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                    "text": "Informed consent will be appropriately documented or appropriately waived in accordance with 45 CFR § 46.117.",
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                    "text": "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.",
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                    "text": "When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.",
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                    "text": "For purposes of conducting the limited IRB review required by 45 CFR § 46.104(d)(7)), the IRB need not make the determinations on 1. through 7. of this section, and shall make the following determinations: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of 45 CFR § 46.116(a)(1)–(4), (a)(6), and (d); (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with 45 CFR § 46.117; and (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.",
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            "text": "Furthermore, when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects."
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            "text": "7.2 Informed Consent",
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            "text": "The IRB will carefully review informed consent processes—and if children are involved, assent processes—to include when, where and how consent or assent is obtained, and any provisions for the on-going consent or assent of subjects. Informed consent shall be obtained only under circumstances that provide the prospective subjects or the subject's legally authorized representative with sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion and undue influence. Generally, the IRB will not dictate the procedure to be used to obtain informed consent or assent, but reserves the right to do so if deemed necessary."
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            "text": "General Requirements",
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            "text": "According to 45 CFR 46.116, general requirements for informed consent include:",
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                    "text": "45 CFR § 46.116,",
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            "text": "1. Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative."
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