Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?
Documentation is required unless waived by an IRB.
Who is considered a child according to the federal regulations?
According to federal regulations, “children” are defined as:
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted
.
What procedures must be described in an agreement called an?
What procedures must be described in an agreement called an “
assurance of compliance
” with a U.S. federal agency? Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
When research is conducted in educational settings with children?
When research is conducted in educational settings with children, when is the assent of potential student subjects required?
When the IRB has determined that students are capable of providing assent
. You just studied 2 terms!
Which of the following is something an IRB should do with respect to review of GSD research?
Which of the following is something an IRB should do with respect to review of GSD research?
Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities
.
What are the four forms of abuse?
Child maltreatment is behavior toward a child that is outside the norms of conduct and entails substantial risk of causing physical or emotional harm. Four types of maltreatment are generally recognized:
physical abuse, sexual abuse, emotional abuse (psychologic abuse), and neglect
.
What are the 4 types of child neglect?
- What is Neglect? …
- Types of Child Neglect.
- Physical Neglect. …
- Educational Neglect. …
- Emotional Neglect. …
- Medical Neglect. …
- What You Can Do to Help.
What activities constitutes engagement in research?
In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1)
data about the subjects of the research through intervention or interaction with them
; (2) identifiable private information about …
What is the term for management controls that are?
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
.
What is engagement in research?
In brief, an “engaged” institution is
one whose agents (faculty, students, or staff) recruit and secure consent from subjects, conduct research procedures, or who receive or share private, identifiable information
. … This definition parallels the federal definition of research with human subjects.
Do children need parental consent to participate in research?
The legal age of majority in Alberta is 18.
Alberta law does not specifically prevent a person under the age of majority from consenting to participate in
research. …
Can children give consent in research?
Children under 16 are able to give their full consent
providing they have been counselled
and do not wish to involve their parents and they have sufficient maturity to understand the nature, purpose and likely outcome of the proposed research.
When research is conducted in educational settings with children when is the assent of potential student subjects required?
When research is conducted in educational settings with children, when is the assent of potential student subjects required?
When the IRB has determined that students are capable of providing assent
. You just studied 2 terms!
What are the three fundamental principles of informed consent?
According to the report, informed consent requires three elements:
information, comprehension and voluntariness
.
Which of the following statements best describes the role of an IRB?
Which statement best describes the role of an IRB: a committee that reviews different types of human subjects research. …
A description of the research's potential benefits and risks.
How does the common rule define human subjects?
Common Rule Definition of Human Subject:
HHS regulations define a human subject as
any livingindividual about whom an investigator conducting research obtains information or biospecimens
: … obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
