Research Ethics and IRB Guidelines
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Questions and Answers

Which of the following statements about Institutional Review Boards (IRBs) is true?

  • IRBs can independently make research decisions without investigator input.
  • IRBs are not required to review adverse events promptly.
  • IRB approval is necessary before changes to a research project can be implemented. (correct)
  • Changes to research projects can be made without any form of approval.

What must be ensured when obtaining informed consent from research subjects?

  • Informed consent can be given verbally without further documentation.
  • Consent should be coerced if deemed necessary for the study.
  • Subjects must sign the consent form in the presence of the investigator.
  • Individuals must feel free to decline participation. (correct)

What is required from an institution before it can receive federal funds for research?

  • Approval from a state regulatory body.
  • Federal-Wide Assurance (FWA) of compliance. (correct)
  • A Formal Research Agreement.
  • A completed project proposal.

Under what circumstances can the Office for Human Research Protection (OHRP) terminate an institution’s assurance?

<p>If the institution fails to comply with regulations. (A)</p> Signup and view all the answers

What is a potential consequence for an institution if its assurance is suspended by the OHRP?

<p>No federally funded research can be conducted until compliance is restored. (C)</p> Signup and view all the answers

What is the primary function of an Institutional Review Board (IRB)?

<p>To ensure the safety and compliance of medical research involving human subjects. (C)</p> Signup and view all the answers

Which of the following is NOT considered an adverse event?

<p>A resolved case of mild nausea (D)</p> Signup and view all the answers

What characterizes a serious adverse event?

<p>Any event that can potentially lead to death (B)</p> Signup and view all the answers

Which assessment criterion applies when determining if an adverse event was expected?

<p>Attribution level to the investigational therapy (B)</p> Signup and view all the answers

In the context of reporting adverse events, what does 'acute' refer to?

<p>Events happening within hours of administration (C)</p> Signup and view all the answers

Which grade indicates the presence of painful ulcers that may require IV hydration?

<p>Grade 3 (A)</p> Signup and view all the answers

What is NOT required to be included in an adverse event report?

<p>The patient's address (D)</p> Signup and view all the answers

What is the minimum duration for retaining study records after FDA approval?

<p>2 years (D)</p> Signup and view all the answers

Which statement about informed consent requirements is true for FDA regulations?

<p>The consent form must include a clause for FDA review. (C)</p> Signup and view all the answers

What is one key difference between DHHS and FDA records retention requirements?

<p>FDA requires 2 years of retention after marketing application approval. (A)</p> Signup and view all the answers

What is the primary purpose of the International Conference on Harmonization GCP (ICH-GCP)?

<p>To create a unified set of global standards for clinical research. (A)</p> Signup and view all the answers

Which of the following is addressed by ICH-GCP but not mandated by DHHS guidelines?

<p>The need to date signed consent forms. (A)</p> Signup and view all the answers

Which documents are considered essential according to ICH-GCP?

<p>Signed original consent and investigator’s brochure. (D)</p> Signup and view all the answers

How do ICH-GCP guidelines primarily relate to US federal regulations?

<p>ICH-GCP is based on US federal regulations. (B)</p> Signup and view all the answers

Which of the following statements about monitoring responsibilities in clinical trials is accurate?

<p>FDA outlines specific monitoring requirements within guidelines. (A)</p> Signup and view all the answers

What does 'GCP' stand for in the context of clinical research?

<p>Good Clinical Practices (C)</p> Signup and view all the answers

Which of the following is NOT a required element in the IRB application protocol?

<p>Research assistants' qualifications (B)</p> Signup and view all the answers

Under what circumstances does IRB review become mandatory?

<p>When the research has the intent to publish (A)</p> Signup and view all the answers

Which of the following is considered a 'Human Subject' according to 45 CFR 46?

<p>A living individual from whom data is collected (A)</p> Signup and view all the answers

Which of the following elements is included in the mandatory Informed Consent Form?

<p>Confidentiality of the subject's information (B)</p> Signup and view all the answers

What type of information can be protected using a Certificate of Confidentiality?

<p>Substance abuse or illegal behaviors (C)</p> Signup and view all the answers

Which aspect is NOT part of the IRB review process?

<p>Setting the research budget (D)</p> Signup and view all the answers

What should an IRB application protocol begin with?

<p>Independent protocol document (B)</p> Signup and view all the answers

Which of the following is NOT a typical element of a research plan included in the protocol?

<p>Past research results (D)</p> Signup and view all the answers

What is the primary purpose of IRBs as related to clinical research?

<p>To ensure ethical and safety standards for human subjects (C)</p> Signup and view all the answers

Flashcards

IRB Role

IRBs review and approve research involving human subjects, ensuring compliance with regulations and ethical guidelines.

Informed Consent

Participants must understand research and freely choose to participate. Information needs to be clear.

Institutional Assurance

Institutions with federally funded research need to have an FWA to comply with OHRP regulations.

FDA vs. DHHS

FDA and DHHS have different regulations for research, differing in emergency drug use, informed consent, and record retention.

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ICH GCP

International standard for clinical research in pharmaceuticals, promoting consistency and data harmonization.

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Source Documents

Original records of data collection, such as chart notes or lab results.

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Adverse Event (AE)

Any noxious (harmful) or unintended response to a drug.

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Serious Adverse Event (SAE)

An AE causing death, life-threatening situation, hospitalization, serious disability.

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Data Monitoring Safety Board (DSMB)

Monitors clinical trial data for safety and efficacy, may recommend trial termination.

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Research Documents

Detailed documentation of all research protocols, including IRB correspondence, investigator’s brochures, subject consent forms, data, and lab certifications.

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Acute AE

Adverse events occurring within hours of drug administration.

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Subacute AE

Adverse events occurring within days of drug administration.

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Delayed AE

Adverse events occurring after weeks of drug administration.

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Chronic AE

Adverse events occurring months or years after drug administration.

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Reporting AEs

Reporting of AEs within 30 days of the last dose and reporting SAE immediately to the responsible parties.

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Annual Review

IRBs review/approve research protocols every year.

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Study Notes

Institutional Review Boards (IRBs)

  • IRBs review and approve research involving human subjects.
  • They ensure research complies with regulations and ethical guidelines.
  • An IRB may suspend or terminate approval if there are serious violations or problems.
  • IRBs must review and approve research at least annually.
  • Informed consent must be obtained from all research participants.
  • Participants must understand the research and freely choose to participate.
  • Information about the research should be clear, concise, and free of jargon.

Institutional Assurances

  • Institutions conducting federally funded research must have an “Assurance of Compliance” or Federal-Wide Assurance (FWA) with the Office for Human Research Protection (OHRP).
  • This agreement ensures compliance with federal regulations for research.
  • OHRP oversees Assurances for US institutions and international institutions receiving DHHS funds.

FDA and DHHS Regulations

  • The FDA and DHHS have different regulations for research.
  • FDA allows emergency use of drugs but DHHS does not.
  • There are differences in informed consent requirements.
  • There are differences in requirements for retaining research records.

International Conference on Harmonization (ICH) Good Clinical Practice (GCP)

  • ICH GCP sets international standards for clinical research in the pharmaceutical industry.
  • The guidelines promote global consistency and data harmonization.
  • ICH GCP builds on US regulations and includes additional informed consent elements.

Essential Documents

  • All research protocols must be documented, including IRB correspondence, investigator’s brochures, subject consent forms, data, and lab certifications.
  • Source documentation must be kept for all research procedures, this includes the first place recorded data is recorded.
  • Examples of source documents include: Chart notes, EKGs, laboratory test results, and medication records.

Adverse Event (AE) Reporting

  • An AE is any noxious or unintended response to a drug.
  • Types of AEs include:
  • Acute –within hours
  • Subacute - days after
  • Delayed - weeks after
  • Chronic - months or years after
  • If an AE occurs within 30 days of the last drug dose it must be reported.

Serious Adverse Event (SAE) Reporting

  • An SAE is any AE resulting in death, life-threatening events, hospitalization, congenital anomaly, or disability.
  • SAEs must be reported to the sponsor and FDA immediately.

Data Monitoring Safety Board (DSMB)

  • A DSMB monitors clinical trial data for safety and efficacy.
  • They can recommend early termination of a trial if safety concerns arise.

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Related Documents

Regulatory Aspects of Human Subjects Research Lecture 4 PDF

Description

This quiz covers the essential concepts related to Institutional Review Boards (IRBs), informed consent in research, and federal regulatory compliance. Understand the ethical guidelines and requirements for conducting research involving human subjects, including the role of the FDA and DHHS. Test your knowledge on crucial aspects of research ethics.

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