SPECIAL POPULATIONS
Children
Children are defined as anyone who is under 18 years of age so those who may want to do research on teenagers in the community should be aware that they are really doing research on children (regardless of how they behave). Children can be included as subjects of research only if there is no greater than minimal risk to them, AND the HSC finds that adequate provisions have been made for soliciting the assent of the children and the consent of their parents or guardians. If the child is 11 years old or older, this means that both the parent or guardian AND the child must give their written consent or assent to participate in the research. The consent form should include, in addition to the 8 mandatory elements described above, a 9th element: a statement that either the parent or the child may withdraw the child from the research at any time. The assent form given to the children should be written in language appropriate to their age level. Research that involves pre-school-age children must also indicate when the research will be conducted (for example, during the month of April, 2002).
The HSC has decided that there is only ONE condition under which ANY research involving children could be exempt: when the research consists of observation of public behavior, and the investigator does not participate in the behavior being observed. ALL other research involving children will receive a full committee review.
Prisoners
A prisoner is defined as any individual involuntarily confined or detained in a penal institution. This definition is intended to include individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution as well as individuals being held prior to arraignment, trial or sentencing. When reviewing protocols involving prisoners, at least one Committee member must be a prisoner or a prisoner representative.
Institutionalized Persons
This is someone who is confined to an institution, usually for reasons relating to their mental health, and that means that they require special consideration. Permission to conduct research at that institution must first be obtained from its responsible officials. If the subjects are not capable of giving consent for themselves, then consent must be obtained from their legal guardians. If the subjects are capable of giving consent, then the informed consent form should be written in language appropriate to their understanding.
