| 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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