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Centre of Inflammation and Metabolism (CIM)
 

CIM Ethical considerations

Many researchers within CIM have long-term experience in conducting experimental research with healthy and diseased people. Several researchers have long-term experience with animal research.

We will assure that all research within CIM will be of high ethical standard and that gender aspects shall not be ignored.

Approval and information
All human studies included in the CIM protocol are performed according to the Helsinki Declaration II and according to “the convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine.” We specifically declare that CIM research does not involve 1) research activity aimed at human cloning for reproductive purposes, 2) research activity intended to modify the genetic heritage of human beings, which could make such changes heritable, 3) research activity intended to create human embryos, or 4) research involving the use of human embryos or embryonic stem cells.

Approval by ethical committee systems
The investigators will report any biomedical research project to the relevant ethical committee. With the regard to CIM, a biomedical research project means a project that involves tests on human, adult individuals. Local and national ethical approval will be obtained before any research project can be carried out. The rules of the ethical committee systems assure the following:

Informed consent
A trial subject is an individual who participates in a biomedical research project, as either a
recipient of investigational medicinal products or treatments, or a participant in a control group. Informed consent will be obtained from all trial subjects. Informed consent means a decision in writing, dated and signed to take part in a biomedical research project, such decision being taken freely following satisfactory information about the nature, significance, implications and risk of the project and receipt of suitable documentation by a person capable of giving consent. The volunteer will also be fully informed about sponsors, planned commercialisation and potential commercialisation. Informed consent will be obtained in a peaceful atmosphere and the trial subject will at the same time be presented for the rooms in which the research experiment will be conducted. It will be made clear that possible commercialisation does not in any way impact on the trial subject’s rights, including the right to withdraw at any time. The trial subject is particularly informed that he/she has the rights to withdraw from a project at any time. This means that he/she may withdraw before a study is actually started, at any time during a study, and at any time following a project. If a trial subject decides to withdraw after the study has been completed, any biological material and data from such a person will be destroyed. Furthermore, the patients used as trial subjects in CIM can withdraw their informed consent without it having any influence on their access to health care of appropriate quality. Where data are to be shared with researchers from other countries, the persons whose data are collected will be asked to give specific consent. All personal data will be encoded and anonymised. Thus, the list of codes identifying each individual will be kept independently of description of personal data.

We ensure that all personal data will be handled with adequate security.

We assure that the right of the trial subject to physical and mental integrity and the right to privacy will always be respected.

Issues relating to human experimentation and
sampling of tissue

The research groups of CIM have long-term experience in conducting invasive experiments on human beings.

Muscle and adipose tissue biopsies
Muscle biopsies are obtained from vastus lateralis using local anaesthesia. Subjects may experience some discomfort when biopsies are collected, side effects may include tenderness lasting a few days and very seldom a local haematoma. Adipose tissue biopsies are obtained from subcutaneous abdomen using local anaesthesia. Thus, subjects do not experience any pain, but may develop a small haematoma.

Blood sampling
In some projects, catheters will be inserted into the arm vein, the femoral vein and maybe into the femoral, brachial, or radial artery. Such procedures will be conducted by medical doctors with long-term clinical experience. When catheters are placed in the femoral vein or artery, local anaesthesia is applied. The subjects will seldom experience a haematoma.

Acute exercise models
We apply exercise models such as the kicking exercise model or bicycling, which do not cause muscle damage.

Infusion of rhTNF and rhIL-6
Some studies include infusion of rhTNF and rhIL-6 into healthy volunteers. The plasma concentrations of TNF and IL-6 following infusion of rhTNF and rhIL-6 are so low that subjects cannot distinguish between whether they receive a cytokine or placebo (saline). Thus, based on approximately 100 infusions of rhIL-6 and 20 infusions with rhTNF, it is our experience that volunteers do not report any side effects (vomiting, fever, headache, or other).

Insulin clamp
Insulin infusion with concomitant infusion of glucose to obtain euglycemic conditions is applied in some protocols. This method has been used extensively by the researchers involved in the projects. Researchers are medical doctors with a long record of clinical medicine and in the conduction of invasive humane experiments.

Stable isotope tracer technique
We have long-term experience in the use of stable isotope techniques. The trial subject receives an infusion of a stable isotope and does not experience any adverse effects. The projects outlined in which stable isotope techniques will be applied have already been approved by the ethical committee system in Denmark. Any stable isotope procedure that we may apply does not in principle differ from related projects in which ethical approval has already been obtained.

Storage of biological human material
We handle storage of data and biopsy specimens by procedures that ensure patient data protection and confidentiality. We encode and provide anonymity for the banked biomaterial data using adequate security for storage and handling of material and data. Thus, the code list, which identifies individual trial subjects, is kept separately from subject material and data.

Issues relating to genetics and epidemiology
The researchers of CIM have long-term experience in handling large cohort studies. The projects have been approved or partially approved by the ethical committee systems in Denmark and Finland.

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