PRC Institutional Review Board Processes 5

Question 1

When is waiver of parental permission permitted in pediatric research?

Accepted Answer

When parental permission is not a reasonable requirement to protect subjects, such as research on emancipated minors or neglected youth

Answer

Whenever the researcher believes the child is mature enough

Answer

Only for exempt research categories

Answer

When the study involves less than two hours of participation

Question 2

What is an 'assurance' in the context of OHRP and human subjects research?

Accepted Answer

A formal commitment filed with OHRP by an institution to comply with federal human subjects regulations

Answer

A written guarantee to participants that the study is safe

Answer

An insurance policy covering adverse events in clinical trials

Answer

A researcher's signed statement of ethical conduct

Question 3

A researcher conducting online social media research wants to analyze public posts without contacting users. Which ethical concern is most relevant?

Accepted Answer

Whether the platform's Terms of Service permit research use of public data

Answer

Whether each user must be individually debriefed

Answer

Whether the study qualifies for full board review due to internet use

Answer

Whether HIPAA applies to social media content

Question 4

Which of the Belmont Report's three core principles most directly addresses the informed consent requirement?

Accepted Answer

Respect for Persons

Answer

Justice

Answer

Beneficence

Answer

Non-maleficence

Question 5

A researcher collecting biospecimens wants to store them for future unspecified research. What must the consent process address?

Accepted Answer

Participants must be informed about future use possibilities and given options regarding storage and secondary use of their samples

Answer

Only the immediate study purpose needs to be described

Answer

Future use is automatically covered if the initial consent is comprehensive

Answer

Biospecimen storage only requires an IRB waiver, not participant consent

Question 6

What is the key ethical issue when researchers offer significant financial compensation to research participants?

Accepted Answer

Excessive payment may constitute undue inducement, compromising voluntary participation

Answer

It violates IRS regulations for non-profit research institutions

Answer

All financial compensation must be pre-approved by OHRP

Answer

Payment is prohibited in federally funded studies

Question 7

Under the Common Rule, which activity is explicitly excluded from the definition of 'research' and therefore not subject to IRB oversight?

Accepted Answer

Scholarly and journalistic activities such as oral history, journalism, biography, and historical scholarship not subject to IRB oversight

Answer

A faculty member collecting data for an unpublished class project intended for publication

Answer

Any study involving fewer than ten participants

Answer

Pilot studies conducted before formal IRB submission