CRA Regulatory Compliance and Ethics 5

Question 1

A PI wants to conduct an international research study in a country that has no local IRB or ethics review process. Under U.S. federal regulations, the research must:

Accepted Answer

Comply with local laws and customs, with the U.S. IRB verifying that protections are 'at least equivalent'

Answer

OHRP guidance requires that international research comply with local laws and that the U.S. IRB determine that protections afford at least equivalent protections to those in 45 CFR Part 46.

Question 2

When must an institution report an unanticipated problem involving risks to subjects or others (UPIRTSO) to OHRP?

Accepted Answer

Within a reasonable time frame after the IRB determines it meets UPIRTSO criteria

Answer

OHRP expects prompt reporting after the IRB makes its determination that a problem meets UPIRTSO criteria; timelines are institution-specific but must be prompt.

Question 3

A research team realizes mid-study that they need to collect additional biological specimens not described in the approved protocol. Before proceeding, they must:

Accepted Answer

Submit a protocol amendment and receive IRB approval before collecting specimens

Answer

Any change to an approved protocol that increases risk or alters procedures requires submission of a protocol amendment and IRB approval prior to implementation.

Question 4

Under 21 CFR Part 11, electronic records and signatures used in FDA-regulated research must meet requirements for:

Accepted Answer

Trustworthiness, reliability, and equivalence to paper records and handwritten signatures

Answer

21 CFR Part 11 requires that electronic records and signatures be trustworthy, reliable, and generally equivalent in their regulatory standing to paper records and handwritten signatures.

Question 5

A graduate student discovers that her thesis advisor published her data without her knowledge or consent, listing himself as sole author. This situation primarily raises concerns under which ethical domain?

Accepted Answer

Research misconduct (plagiarism) and authorship/attribution ethics

Answer

Publishing another researcher's data without attribution or consent constitutes plagiarism and violates authorship norms, both of which fall under research misconduct and publication ethics.

(CRA) Certified Research Administrator Practice Test

(CRA) Certified Research Administrator Practice Test

CRA Regulatory Compliance and Ethics 5