Respuesta :
Answer:
the correct option is "B," The research could not practicably be carried out without the waiver of consent.
Explanation:
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
Moreover, research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a member of IRB staff.
In other words, Case studies—explorations of particular individuals or small groups in very specific contexts--generally do not involve systematic investigation or lead to generalizable results and, therefore, do not meet the definition of research involving human subjects and do not require prior IRB review and approval.
The correct statement regarding the order to grant or alteration of the requirements of informed consent the IRB must find that the research could possibly not be carried out without the waiver of consent.
The correct option that matches the statement quoted above is B. IRB is mandated to carry out this procedure as an important data of the government function.
- IRB refers to the Institutional Review Board whose main function is protecting the rights and interests of the humans who are a subject to the issue concerned.
- IRB however must ensure that the risks involved are not of a nature which involves major risk. If there is a bigger risk involved the consent is mandatory in such cases.
- If the consent waiver does not relate to the life and liberty of a person, only in such cases a consent may be avoided. IRB has no authority over such warrants related to life.
So, the correct option is B that the research which could practicably not be carried out without the waiver of consent is the basic requirement of the IRB in order to grant a waiver.
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