Certification for IRB Professionals (CIP) Exam:
Questions & Answers: Latest Updated
Vulnerable subjects - ANSWERpersons who "have difficulty providing voluntary,
informed consent arising from limitations in decision-making capacity ... or
situational circumstances ..., or because they are especially at risk for exploitation."
What is the first question when thinking about conducting research on vulnerable
subjects? - ANSWERTo ask whether the research could include a less vulnerable
population instead, and still answer the research question
Vulnerable Populations - ANSWERpregnant women, human fetuses, neonates,
prisoners, children, individuals with physical disabilities, individuals with mental
disabilities or cognitive impairments, economically disadvantaged, socially
disadvantaged, terminally ill or very sick, racial or ethnic minorities, institutionalized
persons (correctional facilities, nursing homes, mental health facilities)
Physical control - ANSWERsubjects who are physically forced to participate in
research
Coercion - ANSWERThe use of a credible threat of harm or force to control another
person
Undue influence - ANSWERThe misuse of a position of confidence or power to lead
or influence others to make a decision they would not otherwise make
Manipulation - ANSWERThe deliberate design and management of conditions or
information intended to lead subjects to make decision they would not otherwise
make (lying, withholding information, exaggerating)
Exploitation - ANSWERthe action of treating someone unfairly in order to benefit
from them in some way
What does vulnerability arise from? - ANSWERIntrinsic factors, characteristics, or
attributes of the individual
Capacity-related cognitive vulnerability - ANSWERsubjects to some extent lack
capacity to make informed choices
Situational cognitive vulnerability - ANSWERsubjects do not lack capacity, but are in
situations that do not allow them to exercise their capacities effectively (distraction
or emergency)
Communicative vulnerability - ANSWERsubjects do not lack capacity, but due to
limited ability to communicate with the researchers are not able to exercise their
capacities effectively
, Institutional Vulnerability - ANSWERSubjects who are subject to the formal authority
of others (prisoners, enlistees, employees, college students) subordinate
Deferential Vulnerability - ANSWERAuthority over the prospective subject is due to
informal power relationships rather than formal hierarchies (gender, race, class, and
knowledge inequalities)
Medical Vulnerability - ANSWERprospective subjects have serious health conditions
for which there are no satisfactory standard treatments (research vs. treatment)
Economic vulnerability - ANSWERsubjects are disadvantaged in the distribution of
social goods and services (income, housing, or health care) (possibility of payment or
attainment of these services)
Social Vulnerability - ANSWERProspective subjects who belong to undervalued social
groups (reduced concern for them)
HHS Criteria for Approval - ANSWERShould be cognizant of the special problems of
research involving vulnerable populations; additional safeguards should be included
in the study to protect the rights and welfare of these subjects
T/F Consideration should be given to the inclusion of one or more individuals who
are knowledgeable about and experienced with working with vulnerable subjects -
ANSWERTrue
Subpart B - ANSWERAdditional Protections for Pregnant Women, Human Fetuses
and Neonates Involved in Research
Subpart C - ANSWERAdditional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
Subpart D - ANSWERAdditional Protections for Children Involved as Subjects in
Research
Vulnerability Due to Critical Illness - ANSWERVulnerability in emergency research
may be due to intrinsic factors and situational factors
Vulnerability Due to Terminal illness - ANSWERCognitive and physical impairments;
desperation; perception of burden and risk may change
Vulnerability Due to Decisional Impairment - ANSWERresult from many causes
including stroke and other Central Nervous System (CNS) disorders, trauma, medical
treatment, and substance abuse.; situational factors (stigma, lack of insurance,
education, discrimination)
Questions & Answers: Latest Updated
Vulnerable subjects - ANSWERpersons who "have difficulty providing voluntary,
informed consent arising from limitations in decision-making capacity ... or
situational circumstances ..., or because they are especially at risk for exploitation."
What is the first question when thinking about conducting research on vulnerable
subjects? - ANSWERTo ask whether the research could include a less vulnerable
population instead, and still answer the research question
Vulnerable Populations - ANSWERpregnant women, human fetuses, neonates,
prisoners, children, individuals with physical disabilities, individuals with mental
disabilities or cognitive impairments, economically disadvantaged, socially
disadvantaged, terminally ill or very sick, racial or ethnic minorities, institutionalized
persons (correctional facilities, nursing homes, mental health facilities)
Physical control - ANSWERsubjects who are physically forced to participate in
research
Coercion - ANSWERThe use of a credible threat of harm or force to control another
person
Undue influence - ANSWERThe misuse of a position of confidence or power to lead
or influence others to make a decision they would not otherwise make
Manipulation - ANSWERThe deliberate design and management of conditions or
information intended to lead subjects to make decision they would not otherwise
make (lying, withholding information, exaggerating)
Exploitation - ANSWERthe action of treating someone unfairly in order to benefit
from them in some way
What does vulnerability arise from? - ANSWERIntrinsic factors, characteristics, or
attributes of the individual
Capacity-related cognitive vulnerability - ANSWERsubjects to some extent lack
capacity to make informed choices
Situational cognitive vulnerability - ANSWERsubjects do not lack capacity, but are in
situations that do not allow them to exercise their capacities effectively (distraction
or emergency)
Communicative vulnerability - ANSWERsubjects do not lack capacity, but due to
limited ability to communicate with the researchers are not able to exercise their
capacities effectively
, Institutional Vulnerability - ANSWERSubjects who are subject to the formal authority
of others (prisoners, enlistees, employees, college students) subordinate
Deferential Vulnerability - ANSWERAuthority over the prospective subject is due to
informal power relationships rather than formal hierarchies (gender, race, class, and
knowledge inequalities)
Medical Vulnerability - ANSWERprospective subjects have serious health conditions
for which there are no satisfactory standard treatments (research vs. treatment)
Economic vulnerability - ANSWERsubjects are disadvantaged in the distribution of
social goods and services (income, housing, or health care) (possibility of payment or
attainment of these services)
Social Vulnerability - ANSWERProspective subjects who belong to undervalued social
groups (reduced concern for them)
HHS Criteria for Approval - ANSWERShould be cognizant of the special problems of
research involving vulnerable populations; additional safeguards should be included
in the study to protect the rights and welfare of these subjects
T/F Consideration should be given to the inclusion of one or more individuals who
are knowledgeable about and experienced with working with vulnerable subjects -
ANSWERTrue
Subpart B - ANSWERAdditional Protections for Pregnant Women, Human Fetuses
and Neonates Involved in Research
Subpart C - ANSWERAdditional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
Subpart D - ANSWERAdditional Protections for Children Involved as Subjects in
Research
Vulnerability Due to Critical Illness - ANSWERVulnerability in emergency research
may be due to intrinsic factors and situational factors
Vulnerability Due to Terminal illness - ANSWERCognitive and physical impairments;
desperation; perception of burden and risk may change
Vulnerability Due to Decisional Impairment - ANSWERresult from many causes
including stroke and other Central Nervous System (CNS) disorders, trauma, medical
treatment, and substance abuse.; situational factors (stigma, lack of insurance,
education, discrimination)
