Medical research ethics committee Flashcards
Why do we need legislation?
- Protection of the participants of a study (safety, integrity and privacy)
- Quality of research (verifiability of actions, responsibilities and clear obligations, transparancy during the study and afterwards, quality of data)
For what kind of research does the WMO law apply? And for what kind of research does the non WMO law apply?
- WMO → interventional research
- non WMO → observational research
What type of research belongs within the WMO?
- If additional actions are performed
- If rules of conduct are imposed on the participants
- If more or different tests/procedures are performed than usual in standard care
- medical-scientific research in which standard treatments are compared via randomisation
What kind of responsibilities has the following person in research:
- sponsor
- investigator
- Sponsor → an individual, companby, institution, or organization which takes responsibility for the initiation, managment, and/or financing of a clinical trial.
- Investigator → a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principle investigator.
What kind of responsibilities has the sponsor-investigator?
- Sponsor-investigator → an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual. The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
Responsibilities or tasks. What may be delegated and what may not be delegated?
- A sponsor may delegate tasks to investigators, but not responsibilities.
- An investigator may delegate tasks to qualified personnel, but not responsibilities for performing the study and safety of participants.
- All delegated tasks must be written down in a protocol/contract and/or delegation list.
How is research with pharmaceuticals defined by the WMO law?
Pharmaceutical research intended to establish clinical, pharmacological or other pharmacodynamic effects of one or more pharmaceutials or investigate the resorption, distribution, metabolism and excretion of one or more pharmaceuticals for research, with the intention to establish the safety or efficacy of these pharmaceuticals.
What are additional good clinical practice (GCP) guidelines regarding research with pharmaceuticals?
- Scientific research with pharmaceuticals must be in accordance with the principles of good clinical practice (GCP) regarding the design, implementation and reporting.
- All research with unregistered and registered pharmaceuticals involving an intervention: GCP and WMO requirements for all participants (sponsors and investigators).
What is the The International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH-GCP)?
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
- There’s an uniform standard regarding the ICH-GCP for Japan, North America and the EU.
What is the definition of a medical device?
Any instrument, apparatus, appliance, material or software or other article, whether used alone
or in combination, including the software necessary for its proper functioning, and intended by
the manufacturer to be used in man for the following purposes:
- diagnosis, prevention, monitoring, treatment or alleviation of a disease
- diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process;
- Control of conception
- with its principal intended action in or on the human body not by pharmacological, immunological or metabolic means, but which may be assisted by such means.
What is the ISO14155 regarding clinical research with medical devices?
It is the GCP guideline for clincal research with medical devices. It is almost identical with ICH-GCP (minus some minor difference).
How is WMO research approved?
- Medical ethical review is compulsory for WMO research.
- WMO research must first be reviewed by an accredited medical research ethics committee (MREC) or the CCMO.
Note:
- there are also regulations for clinical trials with medical devices (Medical Device Regulation (MDR))
- there are also regulations for clinical trials with medicinal products (Clinical Trial Regulation (CTR))
Ok
Choose the words and complete the sentences.
- Words: Embryo’s Act, committee of experts, CCMO, WMO, subjects.
- Sentence 1: The … executes the … and the … Research that falls under the … or the … must be reviewed by an independent … Research is not allowed to start without a positive decision of this ….
- Sentence 2: The … protects … taking part in medical research by reviewing the research on the basis of the statutory provisions laid down for them and takinginto account the interest of medical progress.
- Sentence 1: The CCMO executes the WMO and the Embryo’s Act. Research that falls under the WMO or the Embryo’s Act must be reviewed by an independent committee of experts. Research is not allowed to start without a positive decision of this committee of experts.
- Sentence 2: The CCMO protects subjects taking part in medical research by reviewing the research on the basis of the statutory provisions laid down for them and takinginto account the interest of medical progress.
What is the purpose of the Medical Ethics Review Board (MERC)?
The MERC must guarantee the rights, safety and well-being of all subjects participating in clinical trials. Special attention should be paid to research involving vulnerable persons.
