Regulatory Compliance and Ethics Flashcards

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:

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

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.

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

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

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

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

Answer: Submit a protocol amendment and receive IRB approval before collecting specimens

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

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

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

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.

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?

Answer: Research misconduct (plagiarism) and authorship/attribution ethics

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.

The Federal Acquisition Regulation (FAR) applies to research agreements when:

Answer: The federal government is acquiring a product or service for its direct benefit and use (procurement contract)

FAR applies to procurement contracts where the government acquires goods or services for its own use, whereas grants and cooperative agreements are governed by 2 CFR Part 200.

Which of the following is an example of 'salami slicing' in research publication ethics?

Answer: Dividing one study's findings into the smallest possible number of separate publications to maximize output

Salami slicing refers to fragmenting the results of a single study into multiple publications to artificially inflate the publication record, which is considered a questionable research practice.