IEC: Independent Ethics Committee.

What does IEC stand for?

The International Electrotechnical Commission (IEC; in French: Commission électrotechnique internationale) is an international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as “electrotechnology”.

What is the difference between IEC and IRB?

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 IEC in research?

The Institutional Ethics Committee (IEC) of the Insititute was established on 21. st. October. 1994 in order to provide independent guidance, advice,and decision (in the form of. “approval/recommendation/disapproval”) on health research or other specific research.

What does or stand for in research?

OR stands for Operational Research, which is a way of using analytical methods to help make better decisions. Its methods can be used by almost all organisations, groups and individuals.

What is IEC in clinical trial?

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 IRB in clinical research?

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

What is GCP in research?

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.

What does IEC stand for good clinical practice?

Within GCP, studies must be reviewed and receive approval/ favourable opinion from an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) prior to enrollment of study subjects.

Who informs the investigator about record retention?

As the sponsor is knowledgeable about the status of its investigational product, it is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained.

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What is the appropriate definition of therapeutic misconception?

Therapeutic misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut the process of obtaining meaningful consent to clinical research participation.

What is the acronym for research?

AcronymDefinitionRESEARCHRapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital RegistryRESEARCHRenewable Energy Society for Education, Awareness, Research & Community Help (Pakistan)

Which abbreviations can be used in research report?

As a general rule, all non-standard abbreviations/acronyms should be written out in full on first use (in both the abstract and the paper itself) and followed by the abbreviated form in parentheses, as in ‘the American Psychological Association (APA)’. Latin abbreviations, such as ‘etc. ‘, ‘i.e.’, ‘e.g.’ and ‘cf.

What is abbreviation in research?

Abbreviations are shortened forms of words and phrases and are a common occurrence in research manuscripts as they can help make highly complex technical writing more concise and easier to read.

Why is the IRB so important in a research study?

This group review serves an important role in the protection of the rights and welfare of human research subjects. 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 types of research require 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).

Do you need IRB approval for independent research?

A majority of peer-reviewed journals and conferences now require documentation of IRB review prior to publication. … If you are not affiliated with an university or hospital IRB, you will need to use an independent institutional review board.

What is the composition of the IRB?

An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific.

What is IRB IEC composition?

Composition, Functions and Operations 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.

What is IRB in GCP?

INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) – ICH GCP.

Why is GCP important to clinical research?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

What is considered clinical research?

Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. … Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients.

What information should be provided to an IRB for review at the initiation of a study?

The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the Investigator Brochure (or drug label), any other relevant safety information, and an outline of the qualifications of the investigator.

Is GCP a regulation?

GCP standards contained in the ICH document are not regulatory requirements in the United States.

Is GCP a law?

Compliance with GCP is a legal obligation in Europe for all trials of investigational medicinal products. Comprising 13 core principles, GCP applies to all clinical investigations that can affect the safety and wellbeing of human participants, particularly Clinical Trials of Investigational Medicinal Products.

What is ICH research?

This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.

At which study visits can the site expect the sponsor to review?

At which study visits can the site expect the sponsor to review subjects’ signed informed consent forms? Periodic and termination site visits. The subject informed consent forms are reviewed at the periodic site visits and the termination site visit.

How long do you have to keep medical research records?

HIPAA Requirements: Any research that involved collecting identifiable health information is subject to HIPAA requirements. As a result records must be retained for a minimum of 6 years after each subject signed an authorization.

How long should research records be kept?

Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) and UVA regulations require that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan.

What is an example of the therapeutic misconception?

Box 1. Therapeutic misconception exists when individuals do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled in the trial may potentially benefit from the intervention under study or from other aspects of the clinical trial.

What is therapeutic misconception how can it hinder a person's interest in a research trial?

The therapeutic misconception is of concern because it may adversely affect understanding about the nature of the research and the likelihood that the experimental intervention will be beneficial for subjects. It thus might, but does not necessarily, compromise decision-making by patient-subjects.