Research studies involving pregnant women and fetuses must comply with specific federal regulations (Table 2). The following appropriate precautions should be taken in research studies with pregnant women: A pregnant woman should not be involved as a subject in a clinical research project involving humans, unless the purpose of the research is to meet the health needs of the mother and the fetus is at risk only to the minimum extent necessary to meet those needs; or the risk to the fetus is minimal . The IRB must review and approve all changes to the approved consent process, including changes to the content described in the items listed in 45 CFR 46.116 or its Schedule, and may determine whether it is necessary to repeat the process (45 CFR 46 103(b)(4)). The IRB should consider whether the changes could affect a subject`s understanding of the nature of the study or a subject`s willingness to participate. If this is the case, such changes must be made to the informed consent document. Even in the absence of significant changes to a protocol or declaration of consent, regular repetition or confirmation of consent is often a good idea, especially if the study takes place over a long period of time or is particularly complex. Minor changes, such as correcting non-substantial typographical errors in the consent document, would generally not reach a level that requires a repeat of the consent process. The examiner (or a representative approved by the IRB) must explain the study orally to the potential subject, provide all relevant information (purpose, procedures, risks, benefits, alternatives to participation, etc.) and give the potential subject ample opportunity to ask questions. Review of the cessation of obtaining informed consent from «vulnerable population groups». In some research, such as longitudinal studies. B with progressive disorders or aging populations, enrolled subjects may be able to get along on their own behalf from the outset, but may experience effects of progressive or intermittent disorders that lead to decision-making disorders during the study.
In these situations, IRBs and investigators should consider the need to discuss with potential subjects whether they should appoint someone to act as a legally authorized representative at the outset of the study, in accordance with all applicable laws. Even if a subject has consented on his or her own initiative, a designated representative would be prepared to intervene as a legally authorized representative if the subject`s ability to assess his or her own needs and interests is compromised during the course of the study. A statement that important results discovered during the clinical trial will be provided to the research participant. Reasonable time to ask questions and discuss the research protocol with family and friends and whether you should attend. The informed consent process should be an active process of information exchange between the examiner and the potential subject. The exchange of information between the examiner and potential subjects may take place, inter alia, through one or more of the following forms of communication: personal contact; Post; telephone; Video; or by fax. Potential topics should have ample opportunity to ask questions and seek clarification from the examiner. Potential subjects should be able to decide freely whether to register for research first or to retire later, or whether they continue to participate in research. The informed consent process should ensure that all critical information about a study is fully disclosed and that potential subjects or their legally authorized representatives adequately understand the research so that they can make informed decisions. Yes, in certain circumstances. Although HHS regulations do not explicitly refer to this type of activity, sometimes referred to as «research preparation,» this activity must be reviewed and approved by an IRB in accordance with HHS regulations in 45 CFR 46,109(a) if: Due to the fact that patients are assigned standard treatments, neither pragmatic low-risk rcts  nor initiated of optional randomised trials [18, 19]. However, with a pragmatic, low-risk RCT, patients do not have the option of choosing one of two standard treatments, while in an optional randomisation study, researchers and enrolled patients may choose one type of treatment over another despite the results of randomisation .
No, the IRB is responsible for deciding whether the child`s consent is required for the proposed research activities. Consent means a child`s consent to participate in research. The mere failure to object should not be construed as consent without express consent (45 CFR 46.402(b)). The child`s consent is required, except in the following three circumstances described in paragraph 46.408(a) of the CFR): Due to their relative nature and the lack of clear standards regarding the limits of inappropriate and appropriate forms of influence, investigators and CIRs must be vigilant to minimize the possibility of coercion and undue influence. Reasonable estimates can be made to minimize the likelihood of undue influence or coercion. For example, CISRs may limit the level of financial or non-financial incentives to participate and should carefully review the information to be disclosed to potential subjects to ensure that the incentives and how they are provided are clearly described. .