What is IEC in clinical research?
IRBs can also be called independent ethics committees (IECs). An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants.
What is difference between IRB and IEC?
What is the difference between an IRB and IEC? Clinical trials conducted in the European Union are held accountable by Independent Ethics Committees (IECs). In the United States, Institutional Review Boards (IRBs) have oversight and must abide by the United States Food and Drug Administration (FDA) regulations.
What is IRB IEC composition?
1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial.
Is IRB approval required for clinical trials?
VII. Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects.
What is the role of IRB in clinical trials?
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.
What is IEC in nursing?
Information, Education and Communication (IEC) is a public health system approach aiming at changing or reinforcing health-related behaviors in a target audience, concerning a specific problem and within a pre-defined period of time, through communication methods and principles.
What are the 4 important ethical issues IRB guidelines address?
IRB’S must be guided by principles outlined in Belmont Report:
- Respect for persons: respect for patient autonomy.
- Beneficence: maximize benefits and minimize harm.
- Justice: Equitable distribution of research burdens and benefits.
What requires IRB approval?
FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
What research does not require IRB approval?
Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
What are the primary responsibilities and priorities of the IRB?
The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.
What is the main objective of IEC?
The real goal of IEC is the advancement of knowledge and the dissemination of truth.
What is an IRB in clinical trials?
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup.
When should the IRB/IEC conduct continuing review of clinical trials?
3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.
What does IRB/IEC mean?
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) – ICH GCP 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 3.1. Responsibilities 3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.
What is the role of the IEC in clinical trials?
Role of Institutional Ethics Committee (IEC) in Clinical Trials. As per the WHO definition, a clinical trial is any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome.