SOCRA CERTIFICATION (ACTUAL 2025/2026) EXAM QUESTIONS
WITH VERIFIED ANSWERS
When can nonviable and questionably viable neonates be
included in research? - ---Answers---preclinical/clinical
studies have been conducted.
-researchers have no role in determining viability
-research enhances possibility of survival
-biomedical knowledge cannot be obtained ANY other way
If Nonviable neonates are included in research... what are
some protections that limit the research that can be done on
them? - ---Answers---Cannot artificially maintain a heartbeat
or vitals
-cannot TERMINATE the heartbeat or respiration/ vitals
-No additional risk to the neonate
-biomedical knowledge cannot be obtained any other way
For a nonviable neonate, who needs to consent? - ---
Answers---Both parents (exceptions for unavailability, rape,
incest etc)
IRB rules when prison research is involved - ---Answers---
majority of the IRB members can have no relation to the
prisoners.
,A prisoner or prisoner representative with appropriate
background must serve
Name some protections against coercion in prison research -
---Answers---Cannot affect his/her parole status. Cannot give
advantages or compensation that would coerce. Subject
selection must be equitable/random.
When can research include prisoners? - ---Answers---If it is
RELEVANT to incarcerated peoples.
Does the FDA define the term children in terms of years? - ---
Answers---No. A child is someone who cannot legally consent
to treatments or procedures in research (defined locally)
Describe some instances when children MAY be included in
research. - ---Answers----Minimal risk
-risk is small in comparison to direct anticipated benefit
-NO OTHER WAY of obtaining this information
-appropriate preclinical trials
-yield knowledge about a disease or condition
-adequate assent/consent in place
When is assent not needed? - ---Answers----Children are
incapacitated/not sound to assent
-Benefit is so great to the child
-minimal risk
, Are there instances in which both parents need to consent for
a child to participate in research? - ---Answers---YES. I
suppose more than minimal risk? of course, there are
exceptions
Are there exceptions for parental consent when a child is
neglected or abused? - ---Answers---Yes
When can WARDS be included in research? - ---Answers---If
the research is directly related to their status as wards. If they
are part of a big group... like a (non-ward) school, where
excluded them would be inappropriate
What government office do IRBs register under? - ---
Answers---OHRP (office of human research protections)
When an IRB submits appropriate information to OHRP and is
registered, how long is their registration active for? - ---
Answers---3 years
FDA Notice Of Inspection (482) - ---Answers---An FDA
Inspector presents this form which details rights, policies etc
when they arrive on-site to Inspect an organization
FDA Inspectional Observations (483) - ---Answers---Lists
(negative) observations during an inspection. A copy has to be
given to organization. This form should include recommended
WITH VERIFIED ANSWERS
When can nonviable and questionably viable neonates be
included in research? - ---Answers---preclinical/clinical
studies have been conducted.
-researchers have no role in determining viability
-research enhances possibility of survival
-biomedical knowledge cannot be obtained ANY other way
If Nonviable neonates are included in research... what are
some protections that limit the research that can be done on
them? - ---Answers---Cannot artificially maintain a heartbeat
or vitals
-cannot TERMINATE the heartbeat or respiration/ vitals
-No additional risk to the neonate
-biomedical knowledge cannot be obtained any other way
For a nonviable neonate, who needs to consent? - ---
Answers---Both parents (exceptions for unavailability, rape,
incest etc)
IRB rules when prison research is involved - ---Answers---
majority of the IRB members can have no relation to the
prisoners.
,A prisoner or prisoner representative with appropriate
background must serve
Name some protections against coercion in prison research -
---Answers---Cannot affect his/her parole status. Cannot give
advantages or compensation that would coerce. Subject
selection must be equitable/random.
When can research include prisoners? - ---Answers---If it is
RELEVANT to incarcerated peoples.
Does the FDA define the term children in terms of years? - ---
Answers---No. A child is someone who cannot legally consent
to treatments or procedures in research (defined locally)
Describe some instances when children MAY be included in
research. - ---Answers----Minimal risk
-risk is small in comparison to direct anticipated benefit
-NO OTHER WAY of obtaining this information
-appropriate preclinical trials
-yield knowledge about a disease or condition
-adequate assent/consent in place
When is assent not needed? - ---Answers----Children are
incapacitated/not sound to assent
-Benefit is so great to the child
-minimal risk
, Are there instances in which both parents need to consent for
a child to participate in research? - ---Answers---YES. I
suppose more than minimal risk? of course, there are
exceptions
Are there exceptions for parental consent when a child is
neglected or abused? - ---Answers---Yes
When can WARDS be included in research? - ---Answers---If
the research is directly related to their status as wards. If they
are part of a big group... like a (non-ward) school, where
excluded them would be inappropriate
What government office do IRBs register under? - ---
Answers---OHRP (office of human research protections)
When an IRB submits appropriate information to OHRP and is
registered, how long is their registration active for? - ---
Answers---3 years
FDA Notice Of Inspection (482) - ---Answers---An FDA
Inspector presents this form which details rights, policies etc
when they arrive on-site to Inspect an organization
FDA Inspectional Observations (483) - ---Answers---Lists
(negative) observations during an inspection. A copy has to be
given to organization. This form should include recommended
