Mixed Deck — All CIP Topics Flashcards

What is expedited review by an IRB?

Answer: Faster review for minimal risk

Expedited review is a specific category of IRB review designed for research studies that pose no more than minimal risk to participants and fall into certain federally defined categories. This process allows for a quicker review by a single IRB member or a small subcommittee, rather than the full board. It streamlines the approval process for low-risk research while still ensuring ethical oversight.

A pregnant researcher wants to enroll herself in a minimal-risk survey study at her own institution. This situation primarily raises concerns about:

Answer: Undue influence and voluntariness of consent given the dual role

When a researcher enrolls themselves in their own study, voluntariness of consent is compromised by the dual role, making this the primary IRB concern.

What is continuing review?

Answer: Periodic compliance review

Continuing review is a mandatory periodic review of ongoing research protocols by the IRB, typically conducted at least annually. Its purpose is to ensure that the research continues to meet ethical standards, that participant safety is maintained, and that any changes or new information are properly assessed. This ongoing oversight ensures compliance throughout the study's duration.

What is the role of data confidentiality in IRB oversight?

Answer: Protect participant privacy

Data confidentiality is a cornerstone of ethical research overseen by IRBs. It ensures that sensitive information collected from participants is safeguarded, preventing unauthorized access or disclosure. This protection is crucial for upholding the trust between researchers and participants, and for minimizing potential harm or stigma associated with their involvement in a study.

A researcher asks the IRB to waive documentation of informed consent (i.e., no signed form) for an online survey involving sensitive mental health topics. Which criterion would SUPPORT granting this waiver?

Answer: The only record linking the subject to the research would be the consent document itself, creating a risk of harm

A waiver of documentation is appropriate when the signed consent form would be the only link between the participant and the research, and breach of confidentiality could cause harm.

How does the CIP body of knowledge relate to daily practice?

Answer: Provides the framework guiding decisions and standard practices

The body of knowledge guides daily decision-making.

Which of the following actions requires prospective IRB review and approval rather than merely a notification report?

Answer: Making a protocol amendment that increases risk or burden to subjects

Protocol amendments that increase risk or burden to subjects must receive prospective IRB approval before implementation; retrospective events require reporting but not pre-approval.

An investigator wants to conduct a study entirely within a single classroom using an educational intervention on normal school curriculum. Under 45 CFR 46, which exemption category is most applicable?

Answer: Category 1 — research conducted in established educational settings involving normal educational practices

Category 1 exemption applies to research involving normal educational practices in established educational settings, such as comparing instructional methods or curricula.

What is a primary responsibility of IRB administrators?

Answer: Coordinate meetings and ensure compliance

IRB administrators are responsible for the operational aspects of the IRB, including scheduling meetings, preparing agendas, and ensuring all necessary documentation is present. They play a critical role in maintaining compliance with federal regulations, institutional policies, and ethical guidelines by managing the review process efficiently and accurately. Their work supports the IRB's ability to protect human subjects effectively.

The principle of 'respect for persons' in the Belmont Report encompasses which two moral requirements?

Answer: Autonomy of individuals and protection of those with diminished autonomy

Respect for Persons requires acknowledging individual autonomy and providing additional protections for those with diminished autonomy, forming the ethical basis for informed consent requirements.

What happens if the IRB requests modifications to a protocol?

Answer: Make required changes

If the IRB requests modifications to a protocol, it means they have identified areas that need adjustment to ensure participant safety, ethical conduct, or regulatory compliance. Researchers are obligated to address these concerns by making the required changes and resubmitting the revised protocol. The study cannot proceed until the IRB is satisfied and grants full approval.

Which federal regulation establishes the basic requirements for informed consent in human subjects research in the US?

Answer: 45 CFR 46

45 CFR 46 (the Common Rule) establishes the foundational informed consent requirements for federally funded human subjects research.

Under the Common Rule, which of the following activities is NOT considered 'research' requiring IRB oversight?

Answer: Quality improvement projects designed solely to improve local practice

Quality improvement projects intended solely to improve local practice, not to generate generalizable knowledge, do not meet the regulatory definition of research.

What is informed consent?

Answer: Providing information for informed decision

Informed consent is the ethical and legal process of providing potential research participants with comprehensive information about a study, including its purpose, procedures, risks, and benefits. This enables them to make a voluntary, educated, and autonomous decision about whether or not to participate, ensuring respect for their rights.

Which scenario requires submission of a continuing review report to the IRB for studies approved under the 2018 Common Rule?

Answer: A study involving greater than minimal risk that has not yet closed to enrollment

Under the 2018 Common Rule, continuing review is no longer required for most minimal-risk studies, but remains required for studies that have not yet closed to enrollment and involve greater than minimal risk.

When planning a Certified Institutional Review Board Professional project, what should be established FIRST?

Answer: Clear objectives, scope, and success criteria

Objectives form the foundation for all other planning decisions.

Which risk management approach is MOST effective for CIP professionals evaluating workplace hazards?

Answer: Proactive hazard identification and assessment

Proactive identification allows mitigation before incidents occur.

During a convened IRB meeting, a member discloses a financial conflict of interest with a study on the agenda. The correct procedure is to:

Answer: Require the member to leave the room for both discussion and vote on that study

IRB members with a conflicting interest must recuse themselves from both deliberation and voting on the affected study, typically by leaving the room.

A Certificate of Confidentiality (CoC) issued by NIH protects researchers from being compelled to disclose:

Answer: Identifying information about research participants in legal proceedings

A Certificate of Confidentiality protects researchers from being forced to disclose identifying information about participants in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding.

What is the first step in the IRB protocol review process?

Answer: Submitting the protocol

The first essential step in the IRB protocol review process is for the researcher to formally submit their complete research protocol to the IRB. This submission includes all necessary documents, such as the detailed research plan, informed consent forms, and recruitment materials. The IRB cannot begin its ethical and regulatory review until all required documentation has been received.