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.
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.
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.
According to 45 CFR § 46.116, general requirements for informed consent include:
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.
An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.
The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
Except for broad consent obtained in accordance with paragraph (d) of this section:
(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally