A child is anyone under the age of
majority in your state. A child's parent or legal guardian must accompany a
child during the informed consent process. A written assent should be obtained
from children 7 years or older unless assent is waived by the IRB. The child
should be given an opportunity to decide, independently, whether or not to
participate in the study. If the child agrees, his/her signature (or printed
name) indicates assent. In Alabama and Nebraska, 18 year olds are considered
children.
The site must ensure that the compensation
is not presented in a manner that may unduly influence a subject to
participate or that is coercive. Payment must not be contingent upon
completion of the entire study. There must be a plan to pro-rate payments. Any
compensation or bonus for completion must be reasonable and not so large as to
influence the subjects to enroll or stay in the study.
For an individual who may have trouble
comprehending the written ICD, the person conducting the consent discussion
must review each section of the ICD with the potential subject and pose
questions after each section to ensure an adequate understanding. For an
illiterate subject, an independent witness must also be present during the
presentation of and signing of the ICD and must also sign the ICD. An
independent witness must not be an employee of the investigator or research
site.
Measures must be taken to ensure the
confidentiality of an employee's study-related medical records. Additionally,
no action can be taken against an employee based on information to which an
employer would not otherwise be entitled but obtains because of an employee's
participation in a study. An employee who participates in a research study must
be treated as other subjects and must be able to decide not to participate or
to discontinue study participation without any impact on his/her employment
status. The Board requires that each employee sign a non-coercion addendum
prior to the subject's participation in the study. If consistent with the
protocol and if you indicate on the Research Site Submission form that you plan
to enroll employees, Schulman will send a Non-Coercion Addendum with the
initial approval document. If, after receiving your initial approval documents,
your site decides to enroll an employee, please send a written request for a
Non-Coercion Addendum, along with safeguards before enrolling the employee in
the study. "Employee" refers to either an employee or an employee's family
member who is participating in a research study.
An individual with physical impairment(s)
(e.g., visual, hearing, speech) that would prevent normal communication, and
who is unable to read and/or sign the ICD, must have an independent witness
present during the informed consent process. The independent witness must also
sign the ICD. An independent witness must not be an employee of the
investigator or research site.
An individual with a life-threatening
condition must be told of alternative treatments and that participation in a
research study may not benefit his/her present medical condition. The
Investigator must confirm that the subject understands this information.
An individual who is not competent to
understand verbal and written information and provide informed consent must
have a Legally Authorized Representative (LAR). The law of the state where the
site is located defines who has legal authority to act as an LAR. The LAR must
sign the ICD on behalf of the subject.
If the site consents a non-English
speaking subject, it must use an IRB approved translated informed consent
document. The site must also provide someone who is capable of answering
questions in the language of the non-English speaking subject throughout the
study.
Each state has a "Nursing Home Bill of
Rights" of which the investigator, study staff, subject and LAR, if
appropriate, must be fully aware.
A pregnant woman must be fully informed
regarding the foreseeable impact of the research on the fetus or resultant
child. In addition, the individuals engaged in research must have no part in
any decisions as to the timing, method, or procedures used to terminate a
pregnancy and must have no part in determining the viability of the fetus. No
inducements, monetary or otherwise, can be offered to terminate a pregnancy.
Schulman does not review studies in which
prisoners are the targeted population.