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IRB, IEC, Ethics

The document discusses the role of Institutional Review Boards (IRB) and Independent Ethics Committees (IEC) in ensuring ethical compliance and participant protection in clinical trials. It highlights historical ethical guidelines, core principles, and the responsibilities of IRBs/IECs, including informed consent and risk-benefit analysis. The importance of transparency, continuous oversight, and the challenges faced by IRBs/IECs in modern trials are also emphasized.

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0% found this document useful (0 votes)
10 views35 pages

IRB, IEC, Ethics

The document discusses the role of Institutional Review Boards (IRB) and Independent Ethics Committees (IEC) in ensuring ethical compliance and participant protection in clinical trials. It highlights historical ethical guidelines, core principles, and the responsibilities of IRBs/IECs, including informed consent and risk-benefit analysis. The importance of transparency, continuous oversight, and the challenges faced by IRBs/IECs in modern trials are also emphasized.

Uploaded by

Prince Patil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Role of Institutional Review

Board (IRB/IEC) & Ethics in


Clinical Trials
Clinical Research & Pharmacovigilance Dr. Sharad Chand
Assistant Professor
SoHST, Dr. Vishwanath Karad
MITWPU, Pune

CERTIFICATE COURSE IN CLINICAL RESEARCH AND PHARMACOVIGILANCE


Introduction
● Clinical trials are vital for drug development
and safety evaluation.
● IRB/IEC ensures ethical compliance and
participant protection.
● Ethics safeguard human rights in research.

What is an IRB/IEC?IRB:
● IEC: Independent Ethics Committee (Global
term).
● Institutional Review Board (US term).
● Purpose: Protect participant rights and
welfare.
Historical Background

● Nuremberg Code (1947): Established


informed consent principle. (Voluntary
Consent, Beneficial Research, Avoiding Harm,
No Death or Disabling Injury, Risk-Benefit
Analysis, Subject Welfare, Right to Withdraw,
Scientific Rigor)
● Declaration of Helsinki (1964): Ethical
principles for human research. (Following
Local Regulatory Norms, Protection of
Vulnerable Groups and Individuals, Focus on
Ethics, Protection of Privacy and
Confidentiality
● Belmont Report (1979): Respect,
beneficence, and justice. (do not harm
Core Ethical Principles
● Respect for
persons:
Protecting
autonomy and
ensuring informed
consent.
● Beneficence:
Minimizing harm
and maximizing
benefits.
● Justice: Fair
distribution of
benefits and risks.
Composition
IRB/IEC Responsibilities
IRB/IEC Review Process
Informed Consent
Participant Rights
Risk-Benefit Analysis
Adverse Event Reporting
Monitoring and Oversight
Regulatory Guidelines
Ethical Challenges in Research
Case Study: The Tuskegee Syphilis
Study
Case Study Findings
Lessons Learned

● Importance of transparency in trials.


● Necessity of informed consent.
● Continuous oversight by IRB/IEC.
Impact of IRB/IEC on Trial Integrity

● Ensuring scientific validity.


● Protecting human subjects.
● Enhancing public trust.
Challenges Faced by IRB/IEC

● Increasing complexity of trials.


● Balancing scientific goals with ethical
concerns.
● Managing large-scale multi-center trials.
Importance of IRB/IEC in Clinical
Trials
● Ensuring participant safety.
● Upholding scientific integrity.
● Promoting public trust in research.
Conclusion

● IRB/IEC ensures ethical compliance in clinical


trials.
● Protects participants’ rights and safety.
● Promotes ethical research practices.
References

● ICH-GCP guidelines
● FDA and EMA regulations
● Declaration of Helsinki
● Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov
M. Ethics Committees: Structure, Roles, and Issues. J
Korean Med Sci. 2023 May;38(25):e198.
● ChatGPT for Infographics.
MCQs

1. What is the primary purpose of an Institutional


Review Board (IRB) or Independent Ethics Committee
(IEC)?
A. To approve new drugs for market release.
B. To ensure ethical compliance and participant protection
in clinical trials.
C. To monitor financial aspects of clinical trials.
D. To develop new clinical trial protocols
MCQs

2. Which historical document first established the


principle of informed consent in research?
A) Declaration of Helsinki
B) Belmont Report
C) Nuremberg Code
D) ICH-GCP Guidelines
MCQs

3. What is the core ethical principle that ensures fairness


in the distribution of benefits and risks in clinical
trials?
A) Beneficence
B) Respect for persons
C) Justice
D) Autonomy
4. During the IRB/IEC review process, what is the
potential outcome after the initial review?
A) Immediate trial approval
B) Automatic rejection without modification
C) Approval, modification, or rejection of the protocol
D) Suspension of the entire trial process
5. Which regulation is an international standard for the
conduct of clinical trials?
A) FDA regulations
B) ICH-GCP guidelines
C) EMA regulations
D) CDSCO guidelines
6. What is a key responsibility of the IRB/IEC regarding
informed consent?
A) To oversee participant recruitment only
B) To ensure participants are forced to comply with the
protocol
C) To ensure proper disclosure of trial objectives, risks, and
benefits
D) To protect the financial interests of the sponsor
7. What was the major ethical violation in the Tuskegee
Syphilis Study?
A) Lack of proper monitoring
B) Lack of informed consent and deception of participants
C) Testing of unapproved medications
D) Lack of proper funding for the study
8. What action is required when an adverse event occurs
during a clinical trial?
A) Immediate reporting to IRB/IEC and regulatory
authorities
B) Termination of the trial without review
C) Keeping the information confidential
D) Informing only the sponsor
9. What is a key challenge faced by IRBs/IECs in
modern clinical trials?
A) Decreasing trial complexity
B) Managing large-scale multi-center trials
C) Reducing the need for participant consent
D) Simplifying regulatory guidelines
10. What is the primary lesson learned from historical
unethical trials like the Tuskegee Syphilis Study?
A) The necessity of skipping informed consent for faster
research
B) The importance of transparency and ethical oversight
C) The elimination of IRBs for efficiency
D) The importance of concealing trial risks from
participants

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