result of rape or incest. (b) The documentation required by this standard shall be retained for at least 3 years and the documentation of the research carried out shall be retained for at least 3 years after completion of the study.

All records may be reviewed and copied by authorized officials of the department or authority at reasonable intervals and in an appropriate manner. (Approved by the Office of Management and Budget under control number 0990-0260.) (b) In addition to the findings set out in other relevant sections of this subsection, the IRB will determine, in accordance with the consent required by section 46.116 of paragraph A, that appropriate steps have been taken to obtain the permission of the parent or guardian of each child. In cases where parental permission is required, the IRB may find that a parent`s permission is sufficient to conduct the investigation under section 46.404 or section 46.405.

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