ETHICAL GUIDELINES IN CLINICAL RESEARCH:
Ethical guidelines play a critical role in clinical research by providing a framework for ensuring the ethical conduct of studies and protecting the rights and welfare of participants. This article provides an overview of ethical guidelines in clinical research, including a general introduction, general ethical principles, twelve basic principles, ethics review board (ERB), and the composition/constitution of Institutional Review Boards (IRBs).
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TABLE OF CONTENTS:
- Introduction
- General Ethical Principles
- Twelve Basic Principles
- Ethics Review Board (ERB)
- Composition/Constitution of IRB
Introduction:
Ethical guidelines in clinical research serve as a compass to guide researchers, sponsors, and ethics review boards in conducting studies that are morally sound and prioritize participant welfare. These guidelines ensure that research is conducted with integrity, respect for human rights, and adherence to established ethical principles.
General Ethical Principles:
Ethical guidelines are built upon general ethical principles that provide a foundation for ethical conduct in clinical research. Some common general ethical principles include:
- Respect for Autonomy: Acknowledging the right of individuals to make informed decisions and participate voluntarily in research.
- Beneficence: Maximizing benefits and minimizing harm to participants.
- Justice: Ensuring fair distribution of research burdens and benefits.
- Non-maleficence: Avoiding harm and minimizing risks to participants.
- Respect for Privacy and Confidentiality: Safeguarding the privacy and confidentiality of participant information.
Twelve Basic Principles:
Ethical guidelines often include a set of twelve basic principles that encompass key ethical considerations in clinical research. These principles address aspects such as informed consent, participant selection, study design, confidentiality, conflict of interest, and publication ethics.
The twelve basic principles commonly covered in ethical guidelines are:
- Respect for Human Dignity
- Scientific Validity
- Social Value
- Fair Participant Selection
- Favorable Risk-Benefit Ratio
- Informed Consent
- Respect for Privacy and Confidentiality
- Special Protection for Vulnerable Groups
- Accountability
- Ethical Review
- Conflict of Interest
- Publication Ethics
Ethics Review Board (ERB):
Ethics Review Boards, also known as Institutional Review Boards (IRBs), play a crucial role in the ethical oversight of clinical research. These independent committees review research protocols to ensure that they comply with ethical guidelines and protect participant rights and welfare.
Composition/Constitution of IRB:
The composition of an IRB is essential to maintain its integrity and effectiveness. IRBs typically consist of multidisciplinary members, including researchers, clinicians, ethicists, legal experts, and representatives from the community. The diverse composition ensures that different perspectives are considered during the ethical review process.
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