The protection of human subject is the utmost necessity in research and must take precedence over all other contributing factors. Children are a vulnerable group and legally, anyone under the age of 18 years must have guardian consent to take part in any research. Furthermore, the IRB “must consider potential benefits, risks, and discomforts of the research of children- to assess justification and inclusion,” (HHS.gov, 2016). Every circumstantial situation must be evaluated including: participant beneficence, potential risks, disease status and society as a whole (HHS.gov, 2016).
Guidelines set forward for minor individuals involved in a protocol must be determined by the IRB from 4 potential categories: (HHS.gov, 2016).
-Research not involving greater than minimal risk to the children.
-Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research.
–Research involving greater than minimal risk and no prospect of direct benefit to the individual child subjects involved in the research, but likely to yield generalizable knowledge about the subject’s disorder or condition.
–Research that the IRB believes does not meet the conditions of 45 CFR 46.404, 46.405, or 46.406,(listed above) but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.
In summary, while the parent or guardian obtains the consent of the child it is important to involve the child (depending on age and mental-status) in decision-making and obtain assent before moving forward.
Original Question: Conducting research projects while ensuring the protection of human subjects is necessary. What are some methods to protect personal rights of someone in one of the groups that is labeled as vulnerable? Justify your rationale